Sharon Worcester

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Breast cancer has replaced lung cancer as the leading cause of cancer-related death among Black women, but lung cancer remains the leading cause of cancer death in Black men, according to a new report from the American Cancer Society (ACS).

Lung cancer remains the second most commonly diagnosed cancer in both Black women and Black men.

These are among the key findings of the report, Cancer Statistics for African American/Black People 2022 – a triannual compilation of U.S. data on cancer incidence, mortality, survival, screening, and risk factors for Black people – and it marks a major shift as of 2019.

“African American/Black people have a disproportionately high cancer burden compared to other population groups. According to the report, the risk of cancer death for Black individuals remains 19% higher for men and 12% higher for women compared to White individuals,” the ACS says in a statement.

“The gap for breast cancer is more alarming,” it adds. “Black women are 41% more likely to die from breast cancer than White women despite a lower risk of being diagnosed with the disease.”

The new report, published online on Feb. 10 in CA: A Cancer Journal for Clinicians, also notes the following:

An estimated 224,080 new cancer cases and 73,680 cancer deaths will occur among Black people in 2022.

Over the past 5 data years, Black women had an 8% lower overall cancer incidence than White women but 12% higher mortality; Black men have 6% higher cancer incidence than White men but 19% higher cancer mortality.

Prostate cancer mortality among Black men decreased by 1.3% per year from 2015 to 2019 despite a 5% increase in the diagnosis of distant-stage prostate cancer annually since 2012, but the decline was slower than the 5% per year decline from 2010 to 2014.

The overall cancer mortality gap between Black and White people is narrowing. This is due to a steeper drop in prostate, lung, and other smoking-related cancers among Black people.

Colorectal cancer incidence and mortality rates are 21% and 44% higher, respectively, in Black men in comparison with White men and 18% and 31% higher, respectively, in Black women in comparison with White women.

The reasons for the disparities are complex but “largely stem from less access to high-quality care and optimal treatment as a repercussion of long-standing institutional racism,” the report concludes.

“We must address structural racism as a public health issue to close the gaps and advance health equity,” Tawana Thomas-Johnson, senior vice president and chief diversity officer at the ACS, said in the press release.

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

Periodontal disease (PD) may increase the risk of sporadic colorectal cancer (CRC), findings from the population-based case-control COLDENT study suggest.

The rate of new CRC diagnoses among individuals in the study who had a history of PD was nearly 50% higher than in those with no such history, after adjustment for a host of medical and demographic factors, the investigators noted.

This isn’t the first time PD has been linked with extra-oral health outcomes, including gastrointestinal cancers. It has been shown to be associated with several major systemic diseases, such as cardiovascular, respiratory, chronic kidney, and metabolic diseases. Evidence also suggests a link between PD and Alzheimer’s disease.

However, prior studies that looked at the connection between PD and CRC have relied on secondary analyses of data from other studies and are limited by other methodologic shortcomings, noted the researchers, led by Amal Idrissi Janati, DDS, University of Montreal.

To better assess the etiologic role of PD in the development of CRC, Dr. Janati and colleagues analyzed 348 histologically confirmed cases of colon or rectal cancer diagnosed from January 2013 to December 2019 and compared them to 310 matched controls.

The rate of new CRC diagnoses among individuals with a history of PD was 1.4 times higher than among those with no PD history after adjustment for age and gender. It increased to 1.45 times higher when the researchers also adjusted for body mass index, education, income, diabetes, family history of CRC, regular use of aspirin and non-aspirin nonsteroidal anti-inflammatory drugs, and lifetime cumulative smoking, consumption of red and processed meats, alcohol consumption, and total physical activity score.

The findings were published online Jan. 26 in Cancer Causes and Control.

“Our results support the hypothesis of an association between PD and sporadic CRC risk,” the researchers said, adding that further epidemiologic studies are recommended.

They speculated that the “putative mechanism of PD and cancer association involves the spread of periodontal pathogens to extra-oral sites, dissemination of bacteria endotoxins, and release of inflammation products directly into the bloodstream.”

The chronic inflammation associated with PD “promotes carcinogenesis by induction of gene mutations, inhibition of apoptosis, stimulation of angiogenesis, cell proliferation, and epigenetic alterations,” they added.

The COLDENT study was supported by the Cancer Research Society. The authors have disclosed no relevant financial relationships.

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

Periodontal disease (PD) may increase the risk of sporadic colorectal cancer (CRC), findings from the population-based case-control COLDENT study suggest.

The rate of new CRC diagnoses among individuals in the study who had a history of PD was nearly 50% higher than in those with no such history, after adjustment for a host of medical and demographic factors, the investigators noted.

This isn’t the first time PD has been linked with extra-oral health outcomes, including gastrointestinal cancers. It has been shown to be associated with several major systemic diseases, such as cardiovascular, respiratory, chronic kidney, and metabolic diseases. Evidence also suggests a link between PD and Alzheimer’s disease.

However, prior studies that looked at the connection between PD and CRC have relied on secondary analyses of data from other studies and are limited by other methodologic shortcomings, noted the researchers, led by Amal Idrissi Janati, DDS, University of Montreal.

To better assess the etiologic role of PD in the development of CRC, Dr. Janati and colleagues analyzed 348 histologically confirmed cases of colon or rectal cancer diagnosed from January 2013 to December 2019 and compared them to 310 matched controls.

The rate of new CRC diagnoses among individuals with a history of PD was 1.4 times higher than among those with no PD history after adjustment for age and gender. It increased to 1.45 times higher when the researchers also adjusted for body mass index, education, income, diabetes, family history of CRC, regular use of aspirin and non-aspirin nonsteroidal anti-inflammatory drugs, and lifetime cumulative smoking, consumption of red and processed meats, alcohol consumption, and total physical activity score.

The findings were published online Jan. 26 in Cancer Causes and Control.

“Our results support the hypothesis of an association between PD and sporadic CRC risk,” the researchers said, adding that further epidemiologic studies are recommended.

They speculated that the “putative mechanism of PD and cancer association involves the spread of periodontal pathogens to extra-oral sites, dissemination of bacteria endotoxins, and release of inflammation products directly into the bloodstream.”

The chronic inflammation associated with PD “promotes carcinogenesis by induction of gene mutations, inhibition of apoptosis, stimulation of angiogenesis, cell proliferation, and epigenetic alterations,” they added.

The COLDENT study was supported by the Cancer Research Society. The authors have disclosed no relevant financial relationships.

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

Periodontal disease (PD) may increase the risk of sporadic colorectal cancer (CRC), findings from the population-based case-control COLDENT study suggest.

The rate of new CRC diagnoses among individuals in the study who had a history of PD was nearly 50% higher than in those with no such history, after adjustment for a host of medical and demographic factors, the investigators noted.

This isn’t the first time PD has been linked with extra-oral health outcomes, including gastrointestinal cancers. It has been shown to be associated with several major systemic diseases, such as cardiovascular, respiratory, chronic kidney, and metabolic diseases. Evidence also suggests a link between PD and Alzheimer’s disease.

However, prior studies that looked at the connection between PD and CRC have relied on secondary analyses of data from other studies and are limited by other methodologic shortcomings, noted the researchers, led by Amal Idrissi Janati, DDS, University of Montreal.

To better assess the etiologic role of PD in the development of CRC, Dr. Janati and colleagues analyzed 348 histologically confirmed cases of colon or rectal cancer diagnosed from January 2013 to December 2019 and compared them to 310 matched controls.

The rate of new CRC diagnoses among individuals with a history of PD was 1.4 times higher than among those with no PD history after adjustment for age and gender. It increased to 1.45 times higher when the researchers also adjusted for body mass index, education, income, diabetes, family history of CRC, regular use of aspirin and non-aspirin nonsteroidal anti-inflammatory drugs, and lifetime cumulative smoking, consumption of red and processed meats, alcohol consumption, and total physical activity score.

The findings were published online Jan. 26 in Cancer Causes and Control.

“Our results support the hypothesis of an association between PD and sporadic CRC risk,” the researchers said, adding that further epidemiologic studies are recommended.

They speculated that the “putative mechanism of PD and cancer association involves the spread of periodontal pathogens to extra-oral sites, dissemination of bacteria endotoxins, and release of inflammation products directly into the bloodstream.”

The chronic inflammation associated with PD “promotes carcinogenesis by induction of gene mutations, inhibition of apoptosis, stimulation of angiogenesis, cell proliferation, and epigenetic alterations,” they added.

The COLDENT study was supported by the Cancer Research Society. The authors have disclosed no relevant financial relationships.

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

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

The pediatric oncology workforce has faced a host of financial, physical, and psychological obstacles during the COVID-19 pandemic, according to a study that surveyed workers from more than 200 institutions in 79 countries.

A snapshot of the extensive findings reveals that half of participating institutions experienced staffing shortages that had a “major impact” on pediatric cancer care. On the financial front, many respondents pointed to instances of unpaid leave and diminished salary, and others highlighted the psychological toll of providing care, including high rates of burnout and stress. The challenges were evident across high- and low-income countries.

Despite these barriers, pediatric oncology clinicians demonstrated incredible perseverance.

Health care professionals “caring for children with cancer across the world were shown to be incredibly resilient, coming together to continue to provide care even in the direst circumstances,” Elizabeth R. Sniderman, MSN, APRN, of St. Jude Children’s Research Hospital, Memphis, and colleagues concluded.

The findings, published online Jan. 24, 2022, in Cancer, highlight the global impact of COVID-19 on pediatric oncology clinicians early in the pandemic.

The survey, conducted in summer 2020, included responses from 311 pediatric oncology clinicians who completed a 60-item questionnaire about their experiences of clinical care, resources, and support. The investigators also convened 19 multidisciplinary focus groups who answered questions related to teamwork, communication, and changes to care. Respondents practiced in low- to high-income countries, and included pediatric hematologists and oncologists, nurses, and infectious disease physicians.

Overall, the investigators found that just over half of institutions experienced “major” shortages of clinical staff (108 of 213), and two-thirds experienced reductions in staffing availability (141 of 213). Notably, national income was not associated with this reduction; rather, staffing shortages were more likely to occur in countries with greater COVID-19 incidence and mortality rates.

Respondents reported experiencing threats to their physical health, with half pointing to a lack of necessary personal protective equipment. The financial and psychological toll of the pandemic represented another major stressor, with the effects described across all income levels.

One respondent from Belarus commented on financial concerns, noting that “people don’t really want to admit that they don’t feel well ... they know, that if infected, unpaid self-isolation is waiting for them. Either you don’t go to work for 2 weeks, unpaid, or you go to work for 2 weeks, paid, and endanger all of your colleagues with your infection.”

A respondent from Mexico described the psychological stress: “Honestly, I think that sometimes we put aside the mental health of all of us involved, myself included. I think we were all on the verge of collapse ... practically all the residents who were rotating here told us that they had anxiety attacks, panic attacks, they could not sleep, [and] many of them needed psychiatric medicine.”

Others highlighted feelings of guilt about their ability to provide the highest level of care. An oncologist in the United States noted: “This was a major stress for many providers because [we are] feeling unable to provide the same level of care which we used to provide. And this is what eventually takes a toll.”

And despite these pandemic-related challenges, the study authors found that only 46% of institutions (99 of 213) made psychological support available to staff.


 

Rays of hope

But it was not all bad news.

Participants also described a greater sense of teamwork, communication, and collegiality throughout the pandemic – “stabilizing elements,” which helped mitigate the many physical, psychological, and financial stressors.

An infection-control physician in Belarus highlighted the importance of receiving “support and encouragement” from colleagues: “When a person gets tired and they have no more enthusiasm, it’s easy to give up and say: ‘I can’t do this anymore.’ But when you see a colleague who tries ... to share the work, and help each other, then you get extra strength.”

An oncologist in South Africa agreed, noting that “everyone has got their sleeves rolled up and are doing the work ... and that’s a testament to everyone that we work with. There was no one that shied away from work or used this as an excuse to do less work.”

An oncologist in Spain described practicing during the pandemic being “one of the best experiences I have had,” explaining that “I have been working in this hospital for ... 25 years, [and] I have never had the feeling of being so informed at all levels.”

Overall, the findings paint a picture of a resilient workforce, and offer lessons about preparedness for future crises, the investigators concluded.

“To protect pediatric oncology providers and their patients, organizations must pay attention to interventions that increase physical, psychological, and financial safety,” the authors stressed. For instance, providing adequate personal protective equipment and vaccines, allowing for time off and rest, and setting up professional psychology services as well as access to peer-support programs can help protect staff.

Although this survey took place relatively early in the pandemic, organizations should take heed of the findings, Lorena V. Baroni, MD, of Hospital J P Garrahan, Buenos Aires, and Eric Bouffet, MD, of The Hospital for Sick Children, Toronto, wrote in an accompanying editorial.

“The results presented in this study should not be taken lightly,” Dr. Baroni and Dr. Bouffet wrote. “The most concerning findings are the physical and psychological impact experienced by pediatric oncology providers.” And perhaps most surprisingly, “the survey did not identify any difference based on country income groups. Participants in both low- and high-income countries described similar oncologic care limitations.”

Overall, these findings “reflect a serious risk that can ultimately affect the care of children and compromise the success of their treatment,” Dr. Baroni and Dr. Bouffet wrote.

This study was supported by the American Lebanese Syrian Associated Charities. The study authors and editorialists have disclosed no relevant financial relationships.

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

Many patients with early breast cancer are being undertreated, concludes a novel study that examined the management of such patients across various geographical regions across the United States.

A standard treatment for early breast cancer is endocrine therapy (ET), with drugs such a tamoxifen and aromatase inhibitors.

But the study found that ET was not being used in about half of the eligible patients.

For example, only 13,115 of 26,255 eligible patients (48.8%) initiated ET within 1 year of diagnosis, and only 13,944 (52.1%) continued with ET.

“This is remarkable, considering that ET confers an impressive one-third reduction in the risk of death from breast cancer in the first 15 years after diagnosis,” comment authors Michael J. Hassett, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues.

The findings were published online on Jan. 27 in JAMA Oncology.

This study provides an “important and disturbing” glimpse of the hidden barriers patients face when seeking quality, guideline-concordant care, says Kathy Miller, MD, the Ballve Lantero professor of oncology at Indiana University School of Medicine and associate director of clinical research at the IU Simon Comprehensive Cancer Center, Indianapolis, who was approached for comment.
 

Geographical variations

In their study, Dr. Hasset and colleagues set out determine the extent to which geospatial variations in early breast cancer care are attributable to health service area versus patient factors. They analyzed Surveillance, Epidemiology, and End Results (SEER) Medicare data for 31,571 patients with newly diagnosed with stage I-II nonmetastatic breast cancer between 2007 and 2013 who were followed for at least 3 years.

The patients had a median age of 71 years, and 61.4% had stage I disease at diagnosis.

Geospatial density maps (heat maps) in the paper highlight regional performance patterns. For initiation of ET within 1 year of diagnosis, the regions that appeared the worst (with less than 50% of patients getting this treatment) were parts of California, Utah, New Mexico, Louisiana, Georgia, Kentucky, Washington, and an isolated patch in Michigan.

In addition to the striking finding that nearly half of all women who are eligible for ET did not receive that therapy, the investigators found that 81.6% of 21,190 eligible patients received radiation therapy and 72.8% of 9,903 eligible patients received chemotherapy.

This also varied across the graphical regions, with the heat maps showing that the areas that were delivering radiation and chemotherapy to 70% to 80% of women were similar to the areas that were not initiating ET in about half of these women.

The authors found that the geographical region and health service area (HSA) explained more observed variation (24% to 48%) than patient factors (1% to 4%).

“While patient characteristics, such as race and ethnicity, were significantly associated with variation in breast cancer care, they explained a relatively small proportion of the total observed geospatial variance,” the authors comment.

“In fact, most of the total observed variance was owing to randomness or unexplained factors,” they add. The largest share of variation – 35% to 45% – was unexplained.

“The ET metrics demonstrated the largest total observed variance, the lowest absolute performance (only 49% of patients had an ET prescription within 1 year of diagnosis), and the strongest association with region/HSA,” they conclude.

Though limited by factors inherent in a retrospective review of SEER-Medicare data, the “unexplained nature of most geospatial variation in initial breast cancer care is not likely to change,” they comment.

Future quality improvement efforts should focus on reducing this unwarranted geospatial variation, particularly through the use of ET in eligible patients and with strategies that work across health care delivery systems, they suggest.

Approached for comment on the new findings, Dr. Miller posits that “many factors may be at play.”

“Unfortunately, the SEER database doesn’t allow us to sort out the impact of poverty/cost of care, distance to medical care, availability of specialty and subspecialty care, and payer/provider networks that may limit choices and options for second opinions,” Dr. Miller told this news organization.

She said that patients should be encouraged to consult reliable patient-focused information, such as that provided by the American Society of Clinical Oncology through its disease-specific sites, and to seek a second opinion from a university center. In many cases, major centers have become more accessible through virtual visits made available in the wake of the COVID-19 pandemic, she noted.

This study was supported by Dana-Farber Cancer Institute and the American Cancer Society. The authors and Dr. Miller have disclosed no relevant financial relationships. Dr. Miller is a regular contributor to Medscape with her Miller on Oncology column.

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

Many patients with early breast cancer are being undertreated, concludes a novel study that examined the management of such patients across various geographical regions across the United States.

A standard treatment for early breast cancer is endocrine therapy (ET), with drugs such a tamoxifen and aromatase inhibitors.

But the study found that ET was not being used in about half of the eligible patients.

For example, only 13,115 of 26,255 eligible patients (48.8%) initiated ET within 1 year of diagnosis, and only 13,944 (52.1%) continued with ET.

“This is remarkable, considering that ET confers an impressive one-third reduction in the risk of death from breast cancer in the first 15 years after diagnosis,” comment authors Michael J. Hassett, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues.

The findings were published online on Jan. 27 in JAMA Oncology.

This study provides an “important and disturbing” glimpse of the hidden barriers patients face when seeking quality, guideline-concordant care, says Kathy Miller, MD, the Ballve Lantero professor of oncology at Indiana University School of Medicine and associate director of clinical research at the IU Simon Comprehensive Cancer Center, Indianapolis, who was approached for comment.
 

Geographical variations

In their study, Dr. Hasset and colleagues set out determine the extent to which geospatial variations in early breast cancer care are attributable to health service area versus patient factors. They analyzed Surveillance, Epidemiology, and End Results (SEER) Medicare data for 31,571 patients with newly diagnosed with stage I-II nonmetastatic breast cancer between 2007 and 2013 who were followed for at least 3 years.

The patients had a median age of 71 years, and 61.4% had stage I disease at diagnosis.

Geospatial density maps (heat maps) in the paper highlight regional performance patterns. For initiation of ET within 1 year of diagnosis, the regions that appeared the worst (with less than 50% of patients getting this treatment) were parts of California, Utah, New Mexico, Louisiana, Georgia, Kentucky, Washington, and an isolated patch in Michigan.

In addition to the striking finding that nearly half of all women who are eligible for ET did not receive that therapy, the investigators found that 81.6% of 21,190 eligible patients received radiation therapy and 72.8% of 9,903 eligible patients received chemotherapy.

This also varied across the graphical regions, with the heat maps showing that the areas that were delivering radiation and chemotherapy to 70% to 80% of women were similar to the areas that were not initiating ET in about half of these women.

The authors found that the geographical region and health service area (HSA) explained more observed variation (24% to 48%) than patient factors (1% to 4%).

“While patient characteristics, such as race and ethnicity, were significantly associated with variation in breast cancer care, they explained a relatively small proportion of the total observed geospatial variance,” the authors comment.

“In fact, most of the total observed variance was owing to randomness or unexplained factors,” they add. The largest share of variation – 35% to 45% – was unexplained.

“The ET metrics demonstrated the largest total observed variance, the lowest absolute performance (only 49% of patients had an ET prescription within 1 year of diagnosis), and the strongest association with region/HSA,” they conclude.

Though limited by factors inherent in a retrospective review of SEER-Medicare data, the “unexplained nature of most geospatial variation in initial breast cancer care is not likely to change,” they comment.

Future quality improvement efforts should focus on reducing this unwarranted geospatial variation, particularly through the use of ET in eligible patients and with strategies that work across health care delivery systems, they suggest.

Approached for comment on the new findings, Dr. Miller posits that “many factors may be at play.”

“Unfortunately, the SEER database doesn’t allow us to sort out the impact of poverty/cost of care, distance to medical care, availability of specialty and subspecialty care, and payer/provider networks that may limit choices and options for second opinions,” Dr. Miller told this news organization.

She said that patients should be encouraged to consult reliable patient-focused information, such as that provided by the American Society of Clinical Oncology through its disease-specific sites, and to seek a second opinion from a university center. In many cases, major centers have become more accessible through virtual visits made available in the wake of the COVID-19 pandemic, she noted.

This study was supported by Dana-Farber Cancer Institute and the American Cancer Society. The authors and Dr. Miller have disclosed no relevant financial relationships. Dr. Miller is a regular contributor to Medscape with her Miller on Oncology column.

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

Many patients with early breast cancer are being undertreated, concludes a novel study that examined the management of such patients across various geographical regions across the United States.

A standard treatment for early breast cancer is endocrine therapy (ET), with drugs such a tamoxifen and aromatase inhibitors.

But the study found that ET was not being used in about half of the eligible patients.

For example, only 13,115 of 26,255 eligible patients (48.8%) initiated ET within 1 year of diagnosis, and only 13,944 (52.1%) continued with ET.

“This is remarkable, considering that ET confers an impressive one-third reduction in the risk of death from breast cancer in the first 15 years after diagnosis,” comment authors Michael J. Hassett, MD, of the Dana-Farber Cancer Institute, Boston, and colleagues.

The findings were published online on Jan. 27 in JAMA Oncology.

This study provides an “important and disturbing” glimpse of the hidden barriers patients face when seeking quality, guideline-concordant care, says Kathy Miller, MD, the Ballve Lantero professor of oncology at Indiana University School of Medicine and associate director of clinical research at the IU Simon Comprehensive Cancer Center, Indianapolis, who was approached for comment.
 

Geographical variations

In their study, Dr. Hasset and colleagues set out determine the extent to which geospatial variations in early breast cancer care are attributable to health service area versus patient factors. They analyzed Surveillance, Epidemiology, and End Results (SEER) Medicare data for 31,571 patients with newly diagnosed with stage I-II nonmetastatic breast cancer between 2007 and 2013 who were followed for at least 3 years.

The patients had a median age of 71 years, and 61.4% had stage I disease at diagnosis.

Geospatial density maps (heat maps) in the paper highlight regional performance patterns. For initiation of ET within 1 year of diagnosis, the regions that appeared the worst (with less than 50% of patients getting this treatment) were parts of California, Utah, New Mexico, Louisiana, Georgia, Kentucky, Washington, and an isolated patch in Michigan.

In addition to the striking finding that nearly half of all women who are eligible for ET did not receive that therapy, the investigators found that 81.6% of 21,190 eligible patients received radiation therapy and 72.8% of 9,903 eligible patients received chemotherapy.

This also varied across the graphical regions, with the heat maps showing that the areas that were delivering radiation and chemotherapy to 70% to 80% of women were similar to the areas that were not initiating ET in about half of these women.

The authors found that the geographical region and health service area (HSA) explained more observed variation (24% to 48%) than patient factors (1% to 4%).

“While patient characteristics, such as race and ethnicity, were significantly associated with variation in breast cancer care, they explained a relatively small proportion of the total observed geospatial variance,” the authors comment.

“In fact, most of the total observed variance was owing to randomness or unexplained factors,” they add. The largest share of variation – 35% to 45% – was unexplained.

“The ET metrics demonstrated the largest total observed variance, the lowest absolute performance (only 49% of patients had an ET prescription within 1 year of diagnosis), and the strongest association with region/HSA,” they conclude.

Though limited by factors inherent in a retrospective review of SEER-Medicare data, the “unexplained nature of most geospatial variation in initial breast cancer care is not likely to change,” they comment.

Future quality improvement efforts should focus on reducing this unwarranted geospatial variation, particularly through the use of ET in eligible patients and with strategies that work across health care delivery systems, they suggest.

Approached for comment on the new findings, Dr. Miller posits that “many factors may be at play.”

“Unfortunately, the SEER database doesn’t allow us to sort out the impact of poverty/cost of care, distance to medical care, availability of specialty and subspecialty care, and payer/provider networks that may limit choices and options for second opinions,” Dr. Miller told this news organization.

She said that patients should be encouraged to consult reliable patient-focused information, such as that provided by the American Society of Clinical Oncology through its disease-specific sites, and to seek a second opinion from a university center. In many cases, major centers have become more accessible through virtual visits made available in the wake of the COVID-19 pandemic, she noted.

This study was supported by Dana-Farber Cancer Institute and the American Cancer Society. The authors and Dr. Miller have disclosed no relevant financial relationships. Dr. Miller is a regular contributor to Medscape with her Miller on Oncology column.

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

Gender equality remains elusive for women in academic oncology, a survey of nearly 700 U.S. female oncologists suggests.

More than half of respondents in academic medicine said they believe their gender adversely affects their likelihood for promotion, and 1 in 5 said they were considering leaving academia in the next 5 years.

Given the percentage of female oncologists planning to exit academia, “gender inequality is at high risk of continuing if the culture is not addressed,” write the authors in their study, published online Dec. 30 in JAMA Network Open.

Although women currently outnumber men in U.S. medical schools – a shift that first occurred in 2019 – female representation in academic oncology dwindles at more senior levels. Women represent 45% of hematology and oncology residents, only about 36% of academic faculty, and an even smaller percentage of leadership positions in academic medicine. Women, for instance, occupy about 31% of the chair positions in medical oncology, 17.4% in radiation oncology, and 11% in surgical oncology.

A team of researchers led by Emily C. Merfeld, MD, of the University of Wisconsin Hospitals and Clinics, Madison, set out to understand the factors influencing female oncologists’ decisions to pursue academic versus nonacademic career paths.

Dr. Merfeld and colleagues analyzed survey responses from 667 female oncologists between August 1 and Oct. 31, 2020 – 422 (63.2%) in academic medicine and 245 (36.8%) in nonacademic practice.

Overall, 1 in 4 oncologists said their spouse or partner and family “extremely or moderately” affected their decision to pursue academic practice.

Almost 43% of academic oncologists perceived time spent with loved ones as the biggest sacrifice related to pursuing a career in academic medicine. Approximately the same percentage (41.6%) of nonacademic oncologists perceived the pressure to achieve academic promotion as the most significant sacrifice associated with academic oncology, whereas only 22.4% perceived less time with loved ones as the biggest sacrifice.

“Although work-life balance was a concern for academic oncologists and may be a factor in female oncologists leaving academia, survey data suggested that women in nonacademic practice faced similar challenges,” the authors write.

More specifically, women in academic oncology reported working 2 more hours on the weekends compared to women not in academic medicine; however, both groups worked a similar number of hours during the week.

On the hiring front, almost 24% of academic oncologists said their gender had a “negative or somewhat negative” impact on their ability to get a job, compared with 21% of nonacademic oncologists. Conversely, nearly 28% of academic oncologists said their gender had a “positive or somewhat positive” influence on whether they were hired compared with 41.2% of nonacademic oncologists.

Respondents, however, perceived that gender strongly influenced promotion opportunities. More than half of the respondents – 54.6% of academic oncologists and 50.6% of nonacademic oncologists – believed they were less likely to be promoted than their male colleagues.

This perception aligns with findings from prior studies, which “found women were less likely than men to be promoted to associate professor, full professor, or department chair positions,” the authors write.

Overall, most respondents in each group – 71.3% in academic medicine and 68.6% in nonacademic practice – said they would choose the same career path again. But almost 22% of those in academia said they were “likely or very likely” to leave academic oncology in the next 5 years. Of these women, 28.2% said they would switch to industry employment and 25% would move to community practice.

“Contrary to popular assumptions,” the researchers note, “a spouse or partner and/or family were not a major factor in female oncologists favoring nonacademic careers, because this factor was similarly important to both academic and nonacademic oncologists.”

However, they note, “the increased financial compensation in nonacademic oncology may play a large role in some women’s career decisions.”
 

Making headway on gender equality?

In 2013, oncologist Katherine Reeder-Hayes, MD, MBA, now an associate at the University of North Carolina, Chapel Hill, published a study on gender equality in oncology in which she concluded that despite “an increasingly significant presence in the oncology physician workforce” women remained “under-represented in leadership positions and at the senior levels of academic medicine.”

Since then, Dr. Reeder-Hayes says that she has seen progress but recognizes the need for more.

“To some extent, I think that representation is improving over time due to factors outside the workplace – women are entering medical school in large numbers and may have more supportive partners and more social support for pursuing a professional career in general, [compared with] a decade or two ago,” Dr. Reeder-Hayes told this news organization.

On a personal level, she noted, “I do see many midcareer women assuming key leadership roles in my own institution.” However, she added, “I think the translation of those good candidates into increased representation in leadership probably varies widely across different institutions.”

In a 2019 editorial, researchers highlighted this variation while calling attention to the “notable progress” made by the American Association for Cancer Research (AACR). Specifically, the editorialists reported that women represent 40% of AACR members, 45% of the AACR Board of Directors, and half of the last 10 association presidents.

Editorial coauthor Elizabeth Jaffee, MD, deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, and former AACR president, told this news organization that she attributes this progress to “concrete measures to ensure equality throughout the organization,” which include gender balance on nominating and program committees as well as research meetings and providing opportunities for mentoring, leadership training, and networking.

Despite this positive change, the COVID-19 pandemic threatens to widen the gender imbalance. In a recent article, Julie Silver, MD, an expert in gender equity in medicine, told this news organization that she anticipates trouble ahead.

“There are many indications that women are leaving medicine in disproportionately high numbers,” said Dr. Silver, associate chair and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

In addition to salary and promotion disparities, the U.S. continues to suffer from “a chronic shortage of available, affordable, and high-quality childcare and a lack of federal-level policy initiatives or employer initiatives to broaden paid family leave and develop childcare infrastructure and workforce,” Dr. Reeder-Hayes said. Providing extended leave for new parents and on-site childcare could go a long way to improving this problem, she said.

However, Dr. Reeder-Hayes noted that perhaps the “leaky pipeline” problem in oncology highlights the fact that women “are making good decisions that reflect balanced life priorities, [and that] if we don’t structure job responsibilities, childcare, and pacing of promotion and tenure in ways that allow people to nurture other parts of their lives, employees will feel they’re being asked to sacrifice key things.”

In other words, she said, “it’s the workplace that needs to change if we’re going to convince [women], and many men with similar values, to stay.”

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

Gender equality remains elusive for women in academic oncology, a survey of nearly 700 U.S. female oncologists suggests.

More than half of respondents in academic medicine said they believe their gender adversely affects their likelihood for promotion, and 1 in 5 said they were considering leaving academia in the next 5 years.

Given the percentage of female oncologists planning to exit academia, “gender inequality is at high risk of continuing if the culture is not addressed,” write the authors in their study, published online Dec. 30 in JAMA Network Open.

Although women currently outnumber men in U.S. medical schools – a shift that first occurred in 2019 – female representation in academic oncology dwindles at more senior levels. Women represent 45% of hematology and oncology residents, only about 36% of academic faculty, and an even smaller percentage of leadership positions in academic medicine. Women, for instance, occupy about 31% of the chair positions in medical oncology, 17.4% in radiation oncology, and 11% in surgical oncology.

A team of researchers led by Emily C. Merfeld, MD, of the University of Wisconsin Hospitals and Clinics, Madison, set out to understand the factors influencing female oncologists’ decisions to pursue academic versus nonacademic career paths.

Dr. Merfeld and colleagues analyzed survey responses from 667 female oncologists between August 1 and Oct. 31, 2020 – 422 (63.2%) in academic medicine and 245 (36.8%) in nonacademic practice.

Overall, 1 in 4 oncologists said their spouse or partner and family “extremely or moderately” affected their decision to pursue academic practice.

Almost 43% of academic oncologists perceived time spent with loved ones as the biggest sacrifice related to pursuing a career in academic medicine. Approximately the same percentage (41.6%) of nonacademic oncologists perceived the pressure to achieve academic promotion as the most significant sacrifice associated with academic oncology, whereas only 22.4% perceived less time with loved ones as the biggest sacrifice.

“Although work-life balance was a concern for academic oncologists and may be a factor in female oncologists leaving academia, survey data suggested that women in nonacademic practice faced similar challenges,” the authors write.

More specifically, women in academic oncology reported working 2 more hours on the weekends compared to women not in academic medicine; however, both groups worked a similar number of hours during the week.

On the hiring front, almost 24% of academic oncologists said their gender had a “negative or somewhat negative” impact on their ability to get a job, compared with 21% of nonacademic oncologists. Conversely, nearly 28% of academic oncologists said their gender had a “positive or somewhat positive” influence on whether they were hired compared with 41.2% of nonacademic oncologists.

Respondents, however, perceived that gender strongly influenced promotion opportunities. More than half of the respondents – 54.6% of academic oncologists and 50.6% of nonacademic oncologists – believed they were less likely to be promoted than their male colleagues.

This perception aligns with findings from prior studies, which “found women were less likely than men to be promoted to associate professor, full professor, or department chair positions,” the authors write.

Overall, most respondents in each group – 71.3% in academic medicine and 68.6% in nonacademic practice – said they would choose the same career path again. But almost 22% of those in academia said they were “likely or very likely” to leave academic oncology in the next 5 years. Of these women, 28.2% said they would switch to industry employment and 25% would move to community practice.

“Contrary to popular assumptions,” the researchers note, “a spouse or partner and/or family were not a major factor in female oncologists favoring nonacademic careers, because this factor was similarly important to both academic and nonacademic oncologists.”

However, they note, “the increased financial compensation in nonacademic oncology may play a large role in some women’s career decisions.”
 

Making headway on gender equality?

In 2013, oncologist Katherine Reeder-Hayes, MD, MBA, now an associate at the University of North Carolina, Chapel Hill, published a study on gender equality in oncology in which she concluded that despite “an increasingly significant presence in the oncology physician workforce” women remained “under-represented in leadership positions and at the senior levels of academic medicine.”

Since then, Dr. Reeder-Hayes says that she has seen progress but recognizes the need for more.

“To some extent, I think that representation is improving over time due to factors outside the workplace – women are entering medical school in large numbers and may have more supportive partners and more social support for pursuing a professional career in general, [compared with] a decade or two ago,” Dr. Reeder-Hayes told this news organization.

On a personal level, she noted, “I do see many midcareer women assuming key leadership roles in my own institution.” However, she added, “I think the translation of those good candidates into increased representation in leadership probably varies widely across different institutions.”

In a 2019 editorial, researchers highlighted this variation while calling attention to the “notable progress” made by the American Association for Cancer Research (AACR). Specifically, the editorialists reported that women represent 40% of AACR members, 45% of the AACR Board of Directors, and half of the last 10 association presidents.

Editorial coauthor Elizabeth Jaffee, MD, deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, and former AACR president, told this news organization that she attributes this progress to “concrete measures to ensure equality throughout the organization,” which include gender balance on nominating and program committees as well as research meetings and providing opportunities for mentoring, leadership training, and networking.

Despite this positive change, the COVID-19 pandemic threatens to widen the gender imbalance. In a recent article, Julie Silver, MD, an expert in gender equity in medicine, told this news organization that she anticipates trouble ahead.

“There are many indications that women are leaving medicine in disproportionately high numbers,” said Dr. Silver, associate chair and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

In addition to salary and promotion disparities, the U.S. continues to suffer from “a chronic shortage of available, affordable, and high-quality childcare and a lack of federal-level policy initiatives or employer initiatives to broaden paid family leave and develop childcare infrastructure and workforce,” Dr. Reeder-Hayes said. Providing extended leave for new parents and on-site childcare could go a long way to improving this problem, she said.

However, Dr. Reeder-Hayes noted that perhaps the “leaky pipeline” problem in oncology highlights the fact that women “are making good decisions that reflect balanced life priorities, [and that] if we don’t structure job responsibilities, childcare, and pacing of promotion and tenure in ways that allow people to nurture other parts of their lives, employees will feel they’re being asked to sacrifice key things.”

In other words, she said, “it’s the workplace that needs to change if we’re going to convince [women], and many men with similar values, to stay.”

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

Gender equality remains elusive for women in academic oncology, a survey of nearly 700 U.S. female oncologists suggests.

More than half of respondents in academic medicine said they believe their gender adversely affects their likelihood for promotion, and 1 in 5 said they were considering leaving academia in the next 5 years.

Given the percentage of female oncologists planning to exit academia, “gender inequality is at high risk of continuing if the culture is not addressed,” write the authors in their study, published online Dec. 30 in JAMA Network Open.

Although women currently outnumber men in U.S. medical schools – a shift that first occurred in 2019 – female representation in academic oncology dwindles at more senior levels. Women represent 45% of hematology and oncology residents, only about 36% of academic faculty, and an even smaller percentage of leadership positions in academic medicine. Women, for instance, occupy about 31% of the chair positions in medical oncology, 17.4% in radiation oncology, and 11% in surgical oncology.

A team of researchers led by Emily C. Merfeld, MD, of the University of Wisconsin Hospitals and Clinics, Madison, set out to understand the factors influencing female oncologists’ decisions to pursue academic versus nonacademic career paths.

Dr. Merfeld and colleagues analyzed survey responses from 667 female oncologists between August 1 and Oct. 31, 2020 – 422 (63.2%) in academic medicine and 245 (36.8%) in nonacademic practice.

Overall, 1 in 4 oncologists said their spouse or partner and family “extremely or moderately” affected their decision to pursue academic practice.

Almost 43% of academic oncologists perceived time spent with loved ones as the biggest sacrifice related to pursuing a career in academic medicine. Approximately the same percentage (41.6%) of nonacademic oncologists perceived the pressure to achieve academic promotion as the most significant sacrifice associated with academic oncology, whereas only 22.4% perceived less time with loved ones as the biggest sacrifice.

“Although work-life balance was a concern for academic oncologists and may be a factor in female oncologists leaving academia, survey data suggested that women in nonacademic practice faced similar challenges,” the authors write.

More specifically, women in academic oncology reported working 2 more hours on the weekends compared to women not in academic medicine; however, both groups worked a similar number of hours during the week.

On the hiring front, almost 24% of academic oncologists said their gender had a “negative or somewhat negative” impact on their ability to get a job, compared with 21% of nonacademic oncologists. Conversely, nearly 28% of academic oncologists said their gender had a “positive or somewhat positive” influence on whether they were hired compared with 41.2% of nonacademic oncologists.

Respondents, however, perceived that gender strongly influenced promotion opportunities. More than half of the respondents – 54.6% of academic oncologists and 50.6% of nonacademic oncologists – believed they were less likely to be promoted than their male colleagues.

This perception aligns with findings from prior studies, which “found women were less likely than men to be promoted to associate professor, full professor, or department chair positions,” the authors write.

Overall, most respondents in each group – 71.3% in academic medicine and 68.6% in nonacademic practice – said they would choose the same career path again. But almost 22% of those in academia said they were “likely or very likely” to leave academic oncology in the next 5 years. Of these women, 28.2% said they would switch to industry employment and 25% would move to community practice.

“Contrary to popular assumptions,” the researchers note, “a spouse or partner and/or family were not a major factor in female oncologists favoring nonacademic careers, because this factor was similarly important to both academic and nonacademic oncologists.”

However, they note, “the increased financial compensation in nonacademic oncology may play a large role in some women’s career decisions.”
 

Making headway on gender equality?

In 2013, oncologist Katherine Reeder-Hayes, MD, MBA, now an associate at the University of North Carolina, Chapel Hill, published a study on gender equality in oncology in which she concluded that despite “an increasingly significant presence in the oncology physician workforce” women remained “under-represented in leadership positions and at the senior levels of academic medicine.”

Since then, Dr. Reeder-Hayes says that she has seen progress but recognizes the need for more.

“To some extent, I think that representation is improving over time due to factors outside the workplace – women are entering medical school in large numbers and may have more supportive partners and more social support for pursuing a professional career in general, [compared with] a decade or two ago,” Dr. Reeder-Hayes told this news organization.

On a personal level, she noted, “I do see many midcareer women assuming key leadership roles in my own institution.” However, she added, “I think the translation of those good candidates into increased representation in leadership probably varies widely across different institutions.”

In a 2019 editorial, researchers highlighted this variation while calling attention to the “notable progress” made by the American Association for Cancer Research (AACR). Specifically, the editorialists reported that women represent 40% of AACR members, 45% of the AACR Board of Directors, and half of the last 10 association presidents.

Editorial coauthor Elizabeth Jaffee, MD, deputy director of the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, and former AACR president, told this news organization that she attributes this progress to “concrete measures to ensure equality throughout the organization,” which include gender balance on nominating and program committees as well as research meetings and providing opportunities for mentoring, leadership training, and networking.

Despite this positive change, the COVID-19 pandemic threatens to widen the gender imbalance. In a recent article, Julie Silver, MD, an expert in gender equity in medicine, told this news organization that she anticipates trouble ahead.

“There are many indications that women are leaving medicine in disproportionately high numbers,” said Dr. Silver, associate chair and director of cancer rehabilitation in the department of physical medicine and rehabilitation at Harvard Medical School, Boston. “A lack of fair pay and promotion opportunities that were present before COVID-19 are now combined with a host of pandemic-related challenges.”

In addition to salary and promotion disparities, the U.S. continues to suffer from “a chronic shortage of available, affordable, and high-quality childcare and a lack of federal-level policy initiatives or employer initiatives to broaden paid family leave and develop childcare infrastructure and workforce,” Dr. Reeder-Hayes said. Providing extended leave for new parents and on-site childcare could go a long way to improving this problem, she said.

However, Dr. Reeder-Hayes noted that perhaps the “leaky pipeline” problem in oncology highlights the fact that women “are making good decisions that reflect balanced life priorities, [and that] if we don’t structure job responsibilities, childcare, and pacing of promotion and tenure in ways that allow people to nurture other parts of their lives, employees will feel they’re being asked to sacrifice key things.”

In other words, she said, “it’s the workplace that needs to change if we’re going to convince [women], and many men with similar values, to stay.”

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

Patients with cancer remain vulnerable to breakthrough COVID-19 infection after vaccination and most experience severe outcomes, according to a review of patient data from the international COVID-19 and Cancer Consortium (CCC19) registry.

Of 54 fully vaccinated patients with cancer and COVID-19, 35 (65%) were hospitalized, 10 (19%) were admitted to the intensive care unit or required mechanical ventilation, and 7 (13%) died within 30 days.

Although the study did not assess the rate of breakthrough infection among fully vaccinated patients with cancer, the findings do underscore the need for continued vigilance in protecting this vulnerable patient population by vaccinating close contacts, administering boosters, social distancing, and mask-wearing.

“Overall, vaccination remains an invaluable strategy in protecting vulnerable populations, including patients with cancer, against COVID-19. However, patients with cancer who develop breakthrough infection despite full vaccination remain at risk of severe outcomes,” Andrew L. Schmidt, MB, of Dana-Farber Cancer Institute, Boston, and associates wrote.

The analysis, which appeared online in Annals of Oncology Dec. 24 as a pre-proof but has not yet been peer reviewed, analyzed registry data from 1,787 adults with current or prior invasive cancer and laboratory-confirmed COVID-19 between Nov. 1, 2020, and May 31, 2021, before COVID vaccination was widespread. Of those, 1,656 (93%) were unvaccinated, 77 (4%) were partially vaccinated, and 54 (3%) were considered fully vaccinated at the time of COVID-19 infection.

Of the fully vaccinated patients with breakthrough infection, 52 (96%) experienced a severe outcome: two-thirds had to be hospitalized, nearly 1 in 5 went to the ICU or needed mechanical ventilation, and 13% died within 30 days.

“Comparable rates were observed in the unvaccinated group,” the investigators write, adding that there was no statistical difference in 30-day mortality between the fully vaccinated patients and the unvaccinated cohort (adjusted odds ratio, 1.08).

Factors associated with increased 30-day mortality among unvaccinated patients included lymphopenia (aOR, 1.68), comorbidities (aORs, 1.66-2.10), worse performance status (aORs, 2.26-4.34), and baseline cancer status (active/progressing vs. not active/ progressing, aOR, 6.07).

No significant differences were observed in ICU, mechanical ventilation, or hospitalization rates between the vaccinated and unvaccinated cohort after adjustment for confounders (aORs,1.13 and 1.25, respectively).

Notably, patients with an underlying hematologic malignancy were overrepresented among those with breakthrough COVID-19 (35% vs. 20%). Compared with those with solid cancers, patients with hematologic malignancies also had significantly higher rates of ICU admission, mechanical ventilation, and hospitalization.

This finding is “consistent with evidence that these patients may have a blunted serologic response to vaccination secondary to disease or therapy,” the authors note.

Although the investigators did not evaluate the risk of breakthrough infection post vaccination, recent research indicates that receiving a COVID-19 booster increases antibody levels among patients with cancer under active treatment and thus may provide additional protection against the virus.

Given the risk of breakthrough infection and severe outcomes in patients with cancer, the authors propose that “a mitigation approach that includes vaccination of close contacts, boosters, social distancing, and mask-wearing in public should be continued for the foreseeable future.” However, “additional research is needed to further categorize the patients that remain at risk of symptomatic COVID-19 following vaccination and test strategies that may reduce this risk.”

The findings are from a pre-proof that has not yet been peer reviewed or published. First author Dr. Schmidt reported nonfinancial support from Astellas, nonfinancial support from Pfizer, outside the submitted work. Other coauthors reported a range of disclosures as well. The full list can be found with the original article.

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

Patients with cancer remain vulnerable to breakthrough COVID-19 infection after vaccination and most experience severe outcomes, according to a review of patient data from the international COVID-19 and Cancer Consortium (CCC19) registry.

Of 54 fully vaccinated patients with cancer and COVID-19, 35 (65%) were hospitalized, 10 (19%) were admitted to the intensive care unit or required mechanical ventilation, and 7 (13%) died within 30 days.

Although the study did not assess the rate of breakthrough infection among fully vaccinated patients with cancer, the findings do underscore the need for continued vigilance in protecting this vulnerable patient population by vaccinating close contacts, administering boosters, social distancing, and mask-wearing.

“Overall, vaccination remains an invaluable strategy in protecting vulnerable populations, including patients with cancer, against COVID-19. However, patients with cancer who develop breakthrough infection despite full vaccination remain at risk of severe outcomes,” Andrew L. Schmidt, MB, of Dana-Farber Cancer Institute, Boston, and associates wrote.

The analysis, which appeared online in Annals of Oncology Dec. 24 as a pre-proof but has not yet been peer reviewed, analyzed registry data from 1,787 adults with current or prior invasive cancer and laboratory-confirmed COVID-19 between Nov. 1, 2020, and May 31, 2021, before COVID vaccination was widespread. Of those, 1,656 (93%) were unvaccinated, 77 (4%) were partially vaccinated, and 54 (3%) were considered fully vaccinated at the time of COVID-19 infection.

Of the fully vaccinated patients with breakthrough infection, 52 (96%) experienced a severe outcome: two-thirds had to be hospitalized, nearly 1 in 5 went to the ICU or needed mechanical ventilation, and 13% died within 30 days.

“Comparable rates were observed in the unvaccinated group,” the investigators write, adding that there was no statistical difference in 30-day mortality between the fully vaccinated patients and the unvaccinated cohort (adjusted odds ratio, 1.08).

Factors associated with increased 30-day mortality among unvaccinated patients included lymphopenia (aOR, 1.68), comorbidities (aORs, 1.66-2.10), worse performance status (aORs, 2.26-4.34), and baseline cancer status (active/progressing vs. not active/ progressing, aOR, 6.07).

No significant differences were observed in ICU, mechanical ventilation, or hospitalization rates between the vaccinated and unvaccinated cohort after adjustment for confounders (aORs,1.13 and 1.25, respectively).

Notably, patients with an underlying hematologic malignancy were overrepresented among those with breakthrough COVID-19 (35% vs. 20%). Compared with those with solid cancers, patients with hematologic malignancies also had significantly higher rates of ICU admission, mechanical ventilation, and hospitalization.

This finding is “consistent with evidence that these patients may have a blunted serologic response to vaccination secondary to disease or therapy,” the authors note.

Although the investigators did not evaluate the risk of breakthrough infection post vaccination, recent research indicates that receiving a COVID-19 booster increases antibody levels among patients with cancer under active treatment and thus may provide additional protection against the virus.

Given the risk of breakthrough infection and severe outcomes in patients with cancer, the authors propose that “a mitigation approach that includes vaccination of close contacts, boosters, social distancing, and mask-wearing in public should be continued for the foreseeable future.” However, “additional research is needed to further categorize the patients that remain at risk of symptomatic COVID-19 following vaccination and test strategies that may reduce this risk.”

The findings are from a pre-proof that has not yet been peer reviewed or published. First author Dr. Schmidt reported nonfinancial support from Astellas, nonfinancial support from Pfizer, outside the submitted work. Other coauthors reported a range of disclosures as well. The full list can be found with the original article.

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

Patients with cancer remain vulnerable to breakthrough COVID-19 infection after vaccination and most experience severe outcomes, according to a review of patient data from the international COVID-19 and Cancer Consortium (CCC19) registry.

Of 54 fully vaccinated patients with cancer and COVID-19, 35 (65%) were hospitalized, 10 (19%) were admitted to the intensive care unit or required mechanical ventilation, and 7 (13%) died within 30 days.

Although the study did not assess the rate of breakthrough infection among fully vaccinated patients with cancer, the findings do underscore the need for continued vigilance in protecting this vulnerable patient population by vaccinating close contacts, administering boosters, social distancing, and mask-wearing.

“Overall, vaccination remains an invaluable strategy in protecting vulnerable populations, including patients with cancer, against COVID-19. However, patients with cancer who develop breakthrough infection despite full vaccination remain at risk of severe outcomes,” Andrew L. Schmidt, MB, of Dana-Farber Cancer Institute, Boston, and associates wrote.

The analysis, which appeared online in Annals of Oncology Dec. 24 as a pre-proof but has not yet been peer reviewed, analyzed registry data from 1,787 adults with current or prior invasive cancer and laboratory-confirmed COVID-19 between Nov. 1, 2020, and May 31, 2021, before COVID vaccination was widespread. Of those, 1,656 (93%) were unvaccinated, 77 (4%) were partially vaccinated, and 54 (3%) were considered fully vaccinated at the time of COVID-19 infection.

Of the fully vaccinated patients with breakthrough infection, 52 (96%) experienced a severe outcome: two-thirds had to be hospitalized, nearly 1 in 5 went to the ICU or needed mechanical ventilation, and 13% died within 30 days.

“Comparable rates were observed in the unvaccinated group,” the investigators write, adding that there was no statistical difference in 30-day mortality between the fully vaccinated patients and the unvaccinated cohort (adjusted odds ratio, 1.08).

Factors associated with increased 30-day mortality among unvaccinated patients included lymphopenia (aOR, 1.68), comorbidities (aORs, 1.66-2.10), worse performance status (aORs, 2.26-4.34), and baseline cancer status (active/progressing vs. not active/ progressing, aOR, 6.07).

No significant differences were observed in ICU, mechanical ventilation, or hospitalization rates between the vaccinated and unvaccinated cohort after adjustment for confounders (aORs,1.13 and 1.25, respectively).

Notably, patients with an underlying hematologic malignancy were overrepresented among those with breakthrough COVID-19 (35% vs. 20%). Compared with those with solid cancers, patients with hematologic malignancies also had significantly higher rates of ICU admission, mechanical ventilation, and hospitalization.

This finding is “consistent with evidence that these patients may have a blunted serologic response to vaccination secondary to disease or therapy,” the authors note.

Although the investigators did not evaluate the risk of breakthrough infection post vaccination, recent research indicates that receiving a COVID-19 booster increases antibody levels among patients with cancer under active treatment and thus may provide additional protection against the virus.

Given the risk of breakthrough infection and severe outcomes in patients with cancer, the authors propose that “a mitigation approach that includes vaccination of close contacts, boosters, social distancing, and mask-wearing in public should be continued for the foreseeable future.” However, “additional research is needed to further categorize the patients that remain at risk of symptomatic COVID-19 following vaccination and test strategies that may reduce this risk.”

The findings are from a pre-proof that has not yet been peer reviewed or published. First author Dr. Schmidt reported nonfinancial support from Astellas, nonfinancial support from Pfizer, outside the submitted work. Other coauthors reported a range of disclosures as well. The full list can be found with the original article.

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

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

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

sworcester@mdedge.com

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

sworcester@mdedge.com

The cardiovascular and cardiometabolic effects of therapy in women with breast cancer vary based on patient factors like weight and menopausal status, according to findings from the Pathways Heart Study recently presented at the San Antonio Breast Cancer Symposium.

Fred Hutchinson Cancer Center

For example, certain chemotherapy drugs may confer higher risk in breast cancer survivors of normal weight, whereas they may lower stroke risk in those who are obese, according to Heather Greenlee, ND, PhD, a public health researcher and naturopathic physician with the Fred Hutchinson Cancer Research Center in Seattle.

In postmenopausal women with breast cancer, aromatase inhibitors may increase cardiovascular risk, while tamoxifen appears to reduce the risk of incident dyslipidemia, she said.

The findings are from separate analyses of data from studies presented during a poster discussion session at the symposium.
 

Breast cancer treatment and cardiovascular effects: The role of weight

In one analysis, Dr. Greenlee and colleagues examined outcomes in 13,582 breast cancer survivors with a median age of 60 years and median follow-up of 7 years to assess whether cardiovascular disease (CVD) risk associated with specific breast cancer therapies varies by body mass index (BMI) category at diagnosis.

Many routinely used breast cancer therapies are cardiotoxic, and being overweight or obese are known risk factors for CVD, but few studies have assessed whether BMI modifies the effect of these treatment on cardiovascular risk, Dr. Greenlee explained.

After adjusting for baseline demographic and health-related factors, and other breast cancer treatment, they found that:

• Ischemic heart disease risk was higher among normal-weight women who received anthracyclines, compared with those who did not (hazard ratio, 4.2). No other risk associations were observed for other breast cancer therapies and BMI groups.
• Heart failure/cardiomyopathy risk was higher among women with normal weight who received anthracyclines, cyclophosphamides, or left-sided radiation, compared with those who did not (HRs, 5.24, 3.27, and 2.05, respectively), and among overweight women who received anthracyclines, compared with those who did not (HR, 2.18). No risk associations were observed for women who received trastuzumab, taxanes, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were obese.
• Stroke risk was higher in normal-weight women who received taxanes, cyclophosphamides, or left-sided radiation versus those who did not (HRs, 2.14, 2.35, and 1.31, respectively), and stroke risk was lower in obese women who received anthracyclines, taxanes, or cyclophosphamide, compared with those who did not (HRs, 0.32, 0.41, and 0.29, respectively). No risk associations were observed for trastuzumab, endocrine therapy, or radiation on any side, and no risk associations were observed for women who were overweight.

The lack of associations noted between treatments and heart failure risk among obese patients could be caused by the “obesity paradox” observed in prior obese populations, the investigators noted, adding that additional analyses are planned to “examine whether different dosage and duration of breast cancer therapy exposures across the BMI groups contributed to these risk associations.”
 

Breast cancer treatment and cardiometabolic effects: The role of menopausal status

In a separate analysis, Dr. Greenlee and colleagues looked at the association between endocrine therapies and cardiometabolic risk based on menopausal status.

Endocrine therapy is associated with CVD in breast cancer survivors and may be associated with developing cardiometabolic risk factors like diabetes, dyslipidemia, and hypertension, they noted, explaining that tamoxifen has mixed estrogenic and antiestrogenic activity, while aromatase inhibitors deplete endogenous estrogen.

Since most studies have compared tamoxifen with aromatase inhibitor use, it has been a challenge challenging to discern the effects of each, Dr. Greenlee said.

She and her colleagues reviewed records for 14,942 breast cancer survivors who were diagnosed between 2005 and 2013. The patients had a mean age of 61 years at baseline, and 24.9% were premenopausal at the time of diagnosis. Of the premenopausal women, 27.3% used tamoxifen, 19.2% used aromatase inhibitors, and 53.5% did not use endocrine therapy, and of the postmenopausal women, 6.6% used tamoxifen, 47.7% used aromatase inhibitors, and 45.7% did not use endocrine therapy.

After adjusting for baseline demographics and health factors, the investigators found that:

• The use of tamoxifen or aromatase inhibitors was not associated with a risk of developing diabetes, dyslipidemia, or hypertension in premenopausal women, or with a risk of developing diabetes or hypertension in postmenopausal women.
• The risk of dyslipidemia was higher in postmenopausal aromatase inhibitor users, and lower in postmenopausal tamoxifen users, compared with postmenopausal non-users of endocrine therapy (HRs, 1.15 and 0.75, respectively).

The lack of associations between endocrine therapy and CVD risk in premenopausal women may be from low power, Dr. Greenlee said, noting that analyses in larger sample sizes are needed.

She and her colleagues plan to conduct further analyses looking at treatment dosage and duration, and comparing steroidal versus nonsteroidal aromatase inhibitors.

Future studies should examine the implications of these associations on long-term CVD and how best to manage lipid profiles in postmenopausal breast cancer survivors who have a history of endocrine therapy treatment, they concluded.

This research was funded by grants from the National Cancer Institute.

sworcester@mdedge.com

Meeting the treatment needs of the nearly 50% of women with metastatic breast cancer in British Columbia who could benefit from continued access to HER2 suppression would cost the province at least $68,000 more per patient, given the changing treatment landscape, an analysis of outcomes and pharmacy data suggests.

The current funding policy in British Columbia restricts patients to two lines of HER2-directed therapy for metastatic breast cancer, but accessing continued HER2 suppression has become more complex as novel agents have emerged, Emily Jackson, MD, and colleagues explained (in poster PD8-09) at the San Antonio Breast Cancer Symposium.

Continuing HER2 suppression has improved progression free survival (PFS) and overall survival (OS), but the financial implications of adapting funding policies to “reflect increasing lines of proven HER2 treatment” are unclear, they noted.

Drug funding is provided through the provincial government, but it can take months – and sometimes years – from when a drug is approved by Health Canada and when provincial protocols are approved and funding is made available, Dr. Jackson, co-chief resident (PGY5) at BC Cancer, Vancouver, said in an interview.

During that “lag time,” the province is negotiating drug prices with pharmaceutical companies and determining “which patients are eligible and under which circumstances,” she said.

To assess the potential costs, the investigators analyzed data from the BC Cancer outcomes unit, which collects clinical and outcome information on 85% of all patients diagnosed with breast cancer in the province. Information on therapy use was obtained from the BC Cancer pharmacy database.

Of 230 patients who received any HER2 treatment for metastatic breast cancer dispensed by BC Cancer between 2013 and 2018, 112 (49%) were eligible to continue beyond their second line of therapy.

“Of these, 86 patients accessed continued HER2-directed therapy, while 26 were eligible but unable to access continued HER2Rx,” they reported, noting that “the remaining 51% (n = 118) were not eligible for consideration of further HER2Rx due to either stable disease (n = 61) or deterioration precluding treatment (n = 57).”

At median follow-up of 42.2 months, the median number of lines of therapy in the entire study population was three. The median number of cycles in those who received HER2-directed therapy beyond second-line therapy was 33.

The median overall survival was 37.5 months for those who were eligible but did not continue HER2, compared with 57.9 months for those who did continue, they found.

The overall survival difference was not statistically significant (P = .13), but this was likely due to the small number of patients included in the initial analysis, Dr. Jackson said, noting that the finding is “hypothesis generating,” and should be further assessed.

Notably, most patients who continued HER2 therapy did so through pharmaceutical company compassionate access programs or clinical trials, she said.

The “conservative estimated cost per cycle of HER2Rx” was based on currently available trastuzumab biosimilars, and the potential financial implications were calculated based on the current cost of commonly used third-line therapies.

The findings demonstrate that most patients access continued treatment despite prohibitive funding policies, and suggest that significant increases in cost per patient can be expected if funding policies don’t evolve to meet treatment needs, they concluded, noting that “if these trends in survival continue we would expect an additional cost of $68,000 per patient over current costs.

“As the cost of novel therapies are likely to be higher than currently available biosimilars, there will be significant implications for both private payer and public payer healthcare systems,” they added.

A larger, more comprehensive analysis of the data is planned, said Dr. Jackson, who did not disclose any funding or other conflicts of interest associated with this study.

sworcester@mdedge.com

Meeting the treatment needs of the nearly 50% of women with metastatic breast cancer in British Columbia who could benefit from continued access to HER2 suppression would cost the province at least $68,000 more per patient, given the changing treatment landscape, an analysis of outcomes and pharmacy data suggests.

The current funding policy in British Columbia restricts patients to two lines of HER2-directed therapy for metastatic breast cancer, but accessing continued HER2 suppression has become more complex as novel agents have emerged, Emily Jackson, MD, and colleagues explained (in poster PD8-09) at the San Antonio Breast Cancer Symposium.

Continuing HER2 suppression has improved progression free survival (PFS) and overall survival (OS), but the financial implications of adapting funding policies to “reflect increasing lines of proven HER2 treatment” are unclear, they noted.

Drug funding is provided through the provincial government, but it can take months – and sometimes years – from when a drug is approved by Health Canada and when provincial protocols are approved and funding is made available, Dr. Jackson, co-chief resident (PGY5) at BC Cancer, Vancouver, said in an interview.

During that “lag time,” the province is negotiating drug prices with pharmaceutical companies and determining “which patients are eligible and under which circumstances,” she said.

To assess the potential costs, the investigators analyzed data from the BC Cancer outcomes unit, which collects clinical and outcome information on 85% of all patients diagnosed with breast cancer in the province. Information on therapy use was obtained from the BC Cancer pharmacy database.

Of 230 patients who received any HER2 treatment for metastatic breast cancer dispensed by BC Cancer between 2013 and 2018, 112 (49%) were eligible to continue beyond their second line of therapy.

“Of these, 86 patients accessed continued HER2-directed therapy, while 26 were eligible but unable to access continued HER2Rx,” they reported, noting that “the remaining 51% (n = 118) were not eligible for consideration of further HER2Rx due to either stable disease (n = 61) or deterioration precluding treatment (n = 57).”

At median follow-up of 42.2 months, the median number of lines of therapy in the entire study population was three. The median number of cycles in those who received HER2-directed therapy beyond second-line therapy was 33.

The median overall survival was 37.5 months for those who were eligible but did not continue HER2, compared with 57.9 months for those who did continue, they found.

The overall survival difference was not statistically significant (P = .13), but this was likely due to the small number of patients included in the initial analysis, Dr. Jackson said, noting that the finding is “hypothesis generating,” and should be further assessed.

Notably, most patients who continued HER2 therapy did so through pharmaceutical company compassionate access programs or clinical trials, she said.

The “conservative estimated cost per cycle of HER2Rx” was based on currently available trastuzumab biosimilars, and the potential financial implications were calculated based on the current cost of commonly used third-line therapies.

The findings demonstrate that most patients access continued treatment despite prohibitive funding policies, and suggest that significant increases in cost per patient can be expected if funding policies don’t evolve to meet treatment needs, they concluded, noting that “if these trends in survival continue we would expect an additional cost of $68,000 per patient over current costs.

“As the cost of novel therapies are likely to be higher than currently available biosimilars, there will be significant implications for both private payer and public payer healthcare systems,” they added.

A larger, more comprehensive analysis of the data is planned, said Dr. Jackson, who did not disclose any funding or other conflicts of interest associated with this study.

sworcester@mdedge.com

Meeting the treatment needs of the nearly 50% of women with metastatic breast cancer in British Columbia who could benefit from continued access to HER2 suppression would cost the province at least $68,000 more per patient, given the changing treatment landscape, an analysis of outcomes and pharmacy data suggests.

The current funding policy in British Columbia restricts patients to two lines of HER2-directed therapy for metastatic breast cancer, but accessing continued HER2 suppression has become more complex as novel agents have emerged, Emily Jackson, MD, and colleagues explained (in poster PD8-09) at the San Antonio Breast Cancer Symposium.

Continuing HER2 suppression has improved progression free survival (PFS) and overall survival (OS), but the financial implications of adapting funding policies to “reflect increasing lines of proven HER2 treatment” are unclear, they noted.

Drug funding is provided through the provincial government, but it can take months – and sometimes years – from when a drug is approved by Health Canada and when provincial protocols are approved and funding is made available, Dr. Jackson, co-chief resident (PGY5) at BC Cancer, Vancouver, said in an interview.

During that “lag time,” the province is negotiating drug prices with pharmaceutical companies and determining “which patients are eligible and under which circumstances,” she said.

To assess the potential costs, the investigators analyzed data from the BC Cancer outcomes unit, which collects clinical and outcome information on 85% of all patients diagnosed with breast cancer in the province. Information on therapy use was obtained from the BC Cancer pharmacy database.

Of 230 patients who received any HER2 treatment for metastatic breast cancer dispensed by BC Cancer between 2013 and 2018, 112 (49%) were eligible to continue beyond their second line of therapy.

“Of these, 86 patients accessed continued HER2-directed therapy, while 26 were eligible but unable to access continued HER2Rx,” they reported, noting that “the remaining 51% (n = 118) were not eligible for consideration of further HER2Rx due to either stable disease (n = 61) or deterioration precluding treatment (n = 57).”

At median follow-up of 42.2 months, the median number of lines of therapy in the entire study population was three. The median number of cycles in those who received HER2-directed therapy beyond second-line therapy was 33.

The median overall survival was 37.5 months for those who were eligible but did not continue HER2, compared with 57.9 months for those who did continue, they found.

The overall survival difference was not statistically significant (P = .13), but this was likely due to the small number of patients included in the initial analysis, Dr. Jackson said, noting that the finding is “hypothesis generating,” and should be further assessed.

Notably, most patients who continued HER2 therapy did so through pharmaceutical company compassionate access programs or clinical trials, she said.

The “conservative estimated cost per cycle of HER2Rx” was based on currently available trastuzumab biosimilars, and the potential financial implications were calculated based on the current cost of commonly used third-line therapies.

The findings demonstrate that most patients access continued treatment despite prohibitive funding policies, and suggest that significant increases in cost per patient can be expected if funding policies don’t evolve to meet treatment needs, they concluded, noting that “if these trends in survival continue we would expect an additional cost of $68,000 per patient over current costs.

“As the cost of novel therapies are likely to be higher than currently available biosimilars, there will be significant implications for both private payer and public payer healthcare systems,” they added.

A larger, more comprehensive analysis of the data is planned, said Dr. Jackson, who did not disclose any funding or other conflicts of interest associated with this study.

sworcester@mdedge.com

Personalizing fludarabine exposure during lymphodepleting chemotherapy may improve the outcomes of ALL patients who subsequently undergo chimeric antigen receptor T-cell therapy (CAR T), retrospective data suggest.

The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.

In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.

Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.

Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.

Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.

High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.

The study was published online Nov. 17 in Blood Advances.

“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.

MSKCC

Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.

In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.

The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.

The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.

“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”

A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m² that most patients receive, is planned for 2022, he noted.

The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.

sworcester@mdedge.com

Personalizing fludarabine exposure during lymphodepleting chemotherapy may improve the outcomes of ALL patients who subsequently undergo chimeric antigen receptor T-cell therapy (CAR T), retrospective data suggest.

The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.

In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.

Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.

Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.

Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.

High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.

The study was published online Nov. 17 in Blood Advances.

“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.

MSKCC

Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.

In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.

The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.

The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.

“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”

A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m² that most patients receive, is planned for 2022, he noted.

The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.

sworcester@mdedge.com

Personalizing fludarabine exposure during lymphodepleting chemotherapy may improve the outcomes of ALL patients who subsequently undergo chimeric antigen receptor T-cell therapy (CAR T), retrospective data suggest.

The findings, if validated in a prospective study, could help cut the rate of relapses after initial response to CAR T-cell therapy, which currently approaches 50%, the investigators noted.

In 152 pediatric and young adult patients with relapsed or refractory B-cell acute lymphoblastic leukemia (B-ALL) who underwent CD-19-directed CAR T-cell therapy after cyclophosphamide/fludarabine lymphodepleting chemotherapy, estimated fludarabine exposure was associated with cumulative incidence of relapse (CIR) and a composite endpoint that included loss of B-cell aplasia (BCA) or relapse, Vanessa Fabrizio, MD, and colleagues found.

Dr. Fabrizio, a pediatric hematologist and oncologist at Children’s Hospital Colorado and the University of Colorado Cancer Center in Aurora, was a fellow at Memorial Sloan Kettering (MSK) Cancer Center during the study.

Optimal fludarabine exposure was identified by the investigators as an area under the curve (AUC) of at least 13.8 mg*hr/L. The fludarabine exposure AUC was calculated for each patient by using a validated pharmacokinetics population model.

Multivariable analyses controlling for baseline patient factors and fludarabine exposure showed that patients without optimal exposure had a 2.5-fold higher CIR (hazard ratio, 2.45), and a twofold higher risk of relapse or loss of BCA (HR, 1.96), compared with those who had optimal fludarabine exposure, they reported.

High pre-infusion disease burden was associated with an increased risk of relapse and death (HRs, 2.66 and 4.77, respectively), they said.

The study was published online Nov. 17 in Blood Advances.

“We know that [with] fludarabine ... everyone’s body clears it differently,” principal investigator Kevin J. Curran, MD, said in an interview.

MSKCC

Factors affecting clearance include kidney function and weight, and it is simple to determine the optimal dose based on these factors and apply that in practice, said Dr. Curran, a pediatric oncologist and assistant attending physician specializing in cellular therapy at MSK Kids.

In fact, in prior studies, optimal fludarabine exposure in patients undergoing allogeneic hematopoietic cell transplantation has been shown to “decrease nonrelapse mortality due to improved immune reconstitution and subsequently improve survival,” he and his colleagues wrote, explaining the rationale for the study.

The participants, who were part of the Pediatric Real-World CAR Consortium (PRWCC), had a median age of 12.5 years, and 131 of 152 (86%) responded to CAR T-cell therapy. The 12-month OS was 75.1%, the 12-month CIR was 36.4%, and 67% of patients had optimal fludarabine exposure, the authors said.

The findings indeed suggest that one way to improve outcomes without changing the actual cell therapy is to tailor the lymphodepleting therapy prior to CAR T-cell therapy, said Dr. Curran.

“That’s what this does. It’s exciting because cell therapy is very effective [in terms of] initial response, but what we don’t like is the durability of the response,” he said “The next step is to prove it in a prospective study.”

A phase 2 study looking at personalized dosing, as opposed to the standard 30 mg/m² that most patients receive, is planned for 2022, he noted.

The study was supported by a St Baldrick’s/Stand Up 2 Cancer Pediatric Dream Team Translational Cancer Research Grant, the Virginia and D.K. Ludwig Fund for Cancer Research, and a National Cancer Institute Cancer Center Support Grant. Dr. Curran has served as a consultant for Novartis and Mesoblast, and received research funding from Novartis and Celgene. Dr. Fabrizio reported having no disclosures.

sworcester@mdedge.com