AVAHO

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

To reduce risks of lung cancer mortality, interventions designed to improve high-risk groups’ uptake of low-dose CT (LDCT) lung cancer screening should focus on perceptions of lung cancer controllability, survival, and perceived effectiveness of changes in behavior, according to analysis of data from the SUMMIT study recently published in the Journal of Thoracic Oncology. Such an approach may be more effective than trying to change risk perceptions.

While 1-year survival among patients diagnosed with early-stage lung cancer is 88%, it is only 19% for those diagnosed with advanced disease. But only 27% of patients are diagnosed with early-stage disease. Screening high-risk asymptomatic adults using LDCT detects early-stage disease and significantly reduces lung cancer mortality, according to Samantha L. Quaife, PhD, of the Wolfson Institute of Population Health at Queen Mary University of London, and associates.

The effectiveness and equity of LDCT lung cancer screening as a population-level early detection strategy is compromised by low uptake among high-risk groups, the authors wrote.

In the United States, only 2% of eligible smokers have been screened since screening was first recommended in 2013. To provide a scientific evidence base for intervention, an understanding of factors making high-risk groups less likely to participate in LDCT screening is critical, Dr. Quaife and colleagues wrote.

Their longitudinal cohort study evaluating psychological correlates of lung cancer screening uptake included 44,000 ever-smokers (aged 55-77 years) who were invited to mail a self-regulatory questionnaire for lung cancer screening. Eligibility for LDCT lung cancer screening and inclusion in the SUMMIT study were further determined through telephone and in-person Lung Health Check (LHC) appointments. The primary outcome was uptake of the invitation to book an LHC appointment by telephone.

Of those invited, 7,966 (18.1%) returned the questionnaire with 7,730 (45% female; mean age, about 64 years) linked to screening uptake data. About 30% reported being current smokers with high tobacco dependence (60.3% smoking within 30 minutes of waking). The analysis from Dr. Quaife and colleagues looked at psychological correlates of lung cancer screening uptake using a psychometrically validated self-regulatory questionnaire for lung cancer screening (SRQ-LCS) to measure psychological constructs hypothesized to be associated with uptake which included consequences, emotional representation, coherence (lung cancer knowledge), treatment control, personal control, risk perception, perceived stigma, response efficacy of smoking cessation, early diagnosis behavioral response, survival from lung cancer, and treatment intention.

Among those who perceived early diagnosis to be more beneficial as a behavioral response, the positive association with uptake was strongest (adjusted odds ratio, 1.37; 95% confidence interval, 1.33-1.41). Those who perceived greater personal control (aOR, 1.09; 95% CI, 1.05-1.11) or believed their risk of lung cancer was high (aOR, 1.08; 95% CI, 1.05-1.10) were also more likely to respond. Other uptake increases were found for those who perceived smoking cessation as an effective means of reducing lung cancer risk or thought the chances of surviving early-stage lung cancer were good or fair (P < .01), and for those who perceived lung cancer as stigmatized (aOR, 1.26; 95% CI, 1.14-1.40). Most of these constructs were also perceived more negatively by current than former smokers.

Income, employment, education, social class, and housing conditions were significantly associated with many of the constructs. Greater affluence correlated with perceived personal control and benefit from early diagnosis, but more negative perceptions of the consequences of lung cancer. Also, those from more affluent areas were more likely to perceive lung cancer to be stigmatized and perceive smoking cessation to be less effective in reducing risk. Current daily smokers were less willing to be treated for early-stage disease, more pessimistic about survival, but had the highest-risk perception scores, at odds with their lower participation in lung screening trials. This contradiction, Dr. Quaife and colleagues suggested, may be explained by current smokers also holding more negative perceptions associated with lower uptake, including negative perceptions of lung cancer controllability, early diagnosis and survival, lower willingness to be treated, and belief that smoking cessation is less effective in reducing risk. All of these undermine positive responses to their high perceived risk.

“These findings pinpoint specific psychological targets for intervention,” the authors wrote. Experimental studies investigating the methods and mechanisms through which these perceptions could be changed are needed.

The study was funded by Cancer Research UK Population Research Fellowship (C50664/A24460) awarded to Dr. Quaife. The study investigators declared no support from financial organizations that might have an interest in the submitted work in the previous 3 years.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

A new analysis of cardiovascular adverse drug reactions for non–small cell lung cancer (NCSLC)–targeted therapies finds that ALK and ROS1 inhibitors are associated with higher odds of conduction disease and QT prolongation than BRAF and EGFR inhibitors.

The findings are especially important because cardiovascular disease is known to be associated with NSCLC. Even before the start of therapy, 14%-22% of patients with stage I-IV NSCLC have heart failure and 26%-31% of patients have arrhythmias. No other study to date has described cardiovascular effects to this extent as a result of treatment.

The findings were published in the Journal of Thoracic Oncology.

Led by Joel W. Neal, MD, PhD, a medical oncologist at Stanford (Calif.) Health Care, researchers evaluated the association between NSCLC-targeted agents with arrhythmia and heart failure. Their findings are based on analysis of data from the World Health Organization pharmacovigilance database VigiBase. They found that of 98,765 adverse reactions, 61,383 occurred in patients treated with EGFR inhibitors, 15,540 were associated with ALK inhibitors, and 21,842 were associated with BRAF and MEK inhibitors. Arrhythmias occurred in 1,783 patients and 1,146 patients had heart failure.
 

The specifics

Strong associations with conduction disease and QT prolongation were found for ALK and ROS1 inhibitors, especially crizotinib. Of QT prolongation cases, 38.5% of patients on ceritinib and 18.4% of patients on crizotinib also had conduction disease and 7.9% of alectinib-associated conduction disease cases also had prolongation.

BRAF and MEK inhibitors had stronger associations with heart failure, while osimertinib, a third-generation EGFR tyrosine kinase inhibitor, was strongly associated with QT prolongation, supraventricular tachycardia, and heart failure.

ALK inhibitors were found to be 13 times more likely to lead to conduction disease and five times more likely to lead to lead to long QT syndrome as compared to all NSCLC-targeted therapies together. ALK inhibitor crizotinib had significantly higher odds of conduction disease, compared with all other targeted therapies, but of all ALK inhibitors, ceritinib and lorlatinib had the lowest odds of conduction disease. Crizotinib was 1.9 times more likely to lead to QT prolongation than other ALK inhibitors.

The EGFR inhibitor osimertinib was associated with 49 times more like to lead to long QT syndrome than other EGFR inhibitors and 6 times more likely as compared with all other targeted therapies. The EGFR inhibitor gefitinib was twice as likely than other EGFR inhibitors to lead to conduction disease. The third-generation EGFR inhibitor osimertinib had approximately two times higher odds of supraventricular tachycardia than other EGFR inhibitors.

Osimertinib was associated with 6.8 times higher chances of heart failure, compared with other EGFR inhibitors, and 3.6 times more than other targeted therapies. Dabrafenib and trametinib were associated with two to three times higher odds of heart failure as compared with other targeted therapies.

“There is a need for an understanding of the mechanisms underlying these toxicities and for additional studies to establish standardized guidelines for monitoring, particularly for osimertinib, crizotinib, and alectinib,” the authors wrote

The authors disclosed a number of paid advisory roles with various pharmaceutical companies.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

Patients diagnosed with breast cancer during incarceration are unlikely to receive neoadjuvant therapy and have an increase time to surgery if they have the procedure upfront compared to other patients, suggests a new study.

The study was presented at the 2021 San Antonio Breast Cancer Symposium on Dec. 10 (Abstract P5-14-10).

Examining the records of more than 4,300 patients with breast cancer who were treated between 2014 and 2020 in North Carolina, researchers identified 34 who were either incarcerated at the time of diagnosis or who were diagnosed before they were imprisoned.

They found that neoadjuvant therapy was not given to incarcerated breast cancer patients as compared to 8% of women who were never incarcerated and 20% of women incarcerated later. Incarcerated patients treated with surgery upfront had to wait on average more than 3 weeks longer than other patients for their procedure. Their findings were followed by a recently published study in JAMA Network Open indicating that young people with a history of incarceration were significantly more likely to experience early mortality and that mortality was higher among Black prisoners.

“These findings are concerning for missed treatment opportunities within the carceral system,” wrote researchers who were led by Oluwadamilola “Lola” Fayanju, MD, MPHS, FACS, chief of breast surgery for the University of Pennsylvania Health System, Philadelphia.

Dr. Fayanju told this news organization that she was “not surprised by the finding that there was no neoadjuvant chemotherapy given to patients at all. Even in the practice of care outside of the carceral system it is striking how much variation there is in regards to treatment sequence if it is not approached in an evidence-based way. Many of the social ills that contribute to incarceration also contribute to this variation in care, and it’s not surprising that in women who are experiencing incarceration, there is geometric escalation of disparities with regards to their opportunities for treatment.”

Erica L. Mayer, MD, MPH, a medical oncologist and clinical investigator in the Breast Oncology Center at the Dana-Faber Cancer Institute, Boston, said “this is really interesting and important work showing some worrisome trends. On the one hand, this is a very small experience and such a small sample size is always vulnerable to bias or skew from factors that become more important. However, this is not the first observation that there are disparities of care in incarcerated populations,”said Dr. Mayer, who was not involved in the study. “This is a topic that has been studied in diseases outside of oncology, such as heart disease and diabetes. There is a theme that patients who are incarcerated have a disparity and inequity of care compared to those who are not.”

The current findings “fit in with general themes,” she said. As rates of cancer are expected to grow in the coming years, “understanding how to provide the best possible care in those settings is very important. This is early data but it’s an important signal and is suggesting to us that a greater understanding of health care access for incarcerated individuals is a very important area of study, and hopefully an area for which one could provide interventions that might help to reduce these disparities.”

Dr. Fayanju and associates. set out to determine the disease and treatment characteristics of individuals with breast cancer and a history of incarceration. They focused on women who had a breast cancer diagnosis at the University of North Carolina Hospitals between April 2014 and December 2020. They gathered data on patient demographics, incarceration status, disease characteristics, treatment types, and dates of receipt of treatment, but there were few data available. “It is really striking how little data there is available. This is a very small study and is the best we could glean from a large state-wide dataset,” she said.

Of 4,332 breast cancer cases, 34 (0.8%) were diagnosed while incarcerated (70.6%) or before incarceration (29.4%). Those who were diagnosed during incarceration were significantly more likely to be single (P < .001), use illicit drugs at the time of diagnosis (P = .01), and have a family history of breast cancer (P = .03) as compared with patients who were never incarcerated and those who were diagnosed before incarceration.

The results also showed that patients diagnosed with breast cancer during incarceration were significantly less likely to receive neoadjuvant therapy at 0% versus 8.2% for those who were never incarcerated, and 20% for those who were diagnosed before incarceration (P = .01 for trend).

“Further research is needed to understand the full scope of cancer inequities and identify factors that contribute to them among patients who experience incarceration,” Dr. Fayanju said.

No funding or relevant financial relationships were declared for this featured study.

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

The drumbeat of U.S. recalls continues for various lots of extended-release metformin because of contamination with unacceptably high levels of a nitrosamine that pose a cancer risk.

On Dec. 28, 2021, Viona Pharmaceuticals voluntarily recalled 33 lots of metformin hydrochloride extended-release tablets, USP 750 mg to the retail level, as a precautionary measure, because of possible contamination with N-nitrosodimethylamine (NDMA).

Metformin is used as an adjunct to diet and exercise to improve blood glucose control in adults with type 2 diabetes mellitus. Patients who have received impacted lots of metformin are advised to continue taking their medication and contact their physician for advice regarding an alternative treatment

The product can be identified as white to off-white, capsule shaped, uncoated tablets, debossed with “Z,” “C” on one side and “20” on the other side, and come in bottles of 100 tablets, which have been distributed nationwide. The 33 batch numbers are listed in a company statement.

The affected product was manufactured by Cadila Healthcare, Ahmedabad, India, for U.S. distribution by Viona.

In its statement, Viona said: “NDMA is classified as a probable human carcinogen (a substance that could cause cancer) based on results from laboratory tests. NDMA is a known environmental contaminant and found in water and foods, including meats, dairy products, and vegetables.”

This recall is being conducted “with the knowledge of the U.S. Food and Drug Administration,” it added.

Consumers with questions regarding this recall can contact the recall processor Eversana Life Science Services by phone at 1-888-304-5022, option 1; Monday-Friday, 8:00 a.m.–7:00 p.m. CT. Customers with medical-related questions who wish to report an adverse event or quality issues about the products being recalled should contact Viona Pharmaceuticals by phone at 888-304-5011, Monday-Friday, 8:30 p.m.–5:30 p.m., EST.
 

Latest in a long line of metformin recalls

This is the second time in 2021 that Viona has voluntarily recalled extended-release metformin tablets, 750 mg, because of potential contamination with NDMA. It recalled two lots in June, as reported by this news organization.

And in January 2021, Nostrum Laboratories recalled another lot of metformin extended-release 750-mg tablets, following on from a prior recall in November 2020.

These recalls follows 258 distinct U.S. lot recalls tracked by the FDA during the past 2 years because of unacceptably high NDMA levels in lots of metformin hydrochloride extended-release tablets.

The FDA has issued several statements about NDMA contamination of metformin formulations over the past 2 years, including a review of the methods used to detect NDMA and a summary of the information the agency had collected on excessive levels of NDMA in metformin.

According to the FDA’s 2020 summary, the agency has not yet determined how or why high levels of NDMA turn up so often in multiple batches of metformin hydrochloride extended-release tablets. However, published research attributed the contamination to certain methods of manufacturing metformin tablets.

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

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

In non–small cell lung cancer (NSCLC), earlier detection may be an under-appreciated factor in recent trends of declining mortality, according to a new analysis of data from the Surveillance, Epidemiology, and End Results (SEER) registries published in JAMA Network Open. Between 2006 and 2016, a stage shift occurred with an increase in stage 1 and 2 diagnoses and a decrease in stage 3 and 4 diagnoses.

While targeted therapy and immunotherapy have rightfully been credited with improved NSCLC survival, the new results underline the importance of screening, according to study author Emanuela Taioli, MD, PhD, director of the Institute for Translational Epidemiology and the associate director for population science at the Tisch Cancer Institute at Mount Sinai, New York.

She noted that the average survival for stage 1 or stage 2 patients was 57 months, but just 7 months when the stage diagnosis was 3 or 4. “So being diagnosed with stage 1 and 2 is a major driver of better survival,” said Dr. Taioli in an interview.

The study included 312,382 individuals diagnosed with NSCLC (53.4% male; median age, 68). Incidence-based, 5-year mortality declined by 3.7% (95% confidence interval, 3.4%-4.1%). Stage 1 or 2 diagnoses increased from 26.5% to 31.2% of diagnoses between 2006 and 2016 (average annual percentage change, 1.5%; 95% CI, 0.5%-2.5%).

“Immunotherapy is a very exciting field. And it is an important contributor for people who have a disease that can be treated with immunotherapy, so that’s why people focus on that. But if you can diagnose the cancer earlier, that’s the best bet,” Dr. Taioli said.

Unfortunately, many patients and physicians haven’t received that message. Even though computed tomography lung cancer screening is covered by Medicare for current or former smokers, only about 7% of eligible patients undergo annual screening. Dr. Taioli said that a belief persists that lung cancer is so deadly that early detection isn’t effective.

But advances in therapy and surgery have changed that outlook. “It’s not true anymore. People don’t know, and physicians are not educated to the idea that lung cancer can be diagnosed earlier and save lives,” she said.

People who have quit smoking may be relatively easy to convince. “They made a big step, because quitting smoking is incredibly hard. I think they will be amenable to screening because they are in a phase [of life] in which they want to take care of themselves. The physician should really explain the benefits, and I don’t think they do it very clearly now,” Dr. Taioli said.

The study is limited by its retrospective nature, and it did not include information on diagnostic method or many NSCLC risk factors.

Dr. Taioli has no relevant financial disclosures.

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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

A Chicago-based medical oncologist has been charged with insider trading by the U.S. Securities and Exchange Commission, according to a Dec. 20 press release issued by the U.S. Department of Justice.

Daniel V.T. Catenacci, MD, PhD, a gastrointestinal medical oncologist and associate professor of medicine at the University of Chicago, is alleged to have used confidential information to purchase shares of California-based biotechnology company Five Prime Therapeutics before it publicly announced positive results from a clinical trial of bemarituzumab, an experimental cancer drug.

Dr. Catenacci served as the lead investigator of the clinical trial that evaluated bemarituzumab. The drug, which earned breakthrough therapy designation from the Food and Drug Administration earlier this year, is designed to target fibroblast growth factor receptor 2b (FGFR2b), overexpressed in about 30% of patients with HER2-negative gastric cancer and other solid tumors.

Bemarituzumab is being positioned as a potential frontline therapy for advanced gastric or gastroesophageal junction cancer. A recent phase 2 trial found that adding bemarituzumab to chemotherapy in this patient population improved survival over chemotherapy alone.

According to the criminal information, filed on Dec. 17 in U.S. District Court in Chicago, the charges state that, in November 2020, Dr. Catenacci “used material, non-public information about the trial results to make more than $134,000 in illegal profits from the purchase and sale of securities in the company.”

More specifically, the SEC’s complaint alleges that Dr. Catenacci received confidential information about the company and its positive clinical trial results through his position as principal investigator. Dr. Catenacci then purchased almost 8,800 shares of Five Prime Therapeutics before the company announced the positive results. Dr. Catenacci subsequently sold those shares shortly after the trial results were announced. In the interim, the shares tripled or quadrupled in value.

He has been charged with one count of securities fraud, punishable by up to 20 years in federal prison. Arraignment in federal court in Chicago has yet to be scheduled.

In addition, the federal complaint alleges that Dr. Catenacci violated the antifraud provisions of the federal securities laws. According to a press release, “Catenacci has agreed to be permanently enjoined from violations of these provisions, and to pay a civil penalty in an amount to be determined by the court later.”

Erin E. Schneider, regional director of the SEC’s San Francisco Regional Office, stated in the press release that clinical drug trials typically involve sensitive and valuable information about the viability of an experimental drug.

“As alleged in our complaint, Catenacci was required to safeguard the material nonpublic information he learned about Five Prime’s clinical trial, and not trade on it,” said Mr. Schneider.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

A high-fiber diet may improve treatment response among patients with advanced melanoma receiving immune checkpoint inhibitors, while probiotics may reduce treatment effectiveness, a new study shows.

Investigators found that the patients who reported consuming at least 20 g of dietary fiber daily had significantly better progression-free survival (PFS) than those who reported consuming lower amounts of dietary fiber. However, patients who took a probiotic supplement in the past month had slightly shorter PFS, but the results were not statistically significant.

And after adjusting for clinical factors, each 5-g increase in daily dietary fiber intake corresponded to a 30% lower risk of disease progression, according to the analysis, published online Dec. 23, 2021, in Science.

“Our study sheds light on the potential effects of a patient’s diet and supplement use when starting treatment with immune checkpoint blockade,” co–lead study author Jennifer Wargo, MD, professor of genomic medicine and surgical oncology at University of Texas MD Anderson Cancer Center, Houston, said in a press release. “These results provide further support for clinical trials to modulate the microbiome with the goal of improving cancer outcomes using dietary and other strategies.”

Previous research has suggested that the microbiome can influence patients’ response to immunotherapy. One recent analysis, for instance, found that fecal microbiota transplant can improve response to immunotherapy in advanced melanoma. And a small 2019 analysis from Dr. Dr. Wargo and colleagues hinted that a high-fiber diet may enhance patients’ ability to respond to immunotherapy in advanced melanoma, while probiotics appear to dampen that response.

Still, the role diet and probiotic supplements play in treatment response remains poorly understood.

In the current study, Dr. Wargo and colleagues assessed fecal microbiota profiles and dietary habits, including fiber intake and probiotic use, in 158 patients with advanced melanoma who received immune checkpoint blockade inhibitors.

In the cohort, 31% (49 of 158) of late-stage melanoma patients reported taking a commercially available probiotic in the past month. When assessing whether probiotic use influenced patient outcomes, the investigators observed a shorter but not statistically significant difference in PFS in those who took a probiotic (median, 17 months) versus those who did not (23 months).

Higher dietary fiber, however, was associated with significantly improved PFS in a subset of 128 patients. The team divided patients into a higher-fiber intake group (those consuming at least 20 g/day) and a low-fiber group (those consuming less than 20 g).

The 37 patients reporting higher fiber intake demonstrated improved PFS, compared with those in the low-intake group (median PFS not reached vs. 13 months), plus a 30% lower risk of disease progression or death for each additional 5 g consumed each day.

“The observed protective effect of dietary fiber intake in relation to PFS and response remained consistent among the subset of patients treated with anti–PD-1 monotherapy, with the exclusion of patients reporting recent antibiotic use,” the authors noted.

When assessing fiber and probiotic intake together, the researchers found that immunotherapy response rate was higher (82%) in the 22 patients who reported sufficient dietary fiber intake with no probiotic use versus 59% in 101 patients who reported either insufficient fiber intake or probiotic use.

Overall, the research suggests that “consuming a diet rich in fiber, like fruits, vegetables, and legumes, could improve your ability to respond to immunotherapy,” co–lead author Giorgio Trinchieri, MD, chief of the Laboratory of Integrative Cancer Immunology in the National Cancer Institute’s Center for Cancer Research, Bethesda, Md., said in a press statement. “The data also suggest that it’s probably better for people with cancer receiving immunotherapy not to use commercially available probiotics.”

The investigators also explored whether dietary fiber intake enhanced treatment response in preclinical mouse models of melanoma. In this instance, mice receiving a fiber-rich diet showed delayed tumor growth after anti–PD-1 treatment, compared with mice given a low-fiber diet or probiotics.

According to the authors, “our preclinical models support the hypothesis that dietary fiber and probiotics modulate the microbiome and that antitumor immunity is impaired in mice receiving a low-fiber diet and in those receiving probiotics – with suppression of intratumoral [interferon-gamma] T-cell responses in both cases.”

Dietary fiber may exert beneficial effect by increasing specific types of bacteria in the gut, such as Ruminococcaceae, which “produce high levels of certain short-chain fatty acids that have an antitumor effect,” Dr. Trinchieri explained.

However, “the impact of dietary fiber and probiotics on the gut microbiota is only part of the bigger picture,” Dr. Trinchieri said in a press release. “Many factors can affect the ability of a patient with melanoma to respond to immunotherapy” but, according to this analysis, “the microbiota seems to be one of the dominant factors.”

While Jeffrey S. Weber, MD, PhD, applauded the “innovative and interesting” research, he believes the patient population is too small to confirm that a high-fiber diet does indeed contribute to improved immunotherapy response and PFS in patients with advanced melanoma.

Additional data are needed to clarify these findings. “I will believe it if I could see it replicated in a larger study,” Dr. Weber, professor and deputy director of the Laura and Isaac Perlmutter Cancer Center, New York University, said in an interview.

Dr. Wargo noted that a randomized clinical trial exploring how diets with varying fiber content affect the microbiome and immune response is currently enrolling patients with stage III and IV melanoma receiving immunotherapy.

This study was supported by the Melanoma Moon Shot, among others. Dr. Wargo is a collaborator on a U.S. patent application that covers methods to enhance immune checkpoint blockade responses by modulating the microbiome. Dr. Weber reported relationships with Bristol-Myers Squibb, GlaxoSmithKline, Genentech BioOncology, Merck, Novartis, EMD Serono, Celldex, CytomX, Nektar, Roche, Altor, Daiichi Sankyo, and Eli Lilly, and is named on patents filed for biomarkers for ipilimumab and nivolumab.

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

The U.S. Multi-Society Task Force on Colorectal Cancer (CRC) has lowered the recommended age to start CRC screening from 50 to 45 years of age for all average-risk individuals.

Although no studies have directly demonstrated the result of lowering the age of screening, lead author Swati G. Patel, MD, of University of Colorado Anschutz Medical Center, Aurora, and colleagues suggested that the increasing incidence of advanced CRC among younger individuals, coupled with the net benefit of screening, warrant a lower age threshold.

“Recent data ... show that CRC incidence rates in individuals ages 50 to 64 have increased by 1% annually between 2011 and 2016,” the authors wrote in Gastroenterology. “Similarly, CRC incidence and mortality rates in persons under age 50, termed early-age onset CRC (EAO-CRC), are also increasing.”

The task force of nine experts, representing the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, conducted a literature review and generated recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition to recommending a lower age for initial screening, Dr. Patel and colleagues provided guidance for cessation of screening among older individuals.
 

Guidance for screening initiation

According to the authors, the present risk of CRC among younger individuals mirrors the historical risk for older individuals before screening was prevalent.

“The current CRC incidence rates in individuals ages 45 to 49 are similar to the incidence rates observed in 50-year-olds in 1992, before widespread CRC screening was performed,” they wrote.

Elevated rates among younger people have been disproportionately driven by rectal cancer, according to the authors. From 2006 to 2015, incidence of rectal cancer among Americans under 50 increased 1.7% per year, compared with 0.7% per year for colon cancer, based on data from the North American Association of Central Cancer Registries.

Associated mortality rates also increased, the authors noted. From 1999-2019, mortality from colon cancer among people 45-49 years increased from 6.4 to 6.6 deaths per 100,000 individuals, while deaths from rectal cancer increased from 1.3 to 1.7 per 100,000, according to the CDC. Concurrently, CRC-associated mortality rates among older individuals generally declined.

While these findings suggest a growing disease burden among the under-50-year age group, controlled data demonstrating the effects of earlier screening are lacking, Dr. Patel and colleagues noted. Still, they predicted that expanded screening would generate a net benefit.

“Although there are no CRC screening safety data for average-risk individuals [younger than] 50, there are ample data that colonoscopy for other indications (screening based on family history, symptom evaluation, etc.) is safer when comparing younger versus older individuals,” they wrote.

Supporting this claim, the authors cited three independently generated microsimulation models from the Agency for Healthcare Research and Quality that “showed a favorable balance of life-years gained compared with adverse events,” given 100% compliance.
 

Guidance for screening cessation

Like the situation with younger individuals, minimal data are available to determine the best time for screening cessation, according to the task force.

“There are no randomized or observational studies after 2017 that enrolled individuals over age 75 to inform the appropriate time to stop CRC screening,” the authors wrote. “In our search of 37 relevant articles, only one presented primary data for when to stop screening.”

This one available study showed that some individuals older than 74 do in fact gain benefit from screening,

“For example,” Dr. Patel and colleagues wrote, “women without a history of screening and no comorbidities benefitted from annual fecal immunochemical test (FIT) screening until age 90, whereas unscreened men with or without comorbidities benefited from annual FIT screening until age 88. Conversely, screening was not beneficial beyond age 66 in men or women with severe comorbidities.”

The task force therefore recommended personalized screening for individuals 76-85 years of age “based on the balance of benefits and harms and individual patient clinical factors and preferences.”

Screening for individuals 86 years and older, according to the task force, is unnecessary.

The authors disclosed relationships with Olympus America, Bayer Pharmaceuticals, Janssen Pharmaceuticals, and others.

This article was updated on Jan. 3, 2022.

The U.S. Multi-Society Task Force on Colorectal Cancer (CRC) has lowered the recommended age to start CRC screening from 50 to 45 years of age for all average-risk individuals.

Although no studies have directly demonstrated the result of lowering the age of screening, lead author Swati G. Patel, MD, of University of Colorado Anschutz Medical Center, Aurora, and colleagues suggested that the increasing incidence of advanced CRC among younger individuals, coupled with the net benefit of screening, warrant a lower age threshold.

“Recent data ... show that CRC incidence rates in individuals ages 50 to 64 have increased by 1% annually between 2011 and 2016,” the authors wrote in Gastroenterology. “Similarly, CRC incidence and mortality rates in persons under age 50, termed early-age onset CRC (EAO-CRC), are also increasing.”

The task force of nine experts, representing the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, conducted a literature review and generated recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition to recommending a lower age for initial screening, Dr. Patel and colleagues provided guidance for cessation of screening among older individuals.
 

Guidance for screening initiation

According to the authors, the present risk of CRC among younger individuals mirrors the historical risk for older individuals before screening was prevalent.

“The current CRC incidence rates in individuals ages 45 to 49 are similar to the incidence rates observed in 50-year-olds in 1992, before widespread CRC screening was performed,” they wrote.

Elevated rates among younger people have been disproportionately driven by rectal cancer, according to the authors. From 2006 to 2015, incidence of rectal cancer among Americans under 50 increased 1.7% per year, compared with 0.7% per year for colon cancer, based on data from the North American Association of Central Cancer Registries.

Associated mortality rates also increased, the authors noted. From 1999-2019, mortality from colon cancer among people 45-49 years increased from 6.4 to 6.6 deaths per 100,000 individuals, while deaths from rectal cancer increased from 1.3 to 1.7 per 100,000, according to the CDC. Concurrently, CRC-associated mortality rates among older individuals generally declined.

While these findings suggest a growing disease burden among the under-50-year age group, controlled data demonstrating the effects of earlier screening are lacking, Dr. Patel and colleagues noted. Still, they predicted that expanded screening would generate a net benefit.

“Although there are no CRC screening safety data for average-risk individuals [younger than] 50, there are ample data that colonoscopy for other indications (screening based on family history, symptom evaluation, etc.) is safer when comparing younger versus older individuals,” they wrote.

Supporting this claim, the authors cited three independently generated microsimulation models from the Agency for Healthcare Research and Quality that “showed a favorable balance of life-years gained compared with adverse events,” given 100% compliance.
 

Guidance for screening cessation

Like the situation with younger individuals, minimal data are available to determine the best time for screening cessation, according to the task force.

“There are no randomized or observational studies after 2017 that enrolled individuals over age 75 to inform the appropriate time to stop CRC screening,” the authors wrote. “In our search of 37 relevant articles, only one presented primary data for when to stop screening.”

This one available study showed that some individuals older than 74 do in fact gain benefit from screening,

“For example,” Dr. Patel and colleagues wrote, “women without a history of screening and no comorbidities benefitted from annual fecal immunochemical test (FIT) screening until age 90, whereas unscreened men with or without comorbidities benefited from annual FIT screening until age 88. Conversely, screening was not beneficial beyond age 66 in men or women with severe comorbidities.”

The task force therefore recommended personalized screening for individuals 76-85 years of age “based on the balance of benefits and harms and individual patient clinical factors and preferences.”

Screening for individuals 86 years and older, according to the task force, is unnecessary.

The authors disclosed relationships with Olympus America, Bayer Pharmaceuticals, Janssen Pharmaceuticals, and others.

This article was updated on Jan. 3, 2022.

The U.S. Multi-Society Task Force on Colorectal Cancer (CRC) has lowered the recommended age to start CRC screening from 50 to 45 years of age for all average-risk individuals.

Although no studies have directly demonstrated the result of lowering the age of screening, lead author Swati G. Patel, MD, of University of Colorado Anschutz Medical Center, Aurora, and colleagues suggested that the increasing incidence of advanced CRC among younger individuals, coupled with the net benefit of screening, warrant a lower age threshold.

“Recent data ... show that CRC incidence rates in individuals ages 50 to 64 have increased by 1% annually between 2011 and 2016,” the authors wrote in Gastroenterology. “Similarly, CRC incidence and mortality rates in persons under age 50, termed early-age onset CRC (EAO-CRC), are also increasing.”

The task force of nine experts, representing the American Gastroenterological Association, the American College of Gastroenterology, and the American Society for Gastrointestinal Endoscopy, conducted a literature review and generated recommendations using the Grading of Recommendations Assessment, Development, and Evaluation (GRADE) criteria. In addition to recommending a lower age for initial screening, Dr. Patel and colleagues provided guidance for cessation of screening among older individuals.
 

Guidance for screening initiation

According to the authors, the present risk of CRC among younger individuals mirrors the historical risk for older individuals before screening was prevalent.

“The current CRC incidence rates in individuals ages 45 to 49 are similar to the incidence rates observed in 50-year-olds in 1992, before widespread CRC screening was performed,” they wrote.

Elevated rates among younger people have been disproportionately driven by rectal cancer, according to the authors. From 2006 to 2015, incidence of rectal cancer among Americans under 50 increased 1.7% per year, compared with 0.7% per year for colon cancer, based on data from the North American Association of Central Cancer Registries.

Associated mortality rates also increased, the authors noted. From 1999-2019, mortality from colon cancer among people 45-49 years increased from 6.4 to 6.6 deaths per 100,000 individuals, while deaths from rectal cancer increased from 1.3 to 1.7 per 100,000, according to the CDC. Concurrently, CRC-associated mortality rates among older individuals generally declined.

While these findings suggest a growing disease burden among the under-50-year age group, controlled data demonstrating the effects of earlier screening are lacking, Dr. Patel and colleagues noted. Still, they predicted that expanded screening would generate a net benefit.

“Although there are no CRC screening safety data for average-risk individuals [younger than] 50, there are ample data that colonoscopy for other indications (screening based on family history, symptom evaluation, etc.) is safer when comparing younger versus older individuals,” they wrote.

Supporting this claim, the authors cited three independently generated microsimulation models from the Agency for Healthcare Research and Quality that “showed a favorable balance of life-years gained compared with adverse events,” given 100% compliance.
 

Guidance for screening cessation

Like the situation with younger individuals, minimal data are available to determine the best time for screening cessation, according to the task force.

“There are no randomized or observational studies after 2017 that enrolled individuals over age 75 to inform the appropriate time to stop CRC screening,” the authors wrote. “In our search of 37 relevant articles, only one presented primary data for when to stop screening.”

This one available study showed that some individuals older than 74 do in fact gain benefit from screening,

“For example,” Dr. Patel and colleagues wrote, “women without a history of screening and no comorbidities benefitted from annual fecal immunochemical test (FIT) screening until age 90, whereas unscreened men with or without comorbidities benefited from annual FIT screening until age 88. Conversely, screening was not beneficial beyond age 66 in men or women with severe comorbidities.”

The task force therefore recommended personalized screening for individuals 76-85 years of age “based on the balance of benefits and harms and individual patient clinical factors and preferences.”

Screening for individuals 86 years and older, according to the task force, is unnecessary.

The authors disclosed relationships with Olympus America, Bayer Pharmaceuticals, Janssen Pharmaceuticals, and others.

This article was updated on Jan. 3, 2022.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.

SAN ANTONIO – In a large prospective, international cohort, food additive nitrates and nitrites, artificial sweeteners (especially aspartame and acesulfame-K), and dietary trans fatty acids were found to be associated with increased cancer risks.

The findings were reported in three poster presentations (P1-09-01, P1-09-02 and P3-12-35) at the 2021 San Antonio Breast Cancer Symposium from the ongoing French NutriNet-Santé web-based study of 171,000 people that was launched in France in 2009 to investigate nutrition and health relationships. The authors of the analyses note that while evidence of deleterious health effects has been established for the dietary focus of their studies, and cancer risks have been suspected, strong evidence of a cancer association has been lacking.

Nitrates and nitrites are used in processed meats to increase shelf life and to avoid bacterial growth, said Eloi Chazelas, PhD, Nutritional Epidemiology Research Team (EREN) at Sorbonne Paris Nord University. Dr. Chazelas looked at consumption of nitrites and nitrates through repeated 24 hour dietary records, linked to a comprehensive food composition database. The study’s main outcome measure was adjusted associations between nitrite and nitrate exposures and the risk of cancer (overall and by main cancer sites).

During follow-up, 966 breast and 400 prostate cancers were diagnosed among 3,311 first incident cancer cases. Breast cancer risk was elevated (HR = 1.24 [1.03-1.48], P = 0.02) among higher consumers of nitrates from food additives, especially with potassium nitrate consumption (HR = 1.25 [1.04-1.50], P = 0.01). Elevated prostate cancer risk was associated with nitrites (HR = 1.58 [1.14-2.18], P = 0.008), specifically for sodium nitrite (HR = 1.62 [1.17-2.25], P = 0.004). Nitrates and nitrites from natural sources were not associated significantly with higher cancer risk, Dr. Chazelas said.

He and his team found that food additive nitrates were positively associated with breast cancer risk, and food additive nitrites were positively associated with prostate cancer risk. “While these results need confirmation in other large-scale prospective studies, they provide new insights in a context of lively debate around the ban of nitrite additives in the food industry,” said Dr. Chazelas, who is a doctoral candidate at Sorbonne Paris Nord University.

In “Breast and prostate cancer risk associated with nitrites and nitrates from food additives (P1-09-01),” the study included 102,046 adults from the French NutriNet-Santé prospective cohort (2009-2021). It examined associations between artificial sweetener intakes (total from all dietary sources, the most frequently consumed ones [aspartame e951, acesulfame-K e950 and sucralose e955]) and cancer risk (overall and by sites: breast, prostate and obesity-related cancers).

Overall cancer risk in people who consumed higher amounts of total sweeteners (i.e. above the median exposure in consumers) was elevated (n = 2,527 cases, hazard ratio = 1.12, 95 percent confidence interval = 1.00-1.25, P-trend=0.005), especially for aspartame (HR = 1.20 [1.05-1.38] P = 0.001) and acesulfame-K (HR = 1.18 [1.04-1.34] P = 0.003). Elevated breast cancer risks (among 723 cases) were observed for total sweeteners (HR = 1.25 [1.02-1.53] P = 0.01), for aspartame (HR = 1.33 [1.05-1.69] P = 0.007), and for acesulfame-K (HR = 1.39 [1.11-1.74] P = 0.003). Also, obesity-related cancers (1,509 cases) were increased for total sweeteners (HR = 1.16 [1.00-1.33] P = 0.02), for aspartame (HR = 1.22 [1.02-1.45] P = 0.01) and for acesulfame-K (HR = 1.23 [1.04-1.45] P = 0.01).

Artificial sweeteners are found in more than 10,000 foods and beverages, said Charlotte Debras, a doctoral candidate in nutritional epidemiology at Sorbonne Paris Nord University. “These findings provide important and novel insights for the ongoing re-evaluation of food additive sweeteners by the European Food Safety Authority and other health agencies globally,” she said.
 

Trans fatty acid intakes and cancer risk

Investigating associations between trans fatty acid intake (total ruminant [rTFAs], industrial [iTFAs], and corresponding specific isomers and cancer risk), the analysis of Gaëlle Wendeu-Foyet, PhD, Sorbonne Paris Nord University, found a total of 3,374 incident cancer cases (982 breast, 405 prostate) in an overall population of 104,909. Dietary intake of total TFAs was associated with higher prostate cancer risk (hazard ration for quartile 4 versus 1: 1.27, 1.11-1.77 P-trend = 0.005). Also, rTFAs were associated with increased overall cancer risk (1.16, 1.02-1.32 P-trend = 0.07), in particular the conjugated linoleic acid isomers (CLA) (1.19, 1.04-1.36 P-trend = 0.04). These associations were specifically observed for breast cancer (rTFAs: 1.35, 1.06-1.72 P-trend = 0.01; CLA: 1.29, 1.00-1.66 P-trend = 0.048), in particular before menopause (rTFAs: 1.68, 1.06-2.67 P-trend = 0.02; CLA: 2.013, 1.25-3.23 P-trend = 0.003). Several iTFAs were associated with overall (1.18, 1.06-1.31 P-trend = 0.02 for transdocosenoic acid), breast (isomer 18:2t: 1.30, 1.06-1.58 P-trend = 0.01; hexadecenoic acid: 1.28, 1.05-1.56 P-trend = 0.02) and prostate (transdocosenoic acid: 1.52, 1.09-2.12 P-trend = 0.07) cancer risks.

“These results support the WHO’s goal of achieving elimination from food supplies of industrially produced TFAs,” Dr. Foyet said. “The consumption of food products containing partially hydrogenated oils should be avoided.”

Nutrition, along with avoiding tobacco intake, is one of the main modifiable risk factors for chronic diseases. “There is a lot at stake in terms of prevention. This requires a combination of actions at the individual level to the public level by informing the public through food labeling,” Ms. Debras said.

It also requires influencing the context in which citizens evolve by encouraging manufacturers to improve their products (pricing policies, commitment charters for product reformulation, etc.), and limiting advertising and marketing for products of poor nutritional quality (especially among children),” she said.

SAN ANTONIO – Breast cancer survivors with chronic musculoskeletal pain may experience relief from pain with electroacupuncture and auricular acupuncture, according to a new study recently presented at the 2021 San Antonio Breast Cancer Symposium.

Both techniques led to clinically meaningful and persistent reduction of pain, but electroacupuncture was more effective in reducing pain severity, according to study author Wanqing Iris Zhi, MD, PhD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center in New York.

Among breast cancer survivors, Dr. Zhi said, chronic musculoskeletal pain is common and debilitating. In earlier results of the PEACE (Personalized Electroacupuncture versus Auricular Acupuncture Comparative Effectiveness) trial, both electroacupuncture and auricular acupuncture improved pain control better than usual care in cancer survivors. The comparative effectiveness between electroacupuncture and auricular acupuncture among breast cancer survivors, specifically for chronic musculoskeletal pain, remains unknown.

To evaluate potential differences between electroacupuncture and auricular acupuncture, Dr. Zhi et al. examined data from PEACE, a three-arm, parallel, single center randomized trial investigating electroacupuncture and auricular acupuncture for chronic musculoskeletal pain, compared with usual care. Among 360 cancer survivors in PEACE, mean age in 165 cancer survivors with a primary diagnosis of breast cancer was 60.3 years (35.8 percent non-White) with a mean of 5.4 years since their cancer diagnoses. Patients in both the electroacupuncture and auricular acupuncture groups received 10 weekly treatments. Change in mean Brief Pain Inventory (BPI) pain severity from baseline to week 12 was the primary endpoint, with BPI change to week 24 as a secondary endpoint. Usual care patients, after week 12, could receive 10 electroacupuncture treatments.

The most common locations of chronic musculoskeletal pain, Dr. Zhi observed, were lower back (24 percent), knee/leg (24 percent) and shoulder/elbow (14 percent). About 70 percent of patients were taking pain medication. Both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reductions among the evaluated breast cancer survivors. The change in BPI severity from baseline to week 12 was –0.29 (confidence interval, –0.08, 0.28) in the UC group. In the electroacupuncture group it was –2.65 (CI, –3.06, –2.25; P ≤0.001 from baseline) and –2.37 versus usual care (CI, –3.05, –1.68; P ≤0.001 versus UC). For the auricular acupuncture group, the change from baseline was –1.75 (CI, –2.15, –1.35; P ≤0.001 from baseline) and –1.46 versus usual care (CI, –2.14, –0.78; P ≤0.001 versus UC). The difference in BPI pain severity reduction from baseline between electroacupuncture and auricular acupuncture of –0.90 (CI, –1.45, –0.36) was statistically significant (P ≤0.001). Electroacupuncture also reduced pain severity significantly more than auricular acupuncture at week 24 (CI, –0.82, [–1.38, –0.27], P = 0.004).

Dr. Zhi concluded that among breast cancer survivors, although both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reduction, electroacupuncture was more effective at reducing pain severity.

She pointed out also that neither surgery type (mastectomy versus lumpectomy; P = 0.83) nor aromatase inhibitor versus tamoxifen versus neither (P = 0.59) was associated with BPI/severity response among electroacupuncture and auricular acupuncture patients.

“Both electroacupuncture and auricular acupuncture are significantly better than usual care, so it suggests that both acupuncture methods can be utilized for treating chronic muscle skeletal pain in breast cancer survivors, but electroacupuncture is preferred,” Dr. Zhi said.

“Auricular acupuncture can be more painful,” said PEACE principal investigator Jun Mao, MD, who is chair of integrative medicine at Memorial Sloan Kettering. “Ten percent of women could not tolerate the ear pain or discomfort. Electroacupuncture is generally well tolerated. People are more relaxed after treatment. If both are available, start with electroacupuncture,” he said.

SAN ANTONIO – Breast cancer survivors with chronic musculoskeletal pain may experience relief from pain with electroacupuncture and auricular acupuncture, according to a new study recently presented at the 2021 San Antonio Breast Cancer Symposium.

Both techniques led to clinically meaningful and persistent reduction of pain, but electroacupuncture was more effective in reducing pain severity, according to study author Wanqing Iris Zhi, MD, PhD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center in New York.

Among breast cancer survivors, Dr. Zhi said, chronic musculoskeletal pain is common and debilitating. In earlier results of the PEACE (Personalized Electroacupuncture versus Auricular Acupuncture Comparative Effectiveness) trial, both electroacupuncture and auricular acupuncture improved pain control better than usual care in cancer survivors. The comparative effectiveness between electroacupuncture and auricular acupuncture among breast cancer survivors, specifically for chronic musculoskeletal pain, remains unknown.

To evaluate potential differences between electroacupuncture and auricular acupuncture, Dr. Zhi et al. examined data from PEACE, a three-arm, parallel, single center randomized trial investigating electroacupuncture and auricular acupuncture for chronic musculoskeletal pain, compared with usual care. Among 360 cancer survivors in PEACE, mean age in 165 cancer survivors with a primary diagnosis of breast cancer was 60.3 years (35.8 percent non-White) with a mean of 5.4 years since their cancer diagnoses. Patients in both the electroacupuncture and auricular acupuncture groups received 10 weekly treatments. Change in mean Brief Pain Inventory (BPI) pain severity from baseline to week 12 was the primary endpoint, with BPI change to week 24 as a secondary endpoint. Usual care patients, after week 12, could receive 10 electroacupuncture treatments.

The most common locations of chronic musculoskeletal pain, Dr. Zhi observed, were lower back (24 percent), knee/leg (24 percent) and shoulder/elbow (14 percent). About 70 percent of patients were taking pain medication. Both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reductions among the evaluated breast cancer survivors. The change in BPI severity from baseline to week 12 was –0.29 (confidence interval, –0.08, 0.28) in the UC group. In the electroacupuncture group it was –2.65 (CI, –3.06, –2.25; P ≤0.001 from baseline) and –2.37 versus usual care (CI, –3.05, –1.68; P ≤0.001 versus UC). For the auricular acupuncture group, the change from baseline was –1.75 (CI, –2.15, –1.35; P ≤0.001 from baseline) and –1.46 versus usual care (CI, –2.14, –0.78; P ≤0.001 versus UC). The difference in BPI pain severity reduction from baseline between electroacupuncture and auricular acupuncture of –0.90 (CI, –1.45, –0.36) was statistically significant (P ≤0.001). Electroacupuncture also reduced pain severity significantly more than auricular acupuncture at week 24 (CI, –0.82, [–1.38, –0.27], P = 0.004).

Dr. Zhi concluded that among breast cancer survivors, although both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reduction, electroacupuncture was more effective at reducing pain severity.

She pointed out also that neither surgery type (mastectomy versus lumpectomy; P = 0.83) nor aromatase inhibitor versus tamoxifen versus neither (P = 0.59) was associated with BPI/severity response among electroacupuncture and auricular acupuncture patients.

“Both electroacupuncture and auricular acupuncture are significantly better than usual care, so it suggests that both acupuncture methods can be utilized for treating chronic muscle skeletal pain in breast cancer survivors, but electroacupuncture is preferred,” Dr. Zhi said.

“Auricular acupuncture can be more painful,” said PEACE principal investigator Jun Mao, MD, who is chair of integrative medicine at Memorial Sloan Kettering. “Ten percent of women could not tolerate the ear pain or discomfort. Electroacupuncture is generally well tolerated. People are more relaxed after treatment. If both are available, start with electroacupuncture,” he said.

SAN ANTONIO – Breast cancer survivors with chronic musculoskeletal pain may experience relief from pain with electroacupuncture and auricular acupuncture, according to a new study recently presented at the 2021 San Antonio Breast Cancer Symposium.

Both techniques led to clinically meaningful and persistent reduction of pain, but electroacupuncture was more effective in reducing pain severity, according to study author Wanqing Iris Zhi, MD, PhD, of the Breast Medicine Service at Memorial Sloan Kettering Cancer Center in New York.

Among breast cancer survivors, Dr. Zhi said, chronic musculoskeletal pain is common and debilitating. In earlier results of the PEACE (Personalized Electroacupuncture versus Auricular Acupuncture Comparative Effectiveness) trial, both electroacupuncture and auricular acupuncture improved pain control better than usual care in cancer survivors. The comparative effectiveness between electroacupuncture and auricular acupuncture among breast cancer survivors, specifically for chronic musculoskeletal pain, remains unknown.

To evaluate potential differences between electroacupuncture and auricular acupuncture, Dr. Zhi et al. examined data from PEACE, a three-arm, parallel, single center randomized trial investigating electroacupuncture and auricular acupuncture for chronic musculoskeletal pain, compared with usual care. Among 360 cancer survivors in PEACE, mean age in 165 cancer survivors with a primary diagnosis of breast cancer was 60.3 years (35.8 percent non-White) with a mean of 5.4 years since their cancer diagnoses. Patients in both the electroacupuncture and auricular acupuncture groups received 10 weekly treatments. Change in mean Brief Pain Inventory (BPI) pain severity from baseline to week 12 was the primary endpoint, with BPI change to week 24 as a secondary endpoint. Usual care patients, after week 12, could receive 10 electroacupuncture treatments.

The most common locations of chronic musculoskeletal pain, Dr. Zhi observed, were lower back (24 percent), knee/leg (24 percent) and shoulder/elbow (14 percent). About 70 percent of patients were taking pain medication. Both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reductions among the evaluated breast cancer survivors. The change in BPI severity from baseline to week 12 was –0.29 (confidence interval, –0.08, 0.28) in the UC group. In the electroacupuncture group it was –2.65 (CI, –3.06, –2.25; P ≤0.001 from baseline) and –2.37 versus usual care (CI, –3.05, –1.68; P ≤0.001 versus UC). For the auricular acupuncture group, the change from baseline was –1.75 (CI, –2.15, –1.35; P ≤0.001 from baseline) and –1.46 versus usual care (CI, –2.14, –0.78; P ≤0.001 versus UC). The difference in BPI pain severity reduction from baseline between electroacupuncture and auricular acupuncture of –0.90 (CI, –1.45, –0.36) was statistically significant (P ≤0.001). Electroacupuncture also reduced pain severity significantly more than auricular acupuncture at week 24 (CI, –0.82, [–1.38, –0.27], P = 0.004).

Dr. Zhi concluded that among breast cancer survivors, although both electroacupuncture and auricular acupuncture were associated with clinically meaningful and persistent pain reduction, electroacupuncture was more effective at reducing pain severity.

She pointed out also that neither surgery type (mastectomy versus lumpectomy; P = 0.83) nor aromatase inhibitor versus tamoxifen versus neither (P = 0.59) was associated with BPI/severity response among electroacupuncture and auricular acupuncture patients.

“Both electroacupuncture and auricular acupuncture are significantly better than usual care, so it suggests that both acupuncture methods can be utilized for treating chronic muscle skeletal pain in breast cancer survivors, but electroacupuncture is preferred,” Dr. Zhi said.

“Auricular acupuncture can be more painful,” said PEACE principal investigator Jun Mao, MD, who is chair of integrative medicine at Memorial Sloan Kettering. “Ten percent of women could not tolerate the ear pain or discomfort. Electroacupuncture is generally well tolerated. People are more relaxed after treatment. If both are available, start with electroacupuncture,” he said.