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MOC opposition continues to gain momentum as ASH weighs in
ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.
“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.
Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”
The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.
The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”
The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.
The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.
In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.
On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.
The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”
After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”
A version of this article first appeared on Medscape.com.
ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.
“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.
Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”
The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.
The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”
The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.
The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.
In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.
On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.
The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”
After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”
A version of this article first appeared on Medscape.com.
ASH president Robert A. Brodsky, MD, sent a letter to ABIM’s President and Chief Executive Officer Richard Baron, MD, highlighting hematologists’ concerns about the MOC process and outlining immediate actions ABIM should take.
“ASH continues to support the importance of lifelong learning for hematologists via a program that is evidence-based, relevant to one’s practice, and transparent; however, these three basic requirements are not met by the current ABIM MOC program,” Dr. Brodsky stated in the Sept. 27 letter to Baron.
Dr. Brodsky highlighted, for instance, the fact that the Longitudinal Knowledge Assessment – the alternative to the 10-year exam – “does not reflect real life practice, nor does it target each individual’s scope of practice.” Dr. Brodsky added that, according to members of ASH, the assessment is also “creating high levels of stress and contributing to burnout.”
The letter from Dr. Brodsky urged ABIM to “establish a new MOC program” that does not involve high-stakes assessments, reduces the number of Longitudinal Knowledge Assessment questions physicians receive, and eliminates redundancy between the MOC requirement to have a current license and the requirement to report continued medical education to ABIM.
The ABIM shared a copy of the letter in a Sept. 28 blog post defending the MOC process, highlighting past collaboration with ASH that “has led to meaningful enhancements to the [MOC] program” and committing to “continue to listen to and learn from the physician community going forward.”
The recent backlash against the MOC process stemmed from a petition demanding an end to the MOC. The petition was launched in July by hematologist-oncologist Aaron Goodman, MD, from the University of California, San Diego, who has been a vocal critic of the MOC process.
The criticism largely centered around the high costs and the “complex and time-consuming process that poses significant challenges to practicing physicians,” Dr. Goodman wrote in the petition, which has garnered more than 20,700 signatures.
In August, the Society for Cardiovascular Angiography and Interventions (SCAI) published “SCAI Position on ABIM Revocation of Certification for Not Participating in MOC.” The Electrophysiology Advocacy Foundation and the Heart Rhythm Society (HRS) issued statements pushing back on the MOC as well.
On Sept. 21, the SCAI, HRS, American College of Cardiology, and the Heart Failure Society of America went a step further and announced plans to create a new certification process that is independent of the ABIM MOC system.
The American Society of Clinical Oncology (ASCO) is now also surveying members about their MOC experience. A Sept. 26 announcement encouraged recipients to check their inboxes for a link to an anonymous MOC Experience Questionnaire before Oct. 12 and thanked respondents for their “engagement as ASCO works to address this critical issue for the oncology community.”
After ASH sent its letter to ABIM, Dr. Goodman applauded the society’s stance in a post on his X (formerly Twitter) account. Vincent Rajkumar, MD, a hematologist at the Mayo Clinic in Rochester, Minn., commented on ABIM’s response to ASH’s letter via X, noting, “If I were @ASH_hematology leadership, I would take ABIM response as disrespectful. A hasty response within a day is not a sign of good faith.”
A version of this article first appeared on Medscape.com.
NCCN survey shows ongoing chemo drug shortages
Although access to carboplatin and cisplatin has improved slightly since June, when 93% and 70% of 27 NCCN member institutions reported shortages of the two agents, supplies remain limited and other anticancer drugs remain scarce, an NCCN follow-up survey shows.
Of 29 institutions surveyed last month, 86% reported having difficulty obtaining at least one anticancer drug, and 72% and 59% reported ongoing shortages of carboplatin and cisplatin, respectively – drugs recommended for treating patients involved in hundreds of different cancer scenarios, according to the NCCN.
“Drug shortages aren’t new, but the widespread impact makes this one particularly alarming,” NCCN’s chief executive officer, Robert W. Carlson, MD, said in a press statement. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months.”
The latest survey, conducted between Sept. 6 and 27, was sent to the 33 NCCN member institutions. Overall, most respondents reported “being able to continue treating every patient who needs carboplatin or cisplatin, despite lowered supply, primarily by implementing strict waste management strategies,” the network noted, adding that “the responses may not reflect any additional challenges experienced by smaller community practices serving rural and marginalized patients.”
In addition to carboplatin and cisplatin shortages, the survey results also revealed that centers are experiencing shortages of a host of other drugs, including methotrexate (66%), 5-flourouracil (55%), fludarabine (45%), hydrocortisone (41%), and dacarbazine (28%), according to the press release.
“These drug shortages are the result of decades of systemic challenges,” noted Alyssa Schatz, senior director of policy and advocacy for NCCN, in a press release. “We recognize that comprehensive solutions take time, and we appreciate everyone who has put forth proposals to improve investment in generics and our data infrastructure. At the same time, we have to acknowledge that the cancer drug shortage has been ongoing for months, which is unacceptable for anyone impacted by cancer today.”
Following the June survey, the NCCN called for action from the federal government, the pharmaceutical industry, providers, and payers, encouraging them “to work together to ensure quality, effective, equitable, and accessible cancer care” and has since worked with multiple stakeholders and policymaking organizations to “advocate for short- and long-term fixes.”
“These new survey results remind us that we are still in an ongoing crisis and must respond with appropriate urgency,” Ms. Shatz added.
A version of this article first appeared on Medscape.com.
Although access to carboplatin and cisplatin has improved slightly since June, when 93% and 70% of 27 NCCN member institutions reported shortages of the two agents, supplies remain limited and other anticancer drugs remain scarce, an NCCN follow-up survey shows.
Of 29 institutions surveyed last month, 86% reported having difficulty obtaining at least one anticancer drug, and 72% and 59% reported ongoing shortages of carboplatin and cisplatin, respectively – drugs recommended for treating patients involved in hundreds of different cancer scenarios, according to the NCCN.
“Drug shortages aren’t new, but the widespread impact makes this one particularly alarming,” NCCN’s chief executive officer, Robert W. Carlson, MD, said in a press statement. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months.”
The latest survey, conducted between Sept. 6 and 27, was sent to the 33 NCCN member institutions. Overall, most respondents reported “being able to continue treating every patient who needs carboplatin or cisplatin, despite lowered supply, primarily by implementing strict waste management strategies,” the network noted, adding that “the responses may not reflect any additional challenges experienced by smaller community practices serving rural and marginalized patients.”
In addition to carboplatin and cisplatin shortages, the survey results also revealed that centers are experiencing shortages of a host of other drugs, including methotrexate (66%), 5-flourouracil (55%), fludarabine (45%), hydrocortisone (41%), and dacarbazine (28%), according to the press release.
“These drug shortages are the result of decades of systemic challenges,” noted Alyssa Schatz, senior director of policy and advocacy for NCCN, in a press release. “We recognize that comprehensive solutions take time, and we appreciate everyone who has put forth proposals to improve investment in generics and our data infrastructure. At the same time, we have to acknowledge that the cancer drug shortage has been ongoing for months, which is unacceptable for anyone impacted by cancer today.”
Following the June survey, the NCCN called for action from the federal government, the pharmaceutical industry, providers, and payers, encouraging them “to work together to ensure quality, effective, equitable, and accessible cancer care” and has since worked with multiple stakeholders and policymaking organizations to “advocate for short- and long-term fixes.”
“These new survey results remind us that we are still in an ongoing crisis and must respond with appropriate urgency,” Ms. Shatz added.
A version of this article first appeared on Medscape.com.
Although access to carboplatin and cisplatin has improved slightly since June, when 93% and 70% of 27 NCCN member institutions reported shortages of the two agents, supplies remain limited and other anticancer drugs remain scarce, an NCCN follow-up survey shows.
Of 29 institutions surveyed last month, 86% reported having difficulty obtaining at least one anticancer drug, and 72% and 59% reported ongoing shortages of carboplatin and cisplatin, respectively – drugs recommended for treating patients involved in hundreds of different cancer scenarios, according to the NCCN.
“Drug shortages aren’t new, but the widespread impact makes this one particularly alarming,” NCCN’s chief executive officer, Robert W. Carlson, MD, said in a press statement. “It is extremely concerning that this situation continues despite significant attention and effort over the past few months.”
The latest survey, conducted between Sept. 6 and 27, was sent to the 33 NCCN member institutions. Overall, most respondents reported “being able to continue treating every patient who needs carboplatin or cisplatin, despite lowered supply, primarily by implementing strict waste management strategies,” the network noted, adding that “the responses may not reflect any additional challenges experienced by smaller community practices serving rural and marginalized patients.”
In addition to carboplatin and cisplatin shortages, the survey results also revealed that centers are experiencing shortages of a host of other drugs, including methotrexate (66%), 5-flourouracil (55%), fludarabine (45%), hydrocortisone (41%), and dacarbazine (28%), according to the press release.
“These drug shortages are the result of decades of systemic challenges,” noted Alyssa Schatz, senior director of policy and advocacy for NCCN, in a press release. “We recognize that comprehensive solutions take time, and we appreciate everyone who has put forth proposals to improve investment in generics and our data infrastructure. At the same time, we have to acknowledge that the cancer drug shortage has been ongoing for months, which is unacceptable for anyone impacted by cancer today.”
Following the June survey, the NCCN called for action from the federal government, the pharmaceutical industry, providers, and payers, encouraging them “to work together to ensure quality, effective, equitable, and accessible cancer care” and has since worked with multiple stakeholders and policymaking organizations to “advocate for short- and long-term fixes.”
“These new survey results remind us that we are still in an ongoing crisis and must respond with appropriate urgency,” Ms. Shatz added.
A version of this article first appeared on Medscape.com.
Advanced practice radiation therapists: Are they worth it?
An innovative care model involving in the radiation oncology department of Mount Sinai Health System in New York.
At a time when clinician burnout is rampant, a novel approach that brings value to both patients and health systems – and helps advance the careers of highly educated and skilled practitioners – represents a welcome step forward, according to Samantha Skubish, MS, RT, chief technical director of radiation oncology and Mount Sinai.
In the new care model, APRTs work alongside radiation oncologists and support “the care of resource-intensive patient populations,” according to the Association of Community Cancer Centers, which recently recognized the Mount Sinai Health System program as a 2023 ACCC Innovator Award winner.
The new and improved “model for continuity of care” with the APRT role has “helped improve the patient experience and create a more streamlined, efficient process while also alleviating some of the burden on our physicians,” Ms. Skubish said in the ACCC press release. She explained that APRTs possess the skills, knowledge, and judgment to provide an elevated level of care, as evidenced by decades of international research.
A 2022 systematic review of APRT-based care models outside the United States explored how the models have worked. Overall, the research shows that such models improve quality, efficiency, wellness, and administrative outcomes, according to investigators.
At Mount Sinai, the first health system to develop the APRT role in the United States, research to demonstrate the benefits of APRT model continues. In 2021, an APRT working group was established to “garner a network of individuals across the country focused on the work to prove the advanced practice radiation therapy model in the U.S.,” according to Danielle McDonagh, MS, RT, Mount Sinai’s clinical coordinator of radiation sciences education and research.
A paper published in May by Ms. McDonagh and colleagues underscored the potential for “positive change and impact” of the APRT care model in radiation oncology.
“We’re all in this current and longstanding crisis of clinician shortages,” Kimberly Smith, MPA, explained in a video introducing the Mount Sinai program.
“If you look at your therapists’ skill set and allow them to work at the top of their license, you can provide a cost-saving solution that lends itself to value-based care,” said Ms. Smith, vice president of radiation oncology services at Mount Sinai.
Indeed, Sheryl Green, MBBCh, professor and medical director of radiation oncology at Mount Sinai, noted that “the APRT has allowed us to really improve the quality of care that we deliver, primarily in the aspects of optimizing and personalizing the patient experience.”
Ms. Skubish and Ms. Smith will share details of the new care model at the ACCC’s upcoming National Oncology Conference.
An innovative care model involving in the radiation oncology department of Mount Sinai Health System in New York.
At a time when clinician burnout is rampant, a novel approach that brings value to both patients and health systems – and helps advance the careers of highly educated and skilled practitioners – represents a welcome step forward, according to Samantha Skubish, MS, RT, chief technical director of radiation oncology and Mount Sinai.
In the new care model, APRTs work alongside radiation oncologists and support “the care of resource-intensive patient populations,” according to the Association of Community Cancer Centers, which recently recognized the Mount Sinai Health System program as a 2023 ACCC Innovator Award winner.
The new and improved “model for continuity of care” with the APRT role has “helped improve the patient experience and create a more streamlined, efficient process while also alleviating some of the burden on our physicians,” Ms. Skubish said in the ACCC press release. She explained that APRTs possess the skills, knowledge, and judgment to provide an elevated level of care, as evidenced by decades of international research.
A 2022 systematic review of APRT-based care models outside the United States explored how the models have worked. Overall, the research shows that such models improve quality, efficiency, wellness, and administrative outcomes, according to investigators.
At Mount Sinai, the first health system to develop the APRT role in the United States, research to demonstrate the benefits of APRT model continues. In 2021, an APRT working group was established to “garner a network of individuals across the country focused on the work to prove the advanced practice radiation therapy model in the U.S.,” according to Danielle McDonagh, MS, RT, Mount Sinai’s clinical coordinator of radiation sciences education and research.
A paper published in May by Ms. McDonagh and colleagues underscored the potential for “positive change and impact” of the APRT care model in radiation oncology.
“We’re all in this current and longstanding crisis of clinician shortages,” Kimberly Smith, MPA, explained in a video introducing the Mount Sinai program.
“If you look at your therapists’ skill set and allow them to work at the top of their license, you can provide a cost-saving solution that lends itself to value-based care,” said Ms. Smith, vice president of radiation oncology services at Mount Sinai.
Indeed, Sheryl Green, MBBCh, professor and medical director of radiation oncology at Mount Sinai, noted that “the APRT has allowed us to really improve the quality of care that we deliver, primarily in the aspects of optimizing and personalizing the patient experience.”
Ms. Skubish and Ms. Smith will share details of the new care model at the ACCC’s upcoming National Oncology Conference.
An innovative care model involving in the radiation oncology department of Mount Sinai Health System in New York.
At a time when clinician burnout is rampant, a novel approach that brings value to both patients and health systems – and helps advance the careers of highly educated and skilled practitioners – represents a welcome step forward, according to Samantha Skubish, MS, RT, chief technical director of radiation oncology and Mount Sinai.
In the new care model, APRTs work alongside radiation oncologists and support “the care of resource-intensive patient populations,” according to the Association of Community Cancer Centers, which recently recognized the Mount Sinai Health System program as a 2023 ACCC Innovator Award winner.
The new and improved “model for continuity of care” with the APRT role has “helped improve the patient experience and create a more streamlined, efficient process while also alleviating some of the burden on our physicians,” Ms. Skubish said in the ACCC press release. She explained that APRTs possess the skills, knowledge, and judgment to provide an elevated level of care, as evidenced by decades of international research.
A 2022 systematic review of APRT-based care models outside the United States explored how the models have worked. Overall, the research shows that such models improve quality, efficiency, wellness, and administrative outcomes, according to investigators.
At Mount Sinai, the first health system to develop the APRT role in the United States, research to demonstrate the benefits of APRT model continues. In 2021, an APRT working group was established to “garner a network of individuals across the country focused on the work to prove the advanced practice radiation therapy model in the U.S.,” according to Danielle McDonagh, MS, RT, Mount Sinai’s clinical coordinator of radiation sciences education and research.
A paper published in May by Ms. McDonagh and colleagues underscored the potential for “positive change and impact” of the APRT care model in radiation oncology.
“We’re all in this current and longstanding crisis of clinician shortages,” Kimberly Smith, MPA, explained in a video introducing the Mount Sinai program.
“If you look at your therapists’ skill set and allow them to work at the top of their license, you can provide a cost-saving solution that lends itself to value-based care,” said Ms. Smith, vice president of radiation oncology services at Mount Sinai.
Indeed, Sheryl Green, MBBCh, professor and medical director of radiation oncology at Mount Sinai, noted that “the APRT has allowed us to really improve the quality of care that we deliver, primarily in the aspects of optimizing and personalizing the patient experience.”
Ms. Skubish and Ms. Smith will share details of the new care model at the ACCC’s upcoming National Oncology Conference.
Discussing family history post–genetic testing may prevent breast cancer overtreatment
, according to findings from a large population-based cohort study.
Similar results were seen for patients with Lynch syndrome.
The findings suggest that a first-degree family history confers much of the risk that is associated with pathogenic variants associated with hereditary breast, ovarian, and colorectal cancers. Furthermore, to avoid overtreatment in those without a first-degree family history who undergo genetic testing, that history should be considered when discussing potential follow-up care, the investigators argue.
“This difference in penetrance in carrier individuals, if replicated in larger studies, could be sufficient to justify stratifying just individuals with a family history into high-risk groups currently eligible for specialist clinical care,” Leigh Jackson, PhD, of the University of Exeter College of Medicine and Health, Royal Devon and Exeter Hospital, England, and his colleagues noted.
To assess how population penetrance of familial cancer syndromes varies based on family history, researchers analyzed exome sequences and clinical data collected between March 2006 and June 25, 2021, from 454,712 UK Biobank participants with either breast or colorectal cancer, a self-reported family history of breast or colorectal cancer, and a pathogenic/likely pathogenic variant in the major genes associated with hereditary breast cancer or Lynch syndrome.
After researchers controlled for sex, death, recruitment center, screening, and prophylactic surgery, those with a pathogenic BRCA1 (n = 230) or BRCA2 (n = 611) variant had an increased risk of breast cancer, and the risk was higher in those with a first-degree family history (relative hazard, 10.3 and 7.8, respectively), than in those without a first-degree family history (relative hazard, 7.2 and 4.7), the investigators reported.
Penetrance to age 60 years was also higher in those with vs. without a first-degree family history (44.7% and 24.1% vs 22.8% and 17.9%, respectively).
Similarly, patients with Lynch syndrome and a pathogenic MLH1, MSH2, or MSH6 variant (n = 89, 71, and 421, respectively) had an increased risk of colorectal cancer, and that risk was higher in those with vs. without a family history (relative hazard, 35.6, 48.0, and 9.9 vs. 13.0, 15.4, and 7.2). Penetrance to age 60 was higher for those with a pathogenic MLH1 and MSH2 variant with vs. without a family history (30.9% and 38% vs. 20.5% and 8.3%).
The study results were published online in eClinicalMedicine, part of The Lancet Discovery Science.
“The findings of this study suggest that any universal policy of returning pathogenic cancer predisposing genetic variants found incidentally or through direct-to-consumer genetic testing of asymptomatic individuals should consider family history and other factors when counseling patients on the risks and benefits of follow-up care,” the investigators recommended. “It will be very difficult to counsel individuals as to their particular risk profile without further pedigree construction or investigations.
“If penetrance estimates from affected families are used, there is a danger of overmanagement of asymptomatic individuals with no family history of disease. These ‘patients-in-waiting’ may be exposed to unnecessary surveillance or more invasive prophylactic procedures,” they added.
This study was supported by an MRC grant. The authors reported having no competing interests.
, according to findings from a large population-based cohort study.
Similar results were seen for patients with Lynch syndrome.
The findings suggest that a first-degree family history confers much of the risk that is associated with pathogenic variants associated with hereditary breast, ovarian, and colorectal cancers. Furthermore, to avoid overtreatment in those without a first-degree family history who undergo genetic testing, that history should be considered when discussing potential follow-up care, the investigators argue.
“This difference in penetrance in carrier individuals, if replicated in larger studies, could be sufficient to justify stratifying just individuals with a family history into high-risk groups currently eligible for specialist clinical care,” Leigh Jackson, PhD, of the University of Exeter College of Medicine and Health, Royal Devon and Exeter Hospital, England, and his colleagues noted.
To assess how population penetrance of familial cancer syndromes varies based on family history, researchers analyzed exome sequences and clinical data collected between March 2006 and June 25, 2021, from 454,712 UK Biobank participants with either breast or colorectal cancer, a self-reported family history of breast or colorectal cancer, and a pathogenic/likely pathogenic variant in the major genes associated with hereditary breast cancer or Lynch syndrome.
After researchers controlled for sex, death, recruitment center, screening, and prophylactic surgery, those with a pathogenic BRCA1 (n = 230) or BRCA2 (n = 611) variant had an increased risk of breast cancer, and the risk was higher in those with a first-degree family history (relative hazard, 10.3 and 7.8, respectively), than in those without a first-degree family history (relative hazard, 7.2 and 4.7), the investigators reported.
Penetrance to age 60 years was also higher in those with vs. without a first-degree family history (44.7% and 24.1% vs 22.8% and 17.9%, respectively).
Similarly, patients with Lynch syndrome and a pathogenic MLH1, MSH2, or MSH6 variant (n = 89, 71, and 421, respectively) had an increased risk of colorectal cancer, and that risk was higher in those with vs. without a family history (relative hazard, 35.6, 48.0, and 9.9 vs. 13.0, 15.4, and 7.2). Penetrance to age 60 was higher for those with a pathogenic MLH1 and MSH2 variant with vs. without a family history (30.9% and 38% vs. 20.5% and 8.3%).
The study results were published online in eClinicalMedicine, part of The Lancet Discovery Science.
“The findings of this study suggest that any universal policy of returning pathogenic cancer predisposing genetic variants found incidentally or through direct-to-consumer genetic testing of asymptomatic individuals should consider family history and other factors when counseling patients on the risks and benefits of follow-up care,” the investigators recommended. “It will be very difficult to counsel individuals as to their particular risk profile without further pedigree construction or investigations.
“If penetrance estimates from affected families are used, there is a danger of overmanagement of asymptomatic individuals with no family history of disease. These ‘patients-in-waiting’ may be exposed to unnecessary surveillance or more invasive prophylactic procedures,” they added.
This study was supported by an MRC grant. The authors reported having no competing interests.
, according to findings from a large population-based cohort study.
Similar results were seen for patients with Lynch syndrome.
The findings suggest that a first-degree family history confers much of the risk that is associated with pathogenic variants associated with hereditary breast, ovarian, and colorectal cancers. Furthermore, to avoid overtreatment in those without a first-degree family history who undergo genetic testing, that history should be considered when discussing potential follow-up care, the investigators argue.
“This difference in penetrance in carrier individuals, if replicated in larger studies, could be sufficient to justify stratifying just individuals with a family history into high-risk groups currently eligible for specialist clinical care,” Leigh Jackson, PhD, of the University of Exeter College of Medicine and Health, Royal Devon and Exeter Hospital, England, and his colleagues noted.
To assess how population penetrance of familial cancer syndromes varies based on family history, researchers analyzed exome sequences and clinical data collected between March 2006 and June 25, 2021, from 454,712 UK Biobank participants with either breast or colorectal cancer, a self-reported family history of breast or colorectal cancer, and a pathogenic/likely pathogenic variant in the major genes associated with hereditary breast cancer or Lynch syndrome.
After researchers controlled for sex, death, recruitment center, screening, and prophylactic surgery, those with a pathogenic BRCA1 (n = 230) or BRCA2 (n = 611) variant had an increased risk of breast cancer, and the risk was higher in those with a first-degree family history (relative hazard, 10.3 and 7.8, respectively), than in those without a first-degree family history (relative hazard, 7.2 and 4.7), the investigators reported.
Penetrance to age 60 years was also higher in those with vs. without a first-degree family history (44.7% and 24.1% vs 22.8% and 17.9%, respectively).
Similarly, patients with Lynch syndrome and a pathogenic MLH1, MSH2, or MSH6 variant (n = 89, 71, and 421, respectively) had an increased risk of colorectal cancer, and that risk was higher in those with vs. without a family history (relative hazard, 35.6, 48.0, and 9.9 vs. 13.0, 15.4, and 7.2). Penetrance to age 60 was higher for those with a pathogenic MLH1 and MSH2 variant with vs. without a family history (30.9% and 38% vs. 20.5% and 8.3%).
The study results were published online in eClinicalMedicine, part of The Lancet Discovery Science.
“The findings of this study suggest that any universal policy of returning pathogenic cancer predisposing genetic variants found incidentally or through direct-to-consumer genetic testing of asymptomatic individuals should consider family history and other factors when counseling patients on the risks and benefits of follow-up care,” the investigators recommended. “It will be very difficult to counsel individuals as to their particular risk profile without further pedigree construction or investigations.
“If penetrance estimates from affected families are used, there is a danger of overmanagement of asymptomatic individuals with no family history of disease. These ‘patients-in-waiting’ may be exposed to unnecessary surveillance or more invasive prophylactic procedures,” they added.
This study was supported by an MRC grant. The authors reported having no competing interests.
FROM ECLINICALMEDICINE
Survey: Lack of awareness hampers cancer prevention efforts
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
The survey, commissioned by Bayer U.S. to identify patient behaviors and care barriers, indicates that more than one in four adults in the United States (27%) would rather not know if they have cancer, and nearly a third (31%) – particularly younger patients aged 18-44 years – avoid going to the doctor because they are afraid of what they might learn.
Similarly, 26% of 2,079 respondents said that fear and anxiety are the main reasons why they don’t make or keep doctor appointments. Those with lower household income and education levels, those with children under age 18 years, and Hispanic adults were most likely to cite this reason.
Almost half (up to 49%) lacked knowledge about certain cancers and risk factors.
For example, 48% of respondents were unaware that breast density affects breast cancer risk and diagnosis, and 38% said they were not very knowledgeable about breast cancer.
Regarding prostate cancer, 49% were unaware that race impacts risk and 49% said they were not knowledgeable about the disease.
The survey highlighted a lack of trust in treatments and health care processes among most adults, especially those with lower income and education levels. Overall, 53% said they have little or no trust in treatments developed by pharmaceutical companies, and 31% said they have little or no trust in medical tests, test results, and other medical processes.
The findings of the survey, which was conducted online June 6-8, 2023, among U.S. adults aged 18 years and older, underscore the need to better educate individuals about cancer risk factors and the benefits of preventative care.
“The increase of fear and anxiety, heightened by a lack of education and in some cases trust barriers, creates an environment where people may not access basic preventative care to ensure early diagnosis,” Sebastian Guth, president of Bayer U.S. and Pharmaceuticals North America, stated in a press release. “This is compounded by the fact that around 27.4 million people of all ages (8.3%) don’t have access to health insurance.
“Companies like Bayer have a responsibility to provide resources that increase health education on the importance of understanding disease risks, early disease screenings, and preventative health care,” Mr. Guth added, noting that the company is partnering with multiple patient advocacy groups to increase trust, awareness, and knowledge “to help individuals understand the resources available to them and their risks for a specific disease.”
Public health initiatives have had mixed results with respect to changing patient behaviors over time, but Breast Cancer Awareness Month (BCAM) in October of each year is a stand-out initiative that could serve as a model for other patient education initiatives, according to a 2022 study.
The Google trends analysis showed that from 2012 to 2021, BCAM was associated with improved public awareness of breast cancer, whereas Lung Cancer Awareness Month and Prostate Cancer Awareness Month had no impact on lung and prostate cancer awareness, respectively, over time, reported Yoshita Nishimura, MD, of Okayama University Graduate School of Medicine, Dentistry, and Pharmaceutical Sciences in Japan, and Jared D. Acoba, MD, of the University of Hawaii, Honolulu.
Dr. Nishimura and Dr. Acoba concluded that the success of BCAM, which was launched in 1985 and is now led by the National Breast Cancer Foundation, is likely a result of “the effective involvement of non-medical industries, influencers affected by breast cancer, and an awareness symbol.”
As for the role of physicians in raising awareness and increasing knowledge at the patient level, various guidelines focus on assessing patient needs and readiness to learn, communicating clearly, and identifying barriers, such as a lack of support and low health literacy.
An American Society of Clinical Oncology consensus guideline for physician-patient communication, for example, provides guidance on core communication skills that apply across the continuum of care, as well as specific topics to address, such as patient goals, treatment options, and support systems – all with an eye toward using “effective communication to optimize the patient-clinician relationship, patient and clinician well-being and family well-being.”
No link between most cancers and depression/anxiety: Study
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
from a large, individual participant data meta-analysis.
An exception was for lung and smoking-related cancers, but key covariates appeared to explain the relationship between depression, anxiety, and these cancer types, the investigators reported.
The findings challenge a common theory that depression and anxiety increase cancer risk and should “change current thinking,” they argue.
“Our results may come as a relief to many patients with cancer who believe their diagnosis is attributed to previous anxiety or depression,” first author Lonneke A. van Tuijl, PhD, of the University of Groningen and Utrecht University, the Netherlands, noted in a press release.
Analyses included data from up to nearly 320,000 individuals from the 18 prospective cohorts included in the international Psychosocial Factors and Cancer Incidence (PSY-CA) consortium. The cohorts are from studies conducted in the Netherlands, United Kingdom, Norway, and Canada, and included 25,803 patients with cancer. During follow-up of up to 26 years and more than 3.2 million person-years, depression and anxiety symptoms and diagnoses showed no association with overall breast, prostate, colorectal, and alcohol-related cancers (hazard ratios, 0.98-1.05).
For the specific cancer types, the investigators “found no evidence for an association between depression or anxiety and the incidence of colorectal cancer (HRs, 0.88-1.13), prostate cancer (HRs, 0.97-1.17), or alcohol-related cancers (HRs, 0.97-1.06).”
“For breast cancer, all pooled HRs were consistently negative but mean pooled HRs were close to 1 (HRs, 0.92-0.98) and the upper limit of the 95% confidence intervals all exceeded 1 (with the exception of anxiety symptoms),” they noted.
An increase in risk observed between depression and anxiety symptoms and diagnoses and lung cancer (HRs, 1.12-1.60) and smoking-related cancers (HRs, 1.06-1.60), in minimally adjusted models, was substantially attenuated after adjusting for known risk factors such as smoking, alcohol use, and body mass index (HRs, 1.04-1.08), the investigators reported.
The findings were published online in Cancer.
“Depression and anxiety have long been hypothesized to increase the risk for cancer. It is thought that the increased cancer risk can occur via several pathways, including health behaviors, or by influencing mutation, viral oncogenes, cell proliferation, or DNA repair,” the authors explained, noting that “[c]onclusions drawn in meta-analyses vary greatly, with some supporting an association between depression, anxiety, and cancer incidence and others finding no or a negligible association.”
The current findings “may help health professionals to alleviate feelings of guilt and self-blame in patients with cancer who attribute their diagnosis to previous depression or anxiety,” they said, noting that the findings “also underscore the importance of addressing tobacco smoking and other unhealthy behaviors – including those that may develop as a result of anxiety or depression.”
“However, further research is needed to understand exactly how depression, anxiety, health behaviors, and lung cancer are related,” said Dr. Tuijl.
Dr. Tuijl has received grants and travel support from the Dutch Cancer Society (KWF).
FROM CANCER
Patient safety vs. public health: The ethylene oxide dilemma
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
Ethylene oxide is a compound used to sterilize more than 20 billion devices sold in the U.S. every year. Although this sterilization process helps keep medical devices – and patients – safe, the odorless, flammable gas may also be harming people who live near sterilization plants and who may inhale the compound, which has been linked to an elevated risk of cancer.
Lawmakers are weighing in on the matter, which has been the source of multiple civil lawsuits filed by individuals who say they have suffered health problems as a result of exposure to ethylene oxide.
The Environmental Protection Agency and the U.S. Food and Drug Administration agree that use of the compound should be limited, but they are at odds about how quickly limits should be put in place, according to Axios.
A new commercial standard for ethylene oxide proposed by the EPA in April would impose stricter emission restrictions for sterilization facilities and chemical plants – a move that would cut ethylene oxide emissions by 80%, the EPA estimates.
While the FDA says it “shares concerns about the release of ethylene oxide at unsafe levels into the environment,” the agency cautions that moving too fast to cut emissions would disrupt the medical supply chain, which is already experiencing turbulence. The U.S. has been facing the worst drug supply shortages in a decade in addition to severe medical device shortages.
Currently, other methods of sterilization cannot replace the use of ethylene oxide for many devices. Ethylene oxide is used to sterilize about half of all medical devices in the U.S., the FDA says. Given the country’s reliance on this compound for sterilization, the FDA says it is “equally concerned about the potential impact of shortages of sterilized medical devices that would result from disruptions in commercial sterilizer facility operations.”
In 2019, Illinois temporarily closed a sterilization facility over concern regarding ethylene oxide emissions. The closure caused a shortage of a pediatric breathing tube.
Some lawmakers agree that an Interior-Environment bill would require FDA certification that any action by the EPA would not cause a medical device shortage.
The FDA has been working to identify safe alternatives to ethylene oxide for sterilizing medical supplies as well as strategies to reduce emissions of ethylene oxide by capturing the gas or by turning it into a harmless byproduct. In 2019, the FDA launched a pilot program to incentivize companies to develop new sterilization technologies.
“The FDA remains focused in our commitment to encourage novel ways to sterilize medical devices while reducing adverse impacts on the environment and public health and developing solutions to avoid potential shortages of devices that the American public relies upon,” the agency said.
A version of this article first appeared on Medscape.com.
Alcohol consumption may not influence breast cancer prognosis, study
, an analysis of data from a prospective cohort study suggests.
The study appears to show that drinking up to one serving of alcohol daily, including wine, beer, and liquor, was not associated with any specific outcomes after breast cancer diagnosis. The authors say these findings could have implications for developing more specific guidelines on alcohol use as it relates to the prevention of death and recurrence for cancer survivors.
Among 3,659 women followed for a mean of 11.2 years after a breast cancer diagnosis, overall alcohol consumption in the months before and up to 6 months after diagnosis was not associated with recurrence or mortality after adjusting for numerous factors such as age at diagnosis, cancer stage, socioeconomic details, smoking history, and preexisting conditions.
However, women with obesity (body mass index of 30 kg/m2 or greater) had a lower risk of mortality with increasing alcohol consumption for occasional drinking of 2 or more alcohol servings per week (hazard ratio, 0.71), and regular drinking of at least one alcohol serving daily (HR, 0.77), in a dose-response manner, Marilyn L. Kwan, PhD, and colleagues found.
Dr. Kwan is a senior research scientist at Kaiser Permanente Northern California Division of Research, Oakland.
Women with BMI less than 30 kg/m2 did not have a higher risk of mortality but a nonsignificant increase in the risk of recurrence was observed for those who consumed alcohol occasionally (HR, 1.29) and regularly (HR, 1.19), the investigators reported.
The findings were published online in Cancer.
Women included in the current study were participants in the Pathways Study and were diagnosed with stage I-IV breast cancer between 2003 and 2015. During follow-up, 524 recurrences and 834 deaths occurred, including 369 breast cancer-specific deaths, 314 cardiovascular disease-specific deaths, and 151 deaths from other health problems.
Alcohol consumption was assessed for the 6 months prior to cohort entry, which occurred at an average of about 2 months after diagnosis, as well as 6 months later – at an average of about 8 months after diagnosis – using a food-frequency questionnaire.
Compared with nondrinkers (36.9%), drinkers were more likely younger, more educated, and current or past smokers, the investigators noted.
“This profile appears counterintuitive yet might reflect a healthier lifestyle contributing to better overall survival. Furthermore, higher levels of alcohol consumption could lead to improvement in insulin sensitivity and reduction in insulin-like growth factor-1,” they speculated, noting that reduced fasting insulin concentrations and lower insulin-like growth factor-1 levels are linked with a decreased risk of type 2 diabetes, cardiovascular disease, and cancer.
“Many women with a history of breast cancer are interested in how to improve their prognosis and survival by making lifestyle changes after diagnosis,” they wrote, explaining the rationale for the study. “Current cancer prevention guidelines recommend avoiding alcohol intake or limiting consumption to no more than one drink per day for women. However, no specific guideline exists for cancer survivors other than following the cancer prevention guidelines to reduce the risk of a second cancer.”
High-quality studies on the impact of alcohol consumption on breast cancer prognosis are lacking, they added.
“Given that consuming alcohol is a potentially modifiable lifestyle factor after breast cancer diagnosis, further confirmation is warranted in other large prospective studies of breast cancer survivors with detailed exposure assessment and focus on body size,” they concluded.
The group is the first to report this finding in obese women, and they “strongly believe more research is needed to see if the same association is seen in other studies,” Dr. Kwan told this news organization.
“After a cancer diagnosis, many patients are motivated to make lifestyle changes,” she said. “That often includes adding exercise to their daily routine and eating a healthier diet. Our study findings suggest that doctors can tell patients that having up to a glass of alcohol a day is not likely to increase their risk of a breast cancer recurrence.”
This study was funded by the National Cancer Institute. The authors reported having no disclosures.
, an analysis of data from a prospective cohort study suggests.
The study appears to show that drinking up to one serving of alcohol daily, including wine, beer, and liquor, was not associated with any specific outcomes after breast cancer diagnosis. The authors say these findings could have implications for developing more specific guidelines on alcohol use as it relates to the prevention of death and recurrence for cancer survivors.
Among 3,659 women followed for a mean of 11.2 years after a breast cancer diagnosis, overall alcohol consumption in the months before and up to 6 months after diagnosis was not associated with recurrence or mortality after adjusting for numerous factors such as age at diagnosis, cancer stage, socioeconomic details, smoking history, and preexisting conditions.
However, women with obesity (body mass index of 30 kg/m2 or greater) had a lower risk of mortality with increasing alcohol consumption for occasional drinking of 2 or more alcohol servings per week (hazard ratio, 0.71), and regular drinking of at least one alcohol serving daily (HR, 0.77), in a dose-response manner, Marilyn L. Kwan, PhD, and colleagues found.
Dr. Kwan is a senior research scientist at Kaiser Permanente Northern California Division of Research, Oakland.
Women with BMI less than 30 kg/m2 did not have a higher risk of mortality but a nonsignificant increase in the risk of recurrence was observed for those who consumed alcohol occasionally (HR, 1.29) and regularly (HR, 1.19), the investigators reported.
The findings were published online in Cancer.
Women included in the current study were participants in the Pathways Study and were diagnosed with stage I-IV breast cancer between 2003 and 2015. During follow-up, 524 recurrences and 834 deaths occurred, including 369 breast cancer-specific deaths, 314 cardiovascular disease-specific deaths, and 151 deaths from other health problems.
Alcohol consumption was assessed for the 6 months prior to cohort entry, which occurred at an average of about 2 months after diagnosis, as well as 6 months later – at an average of about 8 months after diagnosis – using a food-frequency questionnaire.
Compared with nondrinkers (36.9%), drinkers were more likely younger, more educated, and current or past smokers, the investigators noted.
“This profile appears counterintuitive yet might reflect a healthier lifestyle contributing to better overall survival. Furthermore, higher levels of alcohol consumption could lead to improvement in insulin sensitivity and reduction in insulin-like growth factor-1,” they speculated, noting that reduced fasting insulin concentrations and lower insulin-like growth factor-1 levels are linked with a decreased risk of type 2 diabetes, cardiovascular disease, and cancer.
“Many women with a history of breast cancer are interested in how to improve their prognosis and survival by making lifestyle changes after diagnosis,” they wrote, explaining the rationale for the study. “Current cancer prevention guidelines recommend avoiding alcohol intake or limiting consumption to no more than one drink per day for women. However, no specific guideline exists for cancer survivors other than following the cancer prevention guidelines to reduce the risk of a second cancer.”
High-quality studies on the impact of alcohol consumption on breast cancer prognosis are lacking, they added.
“Given that consuming alcohol is a potentially modifiable lifestyle factor after breast cancer diagnosis, further confirmation is warranted in other large prospective studies of breast cancer survivors with detailed exposure assessment and focus on body size,” they concluded.
The group is the first to report this finding in obese women, and they “strongly believe more research is needed to see if the same association is seen in other studies,” Dr. Kwan told this news organization.
“After a cancer diagnosis, many patients are motivated to make lifestyle changes,” she said. “That often includes adding exercise to their daily routine and eating a healthier diet. Our study findings suggest that doctors can tell patients that having up to a glass of alcohol a day is not likely to increase their risk of a breast cancer recurrence.”
This study was funded by the National Cancer Institute. The authors reported having no disclosures.
, an analysis of data from a prospective cohort study suggests.
The study appears to show that drinking up to one serving of alcohol daily, including wine, beer, and liquor, was not associated with any specific outcomes after breast cancer diagnosis. The authors say these findings could have implications for developing more specific guidelines on alcohol use as it relates to the prevention of death and recurrence for cancer survivors.
Among 3,659 women followed for a mean of 11.2 years after a breast cancer diagnosis, overall alcohol consumption in the months before and up to 6 months after diagnosis was not associated with recurrence or mortality after adjusting for numerous factors such as age at diagnosis, cancer stage, socioeconomic details, smoking history, and preexisting conditions.
However, women with obesity (body mass index of 30 kg/m2 or greater) had a lower risk of mortality with increasing alcohol consumption for occasional drinking of 2 or more alcohol servings per week (hazard ratio, 0.71), and regular drinking of at least one alcohol serving daily (HR, 0.77), in a dose-response manner, Marilyn L. Kwan, PhD, and colleagues found.
Dr. Kwan is a senior research scientist at Kaiser Permanente Northern California Division of Research, Oakland.
Women with BMI less than 30 kg/m2 did not have a higher risk of mortality but a nonsignificant increase in the risk of recurrence was observed for those who consumed alcohol occasionally (HR, 1.29) and regularly (HR, 1.19), the investigators reported.
The findings were published online in Cancer.
Women included in the current study were participants in the Pathways Study and were diagnosed with stage I-IV breast cancer between 2003 and 2015. During follow-up, 524 recurrences and 834 deaths occurred, including 369 breast cancer-specific deaths, 314 cardiovascular disease-specific deaths, and 151 deaths from other health problems.
Alcohol consumption was assessed for the 6 months prior to cohort entry, which occurred at an average of about 2 months after diagnosis, as well as 6 months later – at an average of about 8 months after diagnosis – using a food-frequency questionnaire.
Compared with nondrinkers (36.9%), drinkers were more likely younger, more educated, and current or past smokers, the investigators noted.
“This profile appears counterintuitive yet might reflect a healthier lifestyle contributing to better overall survival. Furthermore, higher levels of alcohol consumption could lead to improvement in insulin sensitivity and reduction in insulin-like growth factor-1,” they speculated, noting that reduced fasting insulin concentrations and lower insulin-like growth factor-1 levels are linked with a decreased risk of type 2 diabetes, cardiovascular disease, and cancer.
“Many women with a history of breast cancer are interested in how to improve their prognosis and survival by making lifestyle changes after diagnosis,” they wrote, explaining the rationale for the study. “Current cancer prevention guidelines recommend avoiding alcohol intake or limiting consumption to no more than one drink per day for women. However, no specific guideline exists for cancer survivors other than following the cancer prevention guidelines to reduce the risk of a second cancer.”
High-quality studies on the impact of alcohol consumption on breast cancer prognosis are lacking, they added.
“Given that consuming alcohol is a potentially modifiable lifestyle factor after breast cancer diagnosis, further confirmation is warranted in other large prospective studies of breast cancer survivors with detailed exposure assessment and focus on body size,” they concluded.
The group is the first to report this finding in obese women, and they “strongly believe more research is needed to see if the same association is seen in other studies,” Dr. Kwan told this news organization.
“After a cancer diagnosis, many patients are motivated to make lifestyle changes,” she said. “That often includes adding exercise to their daily routine and eating a healthier diet. Our study findings suggest that doctors can tell patients that having up to a glass of alcohol a day is not likely to increase their risk of a breast cancer recurrence.”
This study was funded by the National Cancer Institute. The authors reported having no disclosures.
FROM CANCER
FDA approves elranatamab for multiple myeloma
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
The B-cell maturation antigen (BCMA) CD3-targeted bispecific antibody (BsAb) was given Priority Review in February and had previously received Breakthrough Therapy Designation for relapsed or refractory multiple myeloma (RRMM), according to Pfizer.
FDA approval was based on favorable response and duration of response rates in the single-arm, phase 2 MagnetisMM-3 trial. The trial showed meaningful responses in heavily pretreated patients with RRMM who received elranatamab as their first BCMA-directed therapy.
The overall response rate in 97 BCMA-naive patients (cohort A) who previously received at least four lines of therapy, including a proteasome inhibitor, an immunomodulatory agent, and an anti-CD38 monoclonal antibody, was 58%, with an estimated 82% maintaining the response for 9 months or longer. Median time to first response was 1.2 months.
In 63 patients who received at least four prior lines of therapy, which also included a BCMA-directed therapy, the overall response rate was 33% after median follow-up of 10.2 months. An estimated 84% maintained a response for at least 9 months.
Elranatamab was given subcutaneously at a dose of 76 mg weekly on a 28-day cycle with a step-up priming dose regimen. The priming regimen included 12 mg and 32 mg doses on days 1 and 4, respectively, during cycle 1. Patients who received at least six cycles and showed at least a partial response for 2 or more months had a biweekly dosing interval.
Elranatamab carries a boxed warning for cytokine release syndrome (CRS) and neurologic toxicity, as well as warnings and precautions for infections, neutropenia, hepatotoxicity, and embryo–fetal toxicity. Therefore, the agent is available only through a restricted Risk Evaluation and Mitigation Strategy (REMS).
The boxed warning is included in the full prescribing information.
A confirmatory trial to gather additional safety and efficacy data was launched in 2022. Continued FDA approval is contingent on confirmed safety and efficacy data.
A version of this article first appeared on Medscape.com.
FDA OKs combo therapy of niraparib, abiraterone acetate for prostate cancer
The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.
The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.
Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.
Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.
The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).
An adverse reaction led to permanent discontinuation of treatment in 15% of patients.
“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”
About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.
The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article appeared on Medscape.com.
The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.
The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.
Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.
Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.
The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).
An adverse reaction led to permanent discontinuation of treatment in 15% of patients.
“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”
About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.
The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article appeared on Medscape.com.
The Food and Drug Administration has approved niraparib and abiraterone acetate (Akeega, Janssen Pharmaceuticals) to treat BRCA-positive, metastatic castration-resistant prostate cancer in adult patients with deleterious or suspected deleterious disease, as determined by an FDA-approved test.
The FDA’s approval was based on findings from the phase 3 MAGNITUDE precision medicine study, a randomized, placebo-controlled trial with 423 patients, 225 (53%) of whom had BRCA gene mutations as determined using a tissue assay such as FoundationOne CDx.
Among the subgroup with a BRCA mutation, radiographic progression-free survival was a median of 16.6 months vs. 10.9 months (hazard ratio [HR], 0.53; 95% confidence interval [CI], 0.36-0.79; P = .0014). In this subgroup, an exploratory overall survival analysis demonstrated a median of 30.4 months vs. 28.6 months (HR, 0.79; 95% CI, 0.55-1.12), favoring the treatment arm.
Although the overall cohort (those with and without BRCA mutations) demonstrated a significant improvement in radiographic progression-free survival, the subgroup with non-BRCA homologous recombination repair mutations did not demonstrate a significant improvement in radiographic progression-free survival, which indicates that the benefit observed was “primarily attributed” to the results in the subgroup of patients with BRCA mutations, according to the FDA.
The safety profile of niraparib and abiraterone acetate plus prednisone was consistent with the known safety profile of each FDA-approved monotherapy. Serious adverse events occurred in 41% of patients in the treatment arm. These most often included musculoskeletal pain (44% vs. 42%), fatigue (43% vs. 30%), constipation (34% vs. 20%), hypertension (33% vs. 27%), and nausea (33% vs. 21%).
An adverse reaction led to permanent discontinuation of treatment in 15% of patients.
“As a physician, identifying patients with a worse prognosis is a priority, especially those whose cancers have a BRCA mutation,” principal investigator Kim Chi, MD, stated in the Janssen press release. “We prospectively designed the MAGNITUDE study to identify the subset of patients most likely to benefit from targeted treatment with AKEEGA and to help us understand how we can potentially achieve better health outcomes for patients.”
About 10%-15% of patients who develop metastatic castration-resistant prostate cancer have BRCA gene alterations, and those patients are more likely to have aggressive disease, poor outcomes, and shorter survival. Therefore, this new agent “brings an important treatment option to patients with prostate cancer as they consider their road ahead,” said Shelby Moneer, vice president of patient programs and education at ZERO Prostate Cancer.
The prescribing information lists the recommended dose at 200 mg niraparib and 1,000 mg abiraterone once daily in combination with 10 mg of prednisone daily until disease progression or unacceptable toxicity. Patients should also receive a gonadotropin-releasing hormone analog concurrently or should have had bilateral orchiectomy.
Health care professionals should report all serious adverse events suspected to be associated with the use of any medicine and device by using the FDA’s MedWatch Reporting System or by calling 1-800-FDA-1088.
A version of this article appeared on Medscape.com.