AVAHO

New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.

In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.

This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.

Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.

'Intriguing Hypothesis'

Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.

About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.

To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.

Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.

Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.

During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).

When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).

“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.

Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.

“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.

During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).

Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.

Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).

Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”

Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.

In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.

Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”

This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.

A version of this article first appeared on Medscape.com.

New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.

In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.

This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.

Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.

'Intriguing Hypothesis'

Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.

About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.

To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.

Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.

Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.

During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).

When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).

“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.

Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.

“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.

During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).

Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.

Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).

Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”

Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.

In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.

Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”

This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.

A version of this article first appeared on Medscape.com.

New data suggest that glucagon-like peptide 1 (GLP-1) receptor agonists, used to treat diabetes and obesity, may also help guard against obesity-related cancers.

In a large observational study, new GLP-1 agonist users with obesity and diabetes had a significantly lower risk for 14 obesity-related cancers than similar individuals who received dipeptidyl peptidase-4 (DPP-4) inhibitors, which are weight-neutral.

This study provides a “reassuring safety signal” showing that GLP-1 drugs are linked to a modest drop in obesity-related cancer risk, and not a higher risk for these cancers, said lead investigator Lucas Mavromatis, medical student at NYU Grossman School of Medicine in New York City, during a press conference at American Society of Clinical Oncology (ASCO) 2025 annual meeting.

However, there were some nuances to the findings. The protective effect of GLP-1 agonists was only significant for colon and rectal cancers and for women, Mavromatis reported. And although GLP-1 users had an 8% lower risk of dying from any cause, the survival benefit was also only significant for women.

Still, the overall “message to patients is GLP-1 receptor treatments remain a strong option for patients with diabetes and obesity and may have an additional, small favorable benefit in cancer,” Mavromatis explained at the press briefing.

'Intriguing Hypothesis'

Obesity is linked to an increased risk of developing more than a dozen cancer types, including esophageal, colon, rectal, stomach, liver, gallbladder, pancreatic, kidney, postmenopausal breast, ovarian, endometrial and thyroid, as well as multiple myeloma and meningiomas.

About 12% of Americans have been prescribed a GLP-1 medication to treat diabetes and/or obesity. However, little is known about how these drugs affect cancer risk.

To investigate, Mavromatis and colleagues used the Optum healthcare database to identify 170,030 adults with obesity and type 2 diabetes from 43 health systems in the United States.

Between 2013 and 2023, half started a GLP-1 agonist and half started a DPP-4 inhibitor, with propensity score matching used to balance characteristics of the two cohorts.

Participants were a mean age of 56.8 years, with an average body mass index of 38.5; more than 70% were White individuals and more than 14% were Black individuals.

During a mean follow-up of 3.9 years, 2501 new obesity-related cancers were identified in the GLP-1 group and 2671 in the DPP-4 group — representing a 7% overall reduced risk for any obesity-related cancer in the GLP-1 group (hazard ratio [HR], 0.93).

When analyzing each of the 14 obesity-related cancers separately, the protective link between GLP-1 use and cancer was primarily driven by colon and rectal cancers. GLP-1 users had a 16% lower risk for colon cancer (HR, 0.84) and a 28% lower risk for rectal cancer (HR, 0.72).

“No other cancers had statistically significant associations with GLP-1 use,” Mavromatis told briefing attendees. But “importantly, no cancers had statistically significant adverse associations with GLP-1 use,” he added.

Experts have expressed some concern about a possible link between GLP-1 use and pancreatic cancer given that pancreatitis is a known side effect of GLP-1 use. However, “this is not borne out by epidemiological data,” Mavromatis said.

“Additionally, we were not able to specifically assess medullary thyroid cancer, which is on the warning label for several GLP-1 medications, but we did see a reassuring lack of association between GLP-1 use and thyroid cancer as a whole,” he added.

During follow-up, there were 2783 deaths in the GLP-1 group and 2961 deaths in the DPP-4 group — translating to an 8% lower risk for death due to any cause among GLP-1 users (HR, 0.92; P = .001).

Mavromatis and colleagues observed sex differences as well. Women taking a GLP-1 had an 8% lower risk for obesity-related cancers (HR, 0.92; P = .01) and a 20% lower risk for death from any cause (HR, 0.80; P < .001) compared with women taking a DPP-4 inhibitor.

Among men, researchers found no statistically significant difference between GLP-1 and DPP-4 use for obesity-related cancer risk (HR, 0.95; P = .29) or all-cause mortality (HR, 1.04; P = .34).

Overall, Mavromatis said, it’s important to note that the absolute risk reduction seen in the study is “small and the number of patients that would need to be given one of these medications to prevent an obesity-related cancer, based on our data, would be very large.”

Mavromatis also noted that the length of follow-up was short, and the study assessed primarily older and weaker GLP-1 agonists compared with newer agents on the market. Therefore, longer-term studies with newer GLP-1s are needed to confirm the effects seen as well as safety.

In a statement, ASCO President Robin Zon, MD, said this trial raises the “intriguing hypothesis” that the increasingly popular GLP-1 medications might offer some benefit in reducing the risk of developing cancer.

Zon said she sees many patients with obesity, and given the clear link between cancer and obesity, defining the clinical role of GLP-1 medications in cancer prevention is “important.”

This study “leads us in the direction” of a potential protective effect of GLP-1s on cancer, but “there are a lot of questions that are generated by this particular study, especially as we move forward and we think about prevention of cancers,” Zon told the briefing.

This study was funded by the National Institute of Diabetes and Digestive and Kidney Diseases of the National Institutes of Health. Mavromatis reported no relevant disclosures. Zon reported stock or ownership interests in Oncolytics Biotech, TG Therapeutics, Select Sector SPDR Health Care, AstraZeneca, CRISPR, McKesson, and Berkshire Hathaway.

A version of this article first appeared on Medscape.com.

TOPLINE: Next-generation sequencing (NGS) analysis of 5015 veterans with metastatic prostate cancer reveals distinct genomic patterns between non-Hispanic Black and White patients, with Black veterans showing higher odds of immunotherapy targets but lower odds of androgen receptor axis alterations. However, the rates of survival were similar despite the differences.

METHODOLOGY: 
Researchers conducted a retrospective cohort study comparing alteration frequencies between 1784 non-Hispanic Black (35.6%) and 3,231 non-Hispanic White (64.4%) veterans who underwent NGS testing from January 23, 2019, to November 2, 2023.

•      Analysis included DNA sequencing data from tissue or plasma biospecimens, including prostate biopsy specimens, radical prostatectomy specimens, and prostate cancer metastases, all sequenced with FoundationOne CDx or FoundationOne Liquid CDx platforms.
•      Investigators examined pathogenic alterations in individual genes, actionable targets, and canonical prostate cancer pathways, while adjusting for NGS analyte and clinicopathologic covariates.
•      Researchers evaluated associations between alteration frequency and race as well as survival through Cox proportional hazards modeling, stratified by race and adjusted for clinical factors.

TAKEAWAY:
Non-Hispanic Black race and ethnicity was associated with higher odds of genomic alterations in SPOP (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.2-2.6) and immunotherapy targets (OR, 1.7; 95% CI, 1.1-2.5), including high microsatellite instability status (OR, 3.1; 95% CI, 1.1-9.4).

•      Non-Hispanic Black veterans showed lower odds of genomic alterations in the AKT/PI3K pathway (OR, 0.6; 95% CI, 0.4-0.7), androgen receptor axis (OR, 0.7; 95% CI, 0.5-0.9), and tumor suppressor genes (OR, 0.7; 95% CI, 0.5-0.8).
•      Tumor suppressor alterations were associated with shorter overall survival in both non-Hispanic Black (hazard ratio [HR], 1.54; 95% CI, 1.13-2.11) and non-Hispanic White (HR, 1.52; 95% CI, 1.25-1.85) veterans.
•      CDK12 alterations significantly increased the hazard of death in non-Hispanic Black veterans (HR, 2.04; 95% CI, 1.13-3.67), while immunotherapy targets were associated with increased mortality in non-Hispanic White veterans (HR, 1.44; 95% CI, 1.02-2.02).

IN PRACTICE: " we did not identify any genomic alterations or biomarkers that should not be tested in PCa based on patient self-identified race. Ultimately, this work emphasizes that precision oncology enables the individualization of treatment decisions without having to rely on imprecise characteristics such as self-identified race.," wrote the study authors.

SOURCE: Isla P. Garraway, MD, PhD; Kosj Yamoah, MD, PhD; and Kara N. Maxwell, MD, PhD were co-senior authors. The article was published online on May 12 in JAMA Network Open.

LIMITATIONS: According to the authors, a lack of matched germline data for patients, complicated the interpretation of plasma results. In addition, survivorship bias may have inadvertently excluded the most aggressive metastatic prostate cancer phenotypes, as patients who did not live long enough to undergo NGS testing were not included. Results seen in the veteran population served by the Veterans Health Administration may not be generalizable to the broader population.

DISCLOSURES: The study received support from Challenge Award PCF22CHALO2 from the Prostate Cancer Foundation and the Veterans Affairs National Precision Oncology Program. Luca F. Valle, MD, reported receiving grant support from the Bristol Myers Squibb Foundation during the conduct of the study. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Next-generation sequencing (NGS) analysis of 5015 veterans with metastatic prostate cancer reveals distinct genomic patterns between non-Hispanic Black and White patients, with Black veterans showing higher odds of immunotherapy targets but lower odds of androgen receptor axis alterations. However, the rates of survival were similar despite the differences.

METHODOLOGY: 
Researchers conducted a retrospective cohort study comparing alteration frequencies between 1784 non-Hispanic Black (35.6%) and 3,231 non-Hispanic White (64.4%) veterans who underwent NGS testing from January 23, 2019, to November 2, 2023.

•      Analysis included DNA sequencing data from tissue or plasma biospecimens, including prostate biopsy specimens, radical prostatectomy specimens, and prostate cancer metastases, all sequenced with FoundationOne CDx or FoundationOne Liquid CDx platforms.
•      Investigators examined pathogenic alterations in individual genes, actionable targets, and canonical prostate cancer pathways, while adjusting for NGS analyte and clinicopathologic covariates.
•      Researchers evaluated associations between alteration frequency and race as well as survival through Cox proportional hazards modeling, stratified by race and adjusted for clinical factors.

TAKEAWAY:
Non-Hispanic Black race and ethnicity was associated with higher odds of genomic alterations in SPOP (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.2-2.6) and immunotherapy targets (OR, 1.7; 95% CI, 1.1-2.5), including high microsatellite instability status (OR, 3.1; 95% CI, 1.1-9.4).

•      Non-Hispanic Black veterans showed lower odds of genomic alterations in the AKT/PI3K pathway (OR, 0.6; 95% CI, 0.4-0.7), androgen receptor axis (OR, 0.7; 95% CI, 0.5-0.9), and tumor suppressor genes (OR, 0.7; 95% CI, 0.5-0.8).
•      Tumor suppressor alterations were associated with shorter overall survival in both non-Hispanic Black (hazard ratio [HR], 1.54; 95% CI, 1.13-2.11) and non-Hispanic White (HR, 1.52; 95% CI, 1.25-1.85) veterans.
•      CDK12 alterations significantly increased the hazard of death in non-Hispanic Black veterans (HR, 2.04; 95% CI, 1.13-3.67), while immunotherapy targets were associated with increased mortality in non-Hispanic White veterans (HR, 1.44; 95% CI, 1.02-2.02).

IN PRACTICE: " we did not identify any genomic alterations or biomarkers that should not be tested in PCa based on patient self-identified race. Ultimately, this work emphasizes that precision oncology enables the individualization of treatment decisions without having to rely on imprecise characteristics such as self-identified race.," wrote the study authors.

SOURCE: Isla P. Garraway, MD, PhD; Kosj Yamoah, MD, PhD; and Kara N. Maxwell, MD, PhD were co-senior authors. The article was published online on May 12 in JAMA Network Open.

LIMITATIONS: According to the authors, a lack of matched germline data for patients, complicated the interpretation of plasma results. In addition, survivorship bias may have inadvertently excluded the most aggressive metastatic prostate cancer phenotypes, as patients who did not live long enough to undergo NGS testing were not included. Results seen in the veteran population served by the Veterans Health Administration may not be generalizable to the broader population.

DISCLOSURES: The study received support from Challenge Award PCF22CHALO2 from the Prostate Cancer Foundation and the Veterans Affairs National Precision Oncology Program. Luca F. Valle, MD, reported receiving grant support from the Bristol Myers Squibb Foundation during the conduct of the study. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

TOPLINE: Next-generation sequencing (NGS) analysis of 5015 veterans with metastatic prostate cancer reveals distinct genomic patterns between non-Hispanic Black and White patients, with Black veterans showing higher odds of immunotherapy targets but lower odds of androgen receptor axis alterations. However, the rates of survival were similar despite the differences.

METHODOLOGY: 
Researchers conducted a retrospective cohort study comparing alteration frequencies between 1784 non-Hispanic Black (35.6%) and 3,231 non-Hispanic White (64.4%) veterans who underwent NGS testing from January 23, 2019, to November 2, 2023.

•      Analysis included DNA sequencing data from tissue or plasma biospecimens, including prostate biopsy specimens, radical prostatectomy specimens, and prostate cancer metastases, all sequenced with FoundationOne CDx or FoundationOne Liquid CDx platforms.
•      Investigators examined pathogenic alterations in individual genes, actionable targets, and canonical prostate cancer pathways, while adjusting for NGS analyte and clinicopathologic covariates.
•      Researchers evaluated associations between alteration frequency and race as well as survival through Cox proportional hazards modeling, stratified by race and adjusted for clinical factors.

TAKEAWAY:
Non-Hispanic Black race and ethnicity was associated with higher odds of genomic alterations in SPOP (odds ratio [OR], 1.7; 95% confidence interval [CI], 1.2-2.6) and immunotherapy targets (OR, 1.7; 95% CI, 1.1-2.5), including high microsatellite instability status (OR, 3.1; 95% CI, 1.1-9.4).

•      Non-Hispanic Black veterans showed lower odds of genomic alterations in the AKT/PI3K pathway (OR, 0.6; 95% CI, 0.4-0.7), androgen receptor axis (OR, 0.7; 95% CI, 0.5-0.9), and tumor suppressor genes (OR, 0.7; 95% CI, 0.5-0.8).
•      Tumor suppressor alterations were associated with shorter overall survival in both non-Hispanic Black (hazard ratio [HR], 1.54; 95% CI, 1.13-2.11) and non-Hispanic White (HR, 1.52; 95% CI, 1.25-1.85) veterans.
•      CDK12 alterations significantly increased the hazard of death in non-Hispanic Black veterans (HR, 2.04; 95% CI, 1.13-3.67), while immunotherapy targets were associated with increased mortality in non-Hispanic White veterans (HR, 1.44; 95% CI, 1.02-2.02).

IN PRACTICE: " we did not identify any genomic alterations or biomarkers that should not be tested in PCa based on patient self-identified race. Ultimately, this work emphasizes that precision oncology enables the individualization of treatment decisions without having to rely on imprecise characteristics such as self-identified race.," wrote the study authors.

SOURCE: Isla P. Garraway, MD, PhD; Kosj Yamoah, MD, PhD; and Kara N. Maxwell, MD, PhD were co-senior authors. The article was published online on May 12 in JAMA Network Open.

LIMITATIONS: According to the authors, a lack of matched germline data for patients, complicated the interpretation of plasma results. In addition, survivorship bias may have inadvertently excluded the most aggressive metastatic prostate cancer phenotypes, as patients who did not live long enough to undergo NGS testing were not included. Results seen in the veteran population served by the Veterans Health Administration may not be generalizable to the broader population.

DISCLOSURES: The study received support from Challenge Award PCF22CHALO2 from the Prostate Cancer Foundation and the Veterans Affairs National Precision Oncology Program. Luca F. Valle, MD, reported receiving grant support from the Bristol Myers Squibb Foundation during the conduct of the study. Additional disclosures are noted in the original article.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication.

There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.

Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.

“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.

“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.

“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.

 

Hidden Dangers

Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.

However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress. 

“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.

Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.

“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.

Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.

 

About Eucalyptol

Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.

For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.

Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.

However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.

“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.

Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.

“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.

 

Open Dialogue

Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.

“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.

“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.

Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.

“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.

“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.

Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.

Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.

“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.

“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.

“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.

 

Hidden Dangers

Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.

However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress. 

“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.

Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.

“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.

Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.

 

About Eucalyptol

Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.

For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.

Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.

However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.

“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.

Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.

“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.

 

Open Dialogue

Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.

“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.

“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.

Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.

“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.

“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.

Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

There’s been renewed interest in recent years for concentrated essential oils to replace or complement pharmaceutical treatments. This is especially concerning among patients with chronic obstructive pulmonary disease (COPD), who might be eager to turn to alternatives but are unaware that COPD increases sensitivity to lung irritants like essential oils.

Eucalyptus oil might be at or near the top of the essential oils list for these patients, given its storied history in both ancient and modern medicine for treating colds and respiratory illnesses. Its inclusion in the United States and European pharmacopoeias has also reinforced its legitimacy. And, today, patients are at risk of confusing the primary active ingredient in eucalyptus — the monoterpene 1,8-cineole (eucalyptol, which has been shown to reduce COPD exacerbations when used adjunctively) — with concentrated essential oils that can be purchased online and in stores here in the United States.

“The more potent active ingredient, eucalyptol (in capsule form), is approved in Germany — not the essential oil of eucalyptus, which contains other compounds. I recommend against using any sort of inhaled essential oils for patients with chronic respiratory illnesses, mainly because they are unregulated and unstandardized,” explained Ni-Chen Liang, MD, an integrative pulmonologist affiliated with Scripps Memorial Hospital Encinitas in Encinitas, California.

“The substances that come out when you create eucalyptus oil are a ‘gamash’ of all sorts of chemicals — some benign, some which taste good, and some that may be irritating or even dangerous,” said Neil Schachter, MD, pulmonologist and professor of medicine (pulmonary, critical care, and sleep medicine) at the Icahn School of Medicine at Mount Sinai, New York City.

“They can also produce volatile organic compounds (VOCs) related to their formulas, which contain fillers and other constituents,” Liang said.

 

Hidden Dangers

Eucalyptus oil was first used by Aboriginal Australians, who crushed the leaves for their antiseptic properties or steamed them for their expectorant activity. Today, eucalyptus oil can be found in mouthwash and soap, used topically to relieve pain or repel insects, or added to cleaning products due to its disinfectant properties.

However, inhalation via diffusers or directly from the bottle can trigger different respiratory reactions, including cough, wheezing, shortness of breath, as well as respiratory distress. 

“The vapors contain oil, ie, fatty products that can be irritating in and of themselves,” said Schachter. “There are cases where people have inhaled these oils and developed lipid pneumonia, which is very hard to treat,” he said.

Anything inhaled into the lungs is a risk, said Juan Rojas, MD, assistant professor, Department of Internal Medicine, Division of Pulmonary, Critical Care, and Sleep Medicine at Rush University Medical Center in Chicago. Rojas compared inhaling essential oils to e-cigarettes, which, in addition to tobacco, contain a variety of chemicals and additives that cause a lung reaction in the short term and create inflammatory patterns in the medium and long term.

“Another problem is that when ingested, eucalyptus oil can be distressing to the gastrointestinal tract. In larger doses, it can actually have some neurological impact as well, including seizures,” said Kalilah L. Gates, MD, associate professor of medicine (pulmonary and critical care) and assistant dean of medical education at Northwestern Feinberg School of Medicine in Chicago.

Clinical trial data have also shown a significant association between long-term exposure to essential oils and cardiopulmonary effects such as increased heart rate and blood pressure and a decline in percentage predicted peak expiratory flow rate in healthy volunteers. In the study of 200 participants (who were homemakers), long-term exposure referred to daily hours (> 4/d) and the study period, which was 10 years.

 

About Eucalyptol

Eucalyptol is rapidly absorbed and quickly distributed throughout the bloodstream, which allows it to reach the bronchial system, where it is expelled by the lungs. It’s been shown in various preclinical studies to have anti-inflammatory, antioxidant, mucolytic, and bronchodilatory activity, as well as antimicrobial effects.

For the past decade, enteric-coated eucalyptol capsules containing 100 mg or 200 mg of 1,8-cineole have been available in Germany for adjunctive treatment of inflammatory respiratory disorders, including asthma and COPD. Due to its limited bioactivity, frequent administration is required.

Clinical evidence of eucalyptol’s effectiveness is somewhat limited. Findings from a 2009 double-blind, placebo-controlled, multicenter study also demonstrated that when used along with beta-agonists, anticholinergics, corticosteroids, or combinations in patients with stable COPD, severity and duration of exacerbations over 6 months were significantly decreased compared with placebo.

However, Liang was quick to point out that studies of oral eucalyptol preparations in pulmonary patients have not been robust enough.

“I haven’t been able to find anything written by a multitude of different authors, which, to me, is a red flag. We want naturally occurring substances to be well tested in multicenter studies across a variety of different patient populations outside of Germany to ensure that results are reproducible,” she said.

Rojas concurred. “Even with the data in Europe, I would say that the studies have been underpowered to support large-scale adoption or suggest that the active ingredient for patients with moderate or severe COPD could be considered an adjunctive therapy with traditional medications,” he said.

“It would be difficult for me to make a recommendation without knowing the full impact,” said Rojas.

 

Open Dialogue

Like many chronic diseases, it’s important to meet patients where they are, including their use of unapproved or unwise treatment strategies.

“More times than not, they’ve already figured out their triggers for worsening respiratory symptoms, what does and doesn’t work for them, and what predicts a good vs a bad day from a respiratory standpoint,” said Liang.

“There’s a lot of popularity and claims related to essential oil use, and ultimately, we need to partner to find healing modalities (which may or may not include essential oils) that are ultimately helpful and minimize harm,” she said.

Gates suggested that when it comes to eucalyptus essential oil vs eucalyptol, education of both patients and doctors is key.

“The issue is that we had a study showing that a particular component — the active ingredient of eucalyptus oil was isolated and put into the capsule form and showed benefit. And then we extrapolated and said, ‘well, let’s just take (or inhale) eucalyptus oil. It’s not the same thing,” she said.

“I feel that it’s my responsibility to make sure that patients have the information they need to make informed decisions. It’s about being willing to communicate and have open conversations about what they may be taking in addition to medications that I prescribe,” said Gates.

Liang, Schachter, Rojas, and Gates reported no relevant financial relationships.

A version of this article first appeared on Medscape.com.

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

A version of this article first appeared on Medscape.com.

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

A version of this article first appeared on Medscape.com.

As Hurricane Helene approached western North Carolina, Martin Palmeri, MD, MBA, didn’t anticipate the storm would disrupt practice operations for more than a day or so.

But the massive rainfall and flooding damage last September proved to be far more challenging. Despite best efforts by the 13-physician practice, basic treatments for most patients were interrupted for about a week.

Flooding washed out some of the major roads leading to the main Asheville clinic and affiliated rural sites, limiting travel and slowing delivery of medications, intravenous (IV) fluids, and other supplies, Palmeri said. Some patients and employees weren’t initially reachable due to the loss of the internet and cell phone service. The storm-related fallout even forced patients to relocate elsewhere for weeks or longer.

During the storm, backup generators kept power on at the Asheville clinic, protecting chemotherapy and other refrigerated drugs, but the storm damaged the municipal water supply.

“Water was the number one thing — how do you get water to the office?” Palmeri said. “You can’t give someone an 8-hour infusion if they don’t have means of going to the toilet or having something to drink.”

Hurricanes. Wildfires. Heat waves. As climate-driven extreme weather has become more common, researchers, oncologists, and patients are increasingly being forced to consider the consequences of these disruptions.

Along with preventing patients and providers from reaching treatment sites, experts said, extreme weather can undercut patients’ health and care in other ways. Patients with more limited lung capacity following lung cancer surgery, for instance, may struggle with breathing during wildfires. Extreme heat can prove risky for patients already dehydrated or weakened by treatment-related side effects. Power outages and severe flooding can affect vital infrastructure, disrupting operations at facilities that manufacture essential drugs. Power outages can also impede radiotherapy, which requires machines powered by electricity.

“Any of these [weather] events can disrupt this critical cancer care continuum among a population of people that already are very vulnerable,” said Joan Casey, PhD, an environmental epidemiologist and associate professor at the University of Washington in Seattle.

 

Extreme Weather and Cancer Survival

For patients with cancer, survival often relies on highly regimented protocols, which may require surgery plus frequent visits for radiation, chemotherapy, or immunotherapy that can last months, said Eric Bernicker, MD, a Colorado oncologist and lead author of a 2023 American Society of Clinical Oncology position statement about the impact of climate change on cancer care.

Interruptions to care, regardless of the cause, can lead to worse outcomes for patients, Bernicker said. “If you’re in the middle of your post-lumpectomy radiation and your radiation center shuts for 2 weeks,” he said, “that is not good.”

Research indicated that even short treatment disruptions can affect outcomes for patients with cancer and that delays caused by extreme weather — which may last for weeks — can affect survival for these patients.

One analysis, published in JAMA Oncology in 2023, found that patients exposed to wildfire within the first year after potentially curative lung cancer surgery had worse survival outcomes than those who weren’t exposed during their recovery.

In another study, patients with lung cancer who had their radiation interrupted when a hurricane struck had a 19% greater risk of dying overall compared with similar patients who were not affected. Another analysis found that patients with breast cancer who were partway through treatment when Hurricane Katrina hit the Louisiana coastline had a significantly greater risk of dying over a 10-year period compared with patients who lived elsewhere.

The potential threats to survival highlighted the impacts of extreme weather on carefully orchestrated systems of care that place patients facing already fragile situations in impossible binds, Casey said.

Douglas Flora, MD, a Kentucky oncologist and president-elect of the Association of Cancer Care Centers, Rockville, Maryland, agreed.

“We’ve seen this with an increasing frequency over the last several years,” Flora said. “It’s one thing if it’s routine follow-up or surveillance care, but many cancer patients’ survivals are directly related to not having interruptions in their care.”

 

Challenging Realities

Following Helene, the most pressing issue was the lack of water, Palmeri said.

The lack of reliable clean water created challenges for patients receiving radiation or chemotherapy infusions, which can cause vomiting and diarrhea that leave patients dehydrated. Toilets were also unusable.

Even when the city of Asheville said the water was likely safe enough to bathe in, local leaders still reported potential risks from bacteria and other contaminants in the water, Palmeri said. Those with a fragile immune system or breaks in the skin “could get serious and life-threatening infections,” he explained.

To make matters worse, damage to a North Carolina facility manufacturing IV fluids left the United States in shortage for months. IV fluids are key not only for providing hydration but also for easing nausea, fatigue, and other issues caused by cancer therapies.

With wildfires, as occurred in southern California early this year, patients undergoing cancer treatment might feel they have no option but to remain near home to continue getting care, Casey said. “It’s restricting their agency in the kinds of choices that they have to make during these severe weather events.”

Meanwhile, thick wildfire smoke can confine patients to their homes, said Lawrence Wagman, MD, a surgical oncologist and a regional medical director at the City of Hope network, who described its main facility in Duarte, California, coming within a dozen miles of the Eaton fire. “One of the biggest problems was so much smoke in the air,” he said. “And the air quality was so low that it was, in many ways, dangerous for patients to travel.”

“These fires were so aggressive, and they kept popping up,” Wagman said. Plus, the emotional strain of looming wildfires persisted for both patients and cancer clinicians for weeks on end, he added.

For those who evacuate, the logistics can be complex.

Not only are cancer treatment plans highly structured, but switching care to another facility is far from easy, Bernicker said. The new facility will likely need to submit a treatment plan and get insurance coverage before moving forward.

“I’m not saying that takes forever,” he said. “But what I’m saying is that it’s not like you just roll in and they hang the [infusion] bag.”

Neither is a shelter typically an option for patients during treatment, said Seth Berkowitz, a licensed clinical social worker and director of Strategic Healthcare Partnerships at The Leukemia & Lymphoma Society. “They have to have a place to go that’s safe and germ-free.”

In western North Carolina, the strain on already ill patients and their caregivers could be overwhelming, Palmeri said. He recounted how the husband of one patient with advanced cancer died after the storm came through.

“He tried to go out there with a chainsaw to clear a way out so that they could get out of their house in case he needed to take her to the hospital,” Palmeri said. “And he had a heart attack there in the driveway.”

 

Rebuilding and Planning Ahead

Experts are only at the early stages of grasping the magnitude of extreme weather on cancer care and developing strategies to curtail care gaps and potential harm to patients, said Katie Lichter, MD, a radiation oncologist at the University of California San Francisco, who studies extreme weather and cancer treatment.

“How does it impact health care delivery services at every step, from prevention to screening to treatment and survivorship?” Lichter asked. “We’re just starting to understand and to even quantify that,” she said, which included identifying patients who are most vulnerable. She worries, in particular, about patients living in rural areas who already travel longer distances and often face more difficulties accessing care.

The gap between research and reality still looms large. A recent analysis, led by Lichter, looked at 176 California radiation oncology clinics and found that all of them were located within 25 miles of a wildfire that had occurred within the prior 5 years. Yet among the 51 clinics that responded to a 2022 survey,just 47% reported that their clinic had a wildfire emergency preparedness plan.

The American Cancer Society does provide some guidance on how patients can prepare for a weather-related crisis, including having extra supplies of medications or special equipment on hand.

Still, providers are often in reaction mode when extreme weather strikes.

Without adequate clean water after Helene, leaders at Palmeri’s practice moved swiftly, purchasing 40,000-50,000 bottles of water and bringing in porta potties from elsewhere. 

“I think we were able to get things up and going very quickly,” said Palmeri, who noted that full services resumed about 10 days after the storm. “For most patients, missing a week of treatment would not do a disservice to their well-being or outcome.”

Going forward, to provide a more comprehensive strategy, Lichter is working with colleagues to develop clinical tool kits to help oncology practices and patients prepare for severe weather events, such as outlining backup treatment contingency plans, ensuring early medication refills, and boosting communication with patient alert systems.

Clinicians are also implementing their own strategies. To limit communication gaps during power outages, Palmeri said that, since Helene, his practice has made sure that their clinic sites, physicians, and other key people now have cell phone service through satellite via Starlink.

“No one has phone books anymore,” he said, so cancer clinicians should keep crucial contact information on paper, such as details about businesses that distribute water and porta potties, given that online searches may not be feasible.

Clinicians should also advise patients to keep a hard copy of recent medical findings handy, including medications and lab results, in case they arrive at an emergency room far from home and physicians can’t access their electronic health record, Bernicker said.

When there is enough advance warning of an approaching weather event, clinicians can help patients keep at least a week’s worth of medication on hand for symptom-related issues, such as nausea or pain, as well as antibiotics so patients don’t have to seek out emergency care during the crisis, Bernicker said. However, Bernicker noted, some insurers may be reluctant to fill certain prescriptions in advance, like those for opioids.

Making headway on more robust preparedness strategies may be slowed. As of March, the National Institutes of Health will no longer fund research about the health effects of climate change.

Bernicker hoped that such cutbacks would be rolled back. What’s on the line, he stressed, is maintaining the highest quality of care for patients with cancer.

“We really are in a golden age of oncology therapeutics,” he said. “We have patients living longer than anyone would have predicted 20 or 25 years ago. But all those advances are contingent on people having access to their centers and not having that interrupted.”

A version of this article first appeared on Medscape.com.

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

Rates of certain cancers in the United States — including breast, colorectal, and thyroid cancers — increased between 2010 and 2019 among patients aged less than 50 years, while overall cancer incidence and mortality rates did not increase, a new study found. 

Among the more than two million cases of early-onset cancer diagnosed during this period, 63.2% were in women, researchers reported recently in Cancer Discovery.

Breast cancer, thyroid cancer, and melanoma were the most common early-onset cancers in women. Among men, the most common were colorectal cancer, testicular cancer, and melanoma. 

Researchers from the National Cancer Institute analyzed cancer incidence data from the United States Cancer Statistics database for 2010-2019 and national death certificate data from the National Center for Health Statistics from 2010 to 2022. The team excluded incidence data from 2020 and 2021, which was artificially low due to COVID.

The researchers divided the data according to age groups: The early-onset age groups were 15-29, 30-39, and 40-49 years, and the late-onset groups were 50-59, 60-69, and 70-79 years. The team also estimated the expected number of early-onset cases in 2019 by multiplying 2010 age-specific cancer incidence rates by population counts for 2019. 

First author Meredith Shiels, of the National Cancer Institute, and colleagues found that the largest absolute increase in incidence of early-onset cancers, compared with expected incidence, were for breast (n = 4834 additional cancers), colorectal (n = 2099), kidney (n = 1793), and uterine cancers (n = 1209). These diagnoses accounted for 80% of the additional cancer diagnoses in 2019 vs 2010.

Looking at increases by age group, Shiels and colleagues reported that 1.9% of all cancers occurred in overall early-onset cohort 15- to 49-year-olds (age-standardized incidence rate of 39.8 per 100,000), and the incidence was greater in the older cohorts: 3.6% for 30- to 39-year-olds (123.5 per 100,000) and 8.8% for 40- to 49-year-olds (293.9 per 100,000).

Overall, 14 of 33 cancer types significantly increased in incidence in at least one early-onset age group. Among these 14 cancer types, five — melanoma, plasma cell neoplasms, cervical cancer, stomach cancer, and cancer of the bones and joints — showed increases only in early-onset age groups, not in late-onset age groups. For example, between 2010 and 2019, cervical cancer rates increased by 1.39% per year among 30- to 39-year-olds, melanoma rates increased by 0.82% per year among 40- to 49-year-olds, and stomach cancer rates increased by 1.38% per year. 

The remaining nine cancer types increased in at least one early-onset and one late-onset group. These included female breast, colorectal, kidney, testicular, uterine, pancreatic cancers as well as precursor B-cell non-Hodgkin lymphoma, diffuse large B-cell lymphoma, and mycosis fungoides/Sézary syndrome.

For four of the 14 cancer types with increasing incidence rates — testicular cancer, uterine cancer, colorectal cancer, and cancer of the bones and joints — mortality also increased in at least one early-onset age group, whereas the remaining 10 cancer types increased in incidence without an increase in mortality for any age group.

Shiels and her colleagues aren’t the first to address the rising incidence of early-onset cancers. In a keynote lecture at the European Society of Medical Oncology (ESMO) 2024 Annual Meeting, Irit Ben-Aharon, MD, PhD, from the Rambam Health Care Campus in Haifa, Israel, noted that from 1990-2019, the global incidence of early-onset cancer increased by 79%.

Although the current study doesn’t identify drivers of rising cancer rates in younger patients, “descriptive data like these provide a critical starting point for understanding the drivers of rising rates of cancer in early-onset age groups and could translate to effective cancer prevention and early detection efforts,” Shiels said in a press release. For instance, “recent guidelines have lowered the age of initiation for breast and colorectal cancer screening based, at least partially, on observations that rates for these cancers are increasing at younger ages.”

This study is “a great step forward” toward understanding the increasing incidence of early-onset cancers, agreed Shuji Ogino, MD, PhD, from Harvard Medical School and Brigham and Women’s Hospital in Boston, who wasn’t involved in the research.

The investigators provide new details, particularly by breaking down the early- and late-onset age groups into subcategories and by comparing incidence and mortality rates, Ogino noted.

“Mortality is a great endpoint because if the increased in early incidence is just an effect of [increased] screening we won’t see a mortality increase,” Ogino said. But “we need more data and some way to tease out the screening effect.” Plus, he added, “we need more mechanistic studies and tissue-based analyses to determine if early-onset cancers that are increasing in incidence are a different beast, rather than just an earlier beast.”

This study was funded by the Intramural Research Program of the National Cancer Institute of the National Institutes of Health and the Institute of Cancer Research. Shiels declared no conflicts of interest.

version of this article first appeared on Medscape.com.

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

US Department of Veterans Affairs (VA) Secretary Doug Collins testified in US House of Representatives and US Senate committees hearings that bringing staff numbers down to fiscal year 2019 figures was simply a goal: “Our goal, as we look at it, as everything goes forward, is a 15% decrease,” he told the senators. “It’s a goal. You have to start somewhere.”

“It’s a process we’re going through and I’m not going to work out a process in front of a committee or anywhere else,” Collins testified in the Senate on May 6, adding that it would be “incompetence” or “malpractice” to do so before time. “[When] we’re doing something as large as we are in an organization as sensitive on this Hill, it would not be right for us to do that in public. It would not be right for us to just come out and say here’s everything that we got and then have everybody scared because in the end it may not be the final decision.”

“We’re going to come to the best possible decision we can for the veterans in this country so they can have a VA system that actually works,” Collins argued in the Senate. “The VA’s been an issue for a long time. We’re trying to not make it an issue anymore.”

Collins later told a House committee on May 15 that VA was conducting a thorough review of department structure and staffing across the enterpise. "Our goal is to increase productivity and efficiency and to eliminate waste and bureaucracy improving health care delivery and benefits to our veterans. We are going to maintain VA essential jobs like doctors and nurses and claims processors" but eliminate positions it deemed "nonmission-critical" and consolidating areas of "overlap and waste."

Senate ranking member Richard Blumenthal (D-CT) and Chairman Jerry Moran (R-KS) both placed an emphasis on accountability for responsible resizing at the hearing. 

“The department is at a critical juncture,” Moran said. “Perhaps that’s always true, and I want to hear from you that the changes under way at the VA are backed by data, informed by veteran demand, focused on improving outcomes for men and women the VA serves, and will be carried out in close coordination with this committee, as well as with veterans, VA staff, and veteran organizations.” Moran stressed that cutting should be about right-sizing, done carefully, and while treating people “with gratitude and respect.”

Blumenthal was more direct in his criticism of the approach: “You cannot slash and trash the VA without eliminating those essential positions which provide access and availability of health care. It simply cannot be done,” he told Collins.

In response, Collins replied, “You have stated on several occasions already that I am saying we are going to fire 83,000 employees. That is wrong.” Collins insisted that the VA was “looking at a goal of how many employees we have and how many employees that are actually working in the front line taking care. I have doctors and nurses right now that do not see patients. Is that helping veteran health care?”

Collins defended the actions of the VA and spoke about challenges he was “constantly fighting” in the early weeks of his tenure. “We’ve been hit by a barrage of false rumors, innuendo, disinformation, speculation implying firing doctors and nurses, and forcing staff to work in closets and showers and that there’s chaos in the department, none of which have been backed up. Why? Because we canceled some contracts that worked for the VA that we should be doing in-house and we let go of less than one half of one percent of nonmission critical employees.”

The Trump Administration offered federal employees the option of resigning, which purportedly will go toward meeting the 15% target. NPR reported that VA employees have since shared data showing that 11,273 agency employees nationwide have applied for deferred resignation. Most of those employees are nurses (about 1300), medical support assistants (about 800), and social workers (about 300). 

Collins stressed that the aim of restructuring was to protect veterans’ health care. By getting rid of DEI initiatives, the VA saved $14 million, which he said was redirected to veterans with disabilities who need prosthetics.

Sen. Bernie Sanders (D-VT) addressed concerns about the existing shortage of clinicians at the VA, asking Collins what he was doing to bring in more doctors, nurses, and social workers. In addition to moving doctors and nurses from nonpatient care to patient care, Collins said, he planned to work with Congress to make salaries more competitive.

But money and adding more employees are not always the solution, Collins said. For example, he said, the VA has been spending $588 million a year veteran suicide research, its top clinical priority. Yet, he said there has not been a significant decrease in veteran suicide rates since 2008. 

The most recent VA suicide report, released in 2024, indicates suicide rates have remained steady since 2001. However, in 2022, the number of suicides among veterans (6407) was actually lower than in 12 of the previous 14 years. 

According to media reports, congressional lawmakers, and union officials, Veteran Crisis Line (VCL) staff were among the 2400 probationary employees fired in February. In a Feb. 20 video, Collins accused Democrats of spreading lies and insisted no one who answered the phone was fired.

Later, in a letter to senators, Collins admitted that 24 VCL support staff were “erroneously” sent termination notices. The firings were later reversed, Collins said, and all VCL employees had been reinstated at the same position they previously held. “Ensuring the VCL is always accessible 24/7 is one of the department’s top priorities,” Collins insisted.

Collins shared his approval of keeping and expanding VA programs and studies on psychedelic treatments for patients with posttraumatic stress disorder and traumatic brain injury. He also spoke to the proposed 2026 budget calling for a $5.4 billion increase for the VA. If approved, that money would be targeted for medical care and homelessness. 

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Comprehensive genomic profiling (CGP) is becoming progressively common and appropriate as the array of molecular targets expands. However, most hospital laboratories in the United States do not perform CGP assays in-house; instead, these tests are sent to reference laboratories. As evidenced by Inal et al, only a minority of guideline-indicated molecular testing is performed.¹

The workload associated with referral testing is a barrier to increased use of such tests; streamlined processes in pathology might increase molecular test use. At 6 high-complexity US Department of Veterans Affairs (VA) medical centers (VAMCs) (Manhattan, Los Angeles, San Diego, Denver, Kansas City, and Salisbury, Maryland) ranging from 150 to 750 beds, a consult process for anatomic pathology molecular testing has increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care. This report comprehensively describes and maps the anatomic pathology molecular testing consult process at a VAMC. We present areas of inefficiency and a target state process map that incorporates best practices.

MOLECULAR TESTING CONSULT PROCESS

At the Kansas City VAMC (KCVAMC), a consult process for anatomic pathology molecular testing was introduced in 2021. Prior to this, requesting anatomic pathology molecular testing was not standardized. A variety of opportunities and methods were used for requests (eg, phone, page, Teams message, email, Computerized Patient Record System alert; or in-person during tumor board, an office meeting, or in passing). Requests were not documented in a standardized way, resulting in duplicate requests. Testing status and updates were documented outside the medical record, so requests for status updates (via various opportunities and methods) were common and redundant. Data from the year preceding consult implementation and the year following consult implementation have demonstrated increased test utilization, appropriateness of orders, standardization of reporting, and efficiency of care.

Consult Request

The precision oncology testing process starts with a health care practitioner (HCP) request on behalf of any physician or advanced practice registered nurse. It can be placed by any health care employee and directed to a designated employee in the pathology department. The request is ultimately reviewed by a pathologist (Figure 1). At KCVAMC, this request comes in the form of a consult in the electronic health record (EHR) from the ordering HCP to a pathologist. The KCVAMC pathology consult form was previously published with a discussion of the rationale for this process as opposed to a laboratory order process.² This consult form ensures ordering HCPs supply all necessary information for the pathologist to approve the request and order the test without needing to, in most cases, contact the ordering HCP for clarification or additional information. The form asks the ordering HCP to specify which test is being requested and why. Within the Veterans Health Administration (VHA) there are local and national contracts with many laboratories with hundreds of precision oncology tests to choose from. Consulting with a pathologist is necessary to determine which test is most appropriate.

The precision oncology consult form cannot be submitted without completing all required fields. It also contains indications for the test the ordering HCP selects to minimize unintentionally inappropriate orders. The form asks which tissue the requestor expects the test to be performed on. The requestor must provide contact information for the originating institution when the tissue was collected outside the VHA. The consult form also asks whether another anatomic site is accessible and could be biopsied without unacceptable risk or impracticality, should all previously collected tissue be insufficient. For CGP requests, this allows the pathologist to determine the appropriateness of liquid biopsy without having to reach out to the ordering HCP or wait for the question to be addressed at a tumor board. When a companion diagnostic is available for a test, the ordering HCP is asked which drug will be used so that the most appropriate assay is chosen.

Consult Review

Pathology service involvement begins with pathologist review of the consult form to ensure that the correct test is indicated. Depending on the resources and preferences at a site, consults can be directed to and reviewed by the pathologist associated with the corresponding pathology specimen or to a single pathologist or group of pathologists charged with attending to consults.

The patient’s EHR is reviewed to verify that the test has not already been performed and to determine which tissue to review. Previous surgical pathology reports are examined to assess whether sufficient tissue is available for testing, which may be determined without the need for direct slide examination. Pathologists often use wording such as “rare cells” or in some cases specify that there are not enough lesional cells for ancillary testing. In biopsy reports, the percentage of tissue occupied by lesional cells or the greatest linear length of tumor cells is often documented. As for quality, pathologists may note that a specimen is largely necrotic, and gross descriptions will indicate if a specimen was compromised for molecular analysis by exposure to fixatives such as Bouin’s solution, B-5, or decalcifying agents that contain strong acids.

Tissue Retrieval

If, after such evaluation, the test is indicated and there is tissue that could be sufficient for testing, retrieval of the tissue is pursued. For in-house cases, the pathologist reviews the corresponding surgical pathology report to determine which blocks and slides to pull from the archives. In the cancer checklist, some pathologists specify the best block for subsequent ancillary studies. From the final diagnosis and gross description, the pathologist can determine which blocks are most likely to contain lesional tissue. These slides are retrieved from the archives.

For cases collected at an outside institution (other VHA facility or non-VHA facility/institution), the outside institution must be contacted to retrieve the needed slides and blocks. The phone numbers, fax numbers, email addresses, and mailing addresses for outside institutions are housed in an electronic file and are specific to the point of contact for such requests. Maintaining a record of contacts increases efficiency of the overall process; gathering contact information and successfully requesting tissue often involves multiple automated answering systems, misdirected calls, and failed attempts.

Tissue Review

After retrieving in-house tissue, the pathologist can proceed directly to slide review. For outside cases, the case must first be accessioned so that after review of the slides the pathologist can issue a report to confirm the outside diagnosis. In reviewing the slides, the pathologist looks to see that the diagnosis is correct, that there is a sufficient number of lesional cells in a section, that the lesional cells are of a sufficient concentration in a section, or subsection of the section that could be dissected, and that the cells are viable. Depending on the requested assay and the familiarity of the pathologist with that assay, the pathologist may need to look up the technical requirements of the assay and capabilities of the testing company. Assays vary in sensitivity and require differing amounts and concentrations of tumor. Some companies will dissect tissue, others will not.

If there is sufficient tissue in the material reviewed, the corresponding blocks are retrieved from in-house archives or requests are placed for outside blocks or unstained slides. If there was not enough tissue for testing, the same process is repeated to retrieve and evaluate any other specimens the patient may have. If there are no other specimens to review, this is simply communicated to the ordering HCP via the consult. If the patient is a candidate for liquid biopsy—ie, current specimens are of insufficient quality and/or quantity and a new tissue sample cannot be obtained due to unacceptable risk or impracticality—the order is placed at this time.

Tissue Transport and Testing

Unstained slides need to be cut unless blocks are sent. Slides, blocks, reports, and requisition forms are packaged for transport. An accession number is created for the precision oncology molecular laboratory test in the clinical laboratory section of the EHR system. The clinical laboratory accession number provides a way of tracking sendout testing status. The case is accessioned just prior to placement in the mail so that when an accession number appears in the EHR, the ordering HCP knows the case has been sent out. When results are received, the clinical laboratory accession is completed and a comment is added to indicate where in the EHR to find the report or, when applicable, notes that testing failed.

RESULT REPORTING

When a result becomes available, the report file is downloaded from the vendor portal. This full report is securely transmitted to the ordering HCP. The file is then scanned into the EHR. Additionally, salient findings from the report are abstracted by the pathologist for inclusion as a supplement to the anatomic pathology case. This step ensures that this information travels with the anatomic pathology report if the patient’s care is transferred elsewhere. Templates are used to ensure essential data is captured based on the type of test. The template reminds the pathologist to comment on things such as variants that may represent clonal hematopoiesis, variants that may be germline, and variants that qualify a patient for germline testing. Even with the template, the pathologist must spend significant time reviewing the chart for things such as personal cancer history, other medical history, other masses on imaging, family history, previous surgical pathology reports, and previous molecular testing.

If results are suboptimal, recommendations for repeat testing are made based on the consult response to the question of repeat biopsy feasibility and review of previous pathology reports. The final consult report is added as a consult note, the consult is completed, and the original vendor report file is associated with the consult note in the EHR.

Ancillary Testing Technician

Due to chronic KCVAMC understaffing in the clerical office, gross room, and histology, most of the consult tasks are performed by a pathologist. In an ideal scenario, the pathology staff would divide its time between a pathologist and another dedicated laboratory position, such as an ancillary testing technician (ATT). The ATT can assume responsibilities that do not require the expertise of a pathologist (Figure 2). In such a process, the only steps that would require a pathologist would be review of requests and slides and completion of the interpretive report. All other steps could be accomplished by someone who lacks certifications, laboratory experience, or postsecondary education.

The ATT can receive the requests and retrieve slides and blocks. After slides have been reviewed by a pathologist, the pathologist can inform the ATT which slides or blocks testing will be performed on, provide any additional necessary information for completing the order, and answer any questions. For send-out tests, this allows the ATT to independently complete online portal forms and all other physical requirements prior to delivery of the slides and blocks to specimen processors in the laboratory.

ATTs can keep the ordering HCPs informed of status and be identified as the point of contact for all status inquiries. ATTs can receive results and get outside reports scanned into the EHR. Finally, ATTs can use pathologistdesigned templates to transpose information from outside reports such that a provisional report is prepared and a pathologist does not spend time duplicating information from the outside report. The pathologist can then complete the report with information requiring medical judgment that enhances care.

Optimal Pathologist Involvement

Only 3 steps in the process (request review, tissue review, and completion of an interpretive report) require a pathologist, which are necessary for optimal care and to address barriers to precision oncology.3 While the laboratory may consume only 5% of a health system budget, optimal laboratory use could prevent as much as 30% of avoidable costs.4 These estimates are widely recognized and addressed by campaigns such as Choosing Wisely, as well as programming of alerts and hard stops in EHR systems to reduce duplicate or otherwise inappropriate orders. The tests associated with precision oncology, such as CGP assays, require more nuanced consideration that is best achieved through pathology consultation. In vetting requests for such tests, the pathologist needs information that ordering HCPs do not routinely provide when ordering other tests. A consult asking for such information allows an ordering HCP to efficiently convey this information without having to call the laboratory to circumvent a hard stop.

Regardless of whether a formal electronic consult is used, pathologists must be involved in the review of requests. Creation of an original in-house report also provides an opportunity for pathologists to offer their expertise and maximize the contribution of pathology to patient care. If outside (other VHA facility or non-VHA facility/institution) reports are simply scanned into the EHR without review and issuance of an interpretive report by an in-house pathologist, then an interpretation by a pathologist with access to the patient’s complete chart is never provided. Testing companies are not provided with every patient diagnosis, so in patients with multiple neoplastic conditions, a report may seem to indicate that a detected mutation is from 1 tumor when it is actually from another. Even when all known diagnoses are considered, a variant may be detected that the medical record could reveal to indicate a new diagnosis.

Variation in reporting between companies necessitates pathologist review to standardize care. Some companies indicate which variants may represent clonal hematopoiesis, while others will simply list the pathogenic variants. An oncologist who sees a high volume of hematolymphoid neoplasia may recognize which variants may represent clonal hematopoiesis, but others may not. Reports from the same company may vary, and their interpretation often requires a pathologist's expertise. For example, even if a sample meets the technical requirements for analysis, the report may indicate that the quality or quantity of DNA has reduced the sensitivity for genomic alteration detection. A pathologist would know how to use this information in deciding how to proceed. In a situation where quantity was the issue, the pathologist may know there is additional tissue that could be sent for testing. If quality is the issue, the pathologist may know that additional blocks from the same case likely have the same quality of DNA and would also be unsuitable for testing.

Pathologist input is necessary for precision oncology testing. Some tasks that would ideally be completed by a molecular pathologist (eg, creation of reports to indicate which variants may represent clonal hematopoiesis of indeterminate potential) may be sufficiently completed by a pathologist without fellowship training in molecular pathology.

There are about 15,000 full-time pathologists in the US.⁴ In the 20 years since molecular genetic pathology was formally recognized as a specialty, there have been < 500 pathologists who have pursued fellowship training in this specialty.5 With the inundation of molecular variants uncovered by routine next-generation sequencing (NGS), there are too few fellowship-trained molecular pathologists to provide all such aforementioned input; it is incumbent on surgical pathologists in general to take on such responsibilities.

Consult Implementation Data

These results support the feasibility and effectiveness of the consult process. Prior to consult implementation, many requests were not compliant with VHA National Precision Oncology Program (NPOP) testing guidelines. Since enactment of the consult, > 90% of requests have been in compliance. In the year preceding the consult (January 2020 to December 2021), 55 of 211 (26.1%) metastatic lung and prostate cancers samples eligible for NGS were tested and 126 (59.7%) NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 151 days. In the year following enactment of the consult (January 2021 to December 2022), 168 of 224 (75.0%) of metastatic lung and prostate cancers eligible for NGS were tested and all 224 NGS vendor reports were scanned into the EHR. The mean time from metastasis to NGS result was 83 days. These data indicate that the practices recommended increase test use, appropriateness of orders, standardization of reporting, and efficiency of care.

CONCLUSIONS

Processing precision oncology testing requires substantial work for pathology departments. Laboratory workforce shortages and ever-expanding indications necessitate additional study of pathology processes to manage increasing workload and maintain the highest quality of cancer care through maximal efficiency and the development of appropriate staffing models. The use of a consult for anatomic pathology molecular testing is one process that can increase test use, appropriateness of orders, standardization of reporting, and efficiency of care. This report provides a comprehensive description and mapping of the process, highlights best practices, identifies inefficiencies, and provides a description and mapping of a target state.

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.¹ In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.^2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. ⁶ This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.⁷ There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X² test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.^8-11 There is also a body of research on the timeline from biopsy to definitive excision. ^6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.¹⁷

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. ¹⁸ However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.¹⁸ Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.¹⁹ The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.¹ In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.^2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. ⁶ This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.⁷ There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X² test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.^8-11 There is also a body of research on the timeline from biopsy to definitive excision. ^6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.¹⁷

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. ¹⁸ However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.¹⁸ Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.¹⁹ The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.

Store-and-forward teledermatology (SFT) allows clinical images and information to be sent to a dermatologist for evaluation. In fiscal year (FY) 2018, 117,780 SFT consultations were completed in the Veterans Health Administration. Continued growth is expected since SFT has proven to be an effective method for improving access to face-to-face (FTF) dermatology care.¹ In the same period, the US Department of Veterans Affairs (VA) Puget Sound Health Care System (VAPSHCS) completed 12,563 consultations in a mean 1.1 days from entry into episode of care (EEC), according to data reported by VA Teledermatology Program Administrator Chris Foster.

Obtaining a prompt consultation is reported to be an overwhelming advantage of using SFT.^2-5 Rapid turnaround may appear to make SFT specialist care more accessible to veterans, yet this is an oversimplification. The process of delivering care (rather than consultation) through SFT is more complex than reading the images and reporting the findings. When a skin condition is identified by a primary care clinician and that person decides to request an SFT consultation, a complex set of tasks and handoffs is set into motion. A swim-lane diagram illustrates the numerous steps and handoffs that go into delivering care to a patient with a malignant melanoma on the SFT platform compared to FTF care, which requires fewer handoffs (Figure).

This process improvement project examined whether handoffs necessitated by SFT care lengthened the timeline of care for biopsy-proven primary cutaneous malignant melanoma. The stakes of delay in care are high. A 2018 study using the National Cancer Database found that a delay of > 30 days from biopsy to definitive excision (the date definitive surgical procedure for the condition is performed) resulted in a measurable increase in melanoma-related mortality. ⁶ This study sought to identify areas where the SFT timeline of care could be shortened.

Methods

This retrospective cohort study was approved by the VAPSHCS Institutional Review Board. The study drew from secondary data obtained from VistA, the VA Corporate Data Warehouse, the Veterans Integrated Service Network (VISN) 20 database, the American Academy of Dermatology Teledermatology Program database, and the VA Computerized Patient Record System.

Patients registered for ≥ 1 year at VAPSHCS with a diagnosis of primary cutaneous malignant melanoma by the Pathology service between January 1, 2006, and December 31, 2013, were included. Patients with metastatic or recurrent melanoma were excluded.

Cases were randomly selected from a melanoma database previously validated and used for another quality improvement project.⁷ There were initially 115 patient cases extracted from this database for both the FTF and SFT groups. Eighty-seven SFT and 107 FTF cases met inclusion criteria. To further analyze these groups, we split the FTF group into 2 subgroups: FTF dermatology (patients whose melanomas were entered into care in a dermatology clinic) and FTF primary care (patients whose melanomas were entered into care in primary care or a nondermatology setting).

The timeline of care was divided into 2 major time intervals: (1) entry into episode of care (EEC; the date a lesion was first documented in the electronic health record) to biopsy; and (2) biopsy to definitive excision. The SFT process was divided into the following intervals: EEC to imaging request (the date a clinician requested imaging); imaging request to imaging completion (the date an imager photographed a patient’s lesion); imaging completion to SFT consultation request (the date the SFT consultation was requested); SFT consultation request to consultation completion (the date an SFT reader completed the consultation request for a patient); and SFT consultation completion to biopsy. Mean and median interval lengths were compared between groups and additional analyses identified steps that may have contributed to delays in care.

To address potential bias based on access to care for rural veterans, SFT and FTF primary care cases were categorized into groups based on their location: (1) EEC and biopsy conducted at the same facility; (2) EEC and biopsy conducted at different facilities within the same health care system (main health care facility and its community-based outpatient clinics); and (3) EEC and biopsy conducted at different health care systems.

Statistics

Means, medians, and SDs were calculated in Excel. The Mann-Whitney U test was used to compare SFT medians to the FTF data and X² test was used to compare proportions for secondary analyses.

Results

The median (mean) interval from EEC to definitive excision was 73 days (85) for SFT and 58 days (73) for FTF (P = .004) (Table). To understand this difference, the distribution of intervals from EEC to biopsy and biopsy to definitive excision were calculated. Only 38% of SFT cases were biopsied within 20 days compared to 65% of FTF cases (P < .001). The difference in time from biopsy to definitive excision distributions were not statistically significant, suggesting that the difference is actually a reflection of the differences seen in the period between EEC and biopsy.

EEC and biopsy occurred at the same facility in 85% and 82% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different facilities within the same health care system in 15% and 16% of FTF primary care and SFT cases, respectively. EEC and biopsy occurred at different health care systems in 0% and 2% of FTF primary care and SFT cases, respectively. Geographic bias did not impact results for either group of veterans.

The interval between EEC and biopsy was shorter for FTF dermatology cases than for FTF primary care cases. For FTF dermatology cases, 96% were biopsied within 20 days compared with 34% of FTF primary care cases (P < .001).

To further analyze the difference in the EEC to biopsy interval duration between SFT and FTF primary care the timeline was divided into smaller steps: EEC to imaging completion, imaging completion to SFT consult completion, and SFT consult completion to biopsy. From EEC to SFT consult completion, SFT cases took a median of 6.0 days and a mean of 12.3 days, reflecting the administrative handoffs that must occur in SFT. A total of 82% of FTF primary care cases were entered into care and consultation was requested on the same day, while this was true for only 1% of SFT cases.

Since mortality data were not collected, the frequency of in situ melanomas and invasive melanomas (pathologic stage pT1a or greater) was used as a proxy for comparing outcomes. No significant difference was found in the frequency of in situ vs invasive melanomas in the SFT and FTF dermatology groups; however, there was a much higher frequency of invasive melanomas in the FTF primary care group (P = .007).

Discussion

This study compared the time to treatment for SFT vs FTF and identified important differences. The episode of care for melanomas diagnosed by SFT was statistically significantly longer (15 days) than those diagnosed by FTF. The interval between biopsy and definitive excision was a median of 34 and 38 days, and a mean of 48 and 44 days for SFT and FTF, respectively, which were not statistically significant. The difference in the total duration of the interval between EEC and definitive excision was accounted for by the duration of the interval from EEC to biopsy. When excluding dermatology clinic cases from the FTF group, there was no difference in the interval between EEC and biopsy for SFT and FTF primary care. The handoffs in SFT accounted for a median of 6 days and mean of 12 days, a significant portion of the timeline, and is a target for process improvement. The delay necessitated by handoffs did not significantly affect the distribution of in situ and invasive melanomas in the SFT and FTF dermatology groups. This suggests that SFT may have better outcomes than FTF primary care.

There has been extensive research on the timeline from the patient initially noticing a lesion to the EEC.^8-11 There is also a body of research on the timeline from biopsy to definitive excision. ^6,12-16 However, there has been little research on the timeline between EEC and biopsy, which comprises a large portion of the overall timeline of both SFT care and FTF care. This study analyzed the delays that can occur in this interval. When patients first enter FTF dermatology care, this timeline is quite short because lesions are often biopsied on the same day. When patients enter into care with their primary or nondermatology clinician, there can be significant delays.

Since the stakes are high when it comes to treating melanoma, it is important to minimize the overall timeline. A 6-day median and 12-day mean were established as targets for teledermatology handoffs. Ideally, a lesion should be entered into an episode of care, imaged, and sent for consultation on the same day. To help further understand delays in administrative handoffs, we stratified the SFT cases by VISN 20 sites and spoke with an administrator at a top performing site. Between 2006 and 2013, this site had a dedicated full-time imager as well as a backup imager that ensured images were taken quickly, usually on the same day the lesion was entered into care. Unfortunately, this is not the standard at all VISN 20 sites and certainly contributes to the overall delay in care in SFT

Minimizing the timeline of care is possible, as shown by the Danish health system, which developed a fast-track referral system after recognizing the need to minimize delays between the presentation, diagnosis, and treatment of cutaneous melanomas. In Denmark, a patient who presents to a general practitioner with a suspicious lesion is referred to secondary care for excision biopsy within 6 days. Diagnosis is made within 2 weeks, and, if necessary, definitive excision is offered within 9 days of the diagnosis. This translates into a maximum 20-day EEC to biopsy timeline and maximum 29-day EEC to definitive excision timeline. Although an intervention such as this may be difficult to implement in the United States due to its size and decentralized health care system, it would, however, be more realistic within the VA due to its centralized structure. The Danish system shows that with appropriate resource allocation and strict timeframes for treatment referrals, the timeline can be minimized.¹⁷

Despite the delay in the SFT timeline, this study found no significant difference between the distribution of in situ vs invasive melanomas in FTF dermatology and SFT groups. One possible explanation for this is that SFT increases access to dermatologist care, meaning clinicians may be more willing to consult SFT for less advanced– appearing lesions.

The finding that SFT diagnosed a larger proportion of in situ melanomas than FTF primary care is consistent with the findings of Ferrándiz et al, who reported that the mean Breslow thickness was significantly lower among patients in an SFT group compared to patients in an FTF group consisting of general practitioners. ¹⁸ However, the study population was not randomized and the results may have been impacted by ascertainment bias. Ferrándiz et al hypothesized that clinicians may have a lower threshold for consulting teledermatology, resulting in lower mean Breslow thicknesses.¹⁸ Karavan et al found the opposite results, with a higher mean Breslow thickness in SFT compared to a primary care FTF group.¹⁹ The data presented here suggest that SFT has room for process improvement yet is essentially equivalent to FTF dermatology in terms of outcomes.

Limitations

The majority of patients in this study were aged > 50 years, White, and male. The results may not be representative for other populations. The study was relatively small compared to studies that looked at other aspects of the melanoma care timeline. The study was not powered to ascertain mortality, the most important metric for melanoma.

Conclusions

The episode of care was significantly longer for melanomas diagnosed by SFT than those diagnosed by FTF; however, timelines were not statistically different when FTF lesions entered into care in dermatology were excluded. A median 6-day and mean 12.3-day delay in administrative handoffs occurred at the beginning of the SFT process and is a target for process improvement. Considering the high stakes of melanoma, the SFT timeline could be reduced if EEC, imaging, and SFT consultation all happened in the same day.