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Huge underuse of germline testing for cancer patients
Information from germline genetic testing could affect a patient’s cancer care. For example, such testing could indicate that targeted therapies would be beneficial, and it would have implications for close relatives who may carry the same genes.
The finding that so few patients with newly diagnosed cancer were tested comes from an analysis of data on more than 1.3 million individuals across two U.S. states. The data were taken from the Surveillance, Epidemiology, and End Results (SEER) registry.
The rate is “well below guideline recommendations,” said study presenter Allison W. Kurian, MD, department of medicine, Stanford (Calif.) University.
“Innovative care delivery” is needed to tackle the problem, including the streamlining of pretest counseling, making posttest counseling more widely available, and employing long-term follow-up to track patient outcomes, she suggested.
“I do think this is a time for creative solutions of a number of different kinds,” she said. She suggested that lessons could be learned from the use of telemedicine during the COVID-19 pandemic. She also noted that “there have been some interesting studies on embedding genetic counselors in oncology clinics.”
Dr. Kurian presented the study at the annual meeting of the American Society of Clinical Oncology (ASCO). The study was simultaneously published in the Journal of the American Medical Association.
The current results represent a “missed opportunity for decrease the population-level burden of cancer,” experts noted in an accompanying editorial.
“Clinicians should recommend testing to their patients and provide them with the information necessary to make informed decisions about whether to undergo testing,” Zsofia K. Stadler, MD, and Deborah Schrag, MD, MPH, of Memorial Sloan Kettering Cancer Center, New York, wrote in their editorial.
They suggested novel approaches to widen access, such as use of point-of-care testing, telecounseling, and, in the future, chatbots to respond to patient questions.
“With greater emphasis on overcoming both health system and patient-level barriers to genetic cancer susceptibility testing for patients with cancer, treatment outcomes will improve and cancer diagnoses and related deaths in family members will be prevented,” they concluded.
At the meeting, invited discussant Erin Frances Cobain, MD, assistant professor of medical oncology, University of Michigan Health, Ann Arbor, referring to breast cancer as an example, said that progress has “stagnated” in recent years.
The study found a higher rate of gene testing among patients with newly diagnosed breast cancer, at just over 20%.
Dr. Cobain argued that this was still too low. She pointed out that “a recent study suggested that over 60% of individuals with an incident cancer diagnosis would meet criteria for genetic testing by National Comprehensive Cancer Network guidelines.
“This may be because testing is not offered, there may be poor access to genetic counseling resources, or patients may be offered testing but decline it,” she suggested.
One compelling reason to conduct genetic testing for patients newly diagnosed with breast cancer is that it may show that they are candidates for treatment with PARP (poly[ADP]-ribose polymerase) inhibitors, which “may have a direct impact on cancer-related mortality,” she pointed out.
“We need increased awareness and access to genetic testing resources for patients with breast cancer, particularly for racial and ethnic minorities,” she said.
Dr. Cobain also noted that finding variants of uncertain significance (VUS) was more likely among patients from racial and ethnic minorities than among White patients. She said such a finding “increases patient and physician anxiety,” and there may be “unclear optimal management recommendations for these patients.”
Details of the study
Germline genetic testing is “increasingly essential for cancer care,” Dr. Kurian said.
It is central to risk-adapted screening and secondary prevention, the use of targeted therapies, including PARP and checkpoint inhibitors, and cascade testing to identify at-risk relatives.
She pointed out that in clinical practice, testing has “evolved rapidly.” Panels include more and more genes. In addition, the cost of these tests is falling, and guidelines have become “more expansive.”
However, “little is known about genetic testing use and results,” Dr. Kurian noted.
The team therefore undertook the SEER-GeneLINK initiative, which involved patients aged ≥ 20 years who were diagnosed with cancer between Jan. 1, 2013, and March 31, 2019, and who were reported to statewide SEER registries in California and Georgia.
The team looked for patients for whom germline genetic test results had been reported by the four laboratories that performed the majority of patient testing in the two states. Results were categorized as pathogenic, benign, or VUS.
The results were classified on the basis of current guidelines for testing and/or management as related to breast/ovarian cancer, gastrointestinal cancer, other hereditary cancers, or those with no guidelines for testing or management.
Dr. Kurian reported that from an overall population of 1,412,388 patients diagnosed with cancer, 1,369,660 were eligible for inclusion. Of those, about half (51.9%) were women, and the majority (86.3%) were aged 50 years or older.
Many of these patients (61.4%) were non-Hispanic White persons, and slightly fewer than half (49.8%) were deemed to be in medium or high poverty, as determined using U.S. Census tract levels.
Overall, germline genetic testing was performed in 93,052 (6.8%) of patients over the study period.
Women were more likely to have undergone germline mutation testing than men, at 13.9% vs. 2.2%, as were patients aged 20-49 years, at 22.1% vs. 8.2% for those aged 50-69 years, and 3.3% for those aged 70 years and older.
The number of genes for which testing was conducted increased from a median of 2 in 2013 to 34 in 2019. Rates of VUS increased more than that for pathologic variants and substantially more so in non-White patients.
By 2019, the ratio of VUS to pathologic variants stood at 1.7 among White patients, vs. 3.9 among Asian patients, 3.6 among Black patients, and 2.2 among Hispanic patients.
The majority of identified pathologic variants that were related to the diagnosed cancer and genes with testing and/or management guidelines accounted for 67.5% to 94.9% of such variants.
Regarding specific cancer diagnoses, Dr. Kurian said that over the course of the study period, testing rates consistently exceeded 50% only among male breast cancer patients.
There were rapid increases in testing for ovarian cancer, from 28.0% of cases in 2013 to 54.0% in 2019. For pancreatic cancer, rates increased from 1.0% to 19.0% over the same period, and for prostate cancer, rates increased from 0.1% to 4.0%. She suggested that these increases in rates may be related to the approval of PARP inhibitors for use in these indications.
However, there was little change in the rates of germline mutation testing for lung cancer patients, from 01% in 2013 to 0.8% in 2019, and for other cancers, from 0.3% to 2.0%.
The results also revealed racial and ethnic differences in testing after controlling for age, cancer type, and year. Over the course of the study period, 8.0% of White patients underwent genetic testing, compared with 6.0% each for Asian, Black, and Hispanic patients and 5.0% for other patients (P < .001).
With regard specifically to male and female breast cancer and ovarian cancer, testing rates were 31% among White patients, 22% for Asian patients, 25% for Black patients, and 23% for Hispanic patients (P < .001).
Dr. Kurian acknowledged that the study is limited by a lack of testing from other laboratories and direct-to-consumer test data, although a recent survey suggested that this represents fewer than 5% of all germline genetic tests.
She also noted that the SEER registries do not collect data on family history or tumor sequencing.
The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention. Dr. Kurian has relationships with Adela, Ambry Genetics, Color Genomics, GeneDx/BioReference, Genentech, InVitae, and Myriad Genetics. Other authors report numerous relationships with industry. Dr. Cobain has ties with AstraZeneca, Daiichi Sankyo, Athenex, Ayala Pharmaceuticals, bioTheranostics, and Immunomedics. Dr. Schrag has relationships with Merck, JAMA, AACR, and Grail. Dr. Stadler has ties with Adverum Biotechnologies, Genentech, Neurogene, Novartis, Optos Plc, Outlook Therapeutics, and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Information from germline genetic testing could affect a patient’s cancer care. For example, such testing could indicate that targeted therapies would be beneficial, and it would have implications for close relatives who may carry the same genes.
The finding that so few patients with newly diagnosed cancer were tested comes from an analysis of data on more than 1.3 million individuals across two U.S. states. The data were taken from the Surveillance, Epidemiology, and End Results (SEER) registry.
The rate is “well below guideline recommendations,” said study presenter Allison W. Kurian, MD, department of medicine, Stanford (Calif.) University.
“Innovative care delivery” is needed to tackle the problem, including the streamlining of pretest counseling, making posttest counseling more widely available, and employing long-term follow-up to track patient outcomes, she suggested.
“I do think this is a time for creative solutions of a number of different kinds,” she said. She suggested that lessons could be learned from the use of telemedicine during the COVID-19 pandemic. She also noted that “there have been some interesting studies on embedding genetic counselors in oncology clinics.”
Dr. Kurian presented the study at the annual meeting of the American Society of Clinical Oncology (ASCO). The study was simultaneously published in the Journal of the American Medical Association.
The current results represent a “missed opportunity for decrease the population-level burden of cancer,” experts noted in an accompanying editorial.
“Clinicians should recommend testing to their patients and provide them with the information necessary to make informed decisions about whether to undergo testing,” Zsofia K. Stadler, MD, and Deborah Schrag, MD, MPH, of Memorial Sloan Kettering Cancer Center, New York, wrote in their editorial.
They suggested novel approaches to widen access, such as use of point-of-care testing, telecounseling, and, in the future, chatbots to respond to patient questions.
“With greater emphasis on overcoming both health system and patient-level barriers to genetic cancer susceptibility testing for patients with cancer, treatment outcomes will improve and cancer diagnoses and related deaths in family members will be prevented,” they concluded.
At the meeting, invited discussant Erin Frances Cobain, MD, assistant professor of medical oncology, University of Michigan Health, Ann Arbor, referring to breast cancer as an example, said that progress has “stagnated” in recent years.
The study found a higher rate of gene testing among patients with newly diagnosed breast cancer, at just over 20%.
Dr. Cobain argued that this was still too low. She pointed out that “a recent study suggested that over 60% of individuals with an incident cancer diagnosis would meet criteria for genetic testing by National Comprehensive Cancer Network guidelines.
“This may be because testing is not offered, there may be poor access to genetic counseling resources, or patients may be offered testing but decline it,” she suggested.
One compelling reason to conduct genetic testing for patients newly diagnosed with breast cancer is that it may show that they are candidates for treatment with PARP (poly[ADP]-ribose polymerase) inhibitors, which “may have a direct impact on cancer-related mortality,” she pointed out.
“We need increased awareness and access to genetic testing resources for patients with breast cancer, particularly for racial and ethnic minorities,” she said.
Dr. Cobain also noted that finding variants of uncertain significance (VUS) was more likely among patients from racial and ethnic minorities than among White patients. She said such a finding “increases patient and physician anxiety,” and there may be “unclear optimal management recommendations for these patients.”
Details of the study
Germline genetic testing is “increasingly essential for cancer care,” Dr. Kurian said.
It is central to risk-adapted screening and secondary prevention, the use of targeted therapies, including PARP and checkpoint inhibitors, and cascade testing to identify at-risk relatives.
She pointed out that in clinical practice, testing has “evolved rapidly.” Panels include more and more genes. In addition, the cost of these tests is falling, and guidelines have become “more expansive.”
However, “little is known about genetic testing use and results,” Dr. Kurian noted.
The team therefore undertook the SEER-GeneLINK initiative, which involved patients aged ≥ 20 years who were diagnosed with cancer between Jan. 1, 2013, and March 31, 2019, and who were reported to statewide SEER registries in California and Georgia.
The team looked for patients for whom germline genetic test results had been reported by the four laboratories that performed the majority of patient testing in the two states. Results were categorized as pathogenic, benign, or VUS.
The results were classified on the basis of current guidelines for testing and/or management as related to breast/ovarian cancer, gastrointestinal cancer, other hereditary cancers, or those with no guidelines for testing or management.
Dr. Kurian reported that from an overall population of 1,412,388 patients diagnosed with cancer, 1,369,660 were eligible for inclusion. Of those, about half (51.9%) were women, and the majority (86.3%) were aged 50 years or older.
Many of these patients (61.4%) were non-Hispanic White persons, and slightly fewer than half (49.8%) were deemed to be in medium or high poverty, as determined using U.S. Census tract levels.
Overall, germline genetic testing was performed in 93,052 (6.8%) of patients over the study period.
Women were more likely to have undergone germline mutation testing than men, at 13.9% vs. 2.2%, as were patients aged 20-49 years, at 22.1% vs. 8.2% for those aged 50-69 years, and 3.3% for those aged 70 years and older.
The number of genes for which testing was conducted increased from a median of 2 in 2013 to 34 in 2019. Rates of VUS increased more than that for pathologic variants and substantially more so in non-White patients.
By 2019, the ratio of VUS to pathologic variants stood at 1.7 among White patients, vs. 3.9 among Asian patients, 3.6 among Black patients, and 2.2 among Hispanic patients.
The majority of identified pathologic variants that were related to the diagnosed cancer and genes with testing and/or management guidelines accounted for 67.5% to 94.9% of such variants.
Regarding specific cancer diagnoses, Dr. Kurian said that over the course of the study period, testing rates consistently exceeded 50% only among male breast cancer patients.
There were rapid increases in testing for ovarian cancer, from 28.0% of cases in 2013 to 54.0% in 2019. For pancreatic cancer, rates increased from 1.0% to 19.0% over the same period, and for prostate cancer, rates increased from 0.1% to 4.0%. She suggested that these increases in rates may be related to the approval of PARP inhibitors for use in these indications.
However, there was little change in the rates of germline mutation testing for lung cancer patients, from 01% in 2013 to 0.8% in 2019, and for other cancers, from 0.3% to 2.0%.
The results also revealed racial and ethnic differences in testing after controlling for age, cancer type, and year. Over the course of the study period, 8.0% of White patients underwent genetic testing, compared with 6.0% each for Asian, Black, and Hispanic patients and 5.0% for other patients (P < .001).
With regard specifically to male and female breast cancer and ovarian cancer, testing rates were 31% among White patients, 22% for Asian patients, 25% for Black patients, and 23% for Hispanic patients (P < .001).
Dr. Kurian acknowledged that the study is limited by a lack of testing from other laboratories and direct-to-consumer test data, although a recent survey suggested that this represents fewer than 5% of all germline genetic tests.
She also noted that the SEER registries do not collect data on family history or tumor sequencing.
The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention. Dr. Kurian has relationships with Adela, Ambry Genetics, Color Genomics, GeneDx/BioReference, Genentech, InVitae, and Myriad Genetics. Other authors report numerous relationships with industry. Dr. Cobain has ties with AstraZeneca, Daiichi Sankyo, Athenex, Ayala Pharmaceuticals, bioTheranostics, and Immunomedics. Dr. Schrag has relationships with Merck, JAMA, AACR, and Grail. Dr. Stadler has ties with Adverum Biotechnologies, Genentech, Neurogene, Novartis, Optos Plc, Outlook Therapeutics, and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
Information from germline genetic testing could affect a patient’s cancer care. For example, such testing could indicate that targeted therapies would be beneficial, and it would have implications for close relatives who may carry the same genes.
The finding that so few patients with newly diagnosed cancer were tested comes from an analysis of data on more than 1.3 million individuals across two U.S. states. The data were taken from the Surveillance, Epidemiology, and End Results (SEER) registry.
The rate is “well below guideline recommendations,” said study presenter Allison W. Kurian, MD, department of medicine, Stanford (Calif.) University.
“Innovative care delivery” is needed to tackle the problem, including the streamlining of pretest counseling, making posttest counseling more widely available, and employing long-term follow-up to track patient outcomes, she suggested.
“I do think this is a time for creative solutions of a number of different kinds,” she said. She suggested that lessons could be learned from the use of telemedicine during the COVID-19 pandemic. She also noted that “there have been some interesting studies on embedding genetic counselors in oncology clinics.”
Dr. Kurian presented the study at the annual meeting of the American Society of Clinical Oncology (ASCO). The study was simultaneously published in the Journal of the American Medical Association.
The current results represent a “missed opportunity for decrease the population-level burden of cancer,” experts noted in an accompanying editorial.
“Clinicians should recommend testing to their patients and provide them with the information necessary to make informed decisions about whether to undergo testing,” Zsofia K. Stadler, MD, and Deborah Schrag, MD, MPH, of Memorial Sloan Kettering Cancer Center, New York, wrote in their editorial.
They suggested novel approaches to widen access, such as use of point-of-care testing, telecounseling, and, in the future, chatbots to respond to patient questions.
“With greater emphasis on overcoming both health system and patient-level barriers to genetic cancer susceptibility testing for patients with cancer, treatment outcomes will improve and cancer diagnoses and related deaths in family members will be prevented,” they concluded.
At the meeting, invited discussant Erin Frances Cobain, MD, assistant professor of medical oncology, University of Michigan Health, Ann Arbor, referring to breast cancer as an example, said that progress has “stagnated” in recent years.
The study found a higher rate of gene testing among patients with newly diagnosed breast cancer, at just over 20%.
Dr. Cobain argued that this was still too low. She pointed out that “a recent study suggested that over 60% of individuals with an incident cancer diagnosis would meet criteria for genetic testing by National Comprehensive Cancer Network guidelines.
“This may be because testing is not offered, there may be poor access to genetic counseling resources, or patients may be offered testing but decline it,” she suggested.
One compelling reason to conduct genetic testing for patients newly diagnosed with breast cancer is that it may show that they are candidates for treatment with PARP (poly[ADP]-ribose polymerase) inhibitors, which “may have a direct impact on cancer-related mortality,” she pointed out.
“We need increased awareness and access to genetic testing resources for patients with breast cancer, particularly for racial and ethnic minorities,” she said.
Dr. Cobain also noted that finding variants of uncertain significance (VUS) was more likely among patients from racial and ethnic minorities than among White patients. She said such a finding “increases patient and physician anxiety,” and there may be “unclear optimal management recommendations for these patients.”
Details of the study
Germline genetic testing is “increasingly essential for cancer care,” Dr. Kurian said.
It is central to risk-adapted screening and secondary prevention, the use of targeted therapies, including PARP and checkpoint inhibitors, and cascade testing to identify at-risk relatives.
She pointed out that in clinical practice, testing has “evolved rapidly.” Panels include more and more genes. In addition, the cost of these tests is falling, and guidelines have become “more expansive.”
However, “little is known about genetic testing use and results,” Dr. Kurian noted.
The team therefore undertook the SEER-GeneLINK initiative, which involved patients aged ≥ 20 years who were diagnosed with cancer between Jan. 1, 2013, and March 31, 2019, and who were reported to statewide SEER registries in California and Georgia.
The team looked for patients for whom germline genetic test results had been reported by the four laboratories that performed the majority of patient testing in the two states. Results were categorized as pathogenic, benign, or VUS.
The results were classified on the basis of current guidelines for testing and/or management as related to breast/ovarian cancer, gastrointestinal cancer, other hereditary cancers, or those with no guidelines for testing or management.
Dr. Kurian reported that from an overall population of 1,412,388 patients diagnosed with cancer, 1,369,660 were eligible for inclusion. Of those, about half (51.9%) were women, and the majority (86.3%) were aged 50 years or older.
Many of these patients (61.4%) were non-Hispanic White persons, and slightly fewer than half (49.8%) were deemed to be in medium or high poverty, as determined using U.S. Census tract levels.
Overall, germline genetic testing was performed in 93,052 (6.8%) of patients over the study period.
Women were more likely to have undergone germline mutation testing than men, at 13.9% vs. 2.2%, as were patients aged 20-49 years, at 22.1% vs. 8.2% for those aged 50-69 years, and 3.3% for those aged 70 years and older.
The number of genes for which testing was conducted increased from a median of 2 in 2013 to 34 in 2019. Rates of VUS increased more than that for pathologic variants and substantially more so in non-White patients.
By 2019, the ratio of VUS to pathologic variants stood at 1.7 among White patients, vs. 3.9 among Asian patients, 3.6 among Black patients, and 2.2 among Hispanic patients.
The majority of identified pathologic variants that were related to the diagnosed cancer and genes with testing and/or management guidelines accounted for 67.5% to 94.9% of such variants.
Regarding specific cancer diagnoses, Dr. Kurian said that over the course of the study period, testing rates consistently exceeded 50% only among male breast cancer patients.
There were rapid increases in testing for ovarian cancer, from 28.0% of cases in 2013 to 54.0% in 2019. For pancreatic cancer, rates increased from 1.0% to 19.0% over the same period, and for prostate cancer, rates increased from 0.1% to 4.0%. She suggested that these increases in rates may be related to the approval of PARP inhibitors for use in these indications.
However, there was little change in the rates of germline mutation testing for lung cancer patients, from 01% in 2013 to 0.8% in 2019, and for other cancers, from 0.3% to 2.0%.
The results also revealed racial and ethnic differences in testing after controlling for age, cancer type, and year. Over the course of the study period, 8.0% of White patients underwent genetic testing, compared with 6.0% each for Asian, Black, and Hispanic patients and 5.0% for other patients (P < .001).
With regard specifically to male and female breast cancer and ovarian cancer, testing rates were 31% among White patients, 22% for Asian patients, 25% for Black patients, and 23% for Hispanic patients (P < .001).
Dr. Kurian acknowledged that the study is limited by a lack of testing from other laboratories and direct-to-consumer test data, although a recent survey suggested that this represents fewer than 5% of all germline genetic tests.
She also noted that the SEER registries do not collect data on family history or tumor sequencing.
The study was funded by the National Institutes of Health, and the Centers for Disease Control and Prevention. Dr. Kurian has relationships with Adela, Ambry Genetics, Color Genomics, GeneDx/BioReference, Genentech, InVitae, and Myriad Genetics. Other authors report numerous relationships with industry. Dr. Cobain has ties with AstraZeneca, Daiichi Sankyo, Athenex, Ayala Pharmaceuticals, bioTheranostics, and Immunomedics. Dr. Schrag has relationships with Merck, JAMA, AACR, and Grail. Dr. Stadler has ties with Adverum Biotechnologies, Genentech, Neurogene, Novartis, Optos Plc, Outlook Therapeutics, and Regeneron Pharmaceuticals.
A version of this article first appeared on Medscape.com.
AT ASCO 2023
DEI training gives oncology fellows more confidence
The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).
Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.
“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”
Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.
The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).
At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.
First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.
Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.
Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.
“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”
Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.
The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.
The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.
Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.
Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.
“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”
No funding for the study was reported.
A version of this article first appeared on Medscape.com.
The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).
Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.
“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”
Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.
The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).
At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.
First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.
Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.
Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.
“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”
Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.
The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.
The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.
Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.
Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.
“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”
No funding for the study was reported.
A version of this article first appeared on Medscape.com.
The finding comes from a survey conducted after the introduction of DEI training within the Yale Medical Oncology-Hematology Fellowship Program. The study was reported by Norin Ansari, MD, MPH, of Yale Cancer Center, New Haven, Conn., at the annual meeting of the American Society of Clinical Oncology (ASCO).
Dr. Ansari emphasized the DEI curriculum in fellowship programs by highlighting the racial and gender disparities that exist among physicians.
“There is a significant representation problem – only 2%-3% of practicing oncologists are Black or Hispanic/Latino,” she said. “And that representation decreases with each stage in the pipeline of the workforce.”
Dr. Ansari also noted gender disparities in the oncologist workforce, reporting that about one-third of faculty positions are held by women.
The anonymous survey was sent to 29 fellows; 23 responded, including 8 first-year fellows and 13 senior fellows. Over 57% of respondents rated the importance of DEI education as 10 on a 10-point scale (mean, 8.6).
At the start of this year, the responses of senior fellows who had already received some DEI training during the previous year’s lecture series were compared with first-year fellows who had not had any fellowship DEI education.
First-year fellows reported a mean confidence score of 2.5/5 at navigating bias and microaggressions when experienced personally and a mean score of 2.9/5 when they were directed at others. Senior fellows reported mean confidence scores of 3 and 3.2, respectively.
Yale then compared longitudinal data on fellows’ comfort levels in navigating discrimination in 2021, 2022, and 2023 a month before the ASCO meeting.
Fellows were asked to rate their comfort level from 1 to 10 in navigating different types of discrimination, including racial inequality, sexual harassment, and gender discrimination. In these three categories, fellows rated comfortability as a 5 in 2021 and as 7 in 2023 after the DEI training.
“Our first goal is to normalize talking about DEI and to recognize that different people in our workforce have different experiences and how we can be allies for them and for our patients,” Dr. Ansari said. “And I think for long-term goals we want to take stock of who’s at the table, who’s making decisions, and how does that affect our field, our science, and our patients.”
Yale designed the 3-year longitudinal curriculum with two annual core topics: upstander training and journal club for discussion and reflection. An additional two to three training sessions per year will focus on either race, gender, LGBTQ+, disability, religion, or implicit bias training.
The most popular topics among fellows were upstander training, cancer treatment and outcomes disparities, recruitment and retention, and career promotion and pay disparities.
The preferred platforms of content delivery were lectures from experts in the field, affinity groups or mentorship links, small group discussions, and advocacy education.
Gerald Hsu, MD, PhD, with the San Francisco VA Medical Center, discussed the results of Yale’s DEI curriculum assessment, saying it represented “best practices” in the industry. However, he acknowledged that realistically, not everyone will be receptive to DEI training.
Dr. Hsu said that holding medical staff accountable is the only way to truly incorporate DEI into everyday practice.
“Collectively, we need to be holding ourselves to different standards or holding ourselves to some standard,” Dr. Hsu said. “Maybe we need to be setting goals to the degree to which we diversify our training programs and our faculty, and there needs to be consequences to not doing so.”
No funding for the study was reported.
A version of this article first appeared on Medscape.com.
FROM ASCO 2023
Drugmakers are abandoning cheap generics, and now U.S. cancer patients can’t get meds
On Nov. 22, three Food and Drug Administration inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck. Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.
Their decisions are likely to result in preventable deaths.
Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, ADHD pills, blood thinners, and antibiotics. COVID-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.
The problem isn’t new, and that’s particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures – undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.
But what about the thousands of patients today who can’t get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?
“It’s just insane,” said Mark Ratain, MD, a cancer doctor and pharmacologist at the University of Chicago. “Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?”
“It’s just a travesty that this is the level of health care in the United States of America right now,” said Stephen Divers, MD, an oncologist in Hot Springs, Ark., who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin. Results from a survey of academic cancer centers released June 7 found 93% couldn’t find enough carboplatin and 70% had cisplatin shortages.
“All day, in between patients, we hold staff meetings trying to figure this out,” said Bonny Moore, MD, an oncologist in Fredericksburg, Virginia. “It’s the most nauseous I’ve ever felt. Our office stayed open during COVID; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug.”
The cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives – though sometimes less effective and often with more side effects – are available. But some doctors are even rationing doses intended to cure.
Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella’s second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.
“They don’t think it will have a negative impact on her treatment, but as far as I am aware, there isn’t any scientific basis to make that conclusion,” he said. “As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard.”
Mr. McDonald stressed that he didn’t blame the staffers at Intermountain Health who take care of Isabella. The family – his other daughter, Cate, made a TikTok video about her sister’s plight – were simply stunned at such a basic flaw in the health care system.
At Dr. Moore’s practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.
On June 2, Dr. Moore and colleagues were glued to their drug distributor’s website, anxious as teenagers waiting for Taylor Swift tickets to go on sale – only with mortal consequences at stake.
She later emailed KFF Health News: “Carboplatin did NOT come back in stock today. Neither did cisplatin.”
Doses remained at 80%, she said. Things hadn’t changed 10 days later.
Generics manufacturers are pulling out
The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.
As generics manufacturers compete to win sales contracts with the big negotiators of such purchases, such as Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Lannett, with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.
The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Mr. Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.
Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it’s harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market. Mr. Sardella testified in May that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions.
The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.
Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.
Asked why it waited 2 months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn’t list a drug in shortage until it has “confirmed that overall market demand is not being met.”
Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-mg bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at dr. Moore’s clinic.
“It’s hard to have these conversations with patients – ‘I have your dose for this cycle, but not sure about next cycle,’” said Mark Einstein, MD, chair of the department of obstetrics, gynecology and reproductive health at New Jersey Medical School, Newark.
Should government step in?
Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.
As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas’ plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.
Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn’t issue an immediate alarm. “It’s a fine balance,” she said. “You don’t want to create panic-buying or hoarding.”
More lasting solutions are under discussion. Mr. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.
“At a certain point the system needs to recognize there’s a high cost to low-cost drugs,” said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Va., that will produce dozens more, Mr. Coukell said.
Dr. Ratain and his University of Chicago colleague Satyajit Kosuri, MD, recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.
In fact, Dr. Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store 2 years’ worth of carboplatin and cisplatin.
“It would almost literally be a drop in the bucket.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – an independent source of health policy research, polling, and journalism. Learn more about KFF.
On Nov. 22, three Food and Drug Administration inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck. Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.
Their decisions are likely to result in preventable deaths.
Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, ADHD pills, blood thinners, and antibiotics. COVID-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.
The problem isn’t new, and that’s particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures – undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.
But what about the thousands of patients today who can’t get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?
“It’s just insane,” said Mark Ratain, MD, a cancer doctor and pharmacologist at the University of Chicago. “Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?”
“It’s just a travesty that this is the level of health care in the United States of America right now,” said Stephen Divers, MD, an oncologist in Hot Springs, Ark., who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin. Results from a survey of academic cancer centers released June 7 found 93% couldn’t find enough carboplatin and 70% had cisplatin shortages.
“All day, in between patients, we hold staff meetings trying to figure this out,” said Bonny Moore, MD, an oncologist in Fredericksburg, Virginia. “It’s the most nauseous I’ve ever felt. Our office stayed open during COVID; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug.”
The cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives – though sometimes less effective and often with more side effects – are available. But some doctors are even rationing doses intended to cure.
Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella’s second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.
“They don’t think it will have a negative impact on her treatment, but as far as I am aware, there isn’t any scientific basis to make that conclusion,” he said. “As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard.”
Mr. McDonald stressed that he didn’t blame the staffers at Intermountain Health who take care of Isabella. The family – his other daughter, Cate, made a TikTok video about her sister’s plight – were simply stunned at such a basic flaw in the health care system.
At Dr. Moore’s practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.
On June 2, Dr. Moore and colleagues were glued to their drug distributor’s website, anxious as teenagers waiting for Taylor Swift tickets to go on sale – only with mortal consequences at stake.
She later emailed KFF Health News: “Carboplatin did NOT come back in stock today. Neither did cisplatin.”
Doses remained at 80%, she said. Things hadn’t changed 10 days later.
Generics manufacturers are pulling out
The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.
As generics manufacturers compete to win sales contracts with the big negotiators of such purchases, such as Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Lannett, with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.
The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Mr. Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.
Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it’s harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market. Mr. Sardella testified in May that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions.
The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.
Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.
Asked why it waited 2 months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn’t list a drug in shortage until it has “confirmed that overall market demand is not being met.”
Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-mg bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at dr. Moore’s clinic.
“It’s hard to have these conversations with patients – ‘I have your dose for this cycle, but not sure about next cycle,’” said Mark Einstein, MD, chair of the department of obstetrics, gynecology and reproductive health at New Jersey Medical School, Newark.
Should government step in?
Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.
As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas’ plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.
Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn’t issue an immediate alarm. “It’s a fine balance,” she said. “You don’t want to create panic-buying or hoarding.”
More lasting solutions are under discussion. Mr. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.
“At a certain point the system needs to recognize there’s a high cost to low-cost drugs,” said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Va., that will produce dozens more, Mr. Coukell said.
Dr. Ratain and his University of Chicago colleague Satyajit Kosuri, MD, recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.
In fact, Dr. Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store 2 years’ worth of carboplatin and cisplatin.
“It would almost literally be a drop in the bucket.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – an independent source of health policy research, polling, and journalism. Learn more about KFF.
On Nov. 22, three Food and Drug Administration inspectors arrived at the sprawling Intas Pharmaceuticals plant south of Ahmedabad, India, and found hundreds of trash bags full of shredded documents tossed into a garbage truck. Over the next 10 days, the inspectors assessed what looked like a systematic effort to conceal quality problems at the plant, which provided more than half of the U.S. supply of generic cisplatin and carboplatin, two cheap drugs used to treat as many as 500,000 new cancer cases every year.
Their decisions are likely to result in preventable deaths.
Cisplatin and carboplatin are among scores of drugs in shortage, including 12 other cancer drugs, ADHD pills, blood thinners, and antibiotics. COVID-hangover supply chain issues and limited FDA oversight are part of the problem, but the main cause, experts agree, is the underlying weakness of the generic drug industry. Made mostly overseas, these old but crucial drugs are often sold at a loss or for little profit. Domestic manufacturers have little interest in making them, setting their sights instead on high-priced drugs with plump profit margins.
The problem isn’t new, and that’s particularly infuriating to many clinicians. President Joe Biden, whose son Beau died of an aggressive brain cancer, has focused his Cancer Moonshot on discovering cures – undoubtedly expensive ones. Indeed, existing brand-name cancer drugs often cost tens of thousands of dollars a year.
But what about the thousands of patients today who can’t get a drug like cisplatin, approved by the FDA in 1978 and costing as little as $6 a dose?
“It’s just insane,” said Mark Ratain, MD, a cancer doctor and pharmacologist at the University of Chicago. “Your roof is caving in, but you want to build a basketball court in the backyard because your wife is pregnant with twin boys and you want them to be NBA stars when they grow up?”
“It’s just a travesty that this is the level of health care in the United States of America right now,” said Stephen Divers, MD, an oncologist in Hot Springs, Ark., who in recent weeks has had to delay or change treatment for numerous bladder, breast, and ovarian cancer patients because his clinic cannot find enough cisplatin and carboplatin. Results from a survey of academic cancer centers released June 7 found 93% couldn’t find enough carboplatin and 70% had cisplatin shortages.
“All day, in between patients, we hold staff meetings trying to figure this out,” said Bonny Moore, MD, an oncologist in Fredericksburg, Virginia. “It’s the most nauseous I’ve ever felt. Our office stayed open during COVID; we never had to stop treating patients. We got them vaccinated, kept them safe, and now I can’t get them a $10 drug.”
The cancer clinicians KFF Health News interviewed for this story said that, given current shortages, they prioritize patients who can be cured over later-stage patients, in whom the drugs generally can only slow the disease, and for whom alternatives – though sometimes less effective and often with more side effects – are available. But some doctors are even rationing doses intended to cure.
Isabella McDonald, then a junior at Utah Valley University, was diagnosed in April with a rare, often fatal bone cancer, whose sole treatment for young adults includes the drug methotrexate. When Isabella’s second cycle of treatment began June 5, clinicians advised that she would be getting less than the full dose because of a methotrexate shortage, said her father, Brent.
“They don’t think it will have a negative impact on her treatment, but as far as I am aware, there isn’t any scientific basis to make that conclusion,” he said. “As you can imagine, when they gave us such low odds of her beating this cancer, it feels like we want to give it everything we can and not something short of the standard.”
Mr. McDonald stressed that he didn’t blame the staffers at Intermountain Health who take care of Isabella. The family – his other daughter, Cate, made a TikTok video about her sister’s plight – were simply stunned at such a basic flaw in the health care system.
At Dr. Moore’s practice, in Virginia, clinicians gave 60% of the optimal dose of carboplatin to some uterine cancer patients during the week of May 16, then shifted to 80% after a small shipment came in the following week. The doctors had to omit carboplatin from normal combination treatments for patients with recurrent disease, she said.
On June 2, Dr. Moore and colleagues were glued to their drug distributor’s website, anxious as teenagers waiting for Taylor Swift tickets to go on sale – only with mortal consequences at stake.
She later emailed KFF Health News: “Carboplatin did NOT come back in stock today. Neither did cisplatin.”
Doses remained at 80%, she said. Things hadn’t changed 10 days later.
Generics manufacturers are pulling out
The causes of shortages are well established. Everyone wants to pay less, and the middlemen who procure and distribute generics keep driving down wholesale prices. The average net price of generic drugs fell by more than half between 2016 and 2022, according to research by Anthony Sardella, a business professor at Washington University in St. Louis.
As generics manufacturers compete to win sales contracts with the big negotiators of such purchases, such as Vizient and Premier, their profits sink. Some are going out of business. Akorn, which made 75 common generics, went bankrupt and closed in February. Israeli generics giant Teva, which has a portfolio of 3,600 medicines, announced May 18 it was shifting to brand-name drugs and “high-value generics.” Lannett, with about 120 generics, announced a Chapter 11 reorganization amid declining revenue. Other companies are in trouble too, said David Gaugh, interim CEO of the Association for Accessible Medicines, the leading generics trade group.
The generics industry used to lose money on about a third of the drugs it produced, but now it’s more like half, Mr. Gaugh said. So when a company stops making a drug, others do not necessarily step up, he said. Officials at Fresenius Kabi and Pfizer said they have increased their carboplatin production since March, but not enough to end the shortage. On June 2, FDA Commissioner Robert Califf announced the agency had given emergency authorization for Chinese-made cisplatin to enter the U.S. market, but the impact of the move wasn’t immediately clear.
Cisplatin and carboplatin are made in special production lines under sterile conditions, and expanding or changing the lines requires FDA approval. Bargain-basement prices have pushed production overseas, where it’s harder for the FDA to track quality standards. The Intas plant inspection was a relative rarity in India, where the FDA in 2022 reportedly inspected only 3% of sites that make drugs for the U.S. market. Mr. Sardella testified in May that a quarter of all U.S. drug prescriptions are filled by companies that received FDA warning letters in the past 26 months. And pharmaceutical industry product recalls are at their highest level in 18 years, reflecting fragile supply conditions.
The FDA listed 137 drugs in shortage as of June 13, including many essential medicines made by few companies.
Intas voluntarily shut down its Ahmedabad plant after the FDA inspection, and the agency posted its shocking inspection report in January. Accord Healthcare, the U.S. subsidiary of Intas, said in mid-June it had no date for restarting production.
Asked why it waited 2 months after its inspection to announce the cisplatin shortage, given that Intas supplied more than half the U.S. market for the drug, the FDA said via email that it doesn’t list a drug in shortage until it has “confirmed that overall market demand is not being met.”
Prices for carboplatin, cisplatin, and other drugs have skyrocketed on the so-called gray market, where speculators sell medicines they snapped up in anticipation of shortages. A 600-mg bottle of carboplatin, normally available for $30, was going for $185 in early May and $345 a week later, said Richard Scanlon, the pharmacist at dr. Moore’s clinic.
“It’s hard to have these conversations with patients – ‘I have your dose for this cycle, but not sure about next cycle,’” said Mark Einstein, MD, chair of the department of obstetrics, gynecology and reproductive health at New Jersey Medical School, Newark.
Should government step in?
Despite a drug shortage task force and numerous congressional hearings, progress has been slow at best. The 2020 CARES Act gave the FDA the power to require companies to have contingency plans enabling them to respond to shortages, but the agency has not yet implemented guidance to enforce the provisions.
As a result, neither Accord nor other cisplatin makers had a response plan in place when Intas’ plant was shut down, said Soumi Saha, senior vice president of government affairs for Premier, which arranges wholesale drug purchases for more than 4,400 hospitals and health systems.
Premier understood in December that the shutdown endangered the U.S. supply of cisplatin and carboplatin, but it also didn’t issue an immediate alarm. “It’s a fine balance,” she said. “You don’t want to create panic-buying or hoarding.”
More lasting solutions are under discussion. Mr. Sardella and others have proposed government subsidies to get U.S. generics plants running full time. Their capacity is now half-idle. If federal agencies like the Centers for Medicare & Medicaid Services paid more for more safely and efficiently produced drugs, it would promote a more stable supply chain, he said.
“At a certain point the system needs to recognize there’s a high cost to low-cost drugs,” said Allan Coukell, senior vice president for public policy at Civica Rx, a nonprofit funded by health systems, foundations, and the federal government that provides about 80 drugs to hospitals in its network. Civica is building a $140 million factory near Petersburg, Va., that will produce dozens more, Mr. Coukell said.
Dr. Ratain and his University of Chicago colleague Satyajit Kosuri, MD, recently called for the creation of a strategic inventory buffer for generic medications, something like the Strategic Petroleum Reserve, set up in 1975 in response to the OPEC oil crisis.
In fact, Dr. Ratain reckons, selling a quarter-million barrels of oil would probably generate enough cash to make and store 2 years’ worth of carboplatin and cisplatin.
“It would almost literally be a drop in the bucket.”
KFF Health News is a national newsroom that produces in-depth journalism about health issues and is one of the core operating programs at KFF – an independent source of health policy research, polling, and journalism. Learn more about KFF.
‘Professional grief’ is a daily reality for oncologists
– but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.
The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.
Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.
The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.
Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.
One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.
“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.
“I love this idea,” she said. “The most important thing is to commemorate that person.”
Amplified during pandemic
Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.
This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.
If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.
The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.
“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”
Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
Teamwork intervention
The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.
The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.
Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.
It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.
After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.
The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.
They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.
Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.
So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.
They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.
The second was time-consuming electronic health record tasks.
Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.
“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”
“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.
“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
Tackling burnout
The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.
Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.
Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.
Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”
Initiatives such as virtual happy hours and game nights may be helpful, she suggested.
A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”
Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.
She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”
No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
– but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.
The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.
Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.
The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.
Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.
One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.
“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.
“I love this idea,” she said. “The most important thing is to commemorate that person.”
Amplified during pandemic
Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.
This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.
If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.
The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.
“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”
Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
Teamwork intervention
The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.
The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.
Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.
It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.
After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.
The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.
They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.
Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.
So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.
They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.
The second was time-consuming electronic health record tasks.
Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.
“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”
“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.
“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
Tackling burnout
The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.
Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.
Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.
Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”
Initiatives such as virtual happy hours and game nights may be helpful, she suggested.
A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”
Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.
She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”
No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
– but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.
The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.
Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.
The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.
Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.
One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.
“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.
“I love this idea,” she said. “The most important thing is to commemorate that person.”
Amplified during pandemic
Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.
This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.
If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.
The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.
“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”
Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
Teamwork intervention
The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.
The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.
Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.
It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.
After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.
The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.
They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.
Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.
So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.
They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.
The second was time-consuming electronic health record tasks.
Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.
“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”
“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.
“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
Tackling burnout
The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.
Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.
Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.
Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”
Initiatives such as virtual happy hours and game nights may be helpful, she suggested.
A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”
Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.
She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”
No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM ASCO 2023
ASCO 2023: Promising results in breast cancer from NATALEE and PHERGain
This transcript has been edited for clarity.
Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.
It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.
The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.
The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.
We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.
We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.
We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.
I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.
Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?
The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.
If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.
There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.
They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.
This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.
This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.
Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.
It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.
The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.
The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.
We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.
We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.
We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.
I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.
Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?
The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.
If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.
There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.
They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.
This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.
This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.
Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
This transcript has been edited for clarity.
Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.
It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.
The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.
The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.
We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.
We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.
We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.
I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.
Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?
The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.
If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.
There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.
They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.
This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.
This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.
Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.
A version of this article first appeared on Medscape.com.
Low-carb, plant-rich diets tied to breast cancer survival?
TOPLINE:
METHODOLOGY:
- The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
- Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
- Cox proportional hazards regression models adjusted for multiple potential confounding factors.
- Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.
TAKEAWAY:
- Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
- Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
- Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
- But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.
IN PRACTICE:
“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.
STUDY DETAILS:
The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.
LIMITATIONS:
Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.
DISCLOSURES:
Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
- Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
- Cox proportional hazards regression models adjusted for multiple potential confounding factors.
- Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.
TAKEAWAY:
- Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
- Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
- Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
- But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.
IN PRACTICE:
“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.
STUDY DETAILS:
The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.
LIMITATIONS:
Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.
DISCLOSURES:
Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.
A version of this article first appeared on Medscape.com.
TOPLINE:
METHODOLOGY:
- The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
- Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
- Cox proportional hazards regression models adjusted for multiple potential confounding factors.
- Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.
TAKEAWAY:
- Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
- Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
- Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
- But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.
IN PRACTICE:
“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.
STUDY DETAILS:
The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.
LIMITATIONS:
Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.
DISCLOSURES:
Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.
A version of this article first appeared on Medscape.com.
Breast cancer and thyroid cancer: What is the link?
Key clinical point: Higher genetic susceptibility to breast cancer (BC) is associated with an increased risk for overall thyroid cancer; however, this association is not valid in case of triple-negative BC (TNBC) and thyroid cancer.
Major finding: The risk for thyroid cancer was significantly elevated in patients with BC (odds ratio 1.135; P = .038); however, no causal link was observed between TNBC and thyroid cancer (OR 0.817; P = .177).
Study details: Findings are from a two-sample mendelian randomization analysis including 133,384 patients with BC and 113,789 BC-free control individuals.
Disclosures: This study was supported by funding from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Tan H et al. Association between breast cancer and thyroid cancer risk: A two-sample Mendelian randomization study. Front Endocrinol (Lausanne). 2023;14:1138149 (May 23). doi: 10.3389/fendo.2023.1138149
Key clinical point: Higher genetic susceptibility to breast cancer (BC) is associated with an increased risk for overall thyroid cancer; however, this association is not valid in case of triple-negative BC (TNBC) and thyroid cancer.
Major finding: The risk for thyroid cancer was significantly elevated in patients with BC (odds ratio 1.135; P = .038); however, no causal link was observed between TNBC and thyroid cancer (OR 0.817; P = .177).
Study details: Findings are from a two-sample mendelian randomization analysis including 133,384 patients with BC and 113,789 BC-free control individuals.
Disclosures: This study was supported by funding from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Tan H et al. Association between breast cancer and thyroid cancer risk: A two-sample Mendelian randomization study. Front Endocrinol (Lausanne). 2023;14:1138149 (May 23). doi: 10.3389/fendo.2023.1138149
Key clinical point: Higher genetic susceptibility to breast cancer (BC) is associated with an increased risk for overall thyroid cancer; however, this association is not valid in case of triple-negative BC (TNBC) and thyroid cancer.
Major finding: The risk for thyroid cancer was significantly elevated in patients with BC (odds ratio 1.135; P = .038); however, no causal link was observed between TNBC and thyroid cancer (OR 0.817; P = .177).
Study details: Findings are from a two-sample mendelian randomization analysis including 133,384 patients with BC and 113,789 BC-free control individuals.
Disclosures: This study was supported by funding from the National Natural Science Foundation of China and other sources. The authors declared no conflicts of interest.
Source: Tan H et al. Association between breast cancer and thyroid cancer risk: A two-sample Mendelian randomization study. Front Endocrinol (Lausanne). 2023;14:1138149 (May 23). doi: 10.3389/fendo.2023.1138149
Early-stage BC: Breast conserving surgery with radiotherapy improves survival without increasing local recurrence risk
Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.
Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.
Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.
Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.
Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005
Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.
Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.
Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.
Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.
Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005
Key clinical point: In patients with early-stage breast cancer (BC), breast conserving surgery with radiotherapy (BCT) provided a significant survival advantage over total mastectomy (TM) without increasing the rates of locoregional recurrence.
Major finding: BCT vs TM improved overall survival by 37% (hazard ratio [HR] 1.37; P < .001) and BC-specific survival by 49% (HR 1.49; P < .001), with rates of locoregional recurrence (P > .9) being comparable between the groups.
Study details: This study analyzed the data of 12,456 patients with pT1-2 pN0 BC from a prospectively maintained database, of which 8422 and 4034 patients underwent BCT and TM, respectively.
Disclosures: This study did not report the source of funding. The authors did not report any conflicts of interest.
Source: Vasilyeva E et al. Breast conserving surgery combined with radiation therapy offers improved survival over mastectomy in early-stage breast cancer. Am J Surg. 2023 (May 22). doi: 10.1016/j.amjsurg.2023.05.005
Family history of breast cancer in first-degree relatives may increase risk for certain cancers in men
Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.
Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).
Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.
Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573
Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.
Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).
Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.
Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573
Key clinical point: Men with a family history of breast cancer (FHBC) in either mother or sister are at a higher risk of developing pancreatic, thyroid, prostate, and breast cancers than men without FHBC and, therefore, may need more vigilant cancer surveillance.
Major finding: An FHBC in both mother and sister was associated with an increased overall cancer risk (hazard ratio [HR] 1.69; 95% CI 1.11-2.57), whereas an FHBC in either mother or sister significantly increased the risk of developing pancreatic cancer (HR 1.35; 95% CI 1.07-1.70), breast cancer (HR 3.03; 95% CI 1.13-8.17), thyroid cancer (HR 1.33; 95% CI 1.12-1.56), and prostate cancer (HR 1.28; 95% CI 1.13-1.44).
Study details: Findings are from a population-based study including 2,734,889 men aged ≥40 years, of which 69,124 men had a FHBC in their mother or sister and 276,496 men had no history of cancer in any of their first-degree relatives.
Disclosures: This study was supported by a National Research Foundation of Korea grant. The authors declared no conflicts of interest.
Source: Song H, Jung YS, et al. Increased risk of pancreatic, thyroid, prostate and breast cancers in men with a family history of breast cancer: A population-based study. Int J Cancer. 2023 (May 29). doi: 10.1002/ijc.34573
Low ERBB2 expression does not worsen prognosis in patients receiving endocrine plus targeted therapy in HR+ BC
Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).
Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.
Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.
Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.
Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017
Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).
Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.
Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.
Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.
Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017
Key clinical point: Low vs no human epidermal growth factor receptor 2 (ERBB2, aka HER2) expression had no impact on survival outcomes in patients with hormone receptor-positive (HR+) metastatic breast cancer (BC) who were treated with targeted therapy (TT) plus endocrine therapy (ET).
Major finding: After a median follow-up of 17.9 months, both progression-free survival (P = .43) and overall survival (P = .41) were not significantly different between patients with low and no ERBB2 expression.
Study details: Findings are from an analysis of 1585 patients with HR+ metastatic BC treated with TT+ET from an institutional review board-approved breast cancer database, of which 572 and 1013 patients had no and low ERBB2 expression, respectively.
Disclosures: This study was supported by the National Cancer Institute and other sources. Some authors declared receiving personal fees, grants, or nonfinancial support from several sources.
Source: Mouabbi JA et al. Survival outcomes in patients with hormone receptor-positive metastatic breast cancer with low or no ERBB2 expression treated with targeted therapies plus endocrine therapy. JAMA Netw Open. 2023;6:e2313017 (May 11). doi: 10.1001/jamanetworkopen.2023.13017