AVAHO

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

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

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

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

TOPLINE:

The Immunoscore biopsy, which quantifies immune cell tumor infiltration in tumor biopsies at baseline, is a strong predictor for rectal cancer recurrence for both local regrowth and distant metastasis during watchful waiting.

METHODOLOGY:

• Currently, oncologists do not have a biomarker that can help select patients with rectal cancer for watchful waiting after neoadjuvant chemoradiotherapy as well as help monitor them over time. And about 25% of patients on watchful waiting will eventually relapse.
• The Immunoscore biopsy quantifies the degree of immune infiltration on pretreatment tumor biopsies, looking at the density of CD3- and CD8-positive T cells at baseline, given that greater infiltration has been associated with prolonged treatment response.
• To determine whether the Immunoscore can help select patients for watchful waiting, investigators correlated Immunoscore with time to recurrence in 249 patients with stage I-III rectal cancer who were undergoing watchful waiting after complete clinical responses to neoadjuvant chemoradiotherapy.
• CD3- and CD8-positive T-cell densities were converted into percentiles and then translated into scores of Immunoscore biopsy: low (0%-25%), intermediate (> 25%-70%), and high (> 70%-100%).

TAKEAWAY:

• The Immunoscore biopsy significantly improved predictions of recurrence: 5-year recurrence-free survival was 91.3% among patients with high scores, 62.5% among those with intermediate scores, and 53.1% among those with low scores.
• The Immunoscore was significantly associated with disease-free survival (log-rank P = .0002) and predicted both local regrowth and distant metastasis.
• On multivariate analysis, the Immunoscore’s predictive ability was independent of age, sex, tumor location, cT stage, and cN stage, and was the strongest predictor of time to recurrence (hazard ratio, high vs. low, 6.93; P = .0017).

IN PRACTICE:

This validation study confirms that the Immunoscore biopsy “is an independent parameter predicting time to recurrence” and can help physicians and patients decide whether to opt for watchful waiting, the study authors wrote.

SOURCE:

The study, led by Carine El Sissy of the Laboratory of Integrative Cancer Immunology, Paris, was published Oct. 3 in the Journal of Clinical Oncology.

LIMITATIONS:

Mismatch repair gene expression status was not assessed.

DISCLOSURES:

The work was supported by the L’Institut National de la Santé et de la Recherche Médicale and others. Investigators disclosed patents related to the work and ties to many companies, including Amgen, AstraZeneca, and Merck. One investigator is an employee of Novo Nordisk, and another is employed by Veracyte.

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

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

The American Cancer Society has updated its screening guidelines for lung cancer, the leading cause of cancer-specific deaths in the United States and the largest driver of potential years of life lost from cancer.

The 2023 screening guidance, aimed principally at reducing lung cancer mortality in asymptomatic but high-risk, tobacco-exposed individuals, expands the age eligibility and lowers both the former smoking history and the years since quitting threshold for screening with low-dose CT (LDCT).

It is based on the most recent evidence on the efficacy and effectiveness of screening and lung cancer risk in persons who formerly smoked, wrote the ACS’s Guideline Development Group led by Robert A. Smith, PhD, senior vice president of early cancer detection science. The new guidelines, which replace the 2013 statement, appear in CA: A Cancer Journal for Physicians.

The primary evidence source for the update was a systematic review of LDCT lung cancer screening conducted for the U.S. Preventive Services Task Force and published in 2021.

The new guideline continues a trend of expanding eligibility for lung cancer screening, which has had low uptake, to prevent more deaths. “Recent studies have shown that extending the age for persons who smoked and formerly smoked, eliminating the ‘years since quitting’ requirement, and lowering the pack-per-year recommendation could make a real difference in saving lives,” Dr. Smith said. “The relative risk of developing lung cancer in people who have smoked most of their life compared to people who never smoked is very high – about 70 times the risk.” Although lung cancer is the third most common malignancy in the United States, it accounts for more deaths than colorectal, breast, prostate, and cervical cancers combined.

The recommendation for annual LDCT for at-risk persons remains unchanged from 2013.

Among the 2023 eligibility changes:

• Age: Expanded to 50-80 years from 55-74 years.
• Smoking status: Changed to current or previous smoker from current smoker or smoker who quit within past 15 years (number of years since quitting no longer a criterion to start or stop screening). Dr. Smith noted that both the 2013 guidelines and other groups’ updated recommendations retained the eligibility cutoff of 15 years since smoking cessation. “But had their risk declined to a level that just did not justify continuing screening?” he asked. “There wasn’t an answer to that question, so we needed to look carefully at the absolute risk of lung cancer in persons who formerly smoked compared with people who currently smoked and people who never smoked.”
• Smoking history: Reduced to 20 or more pack-years (average of 20 cigarettes a day) versus 30 or more pack-years.
• Exclusions: Expanded to health conditions that may increase harm or hinder further evaluation, surgery, or treatment; comorbidities limiting life expectancy to fewer than 5 years; unwillingness to accept treatment for screen‐detected cancer, which was changed from 2013’s life‐limiting comorbid conditions, metallic implants or devices in the chest or back, home oxygen supplementation.

In addition, decision-making should be a shared process with a health professional providing the patient with information on the benefits, limitations, and harms of LDCT screening, as well as prescreening advice on smoking cessation and the offer of assistive counseling and pharmocotherapy.

“Overall, lung cancer screening remains one of the least used early cancer detection modalities in clinical practice. The new guidance opens up lung cancer screening to all former smokers regardless of time of cessation,” said internist William E. Golden, MD, MACP, a professor of medicine and public health at the University of Arkansas for Medical Sciences, Little Rock. “This may promote greater uptake in concert with greater availability of low-radiation CT scanning.”

While agreeing the expanded criteria will enfranchise nearly 5 million current and former U.S. smokers for screening and may reduce deaths, internist Aarati D. Didwania, MD, MMSCI, MACP, a professor of medicine and medical education at Northwestern University, Chicago, warned that increasing actual uptake may be an uphill battle. “The practical part of the equation is seeing that the scans get done. There is often a lag between a recommendation of a yearly test and getting insurance coverage for it, and many disadvantaged people face barriers.” Then there’s the knowledge gap. “Patients and doctors have to know what the new guidelines are and who has access,” she said.

Reaching the target population in rural areas is particularly challenging with the greater distances to imaging centers. Another barrier is that most electronic health records do not identify eligible patients based on smoking and pack‐year history.

In Dr. Didwania’s view, professional medical societies have an important role to play in educating their members, and through them, patients. “Disseminating information about the new recommendations is the first step and would be incredibly helpful.”
 

A brief history of lung cancer screening

1950s: By mid-20th century, the causal association between tobacco exposure and lung cancer became clear and by the late 1950s attempts were made to develop a lung cancer screening strategy for high‐risk individuals, commonly with the combination of sputum cytology and chest x-ray.

1970s: The ACS recommended annual testing for current or former smokers with chest x-ray (and sometimes sputum cytology).

1980: The ACS withdrew the above recommendation for regular radiographic screening after randomized controlled trials failed to yield convincing evidence that such screening saved lives.

2013: After the National Lung Screening Trial found three annual LDCT screenings were associated with a 20% relative mortality reduction, compared with annual chest x-ray, the ACS issued a recommendation for annual screening with LDCT: in persons 55-74 years with a pack‐year history of 30 or more who currently smoke or formerly smoked but had not exceeded 15 years since quitting and had no life-limiting morbidity.
 

Future mortality

Although tobacco controls are expected to reduce age‐adjusted lung cancer mortality in the United States by 79% from 2015 to 2065, 4.4 million lung cancer deaths are projected to occur in this period, the authors stated. “A large fraction of these deaths can be prevented if we embrace the urgent challenge to improve our ability to identify the population at risk and apply our knowledge to achieve high rates of participation in regular [lung cancer screening].”

The study was funded by the American Cancer Society Guideline Development Group and the National Comprehensive Cancer Network. The authors disclosed no relevant competing interests. Dr. Golden and Dr. Didwania had no relevant conflicts of interest to declare with regard to their comments.

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

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

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

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

TOPLINE:

Among patients with colorectal cancer (CRC), those with complicated diabetes were at higher risk of poor survival than their peers without diabetes, while those with uncomplicated diabetes had insignificantly worse cancer outcomes.

METHODOLOGY:

• This population-based retrospective cohort study used 2007-2015 data from the Taiwan Cancer Registry, which is linked to national insurance and death registry data.
• The analysis included 59,202 adults with stage I-III CRC who underwent potentially curative surgery: 44,944 without diabetes, 8,864 with uncomplicated diabetes, and 5,394 with complicated diabetes.
• The association between diabetes severity and CRC survival, overall survival (OS), disease-free survival (DFS), time to recurrence, and cancer-specific survival (CSS) was examined.
•  

TAKEAWAY:

• Patients with uncomplicated diabetes had insignificantly worse OS (hazard ratio, 1.05), DFS (HR, 1.08), and CSS (HR, 0.98), compared with peers who did not have diabetes.
• Patients with complicated diabetes were at significantly higher risk of poor OS (HR, 1.85), DFS (HR, 1.75), and CSS (HR, 1.41), compared with those without diabetes.
• Patients with diabetes were also at higher risk for CRC recurrence than those without diabetes.
• Except for recurrence risk, the impact of complicated diabetes on CRC survival – that is, OS, DFS, and CSS – was more pronounced among women and those with early-stage cancer.

IN PRACTICE:

“These findings indicate that preventing diabetes complications may help improve survival in patients with CRC, especially [in] female patients and those in the early stages of the disease. Thus, a multidisciplinary approach is recommended for patients with CRC,” the authors conclude.

SOURCE:

The study, with first author Hsin-Yin Hsu, MD, National Taiwan University, Taipei, was published online in the journal Cancer.

LIMITATIONS:

Only patients from Taiwan were included, which limits generalizability, because CRC prognosis may vary in accordance with race or cancer treatment strategy – factors that may differ among countries. Data on glucose levels and diabetes duration were unavailable, potentially leading to misclassification of diabetes status.

DISCLOSURES:

Funding was provided by the Ministry of Science and Technology and the Ministry of Health and Welfare. The authors have disclosed no relevant financial relationships.

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

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

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

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

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

Community oncologists across the United States are concerned about a recent lawsuit in Philadelphia between the Jefferson Health hospital system and the largest independent oncology and hematology practice in southeastern Pennsylvania, Alliance Cancer Specialists.

The outcome, some community oncologists say, could set a new precedent in how far large health care organizations will go to take their patients or drive them out of business.
 

The case

On Sept. 5, Alliance sued Jefferson Health after Jefferson canceled the inpatient oncology/hematology privileges of five Alliance oncologists at three Jefferson Health-Northeast hospitals, primarily alleging that Jefferson was attempting to monopolize cancer care in the area.

Jefferson – one of the largest health care systems in the Philadelphia area that includes the NCI-designated Sidney Kimmel Cancer Center – made the move because it had entered into an exclusive agreement with its own medical group to provide inpatient and outpatient oncology/hematology services at the hospitals.

In its court filings, Jefferson said it entered into the exclusive agreement because doing so was in “the best interest of patients, as it would ensure better integration and availability of care and help ensure that Jefferson consistently provides high-quality medical care in accordance with evidence-based standards.”

Tensions had been building between Alliance and Jefferson for years, ever since, according to Alliance, the community practice declined a buyout offer from Jefferson almost a decade ago.

But the revocation of privileges ultimately tipped the scales for Alliance, sparking the lawsuit.

“For us, that crossed a line,” said Moshe Chasky, MD, one of the five Alliance oncologists and a plaintiff in the suit.

Dr. Chasky and his colleagues had provided care at the hospitals for years, with about 10-15 patients admitted at any one time. The quality of their care is not in dispute. Dr. Chasky, for instance, routinely makes Philadelphia Magazine’s Top Doc List.

Under the new arrangement, the five Alliance oncologists have to hand over care of their admitted patients to Jefferson oncologists or send their patients to another hospital farther away where they do have admitting privileges.

“Without having admitting privileges,” community oncologists “can’t look a patient in the eye and say, ‘No matter what, I’ve got you,’ ” explained Nicolas Ferreyros, managing director of policy, advocacy, and communications at the Community Oncology Alliance, a DC-based lobbying group for independent oncologists.

“A doctor doesn’t want to tell a patient that ‘once you go in the hospital, I have to hand you off.’ ” It undermines their practice, Mr. Ferreyros said.

The situation has caught the attention of other community oncologists who are worried that hospitals canceling admitting privileges might become a new tactic in what they characterize as an ongoing effort to elbow-out independent practitioners and corner the oncology market.

Dr. Chasky said he is getting “calls every day from independent oncologists throughout the country” who “are very concerned. People are watching this for sure.”   

Alliance attorney Daniel Frier said that there is nothing unusual about hospitals entering into exclusive contracts with hospital-based practices.

But Mr. Frier said he’s never heard of a hospital entering into an exclusive contract and then terminating the privileges of community oncologists.  

“There’s no direct precedent” for the move, he said.

Jefferson Health did not respond to requests for comment. 
 

The ruling

U.S. District Court Judge Kai Scott, who ruled on Alliance’s motion to block the contract and preserve its oncologists’ admitting privileges, ultimately sided with Jefferson and allowed the contract to go forward.

Judge Scott wrote that, “while the court understands the plaintiffs’ concerns and desires to maintain the continuity of care for their own patients,” the court “is not persuaded that either of the two threshold elements for a temporary restraining order or preliminary injunction are met” – first, that Jefferson’s actions violate antitrust laws and second that the plaintiffs “will suffer immediate, irreparable harm” from having their admitting privileges rescinded.

Alliance argued that Jefferson’s contract violated federal antitrust laws and would allow Jefferson to monopolize the local oncology market.

However, Judge Scott called Alliance’s antitrust argument “lifeless” under the strict requirements for antitrust violations, explaining that, among other reasons, a monopoly is unlikely given that Jefferson competes with several high-profile oncology programs in the Philadelphia area, including the Fox Chase Cancer Center.

Judge Scott also expressed doubt that the Jefferson’s actions would cause irreparable harm to Alliance’s business. Alliance employs more than thirty oncologists affiliated with over a dozen hospitals in the greater Philadelphia area, and the inpatient services provided at Jefferson Health-Northeast did not represent a major part of its business. 

Despite her ruling, Judge Scott did voice skepticism about some of Jefferson’s arguments.

“The court notes that the Jefferson defendants have briefly argued that Jefferson will be better able to ensure that its own patients receive fully integrated and coordinated care” under the exclusive provider agreement, but “it is unclear how the cooperation of ACS [Alliance Cancer Specialists] and JNE [Jefferson Health-Northeast] hospitalists really caused any problems for the coordinated care of” patients in the many years that they worked together.

It also “does not seem to necessarily serve the community to quickly sever the artery between the services that ACS provides and the services that JNE provides,” Judge Scott wrote.

She added that she would consider another motion from Alliance if the practice makes stronger arguments illustrating antitrust violations and demonstrating irreparable harm.

Currently, Dr. Chasky and Mr. Frier are considering their next steps in the case. The oncologists said they can appeal the judge’s decision or file a new complaint.

Meanwhile, Dr. Chasky and his four colleagues requested and were granted internal medicine privileges at Jefferson Health-Northeast, but given the considerable overlap between oncology and internal medicine, the line between what they can and cannot do remains unclear.

“It’s a mess,” he said.
 

A familiar story

Large health care entities have increasingly worked to push out or swallow up smaller, independent practices for years.

“What Dr. Chasky and his practice are going through is a little bit more of an aggressive version of what’s going on in the rest of the country,” said Michael Diaz, MD, a community oncologist at Florida Cancer Specialists, the largest independent medical oncology/hematology group in the United States. “The larger institutional hospitals try to make it a closed system so they can keep everything in-house and refer to their own physicians.”

The incentive, Dr. Diaz said, is the financial windfall that Section 340B of the 1992 Public Health Service Act generates for hospital-based oncology services at nonprofit hospitals, such as the Jefferson Health-Northeast facilities.

The 340B program allows nonprofit hospitals to buy primarily outpatient oncology drugs at steep discounts, sometimes 50% or more, and be reimbursed at full price.

When launched in 1992, the program was meant to help a handful of safety-net hospitals cover the cost of charity care, and now approximately more than half of U.S. hospitals participate in the program, particularly after requirements were loosened by the Affordable Care Act. But there’s little transparency on how the money is spent.

Critics say the incentives have created a feeding frenzy among 340B hospitals to either acquire outpatient oncology practices or take their business because of the particularly high margins on oncology drugs. There are similar incentives for hospital-based infusion centers.

In its lawsuit, Alliance alleged that such incentives are what motivated Jefferson’s recent actions.

“It’s all about the money at the end of the day,” said Christian Thomas, MD, a community oncologist with New England Cancer Specialists, Scarborough, Maine, who, like Dr. Diaz, said he’s seen the dynamic play out repeatedly in his career. 

The American Hospital Association has been a vigorous defender of 340B in the courts and elsewhere, but the Association’s communications staff had little to say when this news organization reached out about the Jefferson-Alliance situation, except that they do not comment on “specific hospital circumstance.”
 

Reverberations around the country

Many community oncologists are keeping close tabs on the Jefferson-Alliance situation.

“Our group has been watching Jefferson closely because our [local] hospital is following the same playbook, but they have not yet gone after our privileges,” said Scott Herbert, MD, a community oncologist with the independent Nexus Health system, Sante Fe, N.M.

Dr. Herbert was referring to what has happened since he and his colleagues declined to renew an exclusive provider agreement early this year with St. Vincent Regional Medical Center, a nonprofit hospital in Sante Fe. The agreement allowed the hospital to take advantage of the 340B program because Nexus oncologists acted on its behalf.

St. Vincent’s owner, Christus Health, did not respond to inquiries from this news organization.

Nexus let the contract lapse because its oncologists wanted to provide services at a second, newer hospital in Santa Fe where some of their patients had begun seeking treatment.

The nonprofit hospital in Sante Fe is now building its own oncology practice. Similar to Dr. Chasky’s experience in Philadelphia, Dr. Herbert said his group has seen referrals from the hospital dry up and existing patients rechanneled to the hospital’s oncologists.  

“We found over 109 patients in January and February that were referred to one of our docs that got rerouted to one of their docs,” he said.

Dr. Herbert has sent cease-and-desist letters, but “after we saw what Jefferson did, my group said, ‘You better back off of the hospital, or it’s going to take our privileges.’ ”

The Jefferson situation “is sending a message,” he said. “Frankly, we’ve been terrified” at the thought of losing privileges there. “It’s the busiest hospital in our area.”
 

The future of community oncology

Despite the challenges, Mr. Ferreyros at the Community Oncology Alliance remains optimistic about the future of independent oncology.

Under the competitive pressures, a lot of independent oncology practices have folded in recent years, but the ones that remain are strong. Payers are also increasingly noticing that community oncology practices are less expensive than hospital-based practices for comparable care, he said.

Relationships with hospitals aren’t always adversarial, either. “A lot of practices have collaborative agreements with local hospitals” that work out well, Mr. Ferreyros said, adding that sometimes hospitals even hand over oncology care to local independents after finding that starting and maintaining an oncology service is harder than they imagined.

“The last two decades have been difficult,” but the remaining community oncology practices “are going strong,” he said, and “we’ve never seen more engagement on our issues,” particularly around the issue of cost savings.

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

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

A new artificial intelligence (AI) model can detect the deadliest skin cancer with 100% accuracy, highlighting the rapid improvement of AI in medicine, say researchers from the United Kingdom. AI detected more than 99% of all skin cancers.

The researchers tested the AI by integrating it into a clinical diagnosis process – anticipating a future in which AI helps doctors catch skin cancer faster and triage patients.

Skin cancer is the most common cancer in the United States;  one in five 5 Americans develop skin cancer by age 70. With melanoma, the deadliest skin cancer, the 5-year survival rate is better than 99% if caught early, though only about three-quarters of melanomas are caught at this stage.

Amid rising skin cancer rates come concerns that the number of dermatologists in the workforce isn’t keeping pace. That may be why the average wait time for a dermatology appointment is trending up – in 2022, it reached 34.5 days.

The study, which was presented at the European Academy of Dermatology and Venereology Congress recently and has not yet been published, involved 6,900 patients in the United Kingdom with suspected skin cancer. The patients had been referred by their primary care physicians. The researchers took images of the suspicious areas and uploaded them to the AI software. The AI’s assessment was then shared with a dermatologist.

“Note that the diagnosis issued by the AI was not hidden from the dermatologist doing the second assessment,” said lead researcher Kashini Andrew, MBBS, a dermatologist and specialist registrar at University Hospitals Birmingham NHS Foundation Trust.

Dr. Andrew acknowledged that this may have influenced the dermatologist’s opinion. But that’s the vision of how doctors could use this tool.

The AI caught 59 of 59 melanomas and 189 of 190 total skin cancers (99.5%). (The one case that the AI missed was caught by the dermatologist.) It also flagged 541 of 585 precancerous lesions (92.5%). This represented a big improvement from a 2021 version of the model, which detected 86% of melanomas, 84% of all skin cancers, and 54% of precancerous lesions.

Over the 10-month period of the study, the system saved more than 1,000 face-to-face consultations, freeing dermatologists’ time to catch more cancers and serve more patients.

Limitations

The patients in the study were from “one hospital in a single region of the UK,” and the sample was not large enough to allow broad statements to be made about the use of AI in dermatology, Dr. Andrew said.

But it can open the conversation. Roxana Daneshjou, MD, PhD, a dermatologist at Stanford (Calif.) University who has studied the pros and cons of AI in medicine, had some concerns. For one thing, doctors can gather more in-depth information during an in-person exam than AI can glean from a photo, Dr. Daneshjou noted. They can examine skin texture, gather patient history, and take photos with special lighting and magnification.

Christopher Smith

And the AI needs to get better at ruling out malignancy, Dr. Daneshjou said. In this study, the AI identified 75% of benign lesions, a decline from the earlier version. The researchers noted in the abstract that this is a potential trade-off for increased sensitivity.

“[Unnecessary] biopsies can clog up the health care system, cost money, and cause stress and scarring,” said Dr. Daneshjou. “You don’t want to increase the burden of that.”

Still, if AI software such as the kind used in the study proves just as accurate in larger, more diverse sample sizes, then it could be a powerful tool for triage, Dr. Daneshjou said. “If AI gets particularly good at finding malignancy and also ruling it out, that would be a win.”

A version of this article appeared on Medscape.com.

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

I, like every pediatrician I know, believe that breast milk is the best nutrition for human newborns. Its balance of nutritive elements and its role in preventing of a wide range of illnesses are so great that we are still learning the extent of their magnitude. It just makes sense that a mother’s milk is most well suited for her baby.

I am a bit less unambiguous about breastfeeding. By that I mean the process of providing breast milk to an infant directly from its mother’s breast. Before you yank my AAP membership card, let me make it clear that I think every woman should consider breastfeeding her infant. But we must accept that in a few situations, even with help from caring and enlightened health care providers and family members, breastfeeding doesn’t work as well as we would have hoped. Fortunately, there are alternatives.

My reservations about the process are few, and until recently I have had an unwaveringly positive attitude toward the safety of breast milk. The cause of my little bit of uncertainty arrived in a recent study by two researchers at the Dana Farber Institute in Boston, in which the investigators examining the health histories of more than 150,000 women found that those who were breastfed incurred a 23% greater risk of developing colorectal cancer when they reached adulthood. A younger cohort within that larger group had a dramatic 40% increased risk of developing high-risk cancer before reaching age 55.

The population the investigators studied came from the large Nurses’ Health Study II, a well-known repository of longitudinal health data. The researchers reported that they included biometric data and a large collection of lifestyle factors including smoking, alcohol intake, and diet in their calculations. However, breastfeeding continued to register the highest association. Interestingly, the investigators found that women who were breastfed for 9 months or longer had twice the risk of colorectal cancer as those who breastfed for from 4 to 8 months.

The study population was all women and predominantly white. However, in the general population it is the non-Hispanic white population that is experiencing the greatest increase in incidence. Of course, the study could not answer whether this association with breastfeeding also existed in minority populations.

The researchers suspect that what they are seeing is a reflection of the Westernization of the American lifestyle. One of the researchers is interested in the gut biome of infants and plans to further the investigation in that direction. Could some substance from the environment be concentrating in breast milk? Or is something missing in breast milk? She points out that, while formulas are generally fortified with vitamin D, breast milk is not.

As concerning as the results of this study may sound, the authors are very careful to urge mothers to continue to breastfeed and choose it as their first choice for feeding their babies. I have been pleasantly surprised that this study has not gotten widespread media attention because bad news travels fast. I have chosen to share it with you because at some point you may begin getting questions from concerned parents.

While apparently well done, this study is just the beginning. Like any good research, it poses more questions than it answers. For us as pediatricians it means we should continue to recommend breast milk as the first food. But, we must stay alert as further research looks deeper into this association.

We should also take advantage of our special access to young parents, a demographic that less frequently sees a physician for preventive care. For whatever reason colorectal cancer is occurring at younger ages. When we have the opportunity we should be reminding 40-year-olds not to wait until age 50 to screen for colorectal cancer, particularly if they have a family history of the disease.

Dr. Wilkoff practiced primary care pediatrics in Brunswick, Maine, for nearly 40 years. He has authored several books on behavioral pediatrics, including “How to Say No to Your Toddler.” Other than a Littman stethoscope he accepted as a first-year medical student in 1966, Dr. Wilkoff reports having nothing to disclose. Email him at [email protected].

Ability to schedule a prompt appointment, patient satisfaction percentages, and revenue compared to cost – these are some metrics that oncology practices track to ensure they’re running a successful practice and see how they measure up against their peers.

“Once practices figure out what they want to measure, and obviously they want to measure things that they’re not doing so well, they can look for opportunities for improvement,” said Diana Berich Brieva, DHA, MBA, CPC-A, the CEO of Ambulatory Care Consultants, which partners with medical practices to optimize operations and increase revenue.

Benchmarking your practice against others shows you how your numbers stack up to other practices’ metrics by percentile – for instance, whether your revenue is in the 25th, 50th, or 75th percentile against similar practices.

The 2024 MIPS Value Pathways (MVP) for Advancing Cancer Care is a new CMS program with specific metric criteria. The voluntary program has a Nov. 30, 2023, deadline for practices to sign up. The purpose of the program is to help practices identify areas where they can improve. Also, oncology societies such as the American Society of Clinical Oncology (ASCO) have developed metrics for this specialty.

Still, for many practices, it’s essential to develop your own metrics according to your patient population and available resources, explained Dr. Brieva.

Here are seven popular oncology metrics that many practices track to measure success.
 

1. Productivity

Every practice may think about productivity differently depending on whether it focuses on new patients, revenue, business development, or a combination. You can measure physician productivity in many ways: by the number of new patients per full-time employee (FTE), work relative value units (wRVU) per FTE, which measures physician work, and established patient visits.

Some clinics measure for wRVU for chemotherapy administration and per-hospital visits as a percentage of total patients as well. “We’re a community-based oncology practice, so we don’t use RVUs, but we do use other production numbers,” said Emily Touloukian, DO, an oncologist-hematologist and president of Coastal Cancer Center with four locations around South Carolina. She is assistant professor of internal medicine at the University of South Carolina, Columbia.

“There are lots of quality programs out there that measure how well oncology practices are meeting guidelines. The one we’ve participated with since its inception is [the] Quality Oncology Practice Initiative (QOPI) through [the] American Society of Clinical Oncology (ASCO),” said Dr. Touloukian. “Basically, it’s a chart review and extraction of various indicators in accordance with quality measures.”

Pontchartrain Cancer Center, with four locations around Louisiana, tracks the number of new patients in hematology and oncology by location and provider. They also track follow-up patients. New and follow-up patient metrics are broken down by visit code.

“The E&M code tells me the level of acuity that the physician coded for,” said Kathy Oubre, MS, the CEO of Pontchartrain. Patients with complicated cases get a higher-paying code since clinics get paid differently for each code. Ms. Oubre tracks the codes by provider and says if they bill every patient with the same code, it can put your practice at risk for an audit, even when it’s the lowest billable code.

In the 2019 ASCO survey, the number of new patient visits reported by participants averaged 301 visits per FTE. Established patient visits averaged 3,334.

“When we talk about metrics and how we measure things and how successful our practice is, productivity also has to do with how satisfied the people working for you and with you are,” said Dr. Touloukian.

“If you’re not providing a supportive workplace for your physicians and employees, you’re not going to be successful,” she said. “You’ll end up with doctors coming and going every 2 years, employees quitting all the time, and a need for retraining.” Instead, if you can create a welcoming, sustainable environment where people are happy to come to work, physicians aren’t burnt out, and get to spend time away from the clinic to recharge, productivity will be more successful. 


 

2. Revenue

When participating in their voluntary survey, practices can get a copy of revenue metric data annually from the Medical Group Management Association (MGMA). It collects the number of FTEs, gross revenue, net revenue, and collection rate and is broken down by specialties so your practice can benchmark against others. Total revenue, including oncologists’ salaries per FTE from the ASCO survey, was $7,323,900, but comparisons are difficult since practices differ in services.

Revenue metrics can consist of total revenue (cash collections), net medical excluding radiation services, drug revenue for infusion services, cash expenses including salaries, net accounts receivable, and gross accounts receivable minus contractual allowances and bad debt. Practices can differ on bad debt collection because of the emotional nature of cancer treatment. However, some use revenue cycle management companies with debt collection services; others find charity foundation funds for patients who can’t pay.

Pontchartrain also tracks when its clinic gets paid. Ms. Oubre said the best practice is that your claims receive payment within 21 days. They send claims out every 24 hours. “For example, most of that money is in drugs we’ve administered to patients we’ve likely already paid for.” Since there is a gap between paying their wholesaler for drugs and receiving reimbursement, they closely track claims and payment metrics.

Any claims that get sent back are refiled and sent out again within 24 hours. When claims hit 31 days without a response, the practice reaches out to learn the problem. “We’re proactive rather than waiting for the denial to come,” Ms. Oubre told this news organization. Dr. Brieva said for every revenue metric a practice tracks in which they’re not performing well, the practice has to find a solution. Are too many claims being denied? Do claim forms contain errors? Are most claims being paid in the 21-day window? Is the problem a user error, an issue with the clearinghouse, or an intake error on the other end? The key to successful metric use is to drill down for answers to these questions.
 

3. Patient satisfaction

Patient satisfaction may be one of the more straightforward metrics practices can track, though not specific to oncology. Dr. Brieva said most metric programs include patient satisfaction surveys against which you can benchmark your practice. You can also create your own emailed patient surveys. The metric can show how satisfied your patients are and how you compare against other practices.

Ms. Oubre said Pontchartrain also tracks metrics around participating in advanced care planning, survivorship care, and transitional care management. Even though most insurers require copays for these services, they’ve found patients who participate in them have an overall better experience.

“The Biden administration also has a Cancer Moon Shot initiative, which intends to reduce cancer deaths by 50% by 2047,” said Dr. Brieva. “They want to reduce deaths and improve the experience of patients. So, tracking survival rates will also be key for this program.”
 

4. Referrals

Oncology is typically a referral business. So, keeping track of the top referring physicians every quarter is the best way to ensure your referring clinicians are happy with your practice’s service. A best practice is that all new oncology referrals are seen within 48 hours. If your referral metric drops off, especially for top referrers, a physician from your practice should check in with the referrer.

Ms. Oubre runs reports out of the EMR and scrubs for referring providers, so she’s alerted to any issues. “It can be as simple as a front office staff who was rude on the phone,” she said. “We had an issue years ago with one of our schedulers who didn’t want to risk staying after 5:00 p.m., so she wouldn’t put anyone on the schedule after 3:00. But if I hadn’t called and identified that from the referring practitioner, I wouldn’t have known that they couldn’t get late-afternoon appointments at our clinic.”
 

5. No-show appointments

Practices track no-shows per week to determine which patients did not show up for their visits vs. those who rescheduled. If a patient on active treatment starts no-showing, practices must find out why. Is it a social or a transportation issue, or do they want to discontinue treatment? Often, you can help with the problem if you know what it is.

“Sometimes we can help from a social determinants of health perspective, helping to provide services like transportation, financial assistance, or other things, and patients appreciate that we would care enough to reach out to see if we can help,” said Ms. Oubre.

For recurring no-shows, practices should notify the referring provider. Letting the referring clinician know that the patient stopped coming is a professional courtesy that helps strengthen your referral relationships. You wouldn’t want the referring physician to think the patient is being treated for cancer only to find out later that they discontinued treatment.
 

6. Injections and infusions

By tracking the number of injections and infusions per location per week, clinics can assess how busy their chemo chairs are and how many injections they give. Benchmarks include the number of initial intravenous infusions/injections and the total number of drug administration services per patient per chair. Similar metrics in radiation oncology are helpful.

7. Pharmacy prescriptions

For practices with an in-house pharmacy, tracking how many prescriptions are written per week by each provider and whether they could fill them in-house or had to send them out to a specialty pharmacy because of an insurance issue tells you the volume of drugs your pharmacy is fulfilling. Point-of-care dispensing pharmacy revenue averaged $1,843,342 in the ASCO survey.

Dr. Brieva mentioned many other trackable metrics, such as the time to start treatment, adherence to treatment guidelines, rates of side effects and complications, patient retention rates, treatment completion rates, and coordination of care with other providers, which may be additional metrics your practice wants to track.

Dr. Touloukian said that practices must be careful how they measure some metrics because if you’re extracting data from the EMR and someone hasn’t entered it correctly, you won’t get accurate information. “I like programs like QOPI because while it’s a little labor intensive, my staff actually goes in and extracts the data from the charts and shows the proof.

“Comparing yourself to other [oncology] practices across the nation helps to ensure you’re achieving a certain level of success on some of these traditional metrics,” said Dr. Touloukian.

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

Ability to schedule a prompt appointment, patient satisfaction percentages, and revenue compared to cost – these are some metrics that oncology practices track to ensure they’re running a successful practice and see how they measure up against their peers.

“Once practices figure out what they want to measure, and obviously they want to measure things that they’re not doing so well, they can look for opportunities for improvement,” said Diana Berich Brieva, DHA, MBA, CPC-A, the CEO of Ambulatory Care Consultants, which partners with medical practices to optimize operations and increase revenue.

Benchmarking your practice against others shows you how your numbers stack up to other practices’ metrics by percentile – for instance, whether your revenue is in the 25th, 50th, or 75th percentile against similar practices.

The 2024 MIPS Value Pathways (MVP) for Advancing Cancer Care is a new CMS program with specific metric criteria. The voluntary program has a Nov. 30, 2023, deadline for practices to sign up. The purpose of the program is to help practices identify areas where they can improve. Also, oncology societies such as the American Society of Clinical Oncology (ASCO) have developed metrics for this specialty.

Still, for many practices, it’s essential to develop your own metrics according to your patient population and available resources, explained Dr. Brieva.

Here are seven popular oncology metrics that many practices track to measure success.
 

1. Productivity

Every practice may think about productivity differently depending on whether it focuses on new patients, revenue, business development, or a combination. You can measure physician productivity in many ways: by the number of new patients per full-time employee (FTE), work relative value units (wRVU) per FTE, which measures physician work, and established patient visits.

Some clinics measure for wRVU for chemotherapy administration and per-hospital visits as a percentage of total patients as well. “We’re a community-based oncology practice, so we don’t use RVUs, but we do use other production numbers,” said Emily Touloukian, DO, an oncologist-hematologist and president of Coastal Cancer Center with four locations around South Carolina. She is assistant professor of internal medicine at the University of South Carolina, Columbia.

“There are lots of quality programs out there that measure how well oncology practices are meeting guidelines. The one we’ve participated with since its inception is [the] Quality Oncology Practice Initiative (QOPI) through [the] American Society of Clinical Oncology (ASCO),” said Dr. Touloukian. “Basically, it’s a chart review and extraction of various indicators in accordance with quality measures.”

Pontchartrain Cancer Center, with four locations around Louisiana, tracks the number of new patients in hematology and oncology by location and provider. They also track follow-up patients. New and follow-up patient metrics are broken down by visit code.

“The E&M code tells me the level of acuity that the physician coded for,” said Kathy Oubre, MS, the CEO of Pontchartrain. Patients with complicated cases get a higher-paying code since clinics get paid differently for each code. Ms. Oubre tracks the codes by provider and says if they bill every patient with the same code, it can put your practice at risk for an audit, even when it’s the lowest billable code.

In the 2019 ASCO survey, the number of new patient visits reported by participants averaged 301 visits per FTE. Established patient visits averaged 3,334.

“When we talk about metrics and how we measure things and how successful our practice is, productivity also has to do with how satisfied the people working for you and with you are,” said Dr. Touloukian.

“If you’re not providing a supportive workplace for your physicians and employees, you’re not going to be successful,” she said. “You’ll end up with doctors coming and going every 2 years, employees quitting all the time, and a need for retraining.” Instead, if you can create a welcoming, sustainable environment where people are happy to come to work, physicians aren’t burnt out, and get to spend time away from the clinic to recharge, productivity will be more successful. 


 

2. Revenue

When participating in their voluntary survey, practices can get a copy of revenue metric data annually from the Medical Group Management Association (MGMA). It collects the number of FTEs, gross revenue, net revenue, and collection rate and is broken down by specialties so your practice can benchmark against others. Total revenue, including oncologists’ salaries per FTE from the ASCO survey, was $7,323,900, but comparisons are difficult since practices differ in services.

Revenue metrics can consist of total revenue (cash collections), net medical excluding radiation services, drug revenue for infusion services, cash expenses including salaries, net accounts receivable, and gross accounts receivable minus contractual allowances and bad debt. Practices can differ on bad debt collection because of the emotional nature of cancer treatment. However, some use revenue cycle management companies with debt collection services; others find charity foundation funds for patients who can’t pay.

Pontchartrain also tracks when its clinic gets paid. Ms. Oubre said the best practice is that your claims receive payment within 21 days. They send claims out every 24 hours. “For example, most of that money is in drugs we’ve administered to patients we’ve likely already paid for.” Since there is a gap between paying their wholesaler for drugs and receiving reimbursement, they closely track claims and payment metrics.

Any claims that get sent back are refiled and sent out again within 24 hours. When claims hit 31 days without a response, the practice reaches out to learn the problem. “We’re proactive rather than waiting for the denial to come,” Ms. Oubre told this news organization. Dr. Brieva said for every revenue metric a practice tracks in which they’re not performing well, the practice has to find a solution. Are too many claims being denied? Do claim forms contain errors? Are most claims being paid in the 21-day window? Is the problem a user error, an issue with the clearinghouse, or an intake error on the other end? The key to successful metric use is to drill down for answers to these questions.
 

3. Patient satisfaction

Patient satisfaction may be one of the more straightforward metrics practices can track, though not specific to oncology. Dr. Brieva said most metric programs include patient satisfaction surveys against which you can benchmark your practice. You can also create your own emailed patient surveys. The metric can show how satisfied your patients are and how you compare against other practices.

Ms. Oubre said Pontchartrain also tracks metrics around participating in advanced care planning, survivorship care, and transitional care management. Even though most insurers require copays for these services, they’ve found patients who participate in them have an overall better experience.

“The Biden administration also has a Cancer Moon Shot initiative, which intends to reduce cancer deaths by 50% by 2047,” said Dr. Brieva. “They want to reduce deaths and improve the experience of patients. So, tracking survival rates will also be key for this program.”
 

4. Referrals

Oncology is typically a referral business. So, keeping track of the top referring physicians every quarter is the best way to ensure your referring clinicians are happy with your practice’s service. A best practice is that all new oncology referrals are seen within 48 hours. If your referral metric drops off, especially for top referrers, a physician from your practice should check in with the referrer.

Ms. Oubre runs reports out of the EMR and scrubs for referring providers, so she’s alerted to any issues. “It can be as simple as a front office staff who was rude on the phone,” she said. “We had an issue years ago with one of our schedulers who didn’t want to risk staying after 5:00 p.m., so she wouldn’t put anyone on the schedule after 3:00. But if I hadn’t called and identified that from the referring practitioner, I wouldn’t have known that they couldn’t get late-afternoon appointments at our clinic.”
 

5. No-show appointments

Practices track no-shows per week to determine which patients did not show up for their visits vs. those who rescheduled. If a patient on active treatment starts no-showing, practices must find out why. Is it a social or a transportation issue, or do they want to discontinue treatment? Often, you can help with the problem if you know what it is.

“Sometimes we can help from a social determinants of health perspective, helping to provide services like transportation, financial assistance, or other things, and patients appreciate that we would care enough to reach out to see if we can help,” said Ms. Oubre.

For recurring no-shows, practices should notify the referring provider. Letting the referring clinician know that the patient stopped coming is a professional courtesy that helps strengthen your referral relationships. You wouldn’t want the referring physician to think the patient is being treated for cancer only to find out later that they discontinued treatment.
 

6. Injections and infusions

By tracking the number of injections and infusions per location per week, clinics can assess how busy their chemo chairs are and how many injections they give. Benchmarks include the number of initial intravenous infusions/injections and the total number of drug administration services per patient per chair. Similar metrics in radiation oncology are helpful.

7. Pharmacy prescriptions

For practices with an in-house pharmacy, tracking how many prescriptions are written per week by each provider and whether they could fill them in-house or had to send them out to a specialty pharmacy because of an insurance issue tells you the volume of drugs your pharmacy is fulfilling. Point-of-care dispensing pharmacy revenue averaged $1,843,342 in the ASCO survey.

Dr. Brieva mentioned many other trackable metrics, such as the time to start treatment, adherence to treatment guidelines, rates of side effects and complications, patient retention rates, treatment completion rates, and coordination of care with other providers, which may be additional metrics your practice wants to track.

Dr. Touloukian said that practices must be careful how they measure some metrics because if you’re extracting data from the EMR and someone hasn’t entered it correctly, you won’t get accurate information. “I like programs like QOPI because while it’s a little labor intensive, my staff actually goes in and extracts the data from the charts and shows the proof.

“Comparing yourself to other [oncology] practices across the nation helps to ensure you’re achieving a certain level of success on some of these traditional metrics,” said Dr. Touloukian.

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

Ability to schedule a prompt appointment, patient satisfaction percentages, and revenue compared to cost – these are some metrics that oncology practices track to ensure they’re running a successful practice and see how they measure up against their peers.

“Once practices figure out what they want to measure, and obviously they want to measure things that they’re not doing so well, they can look for opportunities for improvement,” said Diana Berich Brieva, DHA, MBA, CPC-A, the CEO of Ambulatory Care Consultants, which partners with medical practices to optimize operations and increase revenue.

Benchmarking your practice against others shows you how your numbers stack up to other practices’ metrics by percentile – for instance, whether your revenue is in the 25th, 50th, or 75th percentile against similar practices.

The 2024 MIPS Value Pathways (MVP) for Advancing Cancer Care is a new CMS program with specific metric criteria. The voluntary program has a Nov. 30, 2023, deadline for practices to sign up. The purpose of the program is to help practices identify areas where they can improve. Also, oncology societies such as the American Society of Clinical Oncology (ASCO) have developed metrics for this specialty.

Still, for many practices, it’s essential to develop your own metrics according to your patient population and available resources, explained Dr. Brieva.

Here are seven popular oncology metrics that many practices track to measure success.
 

1. Productivity

Every practice may think about productivity differently depending on whether it focuses on new patients, revenue, business development, or a combination. You can measure physician productivity in many ways: by the number of new patients per full-time employee (FTE), work relative value units (wRVU) per FTE, which measures physician work, and established patient visits.

Some clinics measure for wRVU for chemotherapy administration and per-hospital visits as a percentage of total patients as well. “We’re a community-based oncology practice, so we don’t use RVUs, but we do use other production numbers,” said Emily Touloukian, DO, an oncologist-hematologist and president of Coastal Cancer Center with four locations around South Carolina. She is assistant professor of internal medicine at the University of South Carolina, Columbia.

“There are lots of quality programs out there that measure how well oncology practices are meeting guidelines. The one we’ve participated with since its inception is [the] Quality Oncology Practice Initiative (QOPI) through [the] American Society of Clinical Oncology (ASCO),” said Dr. Touloukian. “Basically, it’s a chart review and extraction of various indicators in accordance with quality measures.”

Pontchartrain Cancer Center, with four locations around Louisiana, tracks the number of new patients in hematology and oncology by location and provider. They also track follow-up patients. New and follow-up patient metrics are broken down by visit code.

“The E&M code tells me the level of acuity that the physician coded for,” said Kathy Oubre, MS, the CEO of Pontchartrain. Patients with complicated cases get a higher-paying code since clinics get paid differently for each code. Ms. Oubre tracks the codes by provider and says if they bill every patient with the same code, it can put your practice at risk for an audit, even when it’s the lowest billable code.

In the 2019 ASCO survey, the number of new patient visits reported by participants averaged 301 visits per FTE. Established patient visits averaged 3,334.

“When we talk about metrics and how we measure things and how successful our practice is, productivity also has to do with how satisfied the people working for you and with you are,” said Dr. Touloukian.

“If you’re not providing a supportive workplace for your physicians and employees, you’re not going to be successful,” she said. “You’ll end up with doctors coming and going every 2 years, employees quitting all the time, and a need for retraining.” Instead, if you can create a welcoming, sustainable environment where people are happy to come to work, physicians aren’t burnt out, and get to spend time away from the clinic to recharge, productivity will be more successful. 


 

2. Revenue

When participating in their voluntary survey, practices can get a copy of revenue metric data annually from the Medical Group Management Association (MGMA). It collects the number of FTEs, gross revenue, net revenue, and collection rate and is broken down by specialties so your practice can benchmark against others. Total revenue, including oncologists’ salaries per FTE from the ASCO survey, was $7,323,900, but comparisons are difficult since practices differ in services.

Revenue metrics can consist of total revenue (cash collections), net medical excluding radiation services, drug revenue for infusion services, cash expenses including salaries, net accounts receivable, and gross accounts receivable minus contractual allowances and bad debt. Practices can differ on bad debt collection because of the emotional nature of cancer treatment. However, some use revenue cycle management companies with debt collection services; others find charity foundation funds for patients who can’t pay.

Pontchartrain also tracks when its clinic gets paid. Ms. Oubre said the best practice is that your claims receive payment within 21 days. They send claims out every 24 hours. “For example, most of that money is in drugs we’ve administered to patients we’ve likely already paid for.” Since there is a gap between paying their wholesaler for drugs and receiving reimbursement, they closely track claims and payment metrics.

Any claims that get sent back are refiled and sent out again within 24 hours. When claims hit 31 days without a response, the practice reaches out to learn the problem. “We’re proactive rather than waiting for the denial to come,” Ms. Oubre told this news organization. Dr. Brieva said for every revenue metric a practice tracks in which they’re not performing well, the practice has to find a solution. Are too many claims being denied? Do claim forms contain errors? Are most claims being paid in the 21-day window? Is the problem a user error, an issue with the clearinghouse, or an intake error on the other end? The key to successful metric use is to drill down for answers to these questions.
 

3. Patient satisfaction

Patient satisfaction may be one of the more straightforward metrics practices can track, though not specific to oncology. Dr. Brieva said most metric programs include patient satisfaction surveys against which you can benchmark your practice. You can also create your own emailed patient surveys. The metric can show how satisfied your patients are and how you compare against other practices.

Ms. Oubre said Pontchartrain also tracks metrics around participating in advanced care planning, survivorship care, and transitional care management. Even though most insurers require copays for these services, they’ve found patients who participate in them have an overall better experience.

“The Biden administration also has a Cancer Moon Shot initiative, which intends to reduce cancer deaths by 50% by 2047,” said Dr. Brieva. “They want to reduce deaths and improve the experience of patients. So, tracking survival rates will also be key for this program.”
 

4. Referrals

Oncology is typically a referral business. So, keeping track of the top referring physicians every quarter is the best way to ensure your referring clinicians are happy with your practice’s service. A best practice is that all new oncology referrals are seen within 48 hours. If your referral metric drops off, especially for top referrers, a physician from your practice should check in with the referrer.

Ms. Oubre runs reports out of the EMR and scrubs for referring providers, so she’s alerted to any issues. “It can be as simple as a front office staff who was rude on the phone,” she said. “We had an issue years ago with one of our schedulers who didn’t want to risk staying after 5:00 p.m., so she wouldn’t put anyone on the schedule after 3:00. But if I hadn’t called and identified that from the referring practitioner, I wouldn’t have known that they couldn’t get late-afternoon appointments at our clinic.”
 

5. No-show appointments

Practices track no-shows per week to determine which patients did not show up for their visits vs. those who rescheduled. If a patient on active treatment starts no-showing, practices must find out why. Is it a social or a transportation issue, or do they want to discontinue treatment? Often, you can help with the problem if you know what it is.

“Sometimes we can help from a social determinants of health perspective, helping to provide services like transportation, financial assistance, or other things, and patients appreciate that we would care enough to reach out to see if we can help,” said Ms. Oubre.

For recurring no-shows, practices should notify the referring provider. Letting the referring clinician know that the patient stopped coming is a professional courtesy that helps strengthen your referral relationships. You wouldn’t want the referring physician to think the patient is being treated for cancer only to find out later that they discontinued treatment.
 

6. Injections and infusions

By tracking the number of injections and infusions per location per week, clinics can assess how busy their chemo chairs are and how many injections they give. Benchmarks include the number of initial intravenous infusions/injections and the total number of drug administration services per patient per chair. Similar metrics in radiation oncology are helpful.

7. Pharmacy prescriptions

For practices with an in-house pharmacy, tracking how many prescriptions are written per week by each provider and whether they could fill them in-house or had to send them out to a specialty pharmacy because of an insurance issue tells you the volume of drugs your pharmacy is fulfilling. Point-of-care dispensing pharmacy revenue averaged $1,843,342 in the ASCO survey.

Dr. Brieva mentioned many other trackable metrics, such as the time to start treatment, adherence to treatment guidelines, rates of side effects and complications, patient retention rates, treatment completion rates, and coordination of care with other providers, which may be additional metrics your practice wants to track.

Dr. Touloukian said that practices must be careful how they measure some metrics because if you’re extracting data from the EMR and someone hasn’t entered it correctly, you won’t get accurate information. “I like programs like QOPI because while it’s a little labor intensive, my staff actually goes in and extracts the data from the charts and shows the proof.

“Comparing yourself to other [oncology] practices across the nation helps to ensure you’re achieving a certain level of success on some of these traditional metrics,” said Dr. Touloukian.

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

A new global analysis highlights the substantial burden of premature deaths from cancer around the world – a burden that could potentially be averted through prevention, early detection, and timely treatment.

According to the analysis, in 2020, over half of all cancer deaths – 5.28 million of 9.96 million – occurred prematurely (before age 70), leading to a loss of roughly 183 million life-years from the disease worldwide.

More than two-thirds of premature cancer-related deaths – 3.6 million, or 68% – were potentially preventable through lifestyle changes or early detection efforts, such as cancer screening, dietary changes, or smoking cessation, and about one-third – 1.65 million, or 31% – may have been treatable.

But two biostatisticians not involved in the study who took a deep dive into it urged caution in interpreting the data.

Nilanjan Chatterjee, PhD, Bloomberg Distinguished Professor, Bloomberg School of Public Health at Johns Hopkins University, Baltimore, said the study does a “great job in bringing a lot of diverse data together to show there is very high potential for preventing premature deaths due to cancer worldwide.”

However, for a variety of reasons, Dr. Chatterjee explained, one should not “overinterpret” the high percentage of potentially preventable cancer deaths.

Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong, in Australia, agreed.

“It’s likely many cancer deaths are, in theory, preventable, but the numbers around just how many are necessarily vague,” said Dr. Meyerowitz-Katz. “Also, ‘in theory preventable’ doesn’t necessarily mean that we can actually do it in practice.”
 

Invest in cancer prevention

The study, led by researchers from the World Health Organization’s International Agency for Research on Cancer and partners, provides estimates of premature deaths from 36 cancers across 185 countries.

The findings, published in The Lancet Global Health along with a new Lancet Commission report – “Women, Power, and Cancer” also highlighted the “underrecognized” cancer burden among women around the world.

Cancer ranks in the top three causes of premature mortality among women in almost all countries worldwide, but it is often “deprioritized,” the Lancet Commission report explained.

Of the nearly 5.3 million premature cancer deaths in 2020, 2.9 million occurred in men, and 2.3 million occurred in women, the investigators found. Of the premature deaths among women, 1.5 million could have potentially been avoided through prevention or detection efforts, while the remaining 800,000 might have been averted “if all women everywhere could access optimal cancer care,” the authors said.

Lung cancer was the leading contributor to preventable premature years of life lost in countries that have medium to very high scores on the Human Development Index (HDI), whereas cervical cancer was the leading contributor in low-HDI countries. HDI rankings are based on life expectancy, education, and gross national income.

Among women, as many as 72% of cancer death were premature in low-HDI countries, vs 36% in very high-HDI countries.

Overall, across all four tiers of HDI, colorectal and breast cancers represented the major treatable cancers.

Reducing exposure to four main risk factors – tobacco smoking, alcohol consumption, high body weight, and infections – would go a long way toward reducing potentially preventable premature cancer-related deaths, the authors said.

“Globally, there are marked inequalities between countries in reaching the target of reducing premature mortality from noncommunicable diseases, including cancer,” author Isabelle Soerjomataram, MD, PhD, deputy head of cancer surveillance at the International Agency for Research on Cancer, said in a press release.

“Greater investments in cancer prevention programs can reduce the prevalence of key risk factors for cancer, and increased coverage of vaccination alongside early diagnosis and screening linked to timely treatment can and must address the current cancer inequalities that are seen worldwide,” she added.
 

Caveats and cautionary notes

The authors acknowledge that the study has limitations related to its methodology and underlying assumptions. For instance, some premature cancer deaths that were classified as preventable may have been averted through curative therapy as well.

The findings also represent a snapshot of premature mortality in 2020 but do not necessarily predict progress in cancer control over time.

In Dr. Chatterjee’s view, this is “an excellent descriptive study that gives a good overall picture about the potential for saving a very large fraction of premature death due to cancer by implementing what is now known about primary and secondary interventions, and treatments.”

However, estimates for the effects of various risk factors and interventions are often derived from observational nonrandomized studies, which can have various types of biases, he said.

“Additionally, availability of data, observational or randomized, are often limited from many countries in Africa, Latin America, and Asia, where the cancer burdens are increasing,” Dr. Chatterjee told this news organization. “Therefore, extrapolating evidence generated mostly from North America and European countries to other understudied settings could be problematic due to difference in background in genetics, environment, socioeconomic, and cultural differences.”

Dr. Meyerowitz-Katz said the issue with this “very complex” article is that it includes “models built upon models, all of which include layers of assumptions that aren’t always obvious and may be wrong.”

On top of that, he said, “there are questions over whether the modifiable risk factors are really modifiable. Can we really get rid of 100% of ‘lack of physical exercise’? What would that even look like?”

Overall, Dr. Meyerowitz-Katz noted, “Yes, some proportion of these cancers could be prevented, and that percentage may be large, but the exact 70% estimate is very uncertain in my opinion.”

The study had no commercial funding. The authors, Dr. Chatterjee, and Dr. Meyerowitz-Katz have disclosed no relevant financial relationships.

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

A new global analysis highlights the substantial burden of premature deaths from cancer around the world – a burden that could potentially be averted through prevention, early detection, and timely treatment.

According to the analysis, in 2020, over half of all cancer deaths – 5.28 million of 9.96 million – occurred prematurely (before age 70), leading to a loss of roughly 183 million life-years from the disease worldwide.

More than two-thirds of premature cancer-related deaths – 3.6 million, or 68% – were potentially preventable through lifestyle changes or early detection efforts, such as cancer screening, dietary changes, or smoking cessation, and about one-third – 1.65 million, or 31% – may have been treatable.

But two biostatisticians not involved in the study who took a deep dive into it urged caution in interpreting the data.

Nilanjan Chatterjee, PhD, Bloomberg Distinguished Professor, Bloomberg School of Public Health at Johns Hopkins University, Baltimore, said the study does a “great job in bringing a lot of diverse data together to show there is very high potential for preventing premature deaths due to cancer worldwide.”

However, for a variety of reasons, Dr. Chatterjee explained, one should not “overinterpret” the high percentage of potentially preventable cancer deaths.

Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong, in Australia, agreed.

“It’s likely many cancer deaths are, in theory, preventable, but the numbers around just how many are necessarily vague,” said Dr. Meyerowitz-Katz. “Also, ‘in theory preventable’ doesn’t necessarily mean that we can actually do it in practice.”
 

Invest in cancer prevention

The study, led by researchers from the World Health Organization’s International Agency for Research on Cancer and partners, provides estimates of premature deaths from 36 cancers across 185 countries.

The findings, published in The Lancet Global Health along with a new Lancet Commission report – “Women, Power, and Cancer” also highlighted the “underrecognized” cancer burden among women around the world.

Cancer ranks in the top three causes of premature mortality among women in almost all countries worldwide, but it is often “deprioritized,” the Lancet Commission report explained.

Of the nearly 5.3 million premature cancer deaths in 2020, 2.9 million occurred in men, and 2.3 million occurred in women, the investigators found. Of the premature deaths among women, 1.5 million could have potentially been avoided through prevention or detection efforts, while the remaining 800,000 might have been averted “if all women everywhere could access optimal cancer care,” the authors said.

Lung cancer was the leading contributor to preventable premature years of life lost in countries that have medium to very high scores on the Human Development Index (HDI), whereas cervical cancer was the leading contributor in low-HDI countries. HDI rankings are based on life expectancy, education, and gross national income.

Among women, as many as 72% of cancer death were premature in low-HDI countries, vs 36% in very high-HDI countries.

Overall, across all four tiers of HDI, colorectal and breast cancers represented the major treatable cancers.

Reducing exposure to four main risk factors – tobacco smoking, alcohol consumption, high body weight, and infections – would go a long way toward reducing potentially preventable premature cancer-related deaths, the authors said.

“Globally, there are marked inequalities between countries in reaching the target of reducing premature mortality from noncommunicable diseases, including cancer,” author Isabelle Soerjomataram, MD, PhD, deputy head of cancer surveillance at the International Agency for Research on Cancer, said in a press release.

“Greater investments in cancer prevention programs can reduce the prevalence of key risk factors for cancer, and increased coverage of vaccination alongside early diagnosis and screening linked to timely treatment can and must address the current cancer inequalities that are seen worldwide,” she added.
 

Caveats and cautionary notes

The authors acknowledge that the study has limitations related to its methodology and underlying assumptions. For instance, some premature cancer deaths that were classified as preventable may have been averted through curative therapy as well.

The findings also represent a snapshot of premature mortality in 2020 but do not necessarily predict progress in cancer control over time.

In Dr. Chatterjee’s view, this is “an excellent descriptive study that gives a good overall picture about the potential for saving a very large fraction of premature death due to cancer by implementing what is now known about primary and secondary interventions, and treatments.”

However, estimates for the effects of various risk factors and interventions are often derived from observational nonrandomized studies, which can have various types of biases, he said.

“Additionally, availability of data, observational or randomized, are often limited from many countries in Africa, Latin America, and Asia, where the cancer burdens are increasing,” Dr. Chatterjee told this news organization. “Therefore, extrapolating evidence generated mostly from North America and European countries to other understudied settings could be problematic due to difference in background in genetics, environment, socioeconomic, and cultural differences.”

Dr. Meyerowitz-Katz said the issue with this “very complex” article is that it includes “models built upon models, all of which include layers of assumptions that aren’t always obvious and may be wrong.”

On top of that, he said, “there are questions over whether the modifiable risk factors are really modifiable. Can we really get rid of 100% of ‘lack of physical exercise’? What would that even look like?”

Overall, Dr. Meyerowitz-Katz noted, “Yes, some proportion of these cancers could be prevented, and that percentage may be large, but the exact 70% estimate is very uncertain in my opinion.”

The study had no commercial funding. The authors, Dr. Chatterjee, and Dr. Meyerowitz-Katz have disclosed no relevant financial relationships.

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

A new global analysis highlights the substantial burden of premature deaths from cancer around the world – a burden that could potentially be averted through prevention, early detection, and timely treatment.

According to the analysis, in 2020, over half of all cancer deaths – 5.28 million of 9.96 million – occurred prematurely (before age 70), leading to a loss of roughly 183 million life-years from the disease worldwide.

More than two-thirds of premature cancer-related deaths – 3.6 million, or 68% – were potentially preventable through lifestyle changes or early detection efforts, such as cancer screening, dietary changes, or smoking cessation, and about one-third – 1.65 million, or 31% – may have been treatable.

But two biostatisticians not involved in the study who took a deep dive into it urged caution in interpreting the data.

Nilanjan Chatterjee, PhD, Bloomberg Distinguished Professor, Bloomberg School of Public Health at Johns Hopkins University, Baltimore, said the study does a “great job in bringing a lot of diverse data together to show there is very high potential for preventing premature deaths due to cancer worldwide.”

However, for a variety of reasons, Dr. Chatterjee explained, one should not “overinterpret” the high percentage of potentially preventable cancer deaths.

Gideon Meyerowitz-Katz, PhD, an epidemiologist at the University of Wollongong, in Australia, agreed.

“It’s likely many cancer deaths are, in theory, preventable, but the numbers around just how many are necessarily vague,” said Dr. Meyerowitz-Katz. “Also, ‘in theory preventable’ doesn’t necessarily mean that we can actually do it in practice.”
 

Invest in cancer prevention

The study, led by researchers from the World Health Organization’s International Agency for Research on Cancer and partners, provides estimates of premature deaths from 36 cancers across 185 countries.

The findings, published in The Lancet Global Health along with a new Lancet Commission report – “Women, Power, and Cancer” also highlighted the “underrecognized” cancer burden among women around the world.

Cancer ranks in the top three causes of premature mortality among women in almost all countries worldwide, but it is often “deprioritized,” the Lancet Commission report explained.

Of the nearly 5.3 million premature cancer deaths in 2020, 2.9 million occurred in men, and 2.3 million occurred in women, the investigators found. Of the premature deaths among women, 1.5 million could have potentially been avoided through prevention or detection efforts, while the remaining 800,000 might have been averted “if all women everywhere could access optimal cancer care,” the authors said.

Lung cancer was the leading contributor to preventable premature years of life lost in countries that have medium to very high scores on the Human Development Index (HDI), whereas cervical cancer was the leading contributor in low-HDI countries. HDI rankings are based on life expectancy, education, and gross national income.

Among women, as many as 72% of cancer death were premature in low-HDI countries, vs 36% in very high-HDI countries.

Overall, across all four tiers of HDI, colorectal and breast cancers represented the major treatable cancers.

Reducing exposure to four main risk factors – tobacco smoking, alcohol consumption, high body weight, and infections – would go a long way toward reducing potentially preventable premature cancer-related deaths, the authors said.

“Globally, there are marked inequalities between countries in reaching the target of reducing premature mortality from noncommunicable diseases, including cancer,” author Isabelle Soerjomataram, MD, PhD, deputy head of cancer surveillance at the International Agency for Research on Cancer, said in a press release.

“Greater investments in cancer prevention programs can reduce the prevalence of key risk factors for cancer, and increased coverage of vaccination alongside early diagnosis and screening linked to timely treatment can and must address the current cancer inequalities that are seen worldwide,” she added.
 

Caveats and cautionary notes

The authors acknowledge that the study has limitations related to its methodology and underlying assumptions. For instance, some premature cancer deaths that were classified as preventable may have been averted through curative therapy as well.

The findings also represent a snapshot of premature mortality in 2020 but do not necessarily predict progress in cancer control over time.

In Dr. Chatterjee’s view, this is “an excellent descriptive study that gives a good overall picture about the potential for saving a very large fraction of premature death due to cancer by implementing what is now known about primary and secondary interventions, and treatments.”

However, estimates for the effects of various risk factors and interventions are often derived from observational nonrandomized studies, which can have various types of biases, he said.

“Additionally, availability of data, observational or randomized, are often limited from many countries in Africa, Latin America, and Asia, where the cancer burdens are increasing,” Dr. Chatterjee told this news organization. “Therefore, extrapolating evidence generated mostly from North America and European countries to other understudied settings could be problematic due to difference in background in genetics, environment, socioeconomic, and cultural differences.”

Dr. Meyerowitz-Katz said the issue with this “very complex” article is that it includes “models built upon models, all of which include layers of assumptions that aren’t always obvious and may be wrong.”

On top of that, he said, “there are questions over whether the modifiable risk factors are really modifiable. Can we really get rid of 100% of ‘lack of physical exercise’? What would that even look like?”

Overall, Dr. Meyerowitz-Katz noted, “Yes, some proportion of these cancers could be prevented, and that percentage may be large, but the exact 70% estimate is very uncertain in my opinion.”

The study had no commercial funding. The authors, Dr. Chatterjee, and Dr. Meyerowitz-Katz have disclosed no relevant financial relationships.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

MADRID – Should patients with resectable non–small cell lung cancer (NSCLC) receive adjuvant therapy, neoadjuvant therapy, or both, experts asked during a special session at the European Society for Medical Oncology 2023 Congress.

Though immunotherapy is beneficial in resectable NSCLC, “we actually don’t know how much of the effect [is due to] the adjuvant and how much to the neoadjuvant therapy,” said Silke Gillessen, MD, head of the department of medical oncology, Università della Svizzera Italiana in Lugano, Switzerland.

Opening the session, Enriqueta Felip, MD, PhD, argued in favor of adjuvant therapy alone in resectable NSCLC.

Adjuvant immunotherapy after adjuvant chemotherapy is already considered standard of care for patients with resected NSCLC who don’t harbor EGFR and ALK mutations, explained Dr. Felip, head of the lung cancer unit at Vall d’Hebron University Hospital in Barcelona.

One major benefit to providing adjuvant therapy is that curative surgery won’t be delayed. Neoadjuvant therapy, on the other hand, leads about 15% of patients to forgo surgery, and about 30% who have both neoadjuvant therapy and surgery end up not receiving their planned adjuvant immunotherapy.

Another benefit: Emerging evidence suggests that the adjuvant-only option can improve disease-free and overall survival in select patients.

In the IMpower010 trial, for instance, adjuvant atezolizumab led to a marked improvement in disease-free survival, compared with best supportive care in patients with stage II-IIIA NSCLC. Patients with programmed death–ligand 1 expression of 50% or higher also demonstrated an overall survival benefit (hazard ratio, 0.42).

In the KEYNOTE-091 trial, adjuvant pembrolizumab significantly improved disease-free survival in all comers vs. placebo in patients with stage IB, II, or IIIA NSCLC who had surgery (HR, 0.76).

Providing adjuvant-only immunotherapy also allows for biomarker testing in resected specimens, Dr. Felip said, which may affect the choice of systemic therapy.

Next, Rafal Dziadziuszko, MD, PhD, argued in favor of neoadjuvant therapy alone in the setting of resectable NSCLC.

The advantages of providing treatment before surgery include initiating systemic treatment at an earlier point when most relapses are distant, possibly reducing the risk for tumor cell seeding during surgery as well as potentially leading to less invasive surgery by shrinking the tumors.

Dr. Dziadziuszko, from the Medical University of Gdansk in Poland, highlighted data from the Checkmate 816 trial, which showed that neoadjuvant nivolumab plus chemotherapy vs. chemotherapy alone increased the chance of having a pathologic complete response by nearly 14-fold in patients with IB-IIIA resectable NSCLC. Patients in the combination arm also demonstrated marked improvements in event-free survival, 31.6 months vs. 20.8 months, and overall survival.

The NADIM II trial, which coupled nivolumab and chemotherapy in stage III disease, found that neoadjuvant chemoimmunotherapy led to a pathologic complete response as well as a 52% improvement in progression-free survival and a 60% improvement in overall survival, compared with chemotherapy alone.

Despite these findings, several important questions remain, said Dr. Dziadziuszko. How many cycles of neoadjuvant immunochemotherapy should a patient receive before surgery? Will neoadjuvant therapy lead to treatment-related adverse events that preclude surgery? And for those who don’t have a strong response to neoadjuvant therapy, who should also receive adjuvant immunotherapy and for how long?

The latter question represents the “elephant in the room,” session chair Tony S. K. Mok, MD, chairman, department of clinical oncology, The Chinese University of Hong Kong.

With a paucity of overall survival data to provide a definitive answer, oncologists still face the age-old concern of “giving too much therapy in those who don’t need it” and “giving not enough therapy for those who need more,” said Dr. Mok.

Federico Cappuzzo, MD, PhD, argued that the key to patient selection for adjuvant therapy after neoadjuvant therapy and surgery lies in who has a pathologic complete response.

The current data suggest that patients receiving neoadjuvant therapy who achieve a pathologic complete response likely do not need adjuvant therapy whereas those who don’t achieve a complete response should receive adjuvant therapy, explained Dr. Cappuzzo, director of the department of oncology and hematology, AUSL della Romagna, Ravenna, Italy.

But, Dr. Mok asked, what about patients who achieve a major pathologic response in which the percentage of residual viable tumor is 10% or less or achieve less than a major pathologic response?

Dr. Mok suggested that measurable residual disease, which is indicative of recurrence, could potentially be used to determine the treatment pathway after neoadjuvant therapy and signal who may benefit from adjuvant therapy. However, he noted, studies evaluating the benefit of adjuvant therapy in this population would need to be done.

For patients who don’t respond well to neoadjuvant therapy and may benefit from adjuvant therapy, the question also becomes: “Do we give more of that same therapy?” asked Zofia Piotrowska, MD, a lung cancer medical oncologist at Massachusetts General Hospital Cancer Center, Boston, who was not involved in the debate.

“I think we really need to rethink that paradigm and try to develop new therapies that may work more effectively for those patients, to improve their outcomes,” Dr. Piotrowska said.

Dr. Mok declared relationships with a range of companies, including AstraZeneca, Boehringer Ingelheim, Pfizer, Novartis, SFJ Pharmaceuticals Roche, Merck Sharp & Dohme, and HutchMed. Dr. Felip declared relationships with AbbVie, Amgen, AstraZeneca, Bayer, Bristol-Myers Squibb, Daiichi Sankyo, Eli Lilly, F Hoffman–La Roche, Genentech, GlaxoSmithKline, Novartis, and others. Dr. Dziadziuszko declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Takeda, Pfizer, Novartis, and others. Dr. Cappuzzo declared relationships with Roche, AstraZeneca, Bristol-Myers Squibb, Pfizer, Takeda, Lilly, Bayer, Amgen, Sanofi, and others.

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

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

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

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

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

VANCOUVER – Two multitarget stool tests in development compare favorably for colorectal cancer (CRC) screening in average-risk people, suggest two new studies.

In a blinded, prospective, cross-sectional study, researchers assessed a multitarget stool RNA test (mt-sRNA; Colosense, Geneoscopy) vs. colonoscopy for detection of advanced adenomas and CRC in average-risk individuals aged 45 years and older.

In a prospective, cross-sectional study, investigators evaluated the clinical performance of a next-generation multitarget stool DNA (mt-sDNA; Cologuard, Exact Sciences) and fecal hemoglobin assay for CRC screening in adults aged 40 years and older.

Both studies were presented at the ACG: American College of Gastroenterology 2023 Annual Scientific Meeting.
 

RNA as a biomarker

For CRC-PREVENT, which evaluated the mt-sRNA test, David Lieberman, MD, professor of medicine and former chief of the division of gastroenterology and hepatology at the Oregon Health & Science University, Portland, and colleagues recruited a diverse group of 8,289 adults undergoing colonoscopy at one of more than 3,800 endoscopy centers nationwide. Recruitment included outreach through social media, which could be used to improve future screening rates, Dr. Lieberman said.

The full study findings of CRC-PREVENT were also published online in the Journal of the American Medical Association.

Participants provided stool samples before colonoscopy. Colosense includes a commercially available fecal immunochemical test (FIT) and tests for eight different strands of RNA. The mt-sRNA test results were compared with the colonoscopy results.

The mt-sRNA test had 100% sensitivity for early, stage I cancers, which were detected in 12 patients. Advanced adenomas were detected with an overall sensitivity of 45%. When the advanced adenomas were ≥ 2 cm, sensitivity increased to 51%.

Specificity was 87% among patients with negative findings for hyperplastic polyps or lesions.

The mt-sRNA test showed significant improvements in sensitivity for CRC (94% vs. 77%; P = .029) and advanced adenomas (45% vs 29%; P < .001), when compared with the FIT results alone.

“This is the first large study to include the 45- to 49-year-old population, for whom screening is now recommended,” Dr. Lieberman told this news organization.

Results show a sensitivity of 100% for detecting CRC and 44% for advanced adenomas in this younger age group. That performance is “excellent,” said Dr. Lieberman.

Results also were reliable across all ages.

“The consistent performance across all age groups for whom screening is recommended is a key finding and was totally unknown” before this study, Dr. Lieberman said.

RNA-based testing may have an advantage over DNA biomarker tests, which can be prone to age-related DNA methylation changes, he added.
 

Detection by DNA

Thomas Imperiale, MD, distinguished professor of medicine at Indiana University, Indianapolis, and colleagues conducted the BLUE-C trial to validate the next-generation mt-sDNA test for CRC screening.

The mt-sDNA assay tests for three novel methylated DNA markers and fecal hemoglobin.

Dr. Imperiale and colleagues studied 20,176 adults (mean age, 63 years) scheduled for screening colonoscopy at one of 186 U.S. sites. Participants provided a stool sample for the mt-sDNA test and comparator FIT prior to colonoscopy preparation. They compared results to colonoscopy and FIT findings.

Colonoscopy revealed 98 people with CRC, 2,144 with advanced precancerous lesions, and 17,934 with no advanced neoplasia.

Sensitivity of the mt-sDNA test for detecting CRC was 93.9% (95% confidence interval, 87.1-97.7), advanced precancerous lesions was 43.4% (95% CI, 41.3-45.6), and advanced precancerous lesions with high-grade dysplasia was 74.6% (95% CI, 65.6-82.3).

Sensitivities of the mt-sDNA test for detecting CRC and advanced precancerous lesions were significantly higher than FIT (P < .0001).

In terms of specificity, the mt-sDNA test had a specificity of 90.6% (95% CI, 90.1-91.0) for the absence of advanced neoplasia. Specificity for non-neoplastic findings or negative colonoscopy was 92.7% (95% CI, 92.2-93.1).

The mt-sDNA test demonstrated high specificity and high CRC and advanced precancerous lesion sensitivity. The test outperformed FIT for these factors on sensitivity but not specificity, the authors noted.

Improved specificity was a goal of developing this next-generation assay. The BLUE-C trial demonstrated a 30% improvement in specificity that “will decrease the number of unnecessary colonoscopies performed for false-positive results,” said Dr. Imperiale.

“I was pleased to see the robust results support this new battery of markers,” Dr. Imperiale added. Improvements associated with this next-generation test could “help further reduce the incidence of and mortality from colorectal cancer.”
 

Tests to provide more noninvasive options

Both are “important studies” that look at a large, average-risk screening population in the United States, said Aasma Shaukat, MD, MPH, who was not affiliated with the research. “Both show high sensitivity for detecting CRC and decent specificity for advanced adenomas.”

While we will have to wait for the full publications, U.S. Food and Drug Administration approvals, and insurance coverage, gastroenterologists can expect to see these tests in clinical use in the near future, added Dr. Shaukat, professor of medicine and population health at NYU Langone Health, New York, and lead author of the ACG 2021 Colorectal Cancer Screening Guidelines.

These tests provide more noninvasive options for CRC screening and are more accurate, which hopefully will translate into increased screening and a reduced burden of CRC, she said.

“We are always looking for ways to increase colon cancer screening uptake,” said Brooks Cash, MD, professor and chief of the division of gastroenterology, hepatology, and nutrition at the University of Texas, Houston, who also was not affiliated with the research.

Certainly, the multitarget stool DNA is not a new concept with Cologuard, but it is a new assay, Dr. Cash said.

“It’s significantly different than their previous version, and they were able to show improved sensitivity as well as specificity, which has been one of the concerns,” he said.

The multitarget stool RNA test “shows very similar results,” Dr. Cash added. “Their predicate is that it’s slightly different and actually may return very good sensitivity for older patients, where you don’t have the same methylation issues with the DNA.”

“It will be interesting to see how they play out,” he added.

“The critical part to all of these tests is that if a patient has a positive test, they need to get a colonoscopy. That doesn’t always happen,” Dr. Cash said. “We have to make sure that there’s appropriate education for not only patients but also providers, many of whom will not be gastroenterologists.”

Geneoscopy funded the CRC-PREVENT trial. Exact Sciences funded the BLUE-C trial. Dr. Lieberman is an advisor or review panel member for Geneoscopy. Dr. Imperiale receives grant or research support from Exact Sciences. Dr. Shaukat reports no relevant financial relationships. Dr. Cash is on the advisory board for Exact Sciences.

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