A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.

According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.

The settlement resolves a federal lawsuit brought by Washington State Attorney General Bob Ferguson that accused the doctor of illegally suppressing patients’ negative reviews by “forcing” them to sign nondisclosure agreements (NDAs) before they received care. In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).

“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”

In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.

The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.” 

The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.

In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.

Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.

After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.

The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.

In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:

• Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
• Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
• Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
• Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.

Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.

The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.

Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.

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

A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.

According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.

The settlement resolves a federal lawsuit brought by Washington State Attorney General Bob Ferguson that accused the doctor of illegally suppressing patients’ negative reviews by “forcing” them to sign nondisclosure agreements (NDAs) before they received care. In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).

“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”

In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.

The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.” 

The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.

In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.

Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.

After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.

The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.

In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:

• Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
• Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
• Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
• Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.

Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.

The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.

Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.

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

A Seattle plastic surgeon who illegally restricted patients from posting negative reviews about his practice and directed his staff to post fake positive reviews will pay $5 million for violating Washington state’s consumer protection law.

According to a July 1 consent decree, Javad Sajan, MD, and his practice Allure Esthetic must pay $1.5 million in restitution to 21,000 patients and $3.5 million to the state for manipulation of patient ratings.

The settlement resolves a federal lawsuit brought by Washington State Attorney General Bob Ferguson that accused the doctor of illegally suppressing patients’ negative reviews by “forcing” them to sign nondisclosure agreements (NDAs) before they received care. In an April decision, US District Judge Ricardo S. Martinez sided with the state, ruling that Allure Esthetic’s actions violated the federal Consumer Review Fairness Act (CRFA).

“Writing a truthful review about a business should not subject you to threats or intimidation,” Mr. Ferguson said in a July 2 statement. “Consumers rely on reviews when determining who to trust, especially services that affect their health and safety. This resolution holds Allure accountable for brazenly violating that trust — and the law — and ensures the clinic stops its harmful conduct.”

In court documents, Dr. Sajan’s attorneys had argued that the agreements did not violate CRFA because patients had the opportunity to modify the language or decline signing them.

The surgeon’s practice is “pleased to have resolved its case with the Attorney General’s Office,” according to a statement provided by Dr. Sajan’s attorney. “The cooperative settlement, while not admitting fault and resolving claims asserted by both sides, allows Allure Esthetic to continue to focus on its core mission of providing compassionate care to patients and serving the community. The decision to settle was not an easy one, but it was necessary to allocate time and resources where they matter most — the patients.” 

The dispute stemmed from NDAs that Dr. Sajan’s practice required patients to sign starting in 2017, according to Mr. Ferguson’s complaint. The terms instructed patients to contact the business directly if they had concerns rather than post a negative review.

If patients posted negative reviews, the clinic, in some cases, threatened litigation, according to the lawsuit. In other cases, patients were allegedly offered money and free services in exchange for taking the reviews down. Patients who accepted cash or services were required to sign a second agreement forbidding them from posting future negative reviews and imposing a $250,000 penalty for failure to comply, according to court documents.

In addition, Mr. Ferguson accused Dr. Sajan of creating fake positive accounts of patient experiences and buying fake followers on social media. State investigators found Dr. Sajan directed Allure Esthetic’s employees to create fake Gmail accounts to post the false reviews, many of which are still online today, according to the state’s complaint.

Mr. Ferguson also claimed Dr. Sajan and his practice manipulated social media to appear more popular by purchasing followers through an online vendor. The practice also allegedly used a social media bot tool to buy thousands of fake likes on Instagram, YouTube, and other social media.

After filing the lawsuit, Mr. Ferguson’s office uncovered further evidence of Dr. Sajan’s efforts to influence his professional reputation through fabrication, according to the July 2 release. Allure Esthetic “rigged” “best doctor” competitions hosted by local media outlets by paying staff and contractors to vote for Dr. Sajan as “best plastic surgeon” in the region, according to the release. The staff cast as many votes as websites allowed, despite not being patients of Allure Esthetic.

The practice also allegedly edited before-and-after photos of patients to make their results appear better and kept tens of thousands of dollars in rebates intended for its patients.

In addition to paying $5 million, the consent decree requires Dr. Sajan and his practice also:

• Stop posting or influencing consumer reviews; perform a full audit of all public reviews on Google, Yelp, and other third-party review platforms; and request removal of every review Allure Esthetic was involved in creating, posting, or shaping in any manner.
• Remove all misleading “before-and-after” photographs of plastic surgery procedures from its website and social media and stop altering photographs of future procedures.
• Cease use of and attempts to enforce all illegal NDAs and notify patients who previously signed them that they are released from the terms of those NDAs.
• Pay a third-party forensic accounting firm to perform a full, independent audit of Allure Esthetic’s consumer rebate program to identify consumers who are owed rebates that were unlawfully claimed by Allure Esthetic.

Additionally, the attorney general’s office will continue to monitor Allure Esthetic, and upon request, the practice must provide information that demonstrates its compliance with the consent decree for the next 10 years.

The practice must also develop internal policies and implement a training program to educate staff about nondeceptive advertising and compliance with consumer protection laws.

Dr. Sajan and his practice agreed to the terms of the consent decree, and the settlement is not considered an admission of liability.

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

TOPLINE:

Patients taking a glucagon-like peptide 1 receptor agonist (GLP-1 RA) experience only a modest delay in gastric emptying of solid foods and no significant delay for liquids, compared with those receiving placebo, indicating that patients may not need to discontinue these medications before surgery.

METHODOLOGY:

• GLP-1 RAs, while effective in managing diabetes and obesity, are linked to delayed gastric emptying, which may pose risks during procedures requiring anesthesia or sedation due to potential aspiration of gastric contents.
• Researchers conducted a meta-analysis to quantify the duration of delay in gastric emptying caused by GLP-1 RAs in patients with diabetes and/or excessive body weight, which could guide periprocedural management decisions in the future.
• The primary outcome was halftime, the time required for 50% of solid gastric contents to empty, measured using scintigraphy. This analysis included data from five studies involving 247 patients who received either a GLP-1 RA or placebo.
• The secondary outcome was gastric emptying of liquids measured using the acetaminophen absorption test. Ten studies including 411 patients who received either a GLP-1 RA or placebo were included in this analysis.

TAKEAWAY:

• The mean gastric emptying halftime for solid foods was 138.4 minutes with a GLP-1 RA and 95.0 minutes with placebo, resulting in a pooled mean difference of 36.0 minutes (P < .01).
• No significant difference was found in the gastric emptying time for liquids between the GLP-1 RA and placebo groups. Furthermore, the amount of gastric emptying noted at 4 or 5 hours on the acetaminophen absorption test was comparable between these groups.
• The gastric emptying time for both solids and liquids did not differ between GLP-1 RA formulations or between short-acting or long-acting GLP-1 RAs.

IN PRACTICE:

“Based on current evidence, a conservative approach with a liquid diet on the day before procedures while continuing GLP-1 RA therapy would represent the most sensible approach until more conclusive data on a solid diet are available,” the authors wrote.

SOURCE:

The study, led by Brent Hiramoto, MD, MPH, of the Center for Gastrointestinal Motility at Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The small number of studies utilizing some diagnostic modalities, such as breath testing, precluded a formal meta-analysis of these subgroups. The results could not be stratified by indication for GLP-1 RA (diabetes or obesity) because of insufficient studies in each category.

DISCLOSURES:

The lead author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. One author declared serving on the advisory boards of three pharmaceutical companies.

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

TOPLINE:

Patients taking a glucagon-like peptide 1 receptor agonist (GLP-1 RA) experience only a modest delay in gastric emptying of solid foods and no significant delay for liquids, compared with those receiving placebo, indicating that patients may not need to discontinue these medications before surgery.

METHODOLOGY:

• GLP-1 RAs, while effective in managing diabetes and obesity, are linked to delayed gastric emptying, which may pose risks during procedures requiring anesthesia or sedation due to potential aspiration of gastric contents.
• Researchers conducted a meta-analysis to quantify the duration of delay in gastric emptying caused by GLP-1 RAs in patients with diabetes and/or excessive body weight, which could guide periprocedural management decisions in the future.
• The primary outcome was halftime, the time required for 50% of solid gastric contents to empty, measured using scintigraphy. This analysis included data from five studies involving 247 patients who received either a GLP-1 RA or placebo.
• The secondary outcome was gastric emptying of liquids measured using the acetaminophen absorption test. Ten studies including 411 patients who received either a GLP-1 RA or placebo were included in this analysis.

TAKEAWAY:

• The mean gastric emptying halftime for solid foods was 138.4 minutes with a GLP-1 RA and 95.0 minutes with placebo, resulting in a pooled mean difference of 36.0 minutes (P < .01).
• No significant difference was found in the gastric emptying time for liquids between the GLP-1 RA and placebo groups. Furthermore, the amount of gastric emptying noted at 4 or 5 hours on the acetaminophen absorption test was comparable between these groups.
• The gastric emptying time for both solids and liquids did not differ between GLP-1 RA formulations or between short-acting or long-acting GLP-1 RAs.

IN PRACTICE:

“Based on current evidence, a conservative approach with a liquid diet on the day before procedures while continuing GLP-1 RA therapy would represent the most sensible approach until more conclusive data on a solid diet are available,” the authors wrote.

SOURCE:

The study, led by Brent Hiramoto, MD, MPH, of the Center for Gastrointestinal Motility at Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The small number of studies utilizing some diagnostic modalities, such as breath testing, precluded a formal meta-analysis of these subgroups. The results could not be stratified by indication for GLP-1 RA (diabetes or obesity) because of insufficient studies in each category.

DISCLOSURES:

The lead author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. One author declared serving on the advisory boards of three pharmaceutical companies.

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

TOPLINE:

Patients taking a glucagon-like peptide 1 receptor agonist (GLP-1 RA) experience only a modest delay in gastric emptying of solid foods and no significant delay for liquids, compared with those receiving placebo, indicating that patients may not need to discontinue these medications before surgery.

METHODOLOGY:

• GLP-1 RAs, while effective in managing diabetes and obesity, are linked to delayed gastric emptying, which may pose risks during procedures requiring anesthesia or sedation due to potential aspiration of gastric contents.
• Researchers conducted a meta-analysis to quantify the duration of delay in gastric emptying caused by GLP-1 RAs in patients with diabetes and/or excessive body weight, which could guide periprocedural management decisions in the future.
• The primary outcome was halftime, the time required for 50% of solid gastric contents to empty, measured using scintigraphy. This analysis included data from five studies involving 247 patients who received either a GLP-1 RA or placebo.
• The secondary outcome was gastric emptying of liquids measured using the acetaminophen absorption test. Ten studies including 411 patients who received either a GLP-1 RA or placebo were included in this analysis.

TAKEAWAY:

• The mean gastric emptying halftime for solid foods was 138.4 minutes with a GLP-1 RA and 95.0 minutes with placebo, resulting in a pooled mean difference of 36.0 minutes (P < .01).
• No significant difference was found in the gastric emptying time for liquids between the GLP-1 RA and placebo groups. Furthermore, the amount of gastric emptying noted at 4 or 5 hours on the acetaminophen absorption test was comparable between these groups.
• The gastric emptying time for both solids and liquids did not differ between GLP-1 RA formulations or between short-acting or long-acting GLP-1 RAs.

IN PRACTICE:

“Based on current evidence, a conservative approach with a liquid diet on the day before procedures while continuing GLP-1 RA therapy would represent the most sensible approach until more conclusive data on a solid diet are available,” the authors wrote.

SOURCE:

The study, led by Brent Hiramoto, MD, MPH, of the Center for Gastrointestinal Motility at Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in The American Journal of Gastroenterology.

LIMITATIONS:

The small number of studies utilizing some diagnostic modalities, such as breath testing, precluded a formal meta-analysis of these subgroups. The results could not be stratified by indication for GLP-1 RA (diabetes or obesity) because of insufficient studies in each category.

DISCLOSURES:

The lead author was supported by the National Institute of Diabetes and Digestive and Kidney Diseases. One author declared serving on the advisory boards of three pharmaceutical companies.

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

Premenopausal patients with hormone receptor positive, HER2 negative (HR+/HER2-) metastatic breast cancer (mBC) continued to show consistent benefit when treated with CDK4/6 inhibition plus endocrine therapy compared with chemotherapy, according to updated survival outcomes of the Young-PEARL study.

“The combination of palbociclib plus exemestane plus leuprolide showed a consistent significant improvement in PFS [progression-free survival] compared to the capecitabine arm,” Yeon Hee Park, MD, PhD, from Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea, reported at the annual meeting of the American Society of Clinical Oncology.
 

Study Methods and Results

Young-PEARL, a prospective, multicenter, open-label, randomized phase 2 study, included 184 patients, median age 44 years, who had relapsed or progressed during previous tamoxifen therapy, with one line of previous chemotherapy for mBC allowed. Patients were randomized to palbociclib plus endocrine therapy (oral palbociclib 125 mg per day for 21 days every 4 weeks, oral exemestane 25 mg per day for 28 days, plus leuprolide 3.75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1250 mg/m^2, twice daily for 2 weeks every 3 weeks).

Previously published initial results (Lancet Oncol. 2019 Dec;20[12]:1750-1759) for the primary endpoint showed a median PFS of 20.1 months in the palbociclib group versus 14.4 months in the capecitabine group, (hazard ratio [HR] 0.659, P = .0235) after median follow-up of 17 months.

Updated results showed this benefit was maintained after a median of 54 months, with a PFS of 19.5 months in the palbociclib arm, versus 14 months in capecitabine arm (HR 0.744, P = .0357), Dr. Park reported. However, this PFS benefit did not lead to an overall survival (OS) benefit, with median OS being similar: 54.8 versus 57.8 months in the palbociclib and capecitabine groups, respectively (HR = 1.02, P = .92).

To explore why PFS — but not OS — was better in the palbociclib arm, the researchers conducted a multivariate analysis which showed that going on to an additional CDK4/6 inhibitor treatment after the end of the study was as an independent variable favoring OS. Because more patients in the capecitabine arm received a post-study CDK4/6 inhibitor (49.3%) compared with in the palbociclib group (15%), this weighted the OS to the capecitabine arm, Dr. Park explained in an interview.

“In the capecitabine arm, excluding post-study CDK4/6 inhibitor use, the median OS was 38.8 months.” This was inferior to the 49 months OS seen in the palbociclib arm (P = .065), she said.

“As expected, hematologic toxicity was more common in the palbociclib arm compared with in the capecitabine arm,” Dr. Park said (92% vs 86%), with neutropenia topping the list [of all adverse events] (65.2% vs 27.9%, all grades). However, “most [adverse events] were not that serious,” Dr. Park said. Arthralgia was more common in the palbociclib arm (25% vs 7%), and diarrhea and hand-foot syndrome were more common in the capecitabine arm (15.2% vs 39.5% and 79.1% vs 2.2%).
 

Study Validates Endocrine Therapy + CDK4/6 Inhibitor as First Line

Commenting on Young-PEARL in an interview, Harold Burstein, MD, PhD, said, “The point of this study was to compare whether upfront chemotherapy would be better than upfront hormonal therapy for patients who had metastatic ER positive breast cancer.”

“This is the first study in probably 20 years that has compared these two approaches, and it validated that for the vast majority of patients with ER positive metastatic breast cancer, the appropriate first treatment is endocrine therapy with a CDK4/6 inhibitor,” continued Dr. Burstein, a breast cancer expert at Dana-Farber Cancer Institute, and professor at Harvard Medical School in Boston.

Dr. Park disclosed honoraria from AstraZeneca, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, and Roche; consulting or advisory roles for AstraZeneca, Boryung, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, Menarini, MSD, Novartis, Pfizer, and Roche; research funding from AstraZeneca, Gencurix, Genome Insight, NGeneBio, Pfizer; and Roche; and travel/accommodations/expenses from Gilead. Dr. Burstein disclosed a research grant from the National Cancer Institute.

Premenopausal patients with hormone receptor positive, HER2 negative (HR+/HER2-) metastatic breast cancer (mBC) continued to show consistent benefit when treated with CDK4/6 inhibition plus endocrine therapy compared with chemotherapy, according to updated survival outcomes of the Young-PEARL study.

“The combination of palbociclib plus exemestane plus leuprolide showed a consistent significant improvement in PFS [progression-free survival] compared to the capecitabine arm,” Yeon Hee Park, MD, PhD, from Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea, reported at the annual meeting of the American Society of Clinical Oncology.
 

Study Methods and Results

Young-PEARL, a prospective, multicenter, open-label, randomized phase 2 study, included 184 patients, median age 44 years, who had relapsed or progressed during previous tamoxifen therapy, with one line of previous chemotherapy for mBC allowed. Patients were randomized to palbociclib plus endocrine therapy (oral palbociclib 125 mg per day for 21 days every 4 weeks, oral exemestane 25 mg per day for 28 days, plus leuprolide 3.75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1250 mg/m^2, twice daily for 2 weeks every 3 weeks).

Previously published initial results (Lancet Oncol. 2019 Dec;20[12]:1750-1759) for the primary endpoint showed a median PFS of 20.1 months in the palbociclib group versus 14.4 months in the capecitabine group, (hazard ratio [HR] 0.659, P = .0235) after median follow-up of 17 months.

Updated results showed this benefit was maintained after a median of 54 months, with a PFS of 19.5 months in the palbociclib arm, versus 14 months in capecitabine arm (HR 0.744, P = .0357), Dr. Park reported. However, this PFS benefit did not lead to an overall survival (OS) benefit, with median OS being similar: 54.8 versus 57.8 months in the palbociclib and capecitabine groups, respectively (HR = 1.02, P = .92).

To explore why PFS — but not OS — was better in the palbociclib arm, the researchers conducted a multivariate analysis which showed that going on to an additional CDK4/6 inhibitor treatment after the end of the study was as an independent variable favoring OS. Because more patients in the capecitabine arm received a post-study CDK4/6 inhibitor (49.3%) compared with in the palbociclib group (15%), this weighted the OS to the capecitabine arm, Dr. Park explained in an interview.

“In the capecitabine arm, excluding post-study CDK4/6 inhibitor use, the median OS was 38.8 months.” This was inferior to the 49 months OS seen in the palbociclib arm (P = .065), she said.

“As expected, hematologic toxicity was more common in the palbociclib arm compared with in the capecitabine arm,” Dr. Park said (92% vs 86%), with neutropenia topping the list [of all adverse events] (65.2% vs 27.9%, all grades). However, “most [adverse events] were not that serious,” Dr. Park said. Arthralgia was more common in the palbociclib arm (25% vs 7%), and diarrhea and hand-foot syndrome were more common in the capecitabine arm (15.2% vs 39.5% and 79.1% vs 2.2%).
 

Study Validates Endocrine Therapy + CDK4/6 Inhibitor as First Line

Commenting on Young-PEARL in an interview, Harold Burstein, MD, PhD, said, “The point of this study was to compare whether upfront chemotherapy would be better than upfront hormonal therapy for patients who had metastatic ER positive breast cancer.”

“This is the first study in probably 20 years that has compared these two approaches, and it validated that for the vast majority of patients with ER positive metastatic breast cancer, the appropriate first treatment is endocrine therapy with a CDK4/6 inhibitor,” continued Dr. Burstein, a breast cancer expert at Dana-Farber Cancer Institute, and professor at Harvard Medical School in Boston.

Dr. Park disclosed honoraria from AstraZeneca, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, and Roche; consulting or advisory roles for AstraZeneca, Boryung, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, Menarini, MSD, Novartis, Pfizer, and Roche; research funding from AstraZeneca, Gencurix, Genome Insight, NGeneBio, Pfizer; and Roche; and travel/accommodations/expenses from Gilead. Dr. Burstein disclosed a research grant from the National Cancer Institute.

Premenopausal patients with hormone receptor positive, HER2 negative (HR+/HER2-) metastatic breast cancer (mBC) continued to show consistent benefit when treated with CDK4/6 inhibition plus endocrine therapy compared with chemotherapy, according to updated survival outcomes of the Young-PEARL study.

“The combination of palbociclib plus exemestane plus leuprolide showed a consistent significant improvement in PFS [progression-free survival] compared to the capecitabine arm,” Yeon Hee Park, MD, PhD, from Samsung Medical Center, Sungkyunkwan University, Seoul, South Korea, reported at the annual meeting of the American Society of Clinical Oncology.
 

Study Methods and Results

Young-PEARL, a prospective, multicenter, open-label, randomized phase 2 study, included 184 patients, median age 44 years, who had relapsed or progressed during previous tamoxifen therapy, with one line of previous chemotherapy for mBC allowed. Patients were randomized to palbociclib plus endocrine therapy (oral palbociclib 125 mg per day for 21 days every 4 weeks, oral exemestane 25 mg per day for 28 days, plus leuprolide 3.75 mg subcutaneously every 4 weeks) or chemotherapy (oral capecitabine 1250 mg/m^2, twice daily for 2 weeks every 3 weeks).

Previously published initial results (Lancet Oncol. 2019 Dec;20[12]:1750-1759) for the primary endpoint showed a median PFS of 20.1 months in the palbociclib group versus 14.4 months in the capecitabine group, (hazard ratio [HR] 0.659, P = .0235) after median follow-up of 17 months.

Updated results showed this benefit was maintained after a median of 54 months, with a PFS of 19.5 months in the palbociclib arm, versus 14 months in capecitabine arm (HR 0.744, P = .0357), Dr. Park reported. However, this PFS benefit did not lead to an overall survival (OS) benefit, with median OS being similar: 54.8 versus 57.8 months in the palbociclib and capecitabine groups, respectively (HR = 1.02, P = .92).

To explore why PFS — but not OS — was better in the palbociclib arm, the researchers conducted a multivariate analysis which showed that going on to an additional CDK4/6 inhibitor treatment after the end of the study was as an independent variable favoring OS. Because more patients in the capecitabine arm received a post-study CDK4/6 inhibitor (49.3%) compared with in the palbociclib group (15%), this weighted the OS to the capecitabine arm, Dr. Park explained in an interview.

“In the capecitabine arm, excluding post-study CDK4/6 inhibitor use, the median OS was 38.8 months.” This was inferior to the 49 months OS seen in the palbociclib arm (P = .065), she said.

“As expected, hematologic toxicity was more common in the palbociclib arm compared with in the capecitabine arm,” Dr. Park said (92% vs 86%), with neutropenia topping the list [of all adverse events] (65.2% vs 27.9%, all grades). However, “most [adverse events] were not that serious,” Dr. Park said. Arthralgia was more common in the palbociclib arm (25% vs 7%), and diarrhea and hand-foot syndrome were more common in the capecitabine arm (15.2% vs 39.5% and 79.1% vs 2.2%).
 

Study Validates Endocrine Therapy + CDK4/6 Inhibitor as First Line

Commenting on Young-PEARL in an interview, Harold Burstein, MD, PhD, said, “The point of this study was to compare whether upfront chemotherapy would be better than upfront hormonal therapy for patients who had metastatic ER positive breast cancer.”

“This is the first study in probably 20 years that has compared these two approaches, and it validated that for the vast majority of patients with ER positive metastatic breast cancer, the appropriate first treatment is endocrine therapy with a CDK4/6 inhibitor,” continued Dr. Burstein, a breast cancer expert at Dana-Farber Cancer Institute, and professor at Harvard Medical School in Boston.

Dr. Park disclosed honoraria from AstraZeneca, Daiichi Sankyo, Eisai, Lilly, MSD, Novartis, Pfizer, and Roche; consulting or advisory roles for AstraZeneca, Boryung, Daiichi Sankyo, Eisai, Gilead Sciences, Lilly, Menarini, MSD, Novartis, Pfizer, and Roche; research funding from AstraZeneca, Gencurix, Genome Insight, NGeneBio, Pfizer; and Roche; and travel/accommodations/expenses from Gilead. Dr. Burstein disclosed a research grant from the National Cancer Institute.

Potential harms and benefits should be weighed carefully before women and their physicians decide on breast cancer screening, according to updated guidelines from the Canadian Task Force on Preventive Health Care.

The draft guidelines stem from a review of more than 165 recent randomized controlled trials, observational studies, mathematical models, and other data.

The guideline working group included four breast cancer experts (a medical oncologist, a radiation oncologist, a surgical oncologist, and a radiologist), three patient partners, six family physicians, a nurse practitioner, evidence review teams, and other experts.

To avoid potential conflicts of interest, the oncologists provided input but did not vote on the final recommendations, Guylène Thériault, MD, a family physician and chair of the task force and Breast Cancer Working Group, said in an interview. 

The guideline recommends that, after the potential benefits and harms of screening have been considered, mammography should be accessible every 2-3 years to women (ie, people assigned female at birth) between ages 40 and 74 years who are at average or moderately increased risk.

Women with a personal or extensive family history of breast cancer or genetic mutations that would increase breast cancer risk; those who have symptoms, such as a lump; those who feel they may be at high risk; and those who are transgender women should consult a healthcare provider about appropriate options, according to the updated guidelines, which do not apply to these patients.

The draft guidelines were published online on May 30 and are open for public comment until August 30.
 

‘Three Big Questions’

To develop the guidelines, the work group asked “three big questions,” said Dr. Thériault. The first was the effectiveness of breast cancer screening for women aged 40 years and over. For this question, this systematic review, unlike the 2018 guideline update, included not only randomized trials but also observational data to ensure that the work group considered all available data.

“The second question was about comparative effectiveness,” which is something the United States considered for the latest US Preventive Services Task Force (USPSTF) update, said Dr. Thériault. The USPSTF asked questions such as “What happens if we start screening patients at age 40 years? Or at age 50 years? What happens if we stop at age 74 years? Or if we use different tests such as 3D versus digital mammography?”

The Canadian Task Force relied on the evidence that the USPSTF found after grading it with its own criteria, she said. The results were similar, and so are the recommendations in this area. “For example, we don’t recommend supplementary screening for women with dense breasts because there are no studies to inform patient-oriented benefits.”

The third question was about the values and preferences of women regarding breast cancer screening, which is something the United States didn’t examine. “We had looked at that issue in 2018, and this time around, even though we expanded the type of studies, we got the same message: That there are differences between women in their 40s and those who are age 50 years and over.”

“The majority of women in their 40s think that the harms outweigh the benefits and are not interested in screening,” said Dr. Thériault. “But when I say the majority, that’s not every woman. So, we had to recognize that there is variability. And the majority, but not all, of women ages 50-74 years thinks the benefits are higher than the harms. That’s why we say in our recommendation that from ages 40 to 74, it’s a personal choice.”
 

Responding to Objections

Not surprisingly, the task force has heard objections to its draft guidelines. The first is that women aged 40-49 years are being denied mammograms, said Michelle Nadler, MD, a medical oncologist at Princess Margaret Cancer Centre in Toronto, Canada. “This [objection] has attained a lot of media coverage, which is unfortunate, because people who have not read the guidelines may believe this is true. The guidelines clearly state that an eligible, informed woman of this age group who wants a screening mammogram should receive one.”

The second commonly heard objection is that the task force is overestimating the harms of screening, such as anxiety and overdiagnosis, she said. But an outcome of “anxiety” was not factored into the guideline. Overdiagnosis was calculated on the basis of the literature, and estimates were converted to a common denominator so that they could be compared, said Dr. Nadler. The same was true of benefits.

Another objection was that screening could mean less need for chemotherapy or full axillary dissection, Dr. Nadler said. However, the task force did not find any primary studies that evaluated these outcomes.

Critics also said that the recommendations do not account for racial or ethnic variations. Although more research is likely needed in this area, “the task force states that individuals should be informed of all of their breast cancer risk factors, including race/ethnicity, and that this should be factored into decisions about screening,” said Dr. Nadler.

“I was very surprised that the task force was accused by some parties of paternalism,” added René Wittmer, MD, adjunct clinical professor of family medicine at the University of Montreal and chair of Choosing Wisely Quebec, Montreal, Canada. “In my opinion, the importance they place on shared decision-making is contrary to medical paternalism and aims to empower women to make a decision that fits with their values and preferences.”

Nevertheless, the inclusion of modeling studies and observational trials “may cause the potential benefits to be amplified, compared with what is seen in randomized controlled trials,” he said in an interview.
 

Decision Aids Help

Once the guidelines are finalized, decision aids will be available to patients and providers to help guide screening discussions, said Dr. Nadler. “Primary care providers need to be aware of an individual’s personal risk factors for breast cancer to know if they are at average, above average, or high lifetime risk of breast cancer. These guidelines do not apply to those with > 20% lifetime risk of breast cancer.”

“The standards for risk communication are in absolute numbers over a common denominator,” she noted. “This is how primary care providers discuss other important primary care topics like smoking cessation, cardiovascular disease (and decisions about statin medications), and osteoporosis risk. These same standards should apply for breast cancer screening.”

Furthermore, she said, providers “should be aware that individuals from marginalized communities may benefit from more than one conversation until they are able to make a decision about screening that is right for them.”

“There is good evidence showing that most advances we’ve seen in breast cancer outcomes (ie, reduction in breast cancer mortality) are likely due to improvements in treatment, not screening,” said Dr. Wittmer. “In fact, mortality reductions are seen even in age groups or countries where there is no routine screening. This means that women benefit from advances in treatments, whether they choose to get screened or not.”
 

‘Mammography Saves Lives’

Commenting on the updated guidelines, Janie Lee, MD, professor of radiology at the University of Washington School of Medicine and director of breast imaging at the Fred Hutchinson Cancer Center, both in Seattle, said: “For the USPSTF, benefits of life years gained were also considered, in addition to breast cancer deaths averted. To save more lives from breast cancer, guidelines may focus on screening women at older ages, when annual rates of breast cancer are higher.” By contrast, when thinking in terms of years of life saved, focusing on screening younger women, who have more years of life left, increases benefits. “Both are important outcomes that we want to improve with effective screening.”

That said, “we should follow the guidelines of our specific national organizations,” she continued. “Overall populations and healthcare systems are different between the US and Canada.”

For example, “the USPSTF specifically highlighted the potential for reducing breast cancer mortality in Black women, who are more likely to develop biologically aggressive tumors that are diagnosed at more advanced stages, when making updated recommendations earlier this year,” she said. “The Canadian guidelines did not make specific recommendations by race or ethnicity group, instead highlighting the need for more research on the impact of screening in these groups.”

In addition, “screening every year versus every other year is more routine in the US compared with Canada,” she noted. And nonmedical factors that influence health and that may influence access to medical care and timely diagnosis of breast cancer “may be different between our two countries.”

“The most important take-home message is that the scientific evidence is strong that screening mammography saves lives,” said Dr. Lee. “These new recommendations will hopefully result in more early diagnoses of breast cancer and save more lives. Screening works best when it’s used regularly, regardless of how frequently you return. Once you start screening, please urge your patients to plan to return.”

Dr. Nadler disclosed speaker honoraria and consulting fees from Novartis and Exact Sciences outside the scope of this interview and innovation funding from the NSH/UHN AMO Innovation Fund Competition for Developing and Implementing a Consensus Recommendation for Breast Cancer Screening Best Practices. Dr. Thériault is chair of the task force and chair of the working group for the draft guidelines. Dr. Wittmer is chair of Choosing Wisely Quebec. Dr. Lee reported no relevant financial relationships related to her interview.

A version of this article appeared on Medscape.com.

Potential harms and benefits should be weighed carefully before women and their physicians decide on breast cancer screening, according to updated guidelines from the Canadian Task Force on Preventive Health Care.

The draft guidelines stem from a review of more than 165 recent randomized controlled trials, observational studies, mathematical models, and other data.

The guideline working group included four breast cancer experts (a medical oncologist, a radiation oncologist, a surgical oncologist, and a radiologist), three patient partners, six family physicians, a nurse practitioner, evidence review teams, and other experts.

To avoid potential conflicts of interest, the oncologists provided input but did not vote on the final recommendations, Guylène Thériault, MD, a family physician and chair of the task force and Breast Cancer Working Group, said in an interview. 

The guideline recommends that, after the potential benefits and harms of screening have been considered, mammography should be accessible every 2-3 years to women (ie, people assigned female at birth) between ages 40 and 74 years who are at average or moderately increased risk.

Women with a personal or extensive family history of breast cancer or genetic mutations that would increase breast cancer risk; those who have symptoms, such as a lump; those who feel they may be at high risk; and those who are transgender women should consult a healthcare provider about appropriate options, according to the updated guidelines, which do not apply to these patients.

The draft guidelines were published online on May 30 and are open for public comment until August 30.
 

‘Three Big Questions’

To develop the guidelines, the work group asked “three big questions,” said Dr. Thériault. The first was the effectiveness of breast cancer screening for women aged 40 years and over. For this question, this systematic review, unlike the 2018 guideline update, included not only randomized trials but also observational data to ensure that the work group considered all available data.

“The second question was about comparative effectiveness,” which is something the United States considered for the latest US Preventive Services Task Force (USPSTF) update, said Dr. Thériault. The USPSTF asked questions such as “What happens if we start screening patients at age 40 years? Or at age 50 years? What happens if we stop at age 74 years? Or if we use different tests such as 3D versus digital mammography?”

The Canadian Task Force relied on the evidence that the USPSTF found after grading it with its own criteria, she said. The results were similar, and so are the recommendations in this area. “For example, we don’t recommend supplementary screening for women with dense breasts because there are no studies to inform patient-oriented benefits.”

The third question was about the values and preferences of women regarding breast cancer screening, which is something the United States didn’t examine. “We had looked at that issue in 2018, and this time around, even though we expanded the type of studies, we got the same message: That there are differences between women in their 40s and those who are age 50 years and over.”

“The majority of women in their 40s think that the harms outweigh the benefits and are not interested in screening,” said Dr. Thériault. “But when I say the majority, that’s not every woman. So, we had to recognize that there is variability. And the majority, but not all, of women ages 50-74 years thinks the benefits are higher than the harms. That’s why we say in our recommendation that from ages 40 to 74, it’s a personal choice.”
 

Responding to Objections

Not surprisingly, the task force has heard objections to its draft guidelines. The first is that women aged 40-49 years are being denied mammograms, said Michelle Nadler, MD, a medical oncologist at Princess Margaret Cancer Centre in Toronto, Canada. “This [objection] has attained a lot of media coverage, which is unfortunate, because people who have not read the guidelines may believe this is true. The guidelines clearly state that an eligible, informed woman of this age group who wants a screening mammogram should receive one.”

The second commonly heard objection is that the task force is overestimating the harms of screening, such as anxiety and overdiagnosis, she said. But an outcome of “anxiety” was not factored into the guideline. Overdiagnosis was calculated on the basis of the literature, and estimates were converted to a common denominator so that they could be compared, said Dr. Nadler. The same was true of benefits.

Another objection was that screening could mean less need for chemotherapy or full axillary dissection, Dr. Nadler said. However, the task force did not find any primary studies that evaluated these outcomes.

Critics also said that the recommendations do not account for racial or ethnic variations. Although more research is likely needed in this area, “the task force states that individuals should be informed of all of their breast cancer risk factors, including race/ethnicity, and that this should be factored into decisions about screening,” said Dr. Nadler.

“I was very surprised that the task force was accused by some parties of paternalism,” added René Wittmer, MD, adjunct clinical professor of family medicine at the University of Montreal and chair of Choosing Wisely Quebec, Montreal, Canada. “In my opinion, the importance they place on shared decision-making is contrary to medical paternalism and aims to empower women to make a decision that fits with their values and preferences.”

Nevertheless, the inclusion of modeling studies and observational trials “may cause the potential benefits to be amplified, compared with what is seen in randomized controlled trials,” he said in an interview.
 

Decision Aids Help

Once the guidelines are finalized, decision aids will be available to patients and providers to help guide screening discussions, said Dr. Nadler. “Primary care providers need to be aware of an individual’s personal risk factors for breast cancer to know if they are at average, above average, or high lifetime risk of breast cancer. These guidelines do not apply to those with > 20% lifetime risk of breast cancer.”

“The standards for risk communication are in absolute numbers over a common denominator,” she noted. “This is how primary care providers discuss other important primary care topics like smoking cessation, cardiovascular disease (and decisions about statin medications), and osteoporosis risk. These same standards should apply for breast cancer screening.”

Furthermore, she said, providers “should be aware that individuals from marginalized communities may benefit from more than one conversation until they are able to make a decision about screening that is right for them.”

“There is good evidence showing that most advances we’ve seen in breast cancer outcomes (ie, reduction in breast cancer mortality) are likely due to improvements in treatment, not screening,” said Dr. Wittmer. “In fact, mortality reductions are seen even in age groups or countries where there is no routine screening. This means that women benefit from advances in treatments, whether they choose to get screened or not.”
 

‘Mammography Saves Lives’

Commenting on the updated guidelines, Janie Lee, MD, professor of radiology at the University of Washington School of Medicine and director of breast imaging at the Fred Hutchinson Cancer Center, both in Seattle, said: “For the USPSTF, benefits of life years gained were also considered, in addition to breast cancer deaths averted. To save more lives from breast cancer, guidelines may focus on screening women at older ages, when annual rates of breast cancer are higher.” By contrast, when thinking in terms of years of life saved, focusing on screening younger women, who have more years of life left, increases benefits. “Both are important outcomes that we want to improve with effective screening.”

That said, “we should follow the guidelines of our specific national organizations,” she continued. “Overall populations and healthcare systems are different between the US and Canada.”

For example, “the USPSTF specifically highlighted the potential for reducing breast cancer mortality in Black women, who are more likely to develop biologically aggressive tumors that are diagnosed at more advanced stages, when making updated recommendations earlier this year,” she said. “The Canadian guidelines did not make specific recommendations by race or ethnicity group, instead highlighting the need for more research on the impact of screening in these groups.”

In addition, “screening every year versus every other year is more routine in the US compared with Canada,” she noted. And nonmedical factors that influence health and that may influence access to medical care and timely diagnosis of breast cancer “may be different between our two countries.”

“The most important take-home message is that the scientific evidence is strong that screening mammography saves lives,” said Dr. Lee. “These new recommendations will hopefully result in more early diagnoses of breast cancer and save more lives. Screening works best when it’s used regularly, regardless of how frequently you return. Once you start screening, please urge your patients to plan to return.”

Dr. Nadler disclosed speaker honoraria and consulting fees from Novartis and Exact Sciences outside the scope of this interview and innovation funding from the NSH/UHN AMO Innovation Fund Competition for Developing and Implementing a Consensus Recommendation for Breast Cancer Screening Best Practices. Dr. Thériault is chair of the task force and chair of the working group for the draft guidelines. Dr. Wittmer is chair of Choosing Wisely Quebec. Dr. Lee reported no relevant financial relationships related to her interview.

A version of this article appeared on Medscape.com.

Potential harms and benefits should be weighed carefully before women and their physicians decide on breast cancer screening, according to updated guidelines from the Canadian Task Force on Preventive Health Care.

The draft guidelines stem from a review of more than 165 recent randomized controlled trials, observational studies, mathematical models, and other data.

The guideline working group included four breast cancer experts (a medical oncologist, a radiation oncologist, a surgical oncologist, and a radiologist), three patient partners, six family physicians, a nurse practitioner, evidence review teams, and other experts.

To avoid potential conflicts of interest, the oncologists provided input but did not vote on the final recommendations, Guylène Thériault, MD, a family physician and chair of the task force and Breast Cancer Working Group, said in an interview. 

The guideline recommends that, after the potential benefits and harms of screening have been considered, mammography should be accessible every 2-3 years to women (ie, people assigned female at birth) between ages 40 and 74 years who are at average or moderately increased risk.

Women with a personal or extensive family history of breast cancer or genetic mutations that would increase breast cancer risk; those who have symptoms, such as a lump; those who feel they may be at high risk; and those who are transgender women should consult a healthcare provider about appropriate options, according to the updated guidelines, which do not apply to these patients.

The draft guidelines were published online on May 30 and are open for public comment until August 30.
 

‘Three Big Questions’

To develop the guidelines, the work group asked “three big questions,” said Dr. Thériault. The first was the effectiveness of breast cancer screening for women aged 40 years and over. For this question, this systematic review, unlike the 2018 guideline update, included not only randomized trials but also observational data to ensure that the work group considered all available data.

“The second question was about comparative effectiveness,” which is something the United States considered for the latest US Preventive Services Task Force (USPSTF) update, said Dr. Thériault. The USPSTF asked questions such as “What happens if we start screening patients at age 40 years? Or at age 50 years? What happens if we stop at age 74 years? Or if we use different tests such as 3D versus digital mammography?”

The Canadian Task Force relied on the evidence that the USPSTF found after grading it with its own criteria, she said. The results were similar, and so are the recommendations in this area. “For example, we don’t recommend supplementary screening for women with dense breasts because there are no studies to inform patient-oriented benefits.”

The third question was about the values and preferences of women regarding breast cancer screening, which is something the United States didn’t examine. “We had looked at that issue in 2018, and this time around, even though we expanded the type of studies, we got the same message: That there are differences between women in their 40s and those who are age 50 years and over.”

“The majority of women in their 40s think that the harms outweigh the benefits and are not interested in screening,” said Dr. Thériault. “But when I say the majority, that’s not every woman. So, we had to recognize that there is variability. And the majority, but not all, of women ages 50-74 years thinks the benefits are higher than the harms. That’s why we say in our recommendation that from ages 40 to 74, it’s a personal choice.”
 

Responding to Objections

Not surprisingly, the task force has heard objections to its draft guidelines. The first is that women aged 40-49 years are being denied mammograms, said Michelle Nadler, MD, a medical oncologist at Princess Margaret Cancer Centre in Toronto, Canada. “This [objection] has attained a lot of media coverage, which is unfortunate, because people who have not read the guidelines may believe this is true. The guidelines clearly state that an eligible, informed woman of this age group who wants a screening mammogram should receive one.”

The second commonly heard objection is that the task force is overestimating the harms of screening, such as anxiety and overdiagnosis, she said. But an outcome of “anxiety” was not factored into the guideline. Overdiagnosis was calculated on the basis of the literature, and estimates were converted to a common denominator so that they could be compared, said Dr. Nadler. The same was true of benefits.

Another objection was that screening could mean less need for chemotherapy or full axillary dissection, Dr. Nadler said. However, the task force did not find any primary studies that evaluated these outcomes.

Critics also said that the recommendations do not account for racial or ethnic variations. Although more research is likely needed in this area, “the task force states that individuals should be informed of all of their breast cancer risk factors, including race/ethnicity, and that this should be factored into decisions about screening,” said Dr. Nadler.

“I was very surprised that the task force was accused by some parties of paternalism,” added René Wittmer, MD, adjunct clinical professor of family medicine at the University of Montreal and chair of Choosing Wisely Quebec, Montreal, Canada. “In my opinion, the importance they place on shared decision-making is contrary to medical paternalism and aims to empower women to make a decision that fits with their values and preferences.”

Nevertheless, the inclusion of modeling studies and observational trials “may cause the potential benefits to be amplified, compared with what is seen in randomized controlled trials,” he said in an interview.
 

Decision Aids Help

Once the guidelines are finalized, decision aids will be available to patients and providers to help guide screening discussions, said Dr. Nadler. “Primary care providers need to be aware of an individual’s personal risk factors for breast cancer to know if they are at average, above average, or high lifetime risk of breast cancer. These guidelines do not apply to those with > 20% lifetime risk of breast cancer.”

“The standards for risk communication are in absolute numbers over a common denominator,” she noted. “This is how primary care providers discuss other important primary care topics like smoking cessation, cardiovascular disease (and decisions about statin medications), and osteoporosis risk. These same standards should apply for breast cancer screening.”

Furthermore, she said, providers “should be aware that individuals from marginalized communities may benefit from more than one conversation until they are able to make a decision about screening that is right for them.”

“There is good evidence showing that most advances we’ve seen in breast cancer outcomes (ie, reduction in breast cancer mortality) are likely due to improvements in treatment, not screening,” said Dr. Wittmer. “In fact, mortality reductions are seen even in age groups or countries where there is no routine screening. This means that women benefit from advances in treatments, whether they choose to get screened or not.”
 

‘Mammography Saves Lives’

Commenting on the updated guidelines, Janie Lee, MD, professor of radiology at the University of Washington School of Medicine and director of breast imaging at the Fred Hutchinson Cancer Center, both in Seattle, said: “For the USPSTF, benefits of life years gained were also considered, in addition to breast cancer deaths averted. To save more lives from breast cancer, guidelines may focus on screening women at older ages, when annual rates of breast cancer are higher.” By contrast, when thinking in terms of years of life saved, focusing on screening younger women, who have more years of life left, increases benefits. “Both are important outcomes that we want to improve with effective screening.”

That said, “we should follow the guidelines of our specific national organizations,” she continued. “Overall populations and healthcare systems are different between the US and Canada.”

For example, “the USPSTF specifically highlighted the potential for reducing breast cancer mortality in Black women, who are more likely to develop biologically aggressive tumors that are diagnosed at more advanced stages, when making updated recommendations earlier this year,” she said. “The Canadian guidelines did not make specific recommendations by race or ethnicity group, instead highlighting the need for more research on the impact of screening in these groups.”

In addition, “screening every year versus every other year is more routine in the US compared with Canada,” she noted. And nonmedical factors that influence health and that may influence access to medical care and timely diagnosis of breast cancer “may be different between our two countries.”

“The most important take-home message is that the scientific evidence is strong that screening mammography saves lives,” said Dr. Lee. “These new recommendations will hopefully result in more early diagnoses of breast cancer and save more lives. Screening works best when it’s used regularly, regardless of how frequently you return. Once you start screening, please urge your patients to plan to return.”

Dr. Nadler disclosed speaker honoraria and consulting fees from Novartis and Exact Sciences outside the scope of this interview and innovation funding from the NSH/UHN AMO Innovation Fund Competition for Developing and Implementing a Consensus Recommendation for Breast Cancer Screening Best Practices. Dr. Thériault is chair of the task force and chair of the working group for the draft guidelines. Dr. Wittmer is chair of Choosing Wisely Quebec. Dr. Lee reported no relevant financial relationships related to her interview.

A version of this article appeared on Medscape.com.

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

Moving for any new opportunity in medicine can feel like starting a new life, not just a new job. This is especially true for residency or fellowships, as taking a step forward in your career is exciting. But in the process, you may be leaving family and friends for an unknown city or region where you will need to find a community. And the changes could be long-term. According to the Association of American Medical Colleges’ 2023 Report on Residents, 57.1% of the individuals who completed residency training between 2013 and 2022 are still practicing in the state where they completed their residency.

The process of planning out the right timeline; securing a comfortable, convenient, and affordable place to live; and meeting people while working long hours in an unfamiliar location can be overwhelming. And in the case of many residency programs and healthcare settings, financial assistance, relocation information, and other resources are scarce.

This news organization spoke to recent residents and medical school faculty members about how to navigate a medical move and set yourself up for success.
 

1. Find Relocation Resources

First things first. Find out what your program or hospital has to offer.

Some institutions help incoming residents by providing housing options or information. The Icahn School of Medicine at Mount Sinai’s Real Estate Division, for example, provides off-campus housing resources that guide new residents and faculty toward safe, convenient places to live in New York City. It also guarantees on-campus or block-leased housing offers to all incoming residents who apply.

Michael Leitman, MD, FACS, professor of surgery and medical education and dean for Graduate Medical Education at the Icahn School of Medicine at Mount Sinai in New York City, recommends connecting with colleagues at your program for guidance on navigating a new city and a new healthcare setting. He encourages incoming residents to use the contact information they receive during the interview and orientation processes to reach out to co-residents and faculty members.

Other residency programs offer partial reimbursement or need-based financial aid to help with the expense of relocation. But this is unlikely to cover all or even most of the cost of a cross-country move.

When Morgen Owens, MD, moved from Alabama to New York City for a physical medicine and rehabilitation residency at Mount Sinai in 2021, her program offered subsidized housing options. But there was little reimbursement for relocation. She paid around $3000 for a one-way rental truck, gas, one night in a hotel, and movers to unload her belongings. She says driving herself kept the price down because full-service movers would have cost her between $4000 and $6000.

If this will strain your finances, several banks offer loans specifically for medical school graduates to cover residency and internship expenses. But be aware that these loans tend to have higher interest rates than federal student loans because they are based on credit score rather than fixed.
 

2. Reach Out and Buddy Up

Reaching out to more senior residents is essential, and some programs facilitate a buddy system for relocation advice.

Family physician Mursal Sekandari, MD, known as “Dr. Mursi,” attended a residency program at St. Luke’s University Hospital–Bethlehem Campus, in Bethlehem, Pennsylvania. The program’s official buddy system paired her with a senior resident who advised her on the area and gave tips for her apartment search.

On the other hand, when America Revere, MD, moved from Texas to Georgia for a surgery residency, she found that her program offered little relocation assistance, financial or otherwise. She leaned on her co-residents, and especially senior ones, for support while she settled in.

Dr. Revere also discovered the importance of accepting invitations to events hosted by both her fellow residents and her program itself, especially in the early stages of residency. “Accepting social invitations is really the only way to get to know people,” she said. “Sure, you’ll meet people at work and get to know their ‘work’ personalities.” But Dr. Revere’s attendings also threw parties, which she says were a great way to connect with a wider group and build a community.

To meet people both within and beyond her own residency program, Dr. Owens joined a group chat for physical medicine and rehab residents in the New York City area. She suggests looking into GroupMe or WhatsApp groups specific to your specialty.
 

3. Play the ‘Doctor Card’

Finding a place to live in an unfamiliar and competitive housing market can be one of the biggest challenges of any move. Dr. Owens’ options were limited by owning a dog, which wouldn’t be allowed in her hospital’s subsidized housing. Instead, she opted to find her own apartment in New York City. Her strategy: Playing the “doctor card.”

“I explained my situation: ‘I’m a doctor moving from out of state,’ ” Owens said. “Own that! These companies and brokers will look at you as a student and think, ‘Oh, she has no money, she has no savings, she’s got all of these loans, how is she going to pay for this apartment?’ But you have to say, ‘I’m a doctor. I’m an incoming resident who has X amount of years of job security. I’m not going to lose my job while living here.’ ”
 

4. Move Early

Dr. Revere found it important to move into her new home 2 weeks before the start of her residency program. Moving in early allowed her to settle in, get to know her area, neighbors, and co-residents, and generally prepare for her first day. It also gave her time to put furniture together — her new vanity alone took 12 hours.

Having a larger window of time before residency can also benefit those who hire movers or have their furniture shipped. When it comes to a cross-country move, it can take a few days to a few weeks for the truck to arrive — which could translate to a few nights or a few weeks without a bed.

“When residency comes, it comes fast,” Dr. Revere said. “It’s very confusing, and the last thing you need is to have half of your stuff unpacked or have no idea where you are or know nobody around you.”
 

5. Make Your New Home Your Sanctuary

During the stress of residency, your home can be a source of peace, and finding that might require trade-offs.

Dr. Sekandari’s parents urged her to live with roommates to save money on rent, but she insisted that spending more for solitude would be worth it. For her first year of residency, she barely saw her apartment. But when she did, she felt grateful to be in such a tranquil place to ease some of the stress of studying. “If you feel uncomfortable while you’re dealing with something stressful, the stress just exponentially increases,” she said. Creating an environment where you can really relax “makes a difference in how you respond to everything else around you.”

Dr. Revere agrees, urging medical professionals — and particularly residents — to invest in the most comfortable mattresses and bedding they can. Whether you are working nights, she also recommends blackout curtains to help facilitate daytime naps or better sleep in general, especially among the bright lights of bigger cities.

“You’re going to need somewhere to decompress,” she said. “That will look different for everyone. But I would definitely invest in your apartment to make it a sanctuary away from work.”
 

6. Consider a ‘Live’ Stress Reliever

When it comes to crucial stress relief during residency, “I like mine live,” Dr. Revere said in a YouTube vlog while petting her cat, Calyx.

Taking on the added responsibility of a pet during residency or any medical role may seem counterintuitive. But Revere has zero regrets about bringing Calyx along on her journey. “Cats are very easy,” she said. “I have nothing but wonderful things to say about having a cat during my difficult surgical residency.”

Dr. Owens admits that moving to New York City with her dog was difficult during her first years of residency. She worked an average of 80 hours each week and had little time for walks. She made room in her budget for dog walkers. Thankfully, her hours have eased up as she has progressed through her program, and she can now take her dog on longer walks every day. “He definitely has a better life now that I work fewer hours,” she said.

Once you’ve prepared, made the move, and found your village, it’s time for the real work to begin. “The first couple of months are certainly a challenge of adjusting to a new hospital, a new electronic medical record, a new culture, and a new geographic location,” said Dr. Leitman, who has relocated several times. “But at the end of the day ... it’s you and the patient.” By minimizing stress and getting the support you need, it can even be “a fun process,” Dr. Mursi added, “so make it an exciting chapter in your life.”

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

A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
 

News From Canada

The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).

Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.

The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
 

News From the USA

Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).

Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.

In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
 

News From Italy

“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”

As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
 

Predicting (and Preventing) Chaos

As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”

The study’s authors noted that in the years considered, the seasonal peak of RSV infections always occurred 4-5 weeks after the week in which the number of hospitalizations doubled or tripled. “It is a curve that rises very rapidly,” said the epidemiologist.

“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
 

News From Canada

The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).

Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.

The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
 

News From the USA

Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).

Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.

In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
 

News From Italy

“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”

As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
 

Predicting (and Preventing) Chaos

As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”

The study’s authors noted that in the years considered, the seasonal peak of RSV infections always occurred 4-5 weeks after the week in which the number of hospitalizations doubled or tripled. “It is a curve that rises very rapidly,” said the epidemiologist.

“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

A recent study published in JAMA Network Open described the epidemiological characteristics of respiratory syncytial virus (RSV) infection in Ontario, Canada, after the onset of the COVID-19 pandemic. It is the latest in a series of studies that suggest that virus circulation dynamics and hospitalizations have changed over time. These are crucial pieces of information for managing the seasonal epidemic.
 

News From Canada

The Canadian study compared hospitalization rates and characteristics of children aged < 5 years who were admitted to the hospital for RSV infection during three prepandemic seasons (2017-2020) and two “postpandemic” seasons (2021-2023).

Compared with the prepandemic period, the 2021-2022 RSV season peaked a little earlier (early December instead of mid-December) but had comparable hospitalization rates. The 2022-2023 season, on the other hand, peaked a month earlier with a more than doubled hospitalization rate. Hospitalizations increased from about 2000 to 4977. In 2022, hospitalizations also occurred in spring and summer. In 2022-2023, more hospitalizations than expected were observed, especially in the 24-59–month-old group.

The percentage of patients hospitalized in intensive care units (ICUs) increased (11.4% in 2021-2022 and 13.9% in 2022-2023 compared with 9.8% in 2017-2018), and the ICU hospitalization rate tripled compared with the prepandemic period. No differences were observed in ICU length of stay or severe outcomes (such as use of extracorporeal membrane oxygenation or hospital mortality). The use of mechanical ventilation increased, however.
 

News From the USA

Another recent study, published in Pediatrics, provides an overview of RSV epidemiology in the United States based on data collected from seven pediatric hospitals across the country. Data from 2021 and 2022 were compared with those from four prepandemic seasons (2016-2020).

Most observations agree with what was reported in the Canadian study. In the four prepandemic years, the peak of RSV-associated hospitalizations was recorded in December-January. In 2021, it was in July, and in 2022, it was in November. Hospitalization rates of RSV-positive patients in 2021 and 2022 were higher than those in the prepandemic period. In 2022, compared with 2021, the hospitalization rate of children aged < 2 years did not change, while that of children aged 24-59 months increased significantly.

In 2022, the percentage of children requiring oxygen therapy was higher. But unlike in the other study, the percentage of children undergoing mechanical ventilation or those hospitalized in ICUs was not significantly different from the past. It is worth noting that in 2022, multiple respiratory coinfections were more frequently found in RSV-positive hospitalized children.
 

News From Italy

“In our experience, as well, the epidemiology of RSV has shown changes following the pandemic,” Marta Luisa Ciofi degli Atti, MD, head of the Epidemiology, Clinical Pathways, and Clinical Risk Complex Operating Unit at the Bambino Gesù Pediatric Hospital in Rome, Italy, told Univadis Italy. “Before the pandemic, RSV infection peaks were regularly in late December-January. The pandemic, with its containment measures, interrupted the typical seasonality of RSV: A season was skipped, and in 2021, there was a season that was different from all previous ones because it was anticipated, with a peak in October-November and a much higher incidence. In 2022, we also had a higher autumn incidence compared with the past, with a peak in November. However, the number of confirmed infections approached prepandemic levels. The season was also anticipated in 2023, so prepandemic epidemiology does not seem to have stabilized yet.”

As did Canada and the USA, Italy had an increase in incidence among older children in 2022. “Cases of children aged 1-4 years increased from 24% in 2018 to 30%, and those of children aged 5-9 years from 5.4% to 8.7%,” said Dr. Ciofi degli Atti. “Children in the first year of life were similarly affected in the pre- and postpandemic periods, while cases increased among older children. It is as if there has been an accumulation of susceptible patients: Children who did not get sick in the first year of life during the pandemic and got sick later in the postpandemic period.”
 

Predicting (and Preventing) Chaos

As described in an article recently published in the Italian Journal of Pediatrics, Dr. Ciofi degli Atti worked on a model to predict the peak of RSV infections. “It is a mathematical predictive model that, based on observations in a certain number of seasons, allows the estimation of expectations,” she explained. It is challenging to develop a model when there are highly disruptive events such as a pandemic, she added, but these situations make predictive tools of the utmost interest. “The predictive capacity for the 2023 season was good: We had predicted that the peak would be reached in week 49, and indeed, the peak was observed in December.”

The study’s authors noted that in the years considered, the seasonal peak of RSV infections always occurred 4-5 weeks after the week in which the number of hospitalizations doubled or tripled. “It is a curve that rises very rapidly,” said the epidemiologist.

“RSV infection causes severe clinical conditions that affect young children who may need hospitalization and sometimes respiratory assistance. The epidemic peaks within a few weeks and has a disruptive effect on healthcare organization,” said Dr. Ciofi degli Atti. “Preventive vaccination is a huge opportunity in terms of health benefits for young children, who are directly involved, and also to reduce the impact that seasonal RSV epidemics have on hospital pathways. At the national and regional levels, work is therefore underway to start vaccination to prevent the circulation of this virus.”
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

Alopecia areata (AA) is an autoimmune condition that affects children, adolescents, and adults. Severe AA often causes significant burdens, physical discomfort, and psychological stress. Yet, response to therapy is often unpredictable, running the gamut from being refractory to treatment to spontaneous remission.

Dermatologists Raj Chovatiya from Chicago Medical School and Jason Hawkes from the Pacific Skin Institute discuss how to assess AA severity and appropriate therapies, particularly the evolving landscape of JAK inhibitors for patients with severe AA.

The panelists begin by defining severe AA on the basis of the Severity of Alopecia Tool (SALT) score, which assesses AA severity by percentage of hair loss. A patient who has lost over 50% of scalp hair is considered to have severe AA.

Until recently, traditional therapy for severe AA has relied on injectable and systemic corticosteroids, both of which have drawbacks for patients with severe disease. The emergence of Janus kinase (JAK) inhibitors has offered another option for these patients. The panelists discuss recent clinical trials that have shown promising results from JAK inhibitors for treatment of severe AA.

--

Raj Chovatiya, MD, PhD, MSCI, Clinical Associate Professor, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; Founder and Director, Center for Medical Dermatology and Immunology Research, Chicago, Illinois

Raj Chovatiya, MD, PhD, MSCI, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Apogee Therapeutics; Arcutis; Argenx; ASLAN Pharmaceuticals; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Cara Therapeutics; Dermavant; Eli Lilly

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Arcutis; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Dermavant; Eli Lilly and Company; Incyte; LEO Pharma

Alopecia areata (AA) is an autoimmune condition that affects children, adolescents, and adults. Severe AA often causes significant burdens, physical discomfort, and psychological stress. Yet, response to therapy is often unpredictable, running the gamut from being refractory to treatment to spontaneous remission.

Dermatologists Raj Chovatiya from Chicago Medical School and Jason Hawkes from the Pacific Skin Institute discuss how to assess AA severity and appropriate therapies, particularly the evolving landscape of JAK inhibitors for patients with severe AA.

The panelists begin by defining severe AA on the basis of the Severity of Alopecia Tool (SALT) score, which assesses AA severity by percentage of hair loss. A patient who has lost over 50% of scalp hair is considered to have severe AA.

Until recently, traditional therapy for severe AA has relied on injectable and systemic corticosteroids, both of which have drawbacks for patients with severe disease. The emergence of Janus kinase (JAK) inhibitors has offered another option for these patients. The panelists discuss recent clinical trials that have shown promising results from JAK inhibitors for treatment of severe AA.

--

Raj Chovatiya, MD, PhD, MSCI, Clinical Associate Professor, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; Founder and Director, Center for Medical Dermatology and Immunology Research, Chicago, Illinois

Raj Chovatiya, MD, PhD, MSCI, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Apogee Therapeutics; Arcutis; Argenx; ASLAN Pharmaceuticals; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Cara Therapeutics; Dermavant; Eli Lilly

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Arcutis; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Dermavant; Eli Lilly and Company; Incyte; LEO Pharma

Alopecia areata (AA) is an autoimmune condition that affects children, adolescents, and adults. Severe AA often causes significant burdens, physical discomfort, and psychological stress. Yet, response to therapy is often unpredictable, running the gamut from being refractory to treatment to spontaneous remission.

Dermatologists Raj Chovatiya from Chicago Medical School and Jason Hawkes from the Pacific Skin Institute discuss how to assess AA severity and appropriate therapies, particularly the evolving landscape of JAK inhibitors for patients with severe AA.

The panelists begin by defining severe AA on the basis of the Severity of Alopecia Tool (SALT) score, which assesses AA severity by percentage of hair loss. A patient who has lost over 50% of scalp hair is considered to have severe AA.

Until recently, traditional therapy for severe AA has relied on injectable and systemic corticosteroids, both of which have drawbacks for patients with severe disease. The emergence of Janus kinase (JAK) inhibitors has offered another option for these patients. The panelists discuss recent clinical trials that have shown promising results from JAK inhibitors for treatment of severe AA.

--

Raj Chovatiya, MD, PhD, MSCI, Clinical Associate Professor, Chicago Medical School, Rosalind Franklin University of Medicine and Science, North Chicago, Illinois; Founder and Director, Center for Medical Dermatology and Immunology Research, Chicago, Illinois

Raj Chovatiya, MD, PhD, MSCI, has disclosed the following relevant financial relationships:

Serve(d) as a director, officer, partner, employee, advisor, consultant, or trustee for: AbbVie; Amgen; Apogee Therapeutics; Arcutis; Argenx; ASLAN Pharmaceuticals; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Cara Therapeutics; Dermavant; Eli Lilly

Serve(d) as a speaker or a member of a speakers bureau for: AbbVie; Arcutis; Beiersdorf; Boehringer Ingelheim; Bristol Myers Squibb; Dermavant; Eli Lilly and Company; Incyte; LEO Pharma

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

More than 90% of internet users are active on social media, which had 4.76 billion users worldwide in January 2023. The digital revolution has reshaped the news landscape and changed how users interact with information. Social media has fostered an active relationship with the media, including the ability to interact directly with the content presented. It also has augmented media’s ability to reach a large audience with tight deadlines.

These developments suggest that social media can be a useful tool in everyday medical practice for professionals and patients. But social media also can spread misinformation, as happened during the COVID-19 pandemic.

This characteristic is the focus of the latest research by Fabiana Zollo, a computer science professor at Ca’ Foscari University of Venice, Italy, and coordinator of the Data Science for Society laboratory. The research was published in The BMJ. Ms. Zollo’s research group aims to assess the effect of social media on misinformation and consequent behaviors related to health. “The study results focus primarily on two topics, the COVID-19 pandemic and vaccinations, but can also be applied to other health-related behaviors such as smoking and diet,” Ms. Zollo told Univadis Italy.

Social media has become an important tool for public health organizations to inform and educate citizens. Institutions can use it to monitor choices and understand which topics are being discussed most at a given time, thus comprehending how the topics evolve and take shape in public discourse. “This could lead to the emergence of people’s perceptions, allowing us to understand, among other things, what the population’s needs might be, including informational needs,” said Ms. Zollo.
 

Tenuous Causal Link

While social media offers public health organizations the opportunity to inform and engage the public, it also raises concerns about misinformation and the difficulty of measuring its effect on health behavior. Although some studies have observed correlations between exposure to misinformation on social media and levels of adherence to vaccination campaigns, establishing a causal link is complex. As the authors emphasize, “despite the importance of the effect of social media and misinformation on people’s behavior and the broad hypotheses within public and political debates, the current state of the art cannot provide definitive conclusions on a clear causal association between social media and health behaviors.” Establishing a clear causal link between information obtained from social media and offline behavior is challenging due to methodologic limitations and the complexity of connections between online and offline behaviors. Studies often rely on self-reported data, which may not accurately reflect real behaviors, and struggle to isolate the effect of social media from other external influences. Moreover, many studies primarily focus on Western countries, limiting the generalizability of the results to other cultural and geographical conditions.

Another issue highlighted by Ms. Zollo and colleagues is the lack of complete and representative data. Studies often lack detailed information about participants, such as demographic or geolocation data, and rely on limited samples. This lack makes it difficult to assess the effect of misinformation on different segments of the population and in different geographic areas.

“The main methodologic difficulty concerns behavior, which is difficult to measure because it would require tracking a person’s actions over time and having a shared methodology to do so. We need to understand whether online stated intentions do or do not translate into actual behaviors,” said Ms. Zollo. Therefore, despite the recognized importance of the effect of social media and misinformation on people’s general behavior and the broad hypotheses expressed within public and political debates, the current state of the art cannot provide definitive conclusions on a causal association between social media and health behaviors.
 

Institutions’ Role

Social media is a fertile ground for the formation of echo chambers (where users find themselves dialoguing with like-minded people, forming a distorted impression of the real prevalence of that opinion) and for reinforcing polarized positions around certain topics. “We know that on certain topics, especially those related to health, there is a lot of misinformation circulating precisely because it is easy to leverage factors such as fear and beliefs, even the difficulties in understanding the technical aspects of a message,” said Ms. Zollo. Moreover, institutions have not always provided timely information during the pandemic. “Often, when there is a gap in response to a specific informational need, people turn elsewhere, where those questions find answers. And even if the response is not of high quality, it sometimes confirms the idea that the user had already created in their mind.”

The article published in The BMJ aims primarily to provide information and evaluation insights to institutions rather than professionals or healthcare workers. “We would like to spark the interest of institutions and ministries that can analyze this type of data and integrate it into their monitoring system. Social monitoring (the observation of what happens on social media) is a practice that the World Health Organization is also evaluating and trying to integrate with more traditional tools, such as questionnaires. The aim is to understand as well as possible what a population thinks about a particular health measure, such as a vaccine: Through data obtained from social monitoring, a more realistic and comprehensive view of the problem could be achieved,” said Ms. Zollo.
 

A Doctor’s Role

And this is where the doctor comes in: All the information thus obtained allows for identifying the needs that the population expresses and that “could push a patient to turn elsewhere, toward sources that provide answers even if of dubious quality or extremely oversimplified.” The doctor can enter this landscape by trying to understand, even with the data provided by institutions, what needs the patients are trying to fill and what drives them to seek elsewhere and to look for a reference community that offers the relevant confirmations.

From the doctor’s perspective, therefore, it can be useful to understand how these dynamics arise and evolve because they could help improve interactions with patients. At the institutional level, social monitoring would be an excellent tool for providing services to doctors who, in turn, offer a service to patients. If it were possible to identify areas where a disinformation narrative is developing from the outset, both the doctor and the institutions would benefit.
 

Misinformation vs Disinformation

The rapid spread of false or misleading information on social media can undermine trust in healthcare institutions and negatively influence health-related behaviors. Ms. Zollo and colleagues, in fact, speak of misinformation in their discussion, not disinformation. “In English, a distinction is made between misinformation and disinformation, a distinction that we are also adopting in Italian. When we talk about misinformation, we mean information that is generally false, inaccurate, or misleading but has not been created with the intention to harm, an intention that is present in disinformation,” said Ms. Zollo.

The distinction is often not easy to define even at the operational level, but in her studies, Ms. Zollo is mainly interested in understanding how the end user interacts with content, not the purposes for which that content was created. “This allows us to focus on users and the relationships that are created on various social platforms, thus bypassing the author of that information and focusing on how misinformation arises and evolves so that it can be effectively combated before it translates into action (ie, into incorrect health choices),” said Ms. Zollo.
 

This story was translated from Univadis Italy, which is part of the Medscape Professional Network, using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

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

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

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

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.

Patients with treatment-refractory cancers who did not meet eligibility criteria for a pan-cancer clinical trial but received waivers allowing them to participate had similar outcomes to patients who participated without waivers, a new analysis revealed.

The study, published online in Clinical Cancer Research, highlighted the potential benefits of broadening eligibility criteria for clinical trials.

“It is well known that results in an ‘ideal’ population do not always translate to the real-world population,” senior author Hans Gelderblom, MD, chair of the Department of Medical Oncology at the Leiden University Medical Center, Leiden, the Netherlands, said in a press release. “Eligibility criteria are often too strict, and educated exemptions by experienced investigators can help individual patients, especially in a last-resort trial.”

Although experts have expressed interest in improving trial inclusivity, it’s unclear how doing so might impact treatment safety and efficacy.

In the Drug Rediscovery Protocol (DRUP), Dr. Gelderblom and colleagues examined the impact of broadening trial eligibility on patient outcomes. DRUP is an ongoing Dutch national, multicenter, pan-cancer, nonrandomized clinical trial in which patients are treated off-label with approved molecularly targeted or immunotherapies.

In the trial, 1019 patients with treatment-refractory disease were matched to one of the available study drugs based on their tumor molecular profile and enrolled in parallel cohorts. Cohorts were defined by tumor type, molecular profile, and study drug.

Among these patients, 82 patients — 8% of the cohort — were granted waivers to participate. Most waivers (45%) were granted as exceptions to general- or drug-related eligibility criteria, often because of out-of-range lab results. Other categories included treatment and testing exceptions, as well as out-of-window testing. 

The researchers then compared safety and efficacy outcomes between the 82 participants granted waivers and the 937 who did not receive waivers. 

Overall, Dr. Gelderblom’s team found that the rate of serious adverse events was similar between patients who received a waiver and those who did not: 39% vs 41%, respectively.

A relationship between waivers and serious adverse events was deemed “unlikely” for 86% of patients and “possible” for 14%. In two cases concerning a direct relationship, for instance, patients who received waivers for decreased hemoglobin levels developed anemia.

The rate of clinical benefit — defined as an objective response or stable disease for at least 16 weeks — was similar between the groups. Overall, 40% of patients who received a waiver (33 of 82) had a clinical benefit vs 33% of patients without a waiver (P = .43). Median overall survival for patients that received a waiver was also similar — 11 months in the waiver group and 8 months in the nonwaiver group (hazard ratio, 0.87; P = .33).

“Safety and clinical benefit were preserved in patients for whom a waiver was granted,” the authors concluded.

The study had several limitations. The diversity of cancer types, treatments, and reasons for protocol exemptions precluded subgroup analyses. In addition, because the decision to grant waivers depended in large part on the likelihood of clinical benefit, “it is possible that patients who received waivers were positively selected for clinical benefit compared with the general study population,” the authors wrote.

So, “although the clinical benefit rate of the patient group for whom a waiver was granted appears to be slightly higher, this difference might be explained by the selection process of the central study team, in which each waiver request was carefully considered, weighing the risks and potential benefits for the patient in question,” the authors explained.

Overall, “these findings advocate for a broader and more inclusive design when establishing novel trials, paving the way for a more effective and tailored application of cancer therapies in patients with advanced or refractory disease,” Dr. Gelderblom said.

Commenting on the study, Bishal Gyawali, MD, PhD, said that “relaxing eligibility criteria is important, and I support this. Trials should include patients that are more representative of the real-world, so that results are generalizable.”

However, “the paper overemphasized efficacy,” said Dr. Gyawali, from Queen’s University, Kingston, Ontario, Canada. The sample size of waiver-granted patients was small, plus “the clinical benefit rate is not a marker of efficacy.

“The response rate is somewhat better, but for a heterogeneous study with multiple targets and drugs, it is difficult to say much about treatment effects here,” Dr. Gyawali added. Overall, “we shouldn’t read too much into treatment benefits based on these numbers.”

Funding for the study was provided by the Stelvio for Life Foundation, the Dutch Cancer Society, Amgen, AstraZeneca, Bayer, Boehringer Ingelheim, Bristol Myers Squibb, pharma&, Eisai Co., Ipsen, Merck Sharp & Dohme, Novartis, Pfizer, and Roche. Dr. Gelderblom declared no conflicts of interest, and Dr. Gyawali declared no conflicts of interest related to his comment.
 

A version of this article appeared on Medscape.com.