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Few Cancer Survivors Meet ACS Nutrition, Exercise Guidelines
TOPLINE:
METHODOLOGY:
- The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
- Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
- The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
- Overall, 9,121 survivors (91%) completed questionnaires for all four domains.
TAKEAWAY:
Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.
When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.
Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.
The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).
IN PRACTICE:
This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”
SOURCE:
This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.
LIMITATIONS:
The authors reported several study limitations, most notably that self-reported data may introduce biases.
DISCLOSURES:
The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
- Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
- The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
- Overall, 9,121 survivors (91%) completed questionnaires for all four domains.
TAKEAWAY:
Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.
When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.
Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.
The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).
IN PRACTICE:
This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”
SOURCE:
This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.
LIMITATIONS:
The authors reported several study limitations, most notably that self-reported data may introduce biases.
DISCLOSURES:
The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The ACS has published nutrition and exercise guidelines for cancer survivors, which include recommendations to maintain a healthy weight and diet, cut out alcohol, and participate in regular physical activities. Engaging in these behaviors is associated with longer survival among cancer survivors, but whether survivors follow these nutrition and activity recommendations has not been systematically tracked.
- Researchers evaluated data on 10,020 individuals (mean age, 64.2 years) who had completed cancer treatment. Data came from the Behavioral Risk Factor Surveillance System telephone-based survey administered in 2017, 2019, and 2021, which represents 2.7 million cancer survivors.
- The researchers estimated survivors’ adherence to guidelines across four domains: Weight, physical activity, fruit and vegetable consumption, and alcohol intake. Factors associated with adherence were also evaluated.
- Overall, 9,121 survivors (91%) completed questionnaires for all four domains.
TAKEAWAY:
Only 4% of patients (365 of 9121) followed ACS guidelines in all four categories.
When assessing adherence to each category, the researchers found that 72% of cancer survivors reported engaging in recommended levels of physical activity, 68% maintained a nonobese weight, 50% said they did not consume alcohol, and 12% said they consumed recommended quantities of fruits and vegetables.
Compared with people in the general population, cancer survivors generally engaged in fewer healthy behaviors than those who had never been diagnosed with cancer.
The authors identified certain factors associated with greater guideline adherence, including female sex, older age, Black (vs White) race, and higher education level (college graduate).
IN PRACTICE:
This study highlights a potential “gap between published guidelines regarding behavioral modifications for cancer survivors and uptake of these behaviors,” the authors wrote, adding that “it is essential for oncologists and general internists to improve widespread and systematic counseling on these guidelines to improve uptake of healthy behaviors in this vulnerable patient population.”
SOURCE:
This work, led by Carter Baughman, MD, from the Division of Internal Medicine at Beth Israel Deaconess Medical Center, Boston, Massachusetts, was published online in JAMA Oncology.
LIMITATIONS:
The authors reported several study limitations, most notably that self-reported data may introduce biases.
DISCLOSURES:
The study funding source was not reported. One author received grants from the US Highbush Blueberry Council outside the submitted work. No other disclosures were reported.
A version of this article appeared on Medscape.com.
Adding ACEI to Chemotherapy Does Not Prevent Cardiotoxicity
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
a new randomized trial showed.
The results suggested adding an ACE inhibitor doesn’t affect cardiac injury or cardiac function outcomes “and should not be used as a preventative strategy” in these patients, David Austin, MD, consultant cardiologist, Academic Cardiovascular Unit, The James Cook University Hospital, Middlesbrough, England, and chief investigator for the PROACT study, told this news organization.
But while these negative results are disappointing, he said, “we now have a definitive result in a robustly conducted trial that will take the field forward.”
The findings were presented on April 8, 2024, at the American College of Cardiology (ACC) Scientific Session 2024.
Anthracyclines, which are extracted from Streptomyces bacterium, are chemotherapy drugs widely used to treat several types of cancer. Doxorubicin is among the most clinically important anthracyclines.
While extremely effective, anthracyclines can cause irreversible damage to cardiac cells and ultimately impair cardiac function and even cause heart failure, which may only be evident years after exposure. “Cardiac injury is very common in patients treated with high dose anthracyclines,” noted Dr. Austin.
The open-label PROACT study included 111 adult patients, mean age 58 years and predominantly White and women, being treated for breast cancer (62%) or NHL (38%) at National Health Service hospitals in England with high-dose anthracycline-based chemotherapy.
Patients were randomized to standard care (six cycles of high-dose doxorubicin-equivalent anthracycline-based chemotherapy) plus the ACE inhibitor enalapril maleate or standard care alone. The mean chemotherapy dose was 328 mg/m2; any dose greater than 300 is considered high.
The starting dose of enalapril was 2.5 mg twice a day, which was titrated up to a maximum of 10 mg twice a day. The ACE inhibitor was started at least 2 days before chemotherapy began and finished 3 weeks after the last anthracycline dose.
During the study, enalapril was titrated to 20 mg in more than 75% of patients, with the mean dose being 17.7 mg.
Myocardial Injury Outcome
The primary outcome was myocardial injury measured by the presence (≥ 14 ng/L) of high sensitivity cardiac troponin T (cTnT) during anthracycline treatment and 1 month after the last dose of anthracycline.
cTnT is highly expressed in cardiomyocytes and has become a preferred biomarker for detecting acute myocardial infarction and other causes of myocardial injury.
Blood sampling for cTnT and cardiac troponin I (cTnI) was performed at baseline, within 72 hours prior to chemotherapy and at trial completion. All patients had negative troponin results at baseline, indicating no heart damage.
A majority of patients experienced elevations in troponin (78% in the enalapril group and 83% in the standard of care group), but there was no statistically significant difference between groups (adjusted odds ratio [OR], 0.65; 95% CI, 0.23-1.78; P = .405).
There was also no significant difference between groups in terms of cTnI, a secondary endpoint. However, the proportion of patients testing positive for cTnI (47% in the enalapril group and 45% in controls) was substantially lower than that for cTnT.
Large Discrepancy
The “large discrepancy in the rate of injury” with cTnT “has implications for the clinical interpretation of cardiac biomarkers in routine practice, and we should proceed with caution,” Dr. Austin told this news organization.
The finding has implications because guidelines don’t currently differentiate based on the type of troponin, Dr. Austin said in a press release. “I was surprised by the difference, and I think this raises the question of what troponin we should be using.”
Secondary outcomes focused on cardiac function, measured using echocardiography and included left ventricular global longitudinal strain (LVGLS) and left ventricular ejection fraction (LVEF). These were measured at baseline, 4 weeks after the last anthracycline dose and 1 year after the final chemotherapy.
There was no between-group difference in LVGLS cardiac function (21% for enalapril vs 22% for standard of care; adjusted OR, 0.95; 95% CI, 0.33-2.74; P = .921). This was also true for LVEF (4% for enalapril vs 0% for standard of care group; adjusted OR, 4.89; 95% CI, 0.40-674.62; P = .236).
Asked what the research team plans to do next, Dr. Austin said “the immediate first step” is to continue following PROACT patients. “We know heart failure events and cardiac dysfunction can occur later down the line.”
Due to the challenge of enrolling patients into trials like PROACT, “we should come together as a sort of a broader cardiovascular/oncology academic community to try to understand how we can better recruit patients into these studies,” said Dr. Austin.
“We need to solve that problem before we then go on to maybe examine other potential preventative therapies.”
He doesn’t think an alternative ACE inhibitor would prove beneficial. “We need to look elsewhere for effective therapies in this area.”
He noted these new findings are “broadly consistent” with other trials that investigated angiotensin receptor blockers.
Tough Population
Commenting on the study during a media briefing, Anita Deswal, chair, medicine, Department of Cardiology, Division of Internal Medicine, The University of Texas, commended the researchers for managing to enroll patients with cancer as this is “a tough” population to get to agree to being in a clinical trial.
“These patients are often overwhelmed financially, physically, and emotionally with the cancer diagnosis, as well as the cancer therapy and, therefore, to enroll them in something to prevent, maybe, some potential cardiac toxicity down the line, is really hard.”
Past trials investigating neuro-hormonal blockers to prevent cardiotoxicity have been criticized for enrolling patients at “too low risk,” said Dr. Deswal. “But investigators here went that step beyond and enrolled patients who were going to receive higher doses of anthracyclines, so kudos to that.”
And she noted investigators managed to get patients on almost the maximum dose of enalapril. “So, the drug was poised to have an effect — if it was there.”
The negative results may have something to do with endpoints. “Maybe we haven’t quite figured out what are the cutoffs for high sensitivity troponin I that identify patients truly at risk” of developing heart failure in the future.
Commenting on the study for this news organization, Anu Lala, MD, assistant professor of medicine at the Icahn School of Medicine at Mount Sinai, New York City, said the results may come as a surprise to some.
“ACE inhibitors are considered cardioprotective and for this reason are often used prophylactically in patients receiving chemotherapy.”
Dr. Lala agrees troponin may not be the right endpoint. “Another question is whether clinical outcomes should be followed in addition to symptoms or onset of any heart failure symptoms, which may hold greater prognostic significance.”
The study was funded by the National Institute for Health and Care Research.
A version of this article appeared on Medscape.com.
FROM THE ACC 2024
What’s Driving the Higher Breast Cancer Death Rate in Black Women?
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
More women today are surviving breast cancer if it’s caught early, largely because of better screening and more effective and targeted treatments.
However, not everyone has benefited equitably from this progress. Critical gaps in breast cancer outcomes and survival remain for women in racial and ethnic minority groups.
Black women for instance, have a 41% higher death rate from breast cancer compared with White patients. They also have a greater incidence of aggressive disease like triple-negative breast cancer. Native American and Hispanic women, meanwhile, are more likely to be diagnosed with breast cancer at an earlier age than White women and experience more aggressive breast cancers.
In 2023, Farhad Islami, MD, PhD, and his team published an updated analysis of racial/ethnic and socioeconomic disparities in cancer trends based on data from 2014 to 2020. The analysis found that Black women in particular, were the least likely to have an early-stage diagnosis of breast cancer. Localized‐stage breast cancer was diagnosed in 57% of Black women versus 68% of White women.
“Despite substantial progress in cancer prevention, early detection, and treatments, the burden of cancer remains greater among populations that have been historically marginalized, including people of color, people with lower socioeconomic status, and people living in nonmetropolitan areas,” said Dr. Islami, who is senior scientific director of cancer disparity research in the Surveillance & Health Equity Science Department at the American Cancer Society.
The reasons behind outcomes disparities in breast cancer are complex, making solutions challenging, say experts researching racial differences in cancer outcomes.
Among the findings of this research is that breast cancer tests may be contributing to the disparities and misguiding care for some patients of color.
SDH and Screening Rates Differences By Race
A range of factors contribute to racial and ethnic disparities in breast cancer outcomes, said Pamela Ganschow, MD, an associate professor in the Department of Internal Medicine at the University of Illinois Cancer Center in Chicago and part of the university’s Cancer Prevention and Control research program. These include socioeconomic status, access to timely and high-quality care across the cancer control continuum, cultural beliefs, differences in genetic makeup and tumor biology, as well as system biases, such as implicit biases and systemic racism, Dr. Ganschow said.
Dr. Islami adds that gaps in access to cancer prevention, early detection, and treatment are largely rooted in fundamental inequities in social determinants of health (SDH), such as whether a patient has safe housing, transportation, education, job opportunities, income, access to nutritious foods, and language and literacy skills, among others.
Dr. Islami’s analysis, for example, shows that people of color are generally more likely to have lower educational attainment and to experience poverty, food insecurity, and housing insecurity compared with White people. Among people aged 18-64 years, the age-adjusted proportion of individuals with no health insurance in 2021 was also higher among Black (13.7%), American Indian/Alaskan Native (18.7%), and Hispanic (28.7%) patients than among White (7.8%) or Asian (5.9%) people, according to the report.
Competing needs can also get in the way of prioritizing cancer screenings, especially for patients in lower socio-economic populations, Dr. Ganschow said.
“You’ve got people who are working a job or three jobs, just to make ends meet for their family and can’t necessarily take time off to get that done,” she said. “Nor is it prioritized in their head because they’ve got to put a meal on the table.”
But the racial disparities between Black and White women, at least, are not clearly explained by differences between the screening rates..
Of patients who received mammograms 76% were White and 79% were Black, according to another recent study coauthored by Dr. Islami. While Black women appear to have the highest breast cancer screening rates, some data suggest such rates are being overreported.
Lower screening rates were seen in American Indian/Alaska Native (59%), Asian (67%), and Hispanic women (74%).
Biological Differences, Bad Testing Recommendations May Contribute to Poor Outcomes
Differences in biology may be one overlooked internal driver of lower breast cancer survival in Black women.
Researchers at Sanford Burnham Prebys in La Jolla, California, recently analyzed the breast cells of White and Black women, finding significant molecular differences that may be contributing to higher breast cancer mortality rates in Black women.
Investigators analyzed both healthy tissue and tumor tissue from 185 Black women and compared the samples to that of White women. They discovered differences among Black and White women in the way their DNA repair genes are expressed, both in healthy breast tissue and in tumors positive for estrogen receptor breast cancer. Molecular differences were also present in the cellular signals that control how fast cells, including cancer cells, grow.
DNA repair is part of normal cellular function and helps cells recover from damage that can occur during DNA replication or in response to external factors, such as stress.
“One of the first lines of defense, to prevent the cell from becoming a tumor are DNA damage repair pathways,” said Svasti Haricharan, PhD, a coauthor of the study and an assistant professor at Sanford Burnham Prebys. “We know there are many different DNA damage repair pathways that respond to different types of DNA damage. What we didn’t know was that, even in our normal cells, based on your race and ethnicity, you have different levels of DNA repair proteins.”
The study found that many of the proteins associated with endocrine resistance and poor outcomes in breast cancer patients are differently regulated in Black women compared with White woman. These differences contribute to resistance to standard endocrine therapy, Dr. Haricharan said.
“Because we never studied the biology in Black woman, it was just assumed that across all demographics, it must be the same,” she said. “We are not even accounting for the possibility there are likely intrinsic differences for how you will respond to an endocrine treatment.”
Testing and treatment may also be playing a role in worse breast cancer outcomes for Black women.
In an analysis of 73,363 women with early-stage, estrogen receptor–positive breast cancer, investigators found that a common test used to decide the treatment course for patients may be leading to bad recommendations for Black women.
The test, known as the 21-gene breast recurrence score, is the most commonly ordered biomarker test used to guide doctor’s recommendations for patients with estrogen receptor–positive breast cancer, the most common form of cancer in Black women, representing about 70%-80% of cases.
The test helps physicians identify which patients are good candidates for chemo, but the test may underestimate the benefit of chemo for Black women. It ranks some Black women as unlikely to benefit from chemo, when they actually would have benefited, according to the January 2024 study, published in the Journal of the National Comprehensive Cancer Network.
The test gives a score of zero to 100, explains Kent Hoskins, MD, oncology service line medical director at the University of Illinois (UI) Health and director of the Familial Breast Cancer Clinic at UI Health, both in Chicago. The higher the score, the higher the risk and the greater the benefit of chemotherapy. A patient is either above the cut-off score and receives chemo, or is below the cut-off score and does not. In the analysis, investigators found that Black women start improving with chemo at a lower score than White women do.
Dr. Hoskins said the results raise questions about whether the biomarker test should be modified to be more applicable to Black women, whether other tests should be used, or if physicians should judge cut-off scores differently, depending on race.
How Neighborhood Impacts Breast Cancer, Death Rates
Living in a disadvantaged neighborhood also lowers breast cancer survival, according to new research. A disadvantaged neighborhood is generally defined as a location associated with higher concentrations of poverty, higher rates of unemployment, and less access to health care, quality housing, food, and community resources, according to the Centers for Disease Control and Prevention.
Authors of a study published in JAMA Network Open on April 18 identified 350,824 patients with breast cancer. Of these, 41,519 (11.8%) were Hispanic, 39,631 (11.3%) were non-Hispanic Black, and 234,698 (66.9%) were non-Hispanic White. Investigators divided the patients into five groups representing the lowest to highest neighborhood socioeconomic indices using the Yost Index. (The Yost Index is used by the National Cancer Institute for cancer surveillance and is based on variables such as household income, home value, median rent, percentage below 150% of the poverty line, education, and unemployment.)
Of the Black and Hispanic patients in the study, the highest proportions of both demographics lived in the most disadvantaged neighborhoods. (16,141 Black patients [30.9%]) and 10,168 Hispanic patients [19.5%]). Although 45% of White patients also fell into that same category, the highest proportion of White patients in the study lived in the most advantaged neighborhoods (66,529 patients [76.2%]).
Findings showed patients in the most disadvantaged neighborhoods had the highest proportion of triple-negative breast cancer. Patients in this group also had the lowest proportion of patients who completed surgery and radiation, and the highest proportion of patients who received chemotherapy, compared with all other neighborhood groups. The most advantaged neighborhoods group had higher proportions of localized-stage cancer, a higher proportion of patients who underwent surgery and radiation, and the lowest proportion of patients receiving chemotherapy treatment.
Patients in the most disadvantaged neighborhoods also had the highest risk of mortality (hazard ratio [HR,] 1.53; 95% CI, 1.48-1.59; P less than .001) compared with patients living in the most advantaged neighborhoods. Non-Hispanic Black patients in particular, had the highest risk of mortality, compared with non-Hispanic White patients (HR, 1.16; 95% CI, 1.13-1.20; P less than .001).
Authors wrote that the findings suggest neighborhood disadvantage is independently associated with shorter survival in patients with breast cancer, even after controlling for individual-level factors, tumor characteristics, and treatment.
“To address these residual disparities associated with neighborhood disadvantage, research must focus on which components of the built environment influence outcomes,” the authors said.
Another recent study also found correlations among where breast cancer patients lived and how they fared with the disease.
Jasmine M. Miller-Kleinhenz, PhD, an assistant professor at University of Mississippi Medical Center in Jackson, studied how historical redlining impacts breast cancer development and outcomes in her research published in JAMA Network Open, earlier this year. Redlining refers to the practice of denying people access to credit because of where they live. Historically, mortgage lenders widely redlined neighborhoods with predominantly Black residents. The 1968 Fair Housing Act outlawed racially motivated redlining, but consequences from historical redlining still exist.
Dr. Miller-Kleinhenz and her colleagues analyzed a cohort of 1764 women diagnosed with breast cancer between January 2010 and December 2017, who were followed up through December 2019. Investigators accessed the cohort based on three exposures: historic redlining (HRL), contemporary mortgage discrimination (CMD), and persistent mortgage discrimination (PMD). Contemporary mortgage discrimination refers to current-day discriminatory mortgage practices and persistent mortgage discrimination refers to neighborhoods that have experienced both HRL and CMD.
Findings showed that Black women living in historical redlined areas had increased odds of being diagnosed with aggressive forms of breast cancer, while White women in redlined areas had increased odds of late-stage diagnosis.
White women exposed to persistent mortgage discrimination were twice as likely to die of breast cancer, compared with their White counterparts living in areas without historical redlining or contemporary mortgage discrimination, the study found.
That is not to say that Black women did not have an increased risk of breast cancer mortality, Dr. Miller-Kleinhenz explained. Black women had a more than threefold elevated risk of breast cancer mortality compared with White women no matter where they lived, according to the findings.
“These results were surprising because it is showing that while neighborhood conditions might be a major driver of breast cancer mortality in White women, there are factors beyond the neighborhood that are additional drivers that are contributing to poor outcomes in Black women,” she said.
Hope for Improved Outcomes, Higher Survival Rates
Investigators hope the findings of all of this new research lead to better, more targeted treatments and, in turn, improved outcomes.
Dr. Haricharan is optimistic about the improvement of breast cancer outcomes as more is learned about the biology of Black patients and other non-White patients.
There is a growing effort to include more data from minoritized populations in breast cancer research studies, Dr. Haricharan said, and she foresees associated changes to clinical protocols in the future. Her own team is working on creating larger data sets that are more representative of non-White patients to further analyze the differences found in their prior study.
“I think there’s this understanding that, until we have data sets that are more representative, we really are catering to [only one] population in terms of our diagnostic and therapeutic technological advances,” she said.
The American Cancer Society meanwhile, is launching a new initiative in May that aims to collect more health data from Black women to ultimately develop more effective cancer interventions. VOICES of Black Women will focus on collecting and studying health data from Black women through online surveys. The society’s goal is to enroll at least 100,000 Black women in the United States between ages 25 and 55.
Dr. Miller-Kleinhenz called the initiative “an important step to starting to research and answer some of these lingering questions about why there continue to be breast cancer disparities.”
Certain Women May Face Higher Risk for Second Breast Cancer
TOPLINE:
METHODOLOGY:
- Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
- However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
- To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
- The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
- The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.
TAKEAWAY:
- Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
- Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
- Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
- The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.
IN PRACTICE:
Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”
SOURCE:
This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.
LIMITATIONS:
A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.
DISCLOSURES:
This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
- However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
- To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
- The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
- The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.
TAKEAWAY:
- Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
- Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
- Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
- The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.
IN PRACTICE:
Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”
SOURCE:
This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.
LIMITATIONS:
A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.
DISCLOSURES:
This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- Women who are diagnosed with breast cancer at age 40 or younger are about two to three times more likely to develop second primary breast cancer compared with women who are older when first diagnosed.
- However, data are lacking on whether certain factors increase a woman’s risk for a second primary breast cancer.
- To classify the risk of developing a second primary breast cancer, the researchers evaluated a main cohort of 685 patients with stages 0-III breast cancer who were diagnosed at age 40 years or younger and had undergone unilateral mastectomy or lumpectomy as primary surgery between August 2006 and June 2015. The team also analyzed data on 547 younger women who had a bilateral mastectomy.
- The researchers assessed various breast cancer risk factors, including self-reported ethnicity, race, age, family history of breast or ovarian cancer, germline genetics, tumor stage, grade, and receptor status.
- The primary outcome was the diagnosis of a second primary breast cancer that occurred at least 6 months after the initial diagnosis of primary breast cancer.
TAKEAWAY:
- Among the 685 main study participants, 17 (2.5%) developed a second primary breast cancer (15 contralateral and 2 ipsilateral) over a median of 4.2 years since their primary diagnosis. The 5- and 10-year cumulative incidence of a second primary breast cancer was 1.5% and 2.6%, respectively.
- Overall, only 33 women were positive for a germline pathogenic variant, and having a pathogenic variant was associated with a fourfold higher risk for second primary breast cancer compared with noncarriers at 5 years (5.5% vs 1.3%) and at 10 years (8.9% vs 2.2%). These findings were held in multivariate models.
- Patients initially diagnosed with in situ disease had more than a fivefold higher risk for second primary breast cancer compared with those initially diagnosed with invasive disease — 6.2% vs 1.2% at 5 years and 10.4% vs 2.1% at 10 years (hazard ratio, 5.25; P = .004). These findings were held in multivariate models (adjusted sub-hazard ratio [sHR], 5.61; 95% CI, 1.52-20.70) and among women without a pathogenic variant (adjusted sHR, 5.67; 95% CI, 1.54-20.90).
- The researchers also found a low risk for contralateral breast cancer among women without pathogenic variants, which could inform surgical decision-making.
IN PRACTICE:
Although the number of women positive for a germline pathogenic variant was small (n = 33) and “results should be interpreted cautiously,” the analysis signals “the importance of genetic testing” in younger breast cancer survivors to gauge their risk for a second primary breast cancer, the authors concluded. The authors added that their “finding of a higher risk of [second primary breast cancer] among those diagnosed with in situ primary [breast cancer] merits further investigation.”
SOURCE:
This study, led by Kristen D. Brantley, PhD, from Harvard T. H. Chan School of Public Health, Boston, was published online in JAMA Oncology.
LIMITATIONS:
A small number of second breast cancer events limited the authors’ ability to assess the effects of multiple risk factors together. Data on risk factors might be incomplete. About 9% of participants completed abbreviated questionnaires that did not include information on body mass index, alcohol, smoking, and family history. Frequencies of pathogenic variants besides BRCA1 and BRCA2 may be underestimated.
DISCLOSURES:
This study received no external funding. Four authors reported receiving grants or royalties outside this work. Other reported no competing interests.
A version of this article appeared on Medscape.com.
Most Targeted Cancer Drugs Lack Substantial Clinical Benefit
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The strength and quality of evidence supporting genome-targeted cancer drug approvals vary. A big reason is the growing number of cancer drug approvals based on surrogate endpoints, such as disease-free and progression-free survival, instead of clinical endpoints, such as overall survival or quality of life. The US Food and Drug Administration (FDA) has also approved genome-targeted cancer drugs based on phase 1 or single-arm trials.
- Given these less rigorous considerations for approval, “the validity and value of the targets and surrogate measures underlying FDA genome-targeted cancer drug approvals are uncertain,” the researchers explained.
- In the current analysis, researchers assessed the validity of the molecular targets as well as the clinical benefits of genome-targeted cancer drugs approved in the United States from 2015 to 2022 based on results from pivotal trials.
- The researchers evaluated the strength of evidence supporting molecular targetability using the European Society for Medical Oncology (ESMO) Scale for Clinical Actionability of Molecular Targets (ESCAT) and the clinical benefit using the ESMO–Magnitude of Clinical Benefit Scale (ESMO-MCBS).
- The authors defined a substantial clinical benefit as an A or B grade for curative intent and a 4 or 5 for noncurative intent. High-benefit genomic-based cancer treatments were defined as those associated with a substantial clinical benefit (ESMO-MCBS) and that qualified as ESCAT category level I-A (a clinical benefit based on prospective randomized data) or I-B (prospective nonrandomized data).
TAKEAWAY:
- The analyses focused on 50 molecular-targeted cancer drugs covering 84 indications. Of which, 45 indications (54%) were approved based on phase 1 or 2 pivotal trials, 45 (54%) were supported by single-arm pivotal trials and the remaining 39 (46%) by randomized trial, and 48 (57%) were approved based on subgroup analyses.
- Among the 84 indications, more than half (55%) of the pivotal trials supporting approval used overall response rate as a primary endpoint, 31% used progression-free survival, and 6% used disease-free survival. Only seven indications (8%) were supported by pivotal trials demonstrating an improvement in overall survival.
- Among the 84 trials, 24 (29%) met the ESMO-MCBS threshold for substantial clinical benefit.
- Overall, when combining all ratings, only 24 of the 84 indications (29%) were considered high-benefit genomic-based cancer treatments.
IN PRACTICE:
“We applied the ESMO-MCBS and ESCAT value frameworks to identify therapies and molecular targets providing high clinical value that should be widely available to patients” and “found that drug indications supported by these characteristics represent a minority of cancer drug approvals in recent years,” the authors said. Using these value frameworks could help payers, governments, and individual patients “prioritize the availability of high-value molecular-targeted therapies.”
SOURCE:
The study, with first author Ariadna Tibau, MD, PhD, Brigham and Women’s Hospital and Harvard Medical School, Boston, was published online in JAMA Oncology.
LIMITATIONS:
The study evaluated only trials that supported regulatory approval and did not include outcomes of postapproval clinical studies, which could lead to changes in ESMO-MCBS grades and ESCAT levels of evidence over time.
DISCLOSURES:
The study was funded by the Kaiser Permanente Institute for Health Policy, Arnold Ventures, and the Commonwealth Fund. The authors had no relevant disclosures.
A version of this article appeared on Medscape.com.
Hormone + Radiation Therapy Better Than Either Treatment in Older Men With Early HR+ BC
Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.
Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.
Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.
Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.
Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source
Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.
Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.
Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.
Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.
Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source
Key clinical point: In older men with early-stage, node-negative, hormone receptor-positive (HR+) breast cancer (BC), only radiation therapy (RT) or only hormone therapy (HT) did not confer overall survival (OS) benefits; however, HT + RT improved OS outcomes significantly.
Major finding: Compared with HT alone, OS outcomes improved significantly with HT + RT (adjusted hazard ratio [aHR] 0.641; P = .042) but not with RT alone (aHR 1.264; P = .420). The adjusted 5-year OS rates with HT, RT, and HT + RT were 84.0% (95% CI 77.1%-91.5%), 81.1% (95% CI 71.1%-92.5%), and 93.0% (95% CI 90.0%-96.2%), respectively.
Study details: This retrospective analysis of data from the National Cancer Database included 523 men and 188,683 matched women (age ≥ 65 years) with early-stage, node-negative, HR+ BC who underwent breast-conserving surgery and received HT alone, RT alone, or HT+RT.
Disclosures: This study received open access funding from the Statewide California Electronic Library Consortium. The authors declared no conflicts of interest.
Source: Vo K, Ladbury C, Yoon S, Bazan J, et al. Omission of adjuvant radiotherapy in low-risk elderly males with breast cancer. Breast Cancer. 2024 (Mar 20). doi: 10.1007/s12282-024-01560-y Source
Impact of Adjuvant Ovarian Function Suppression on Recurrence Risk in Premenopausal HR+ Breast Cancer
Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.
Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio 0.76; 95% CI 0.38-1.33) or tamoxifen + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).
Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).
Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.
Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source
Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.
Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio 0.76; 95% CI 0.38-1.33) or tamoxifen + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).
Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).
Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.
Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source
Key clinical point: In premenopausal women with hormone receptor-positive (HR+) breast cancer (BC), treatment with ovarian function suppression (OFS) plus tamoxifen or OFS plus an aromatase inhibitor did not reduce the risk for recurrence compared with only tamoxifen therapy.
Major finding: Compared with tamoxifen alone, aromatase inhibitor + OFS (hazard ratio 0.76; 95% CI 0.38-1.33) or tamoxifen + OFS (hazard ratio 0.87; 95% CI 0.50-1.45) did not significantly reduce the 5-year recurrence risk. However, the 5-year recurrence risk was reduced by 31% in patients who received tamoxifen or aromatase inhibitor combined with OFS for 2 years or more vs less than 2 years (hazard ratio 0.69; 95% CI 0.54-0.90).
Study details: Findings are from a population-based, retrospective cohort study including 2647 premenopausal women with resected HR+ BC who initiated tamoxifen alone (n = 2260), tamoxifen + OFS (n = 232), or aromatase inhibitor + OFS (n = 155).
Disclosures: This study was supported by the Carole May Yates Memorial Endowment for Cancer Research. The authors did not declare any conflicts of interest.
Source: Basmadjian RB, Lupichuk S, Xu Y, Quan ML, Cheung WY, Brenner DR. Adjuvant ovarian function suppression in premenopausal hormone receptor-positive breast cancer. JAMA Netw Open. 2024;7(3):e242082 (Mar 13). doi: 10.1001/jamanetworkopen.2024.2082 Source
Adjuvant Chemotherapy May be Omitted in Older Women Aged 80 Years or Older With HR+/HER2- BC
Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.
Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).
Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.
Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.
Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source
Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.
Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).
Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.
Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.
Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source
Key clinical point: Among patients with hormone receptor-positive (HR+), human epidermal growth factor receptor 2-negative (HER2−) breast cancer (BC), adjuvant chemotherapy failed to improve survival outcomes in older women (age ≥ 80 years) but improved prognosis in women age 65-79 years.
Major finding: Adjuvant chemotherapy did not significantly improve overall survival (OS; P = .79) and cancer-specific survival (CSS; P = .091) outcomes in patients age 80 years and older. However, in patients age 65-79 years, adjuvant chemotherapy was effective in improving OS (P < .001) but not CSS (P = .092).
Study details: This retrospective cohort study included 45,762 women with HR+/HER2− BC, age 65-79 years (n = 38,128) or 80 years and older (n = 7634) from the Surveillance, Epidemiology, and End Results (SEER) database, of whom 20.7% and 3.8%, respectively, received adjuvant chemotherapy.
Disclosures: This study was supported by the Project '100 Foreign Experts Plan of Hebei Province,' China. The authors did not declare any conflicts of interest.
Source: Ma X, Wu S, Zhang X, et al. Adjuvant chemotherapy and survival outcomes in older women with HR+/HER2- breast cancer: A propensity score-matched retrospective cohort study using the SEER database. BMJ Open. 2024;14:e078782. doi: 10.1136/bmjopen-2023-078782 Source
Antibiotic Exposure During Immunotherapy Increases Disease Burden in HER2− Early BC
Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).
Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).
Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.
Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.
Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w Source
Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).
Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).
Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.
Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.
Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w Source
Key clinical point: Exposure to antibiotics during neoadjuvant pembrolizumab treatment was associated with a high residual cancer burden (RCB) in patients with human epidermal growth factor receptor 2-negative (HER2−), stage II or III breast cancer (BC).
Major finding: During pembrolizumab treatment, antibiotic use was significantly correlated with RCB index (RCB index-coefficient 0.86; P = .01) and was associated with a higher mean RCB index compared with no use of antibiotics (1.80 vs 1.08).
Study details: This secondary analysis of the phase 2 I-SPY2 trial included 66 patients with HER2− stage II or III BC treated with pembrolizumab plus paclitaxel followed by doxorubicin plus cyclophosphamide, of which 27% of patients concurrently used antibiotics.
Disclosures: This study did not receive any funding. Amit A. Kulkarni declared receiving institutional research funding and serving on advisory boards for various sources. The other authors declared no competing interests.
Source: Kulkarni AA, Jain A, Jewett PI, et al, and the ISPY2 Consortium. Association of antibiotic exposure with residual cancer burden in HER2-negative early stage breast cancer. NPJ Breast Cancer. 2024;10:24 (Mar 26). doi: 10.1038/s41523-024-00630-w Source
Breast Cancer Radiation Therapy Raises Risk for Nonkeratinocyte Skin Cancer
Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.
Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).
Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.
Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.
Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source
Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.
Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).
Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.
Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.
Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source
Key clinical point: Patients with newly diagnosed breast cancer (BC) who underwent radiation therapy were at a significantly higher risk of developing nonkeratinocyte skin cancers, particularly melanoma and hemangiosarcoma.
Major finding: Compared with the general population, the risk for nonkeratinocyte skin cancer in the skin of the breast or trunk was 57% higher (standardized incidence ratio [SIR] 1.57; 95% CI 1.45-1.7) after BC treatment with radiation therapy, with a 1.37-fold higher risk for melanoma (SIR 1.37; 95% CI 1.25-1.49) and 27.11-fold higher risk for hemangiosarcoma (SIR 27.11; 95% CI 21.6-33.61).
Study details: This population-based cohort study included 875,880 patients with newly diagnosed BC from the Surveillance, Epidemiology, and End Results (SEER) database of which 50.3% of patients received radiation therapy.
Disclosures: This study did not declare any specific funding. Shawheen J. Rezaei declared being supported by Stanford University School of Medicine. Bernice Y. Kwong declared receiving personal fees from Novocure, Genentech, and Novartis. No other conflicts of interest were reported.
Source: Rezaei SJ, Eid E, Tang JY, et al. Incidence of nonkeratinocyte skin cancer after breast cancer radiation therapy. JAMA Netw Open. 2024;7(3):e241632 (Mar 8). doi: 10.1001/jamanetworkopen.2024.1632 Source