AVAHO

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

TOPLINE:

A dramatic increase in cancer diagnoses following Medicaid expansion in Ohio suggests that expanding the program improves access to cancer care.

METHODOLOGY:

• To assess the impact of Medicaid expansion on cancer diagnosis, investigators compared the volume of patients with newly diagnosed cancer in Ohio, which expanded its Medicaid coverage in 2014, with that of Georgia, which did not.
• State cancer registries were queried from 2010 to 2017 to identify adults younger than 64 years with incident female breast cancer, cervical cancer, or colorectal cancer (CRC).

TAKEAWAY:

• In Ohio, researchers found a substantial increase in diagnoses for all three cancers among Medicaid patients after expansion. The increase ranged from 42% for breast cancer to 77% for CRC.
• In Georgia, fewer Medicaid patients were diagnosed with breast cancer in the postexpansion period. There were also smaller increases in the number of patients diagnosed with cervical cancer (6%) and CRC (13%), compared with the postexpansion increases seen in Ohio.
• The risk of being diagnosed with late-stage breast cancer fell 7% among Medicaid patients in Ohio after expansion.
• The risk of being diagnosed with late-stage CRC fell 6% among Medicaid patients in George and Ohio. The Georgia results are potentially attributable to increases in state and local screening programs, especially in rural areas.

IN PRACTICE:

“These starkly different patterns in changes in the number of diagnosed [breast cancer], [cervical cancer], and CRC cases among patients on Medicaid in Ohio versus Georgia in the postexpansion period suggest that expanding insurance coverage might have effectively improved access to care,” the authors wrote.

SOURCE:

The study, led by Kirsten Eom, PhD, of the MetroHealth Population Health Research Institute, Cleveland, was published online in Cancer.

LIMITATIONS:

• Medicaid status was determined at diagnosis; past studies have associated being enrolled in Medicaid at the time of cancer diagnosis, rather than before, with late‐stage disease.
• The team could not assess the effectiveness of state and local cancer screening programs in preventing late-stage cancer.

DISCLOSURES:

• The study was funded by the Ohio Department of Health and the Georgia Department of Public Health.
• One researcher reported a grant from Celgene.

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

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

Neutropenia and radiological findings affected the presentation and diagnosis of pulmonary mucormycosis in adult patients, based on data from 114 individuals.

Diagnosis of pulmonary mucormycosis (PM), an invasive and potentially life-threatening fungal infection, is often delayed because of its variable presentation, wrote Anne Coste, MD, of La Cavale Blanche Hospital and Brest (France) University Hospital, and colleagues.

Improved diagnostic tools including molecular identification and image-guided lung biopsies are now available in many centers, but relations between underlying conditions, clinical presentations, and diagnostic methods have not been described, they said.

In a study published in the journal Chest, the researchers reviewed data from all cases of PM seen at six hospitals in France between 2008 and 2019. PM cases were based on European Organization for Research and Treatment of Cancer and the National Institute of Allergy and Infectious Diseases Mycoses Study Group (EORTC/MSG) criteria. Diabetes and trauma were included as additional host factors, and positive serum or tissue PCR (serum qPCR) were included as mycological evidence. Participants also underwent thoracic computed tomography (CT) scans.

The most common underlying conditions among the 114 patients were hematological malignancy (49%), allogeneic hematopoietic stem-cell transplantation (21%), and solid organ transplantation (17%).

Among the 40% of the cases that involved dissemination, the most common sites were the liver (48%), spleen (48%), brain (44%), and kidneys (37%).

A review of radiology findings showed consolidation in a majority of patients (58%), as well as pleural effusion (52%). Other findings included reversed halo sign (RHS, 26%), halo sign (24%), vascular abnormalities (26%), and cavity (23%).

Bronchoalveolar lavage (BAL) was present in 46 of 96 patients (50%), and transthoracic lung biopsy was used for diagnosis in 8 of 11 (73%) patients with previous negative BALs.

Seventy patients had neutropenia. Overall, patients with neutropenia were significantly more likely than were those without neutropenia to show an angioinvasive presentation that included both RHS and disease dissemination (P < .05).

In addition, serum qPCR was positive in 42 of 53 patients for whom data were available (79%). Serum qPCR was significantly more likely to be positive in neutropenic patients (91% vs. 62%, P = .02). Positive qPCR was associated with an early diagnosis (P = .03) and treatment onset (P = .01).

Possible reasons for the high rate of disseminated PM in the current study may be the large number of patients with pulmonary involvement, use of body CT data, and availability of autopsy results (for 11% of cases), the researchers wrote in their discussion.

Neutropenia and radiological findings influence disease presentation and contribution of diagnostic tools during PM. Serum qPCR is more contributive in neutropenic patients and BAL examination in nonneutropenic patients. Lung biopsies are highly contributive in case of non-contributive BAL.

The findings were limited by several factors including the retrospective design, the inability to calculate sensitivity and specificity of diagnostic methods, and lack of data on patients with COVID-19, the researchers noted. However, the results provide real-life information for clinicians in centers with current mycological platforms, they concluded.

The study received no outside funding. Dr. Coste had no financial conflicts to disclose.

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

A petition demanding an end to maintenance of certification (MOC) requirements from the American Board of Internal Medicine (ABIM) gained traction among oncologists in late July, garnering nearly 7,500 signatures in 10 days.

The MOC program, “originally intended to uphold the standards of medical practice and promote lifelong learning, has evolved into a complex and time-consuming process that poses significant challenges to practicing physicians,” according to the petition launched on July 21 by hematologist-oncologist Aaron Goodman, MD. The MOC “has become burdensome, costly, and lacks evidence to support its effectiveness in improving patient care or physician competence.”

Dr. Goodman, assistant professor at the University of California, San Diego, is scheduled to debate the matter with ABIM President and Chief Executive Officer Richard J. Baron, MD, during a Healthcare Unfiltered podcast recorded and hosted by Chadi Nabhan, MD. In the August 3 podcast, Dr. Goodman and Dr. Baron will respond to questions posed via tweets, Dr. Goodman said.

A Twitter survey posted by Dr. Nabhan in advance of the debate asked physicians whether the cost of the MOC, the time required for testing, or data sharing by ABIM is most bothersome. Of 158 respondents, 71% selected “all of the above.”
 

ABIM touts MOC ‘values’  

The ABIM requires an initial certification assessment that costs thousands of dollars and must be repeated every 10 years. The annual MOC requirements, which were tacked on within the last decade, involve tests that cost $220 for the first certificate a physician holds and about $120 for each subsequent one.

Over the course of his career, Dr. Goodman estimates he will spend over $40,000 to maintain his three ABIM boards in medicine, hematology, and oncology.

The ABIM did not immediately respond to a request for comment on the petition and debate, but a page on the ABIM website touts the “values of MOC” and says there is “compelling evidence” that the MOC improves the value of care without sacrificing quality and that board-certified physicians earn more.

According to the website, the MOC program “provides doctors with a pathway to know that they are staying current in the medical knowledge they use to treat patients and make important care decisions daily.” The ABIM also says that the “program has evolved to include new assessment options and an increased recognition of the work doctors do every day” and that the ABIM “continuously collaborates with doctors to increase the relevance of exams.”

Aniruddha Singh, MD, also weighed in on the value of MOC in a July 13 ABIM blog post. Dr. Singh is a member of this year’s Cardiovascular Disease Traditional, 10-Year MOC Exam Approval Committee and program director for the General Cardiovascular Fellowship at Drexel University College of Medicine, Reading, Pa.

In his post, Dr. Singh states that the MOC “facilitates a broader perspective on a range of topics [and] enables me to delve deeper into relevant areas, fostering a comprehensive understanding that enhances my quality of care.”
 

Growing resistance

Although Dr. Goodman acknowledged the merit of board testing every decade or so, physicians already do continuing medical education (CME) to keep up-to-date on their specialties. Dr. Goodman believes that most physicians, other than those who work for ABIM, would agree that MOC is a waste of time and money.

“It’s a pain-in-the-ass module that you sit at home and Google – it’s not really any sort of assessment,” nor does it help protect the public, said Goodman. The MOC is ultimately “just a money grab.”

According to the ABIM’s website, the nonprofit has net assets of more than $73.2 million as of June 30, 2022. Last year, the ABIM’s revenue hit $71.9 million, with more than half coming from MOC fees and 48% from certification.

The ABIM also says it spent $58 million in 2022. A breakdown shows about 63% of that money went to administering (28%), researching (13%), overseeing (4%), and developing (18%) the certification and MOC exams and program. ABIM’s CEO Dr. Baron makes about $1.2 million a year, according to recent tax filings. The COO makes about $550,000 from the ABIM and “related” organizations.

Fed up with the requirements and cost, Dr. Goodman decided to launch the petition to see if others agreed and how many.

His petition, addressed to the ABIM, expresses “deep dissatisfaction” with the ABIM MOC program and “respectfully request[s] that the ABIM take immediate action to eliminate the MOC program and adopt alternative, less burdensome methods of ensuring physician competence and continuous professional development.” Dr. Goodman, alongside Vinay Prasad, MD, a hematologist-oncologist and professor at the University of California, San Francisco, reiterated these points in a piece highlighting the petition.

Shortly before the petition went public but after he had been vocal on Twitter about issues with the MOC, Dr. Goodman said he received an invitation to join the ABIM Board of Governors. “My hypothesis is they are trying to ‘friend’ me, so I get credentialed, and they get me to stop yelling. It just made me more pissed off. I don’t want to be any part of that,” he said.

H. Jack West, MD, a thoracic oncologist and associate professor at City of Hope Comprehensive Cancer Center, signed the petition without hesitation.

Dr. West agreed with Dr. Goodman that the 10-year ABIM recertification is sufficient. He also denounced the ABIM testing process, costs, and content, saying he found the questions “so ambiguous that even knowing everything about the subject, I found the assignment of the ‘best’ answer to be a Talmudic interpretation.”

“The questions seem to have a sadistic level of complexity and ambiguity baked into them, rather than being a direct assessment of knowledge,” he explained.

The ABIM is also “completely opaque” about their process of developing questions and defining answers, Dr. West said. And “the ABIM offers no data to support that their processes improve any clinical outcomes.”

Yet, the MOC “forces physicians to spend several hundred dollars every year as well as an incredible amount of their time jumping through hoops at the behest of ABIM to satisfy these imposed requirements,” Dr. West said. The time spent satisfying these requirements is also “strip-mining physician morale” by taking time away from families and personal lives.

As for ABIM finances, Dr. West said the organization offers no justification for “the extortionate costs imposed by this de facto monopoly.”

The glimpses we do see, however, “indicate an organization spending on a lavish condominium and offering conspicuously generous remuneration to its own leadership. The only thing that is assured by the ABIM’s MOC program is that it is wildly profitable for the ABIM,” he added.

In a tweet, he called on physicians to take a stand: “If you think MOC is good, say it. Otherwise, if you don’t sign [the petition], ask yourself why you don’t have the courage & character to do so.”
 

Next steps?

Dr. Goodman’s petition lays out potential alternatives to the MOC that “would better support physician competence and continuing education without imposing unnecessary hurdles.”

Alternatives include encouraging voluntary, accessible, and evidence-based CME programs to promote lifelong learning among physicians, establishing a system for peer evaluation and feedback, encouraging self-assessment, and fostering a culture of continuous quality improvement.

Dr. Goodman’s goal is to garner at least 10,000 signatures and reach out to credentialing committees around the country with the results to promote alternatives to MOC. As of the morning of August 1, the petition had more than 7,900 signatures.

He also gives Dr. Baron credit for his willingness to have a conversation about the MOC and intends for that conversation to be a civil, respectful debate.

“I can’t think of anything he could say that will convince me [MOC] is the right thing to do, but we’ll see what he has to say,” Dr. Goodman said.

A version of this article appeared on Medscape.com.

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

The U.S. Food and Drug Administration has approved dostarlimab-gxly (Jemperli, GlaxoSmithKline) with carboplatin and paclitaxel, followed by single-agent dostarlimab, for primary advanced or recurrent endometrial cancer that is mismatch repair–deficient (dMMR), as determined by an FDA-approved test or microsatellite instability–high (MSI-H).

The approval was based on GSK’s RUBY trial. Across 122 patients with dMMR/MSI-H primary advanced or recurrent endometrial cancer, progression-free survival was 30.3 months in women randomly assigned to dostarlimab on a background of carboplatin and paclitaxel, followed by dostarlimab monotherapy, vs. 7.7 months among women randomly assigned to placebo (hazard ratio, 0.29; P < .0001), according to the FDA’s press release.

MMR/MSI tumor status was determined by local testing or by the Ventana MMR RxDx Panel when local testing was unavailable.

“Until now, chemotherapy alone has been the standard of care with many patients experiencing disease progression,” GSK executive Hesham Abdullah said in the company’s press release. The trial results “and today’s approval underscore our belief in the potential for Jemperli to transform cancer treatment as a backbone immuno-oncology therapy.”

Dostarlimab was already approved in the United States as monotherapy for adults with dMMR recurrent or advanced endometrial cancer that has progressed on or following a platinum-containing chemotherapy and is not a candidate for curative surgery or radiation. The latest approval means that the agent “is now indicated earlier in treatment in combination with chemotherapy,” GSK said.

Dostarlimab also carries an indication for dMMR recurrent or advanced solid tumors that have progressed on or following prior treatment when there are no satisfactory alternative treatment options.

Immune-mediated adverse reactions with dostarlimab include pneumonitis, colitis, hepatitis, endocrinopathies such as hypothyroidism, nephritis with renal dysfunction, and skin adverse reactions. The most common adverse reactions (≥ 20%) with carboplatin and paclitaxel in the Ruby trial were rash, diarrhea, hypothyroidism, and hypertension.

The recommended dostarlimab dose is 500 mg every 3 weeks for 6 doses with carboplatin and paclitaxel, followed by 1,000 mg monotherapy every 6 weeks until disease progression or unacceptable toxicity, or up to 3 years.

Drugs.com lists dostarlimab’s price at $11,712.66 for 500 mg/10 mL intravenous solution.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

Women diagnosed with early-stage breast cancer are more likely to become long-term survivors of the disease now than they were 20 years ago, a new study found.

Researchers at the University of Oxford (England) conducted an observational study that examined case fatality rates for women with breast cancer and found that the prognosis for women has “improved substantially” over the past few decades. For women diagnosed with early invasive breast cancer during the 1990s, the risk of death within 5 years of diagnosis was just over 14% on average. For women diagnosed during the 2010s, it was nearly 5% on average.

“The take-home message in our study is that it’s good news for women who are diagnosed with early breast cancer today because most of them can expect to become long-term cancer survivors, and so I think our results are reassuring,” said lead study author Carolyn Taylor, DPhil, a clinical oncologist from the Nuffield Department Of Population Health, University of Oxford.

The study was published online in the BMJ.

Although breast cancer survival has improved, recent estimates don’t incorporate detailed data on age, tumor size, tumor grade, and nodal and receptor status. In the current population-based study, researchers explored improvement in survival from early-stage breast cancer. They used nine patient and tumor characteristics as factors in their analysis.

The study is based on data from the National Cancer Registration for 512,447 women in England who were diagnosed with early-stage invasive breast cancer between 1993 and 2015. Women were broken into four groups: those diagnosed during 1993-1999, 2000-2004, 2005-2009, and 2010-2015.

The study focused on women who initially underwent either breast-conserving surgery or mastectomy as their first treatment. Data included age, tumor size, tumor grade, number of positive nodes, and estrogen receptor (ER) status. For women who were diagnosed from 2010 to 2015, HER2 status was included. Data regarding recurrence, receipt of neoadjuvant therapy, and patients who were diagnosed with more than one cancer were not included.

The major finding: Among women diagnosed with early-stage invasive breast cancer, the risk of dying decreased almost threefold between 1993 and 2015. The 5-year cumulative case fatality risk was 14.4% for women diagnosed in the 1990s (1993-1999) versus 4.9% for women diagnosed about 2 decades later (2010-2015).

Dr. Taylor and colleagues found that the case fatality rate was highest during the 5 years after diagnosis; within those years, the rates typically increased during the first 2 years, peaked during the third, and declined thereafter.

The 5-year risk of death, however, varied widely among women in the population. For most (62.8%) who were diagnosed between 2010 and 2015, the case fatality risk was 3% or less; however, for a small subset of women (4.6%), the risk reached 20% or higher.

Patients with ER-negative tumors tended to have worse prognoses in the first decade following their diagnosis. Overall, higher tumor size and grade, more positive nodes, and older age tended to be associated with worse prognoses.

Overall, the annual case fatality rates decreased over time in nearly every patient group.

While Dr. Taylor said these findings are encouraging, she added that the investigators did not analyze why survival rates have improved over 2 decades.

“We didn’t explain how much of the improvement was due to advances treatments, improved screening rates, etc,” Dr. Taylor said. Another limitation is that data on recurrence were not available.

Kathy Miller, MD, who specializes in breast cancer at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis, said the 5-year mark for survival is great news for some patients with breast cancer but that the time frame doesn’t apply to all.

While the risk of case fatality from breast cancer may be higher during the first 5 years after diagnosis, Dr. Miller said that is not the case for women with ER-positive breast cancer. In the study, the researchers highlighted this trend for ER status: before the 10-year mark, survival rates for women with ER-positive disease were better, but after the 10-year mark, those with ER-negative tumors seemed to fare slightly better.

“Many patients have heard this very arbitrary 5-year mark, and for patients with ER-positive disease, that 5-year mark has no meaning, because their risk in any given year is very low and it stays at that very low consistent level for at least 15 years, probably longer,” Dr. Miller said in an interview. “I think a better way to think about this for ER-positive patients is that every day that goes by without a problem makes it a tiny bit less likely that you will ever have a problem.”

The authors took a similar view for the overall population, concluding that, “although deaths from breast cancer will continue to occur beyond this [5-year mark], the risk during each subsequent 5-year period is likely to be lower than during the first 5 years.”

The research was funded by Cancer Research UK, the National Institute for Health Research Oxford Biomedical Research Centre, the U.K. Medical Research Council, and the University of Oxford. Some study authors received support for several of these institutions, but they reported no financial relationships with organizations that might have had an interest in the submitted work during the previous 3 years.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

The U.S. Food and Drug Administration today cleared an artificial intelligence (AI)-assisted colonoscopy device called the MAGENTIQ-COLO, according to the Israeli-based manufacturer of the same name.

The device helps identify lesions in real time and is associated with a significant increase in the adenoma detection rate (ADR), according to the press release.

The device was cleared under the FDA’s 510(k) process, and follows the European CE Mark and Israel AMAR approval, which were received in mid-2021. It will be available in the United States in the coming weeks.

In a study performed in 2022 with 29 endoscopy experts and more than 950 patients, the device was validated as “one of the best-performing AI solutions in the category, increasing ADR by 26% relatively (7% in absolute values), which translated into a 21% decrease in colorectal cancer occurrence and a 35% decrease in patient mortality,” according to the press release.

In this multicenter, randomized, controlled trial conducted at 10 hospitals in Europe, the United States, and Israel, and presented at United European Gastroenterology Week 2022, the authors noted that “apart from diminutive lesions, [MAGENTIQ-COLO] increased the detection of 6- to 9-mm adenomas, suggesting that this novel [computer-aided polyp detection] system is also able to detect more clinically relevant lesions.”

The device “takes the video out of the colonoscopy device, breaks it into frames, and analyzes them in real time with its AI engine to detect polyps in them,” Dror Zur, founder and CEO of MAGENTIQ-EYE, explained in an interview. “If a polyp is detected, then MAGENTIQ-COLO signs it with a bounding box on the video’s overlay and sends it as a video with an overlay to the display monitor so the doctor can look at it and find more polyps.”

As previously reported by this news organization, research has shown that conventional colonoscopies miss about a quarter of adenomas. Many AI systems have recently come on the market, promising to improve detection by overcoming human error in detecting polyps.

Colonoscopy has become standard in most developed countries, with 15-20 million procedures performed every year in the United States alone; however, high missed rates and undetected adenomas during the procedures mean that even patients who get regular, recommended screenings are still at risk of developing colon cancer, notes the press release.

“A missed polyp can lead to interval cancer, which accounts for approximately 8%-10% of all CRC in the U.S., translated to over 13,500 cancer cases that could be prevented every year with better detection,” the press release also states.

According to the National Institutes of Health, colorectal cancer is the third leading cause of cancer-related death in the United States.

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

TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

TOPLINE:

Recurrence-free survival (RFS) is not a strong surrogate for overall survival in randomized trials of adjuvant immunotherapy for cancer.

METHODOLOGY:

• FDA approvals in the adjuvant setting for cancer immunotherapy are increasingly based on trials that use RFS as a surrogate endpoint for overall survival, largely because such a design allows for smaller, speedier trials.
• To test the validity of using RFS as a surrogate for overall survival in this setting, investigators conducted a meta-analysis of 15 phase 2 and 3 randomized controlled trials (RCTs) of adjuvant CTLA4 and anti–PD-1/PD-L1 blockers for melanoma, non–small cell lung cancer, renal cell cancer, and other tumors.
• The team used weighted regression at the arm and trial levels to assess the efficacy of RFS as a surrogate for overall survival.
• The strength of the association was quantified by weighted coefficients of determination (R²)12Dante MT Stdplz make sure all mentions of R’2’ are superscript, with a strong correlation considered to be R² of 0.7 or higher.
• If there were strong correlations at both the arm and trial levels, RFS would be considered a robust surrogate endpoint for overall survival; however, if one of the correlations at the arm or trial level was not strong, RFS would not be considered a surrogate endpoint for overall survival.

TAKEAWAY:

• At the arm level, moderate and strong associations were observed between 2-year RFS and 3-year overall survival (R², 0.58) and between 3-year RFS and 5-year overall survival (R², 0.72; 95% confidence interval, 0.38-.00).
• At the trial level, a moderate association was observed between effect of treatment on RFS and overall survival (R², 0.63).
• The findings were confirmed in several sensitivity analyses that were based on different trial phases, experimental arms, cancer types, and treatment strategies.

IN PRACTICE:

“Our meta-analysis failed to find a significantly strong association between RFS and OS in RCTs of adjuvant immunotherapy,” the authors concluded. “RFS should not be used as a surrogate endpoint for OS in this clinical context.” Instead, the finding indicates that overall survival is “the ideal primary endpoint” in this setting.

SOURCE:

The study, led by Yuanfang Li, PhD, of Sun Yat-sen University Cancer Center in Guangzhou, China, was published in the Journal of the National Cancer Institute.

LIMITATIONS:

• Correlations were calculated from a relatively limited number of RCTs that involved different types of cancer, and overall survival data were not fully mature in some of the trials.
• The analysis did not include patient-level data.

DISCLOSURES:

• The work was funded by the National Natural Science Foundation of China and others.
• The investigators had no disclosures.

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

People who do 4-5 minutes of vigorous physical activity daily can reduce their cancer risk by up to 32%, a new study published in  JAMA Oncology says.

Researchers at the University of Sydney studied data from wearable fitness devices worn by more than 22,000 “non-exercisers,” then examined their health records for 6 or 7 years. 

The scientists found that people who did 4-5 minutes of “vigorous intermittent lifestyle physical activity” (VILPA) had a “substantially” lower cancer risk than people who did no VILPA. 

Examples of VILPA are vigorous housework, carrying heavy shopping bags around the grocery store, bursts of power walking, and playing high-energy games with children. The activities could occur in 1-minute bursts, instead of all at once.

Getty Images/Kentaroo Tryman

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

TOPLINE

The use of magnetic resonance–guided daily adaptive stereotactic body radiotherapy for patients with prostate cancer reduces the risk of acute urinary side effects of grade 2 or higher by 44% and the risk of acute bowel side effects of grade 2 or higher by 60%, compared with standard CT-guided SBRT (CT‐SBRT).

METHODOLOGY

• With the use of magnetic resonance–guided daily adaptive SBRT, clinicians can customize radiation dosing to accommodate changes in prostate anatomy during treatment, which may also make SBRT safer and less toxic for patients.
• To determine whether this approach does reduce patient side effects, investigators ran a meta-analysis that included 29 studies with 2547 patients comparing the incidence of short-term, physician-assessed bowel and genitourinary side effects between the MRI-guided approach and standard CT-SBRT.
• The investigators reported no statistically significant differences in age, prescribed radiation doses, planning target volumes, or International Prostatism Symptom Scores between the two groups; the use of rectal spacers and the number of patients who received pelvic lymph node radiation were low in both.
• The average window for collecting acute toxicity data was 70 days in the MRI-guided investigations and 94 days in CT-SBRT investigations.

TAKEAWAY

• The pooled estimate for acute grade 2 or higher genitourinary toxicity was 16% with MRI-guided SBRT versus 28% with CT-SBRT (odds ratio, 0.56; P = .04).
• The pooled estimate for grade 2 or higher gastrointestinal toxicity was 4% with the MRI approach versus 9% with CT-SBRT (OR, 0.40; P = .04).
• There were no differences in grade 3 or higher events, which were rare, between the groups.
• There was also no difference in toxicity among CT‐SBRT studies that used fiducial markers and those that did not.

IN PRACTICE

“These findings suggest that the technical advantages in precision of radiotherapy delivery afforded by [MRI-guided] SBRT translate to measurable clinical benefit,” the authors concluded. Potential reasons for the reduced risk of acute toxicity with the MRI-guided approach include “daily online adaptive planning, MRI‐based contouring that results in smaller treatment volumes, and MRI tracking, all of which may facilitate the precision and accuracy of treatment delivery.”

SOURCE

The study was led by Jonathan Leeman, MD, of the Dana-Farber Cancer Institute, Boston, and was published July 24 in Cancer.

LIMITATIONS

• The analysis did not account for differences in dosimetry, radiation planning, and toxicity management and assessment between the studies.
• Late toxicity and cancer control rates were not tracked and may have differed between the two approaches.

DISCLOSURES

• No external funding was reported.
• The investigators reported grants and consulting, personal, and other payments from Novartis, AstraZeneca, Janssen, and other companies.

A version of this article appeared on Medscape.com.

TOPLINE

The use of magnetic resonance–guided daily adaptive stereotactic body radiotherapy for patients with prostate cancer reduces the risk of acute urinary side effects of grade 2 or higher by 44% and the risk of acute bowel side effects of grade 2 or higher by 60%, compared with standard CT-guided SBRT (CT‐SBRT).

METHODOLOGY

• With the use of magnetic resonance–guided daily adaptive SBRT, clinicians can customize radiation dosing to accommodate changes in prostate anatomy during treatment, which may also make SBRT safer and less toxic for patients.
• To determine whether this approach does reduce patient side effects, investigators ran a meta-analysis that included 29 studies with 2547 patients comparing the incidence of short-term, physician-assessed bowel and genitourinary side effects between the MRI-guided approach and standard CT-SBRT.
• The investigators reported no statistically significant differences in age, prescribed radiation doses, planning target volumes, or International Prostatism Symptom Scores between the two groups; the use of rectal spacers and the number of patients who received pelvic lymph node radiation were low in both.
• The average window for collecting acute toxicity data was 70 days in the MRI-guided investigations and 94 days in CT-SBRT investigations.

TAKEAWAY

• The pooled estimate for acute grade 2 or higher genitourinary toxicity was 16% with MRI-guided SBRT versus 28% with CT-SBRT (odds ratio, 0.56; P = .04).
• The pooled estimate for grade 2 or higher gastrointestinal toxicity was 4% with the MRI approach versus 9% with CT-SBRT (OR, 0.40; P = .04).
• There were no differences in grade 3 or higher events, which were rare, between the groups.
• There was also no difference in toxicity among CT‐SBRT studies that used fiducial markers and those that did not.

IN PRACTICE

“These findings suggest that the technical advantages in precision of radiotherapy delivery afforded by [MRI-guided] SBRT translate to measurable clinical benefit,” the authors concluded. Potential reasons for the reduced risk of acute toxicity with the MRI-guided approach include “daily online adaptive planning, MRI‐based contouring that results in smaller treatment volumes, and MRI tracking, all of which may facilitate the precision and accuracy of treatment delivery.”

SOURCE

The study was led by Jonathan Leeman, MD, of the Dana-Farber Cancer Institute, Boston, and was published July 24 in Cancer.

LIMITATIONS

• The analysis did not account for differences in dosimetry, radiation planning, and toxicity management and assessment between the studies.
• Late toxicity and cancer control rates were not tracked and may have differed between the two approaches.

DISCLOSURES

• No external funding was reported.
• The investigators reported grants and consulting, personal, and other payments from Novartis, AstraZeneca, Janssen, and other companies.

A version of this article appeared on Medscape.com.

TOPLINE

The use of magnetic resonance–guided daily adaptive stereotactic body radiotherapy for patients with prostate cancer reduces the risk of acute urinary side effects of grade 2 or higher by 44% and the risk of acute bowel side effects of grade 2 or higher by 60%, compared with standard CT-guided SBRT (CT‐SBRT).

METHODOLOGY

• With the use of magnetic resonance–guided daily adaptive SBRT, clinicians can customize radiation dosing to accommodate changes in prostate anatomy during treatment, which may also make SBRT safer and less toxic for patients.
• To determine whether this approach does reduce patient side effects, investigators ran a meta-analysis that included 29 studies with 2547 patients comparing the incidence of short-term, physician-assessed bowel and genitourinary side effects between the MRI-guided approach and standard CT-SBRT.
• The investigators reported no statistically significant differences in age, prescribed radiation doses, planning target volumes, or International Prostatism Symptom Scores between the two groups; the use of rectal spacers and the number of patients who received pelvic lymph node radiation were low in both.
• The average window for collecting acute toxicity data was 70 days in the MRI-guided investigations and 94 days in CT-SBRT investigations.

TAKEAWAY

• The pooled estimate for acute grade 2 or higher genitourinary toxicity was 16% with MRI-guided SBRT versus 28% with CT-SBRT (odds ratio, 0.56; P = .04).
• The pooled estimate for grade 2 or higher gastrointestinal toxicity was 4% with the MRI approach versus 9% with CT-SBRT (OR, 0.40; P = .04).
• There were no differences in grade 3 or higher events, which were rare, between the groups.
• There was also no difference in toxicity among CT‐SBRT studies that used fiducial markers and those that did not.

IN PRACTICE

“These findings suggest that the technical advantages in precision of radiotherapy delivery afforded by [MRI-guided] SBRT translate to measurable clinical benefit,” the authors concluded. Potential reasons for the reduced risk of acute toxicity with the MRI-guided approach include “daily online adaptive planning, MRI‐based contouring that results in smaller treatment volumes, and MRI tracking, all of which may facilitate the precision and accuracy of treatment delivery.”

SOURCE

The study was led by Jonathan Leeman, MD, of the Dana-Farber Cancer Institute, Boston, and was published July 24 in Cancer.

LIMITATIONS

• The analysis did not account for differences in dosimetry, radiation planning, and toxicity management and assessment between the studies.
• Late toxicity and cancer control rates were not tracked and may have differed between the two approaches.

DISCLOSURES

• No external funding was reported.
• The investigators reported grants and consulting, personal, and other payments from Novartis, AstraZeneca, Janssen, and other companies.

A version of this article appeared on Medscape.com.

Monitoring early-response biomarkers in patients receiving lutetium-177 (¹⁷⁷Lu)–PSMA-617 for metastatic castrate-resistant prostate cancer may allow physicians to personalize dosing intervals and improve patient outcomes, new research suggests.

The findings indicate that implementing a personalized dosing strategy with the radioligand therapy “allowed for treatment holidays in excellent responders, continuous 6-weekly treatments in moderate responders, and [allowed us] to consider changing or adding treatment in limited responders,” said study author Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the department of theranostics and nuclear medicine at St. Vincent’s Hospital in Sydney.

The research was presented at the annual meeting of the Society of Nuclear Medicine and Molecular Imaging.

Although clinical trials have demonstrated that ¹⁷⁷Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer, the question remains: Can patient outcomes be improved through the use of biomarkers and by escalating or deescalating treatment as appropriate? asked Dr. Nguyen, who presented the findings at the meeting.

Clinical trials use standardized dosing intervals. Adjusting treatment intervals through the use of early-biomarker responses could give some patients a break from treatment and improve overall survival outcomes, Dr. Nguyen explained. For example, the 2021 REALITY study showed that overall survival was significantly better for patients who received ¹⁷⁷Lu-PSMA plus standard care, compared with patients who received standard care alone (median, 15.3 vs. 11.3 months), and that overall survival was better among patients with early prostate-specific antigen (PSA) responses.

In the current study, Dr. Nguyen and colleagues used composite early biomarkers of PSA, imaging with 1⁷⁷Lu-PSMA SPECT, and diagnostic CT to guide a personalized dosing interval strategy for patients with metastatic castration-resistant prostate cancer receiving ¹⁷⁷Lu-PSMA. The team evaluated progression-free survival and overall survival among these patients to determine whether personalizing dosing on the basis of early biomarker levels was associated with survival outcomes.

The cohort included 125 men who received six weekly doses of ¹⁷⁷Lu-PSMA and who underwent imaging with ¹⁷⁷Lu-SPECT/CT after each dose. After the second dose, investigators used the composite of PSA and ¹⁷⁷Lu SPECT/CT response to determine which patients had a partial response, which had stable disease, and which had progressive disease.

The men were divided into three groups on the basis of their level of response. Group 1, which included 35% of participants, achieved a significant reduction in PSA levels and a partial response on ¹⁷⁷Lu-SPECT. These patients were advised to discontinue treatment until PSA levels increased. This treatment holiday lasted a median of about 6 months.

Group 2, which represented 34% of the cohort, had stable or reduced PSA levels as well as stable disease on SPECT imaging. For these patients, the treatment regimen continued.

Group 3 demonstrated rising PSA levels and progressive disease on SPECT imaging. These men were offered an alternative therapy.

Overall, median PSA progression-free survival was 12.1 months in group 1, 6.1 months in group 2, and 2.6 months in group 3. Median overall survival was also significantly better among patients who showed early responses to therapy: 19.2 months in group 1, 13.2 months in group 2, and 11. 2 months in group 3.

Dr. Nguyen noted several limitations to the findings, including the study’s retrospective nature and the fact that some patients in group 1 chose not to resume further treatment after their PSA levels rose.

“Personalizing dosing intervals using early-response biomarkers with ¹⁷⁷Lu-PSMA has the potential to achieve similar overall treatment responses to that published for continuous dosing, while allowing treatment holidays in responders and early crossover to potentially more effective therapies in nonresponders,” the authors conclude.

Given the effectiveness of this strategy, Dr. Nguyen says his team “now routinely uses these composite biomarkers when treating clinical patients.”

A version of this article appeared on Medscape.com.

Monitoring early-response biomarkers in patients receiving lutetium-177 (¹⁷⁷Lu)–PSMA-617 for metastatic castrate-resistant prostate cancer may allow physicians to personalize dosing intervals and improve patient outcomes, new research suggests.

The findings indicate that implementing a personalized dosing strategy with the radioligand therapy “allowed for treatment holidays in excellent responders, continuous 6-weekly treatments in moderate responders, and [allowed us] to consider changing or adding treatment in limited responders,” said study author Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the department of theranostics and nuclear medicine at St. Vincent’s Hospital in Sydney.

The research was presented at the annual meeting of the Society of Nuclear Medicine and Molecular Imaging.

Although clinical trials have demonstrated that ¹⁷⁷Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer, the question remains: Can patient outcomes be improved through the use of biomarkers and by escalating or deescalating treatment as appropriate? asked Dr. Nguyen, who presented the findings at the meeting.

Clinical trials use standardized dosing intervals. Adjusting treatment intervals through the use of early-biomarker responses could give some patients a break from treatment and improve overall survival outcomes, Dr. Nguyen explained. For example, the 2021 REALITY study showed that overall survival was significantly better for patients who received ¹⁷⁷Lu-PSMA plus standard care, compared with patients who received standard care alone (median, 15.3 vs. 11.3 months), and that overall survival was better among patients with early prostate-specific antigen (PSA) responses.

In the current study, Dr. Nguyen and colleagues used composite early biomarkers of PSA, imaging with 1⁷⁷Lu-PSMA SPECT, and diagnostic CT to guide a personalized dosing interval strategy for patients with metastatic castration-resistant prostate cancer receiving ¹⁷⁷Lu-PSMA. The team evaluated progression-free survival and overall survival among these patients to determine whether personalizing dosing on the basis of early biomarker levels was associated with survival outcomes.

The cohort included 125 men who received six weekly doses of ¹⁷⁷Lu-PSMA and who underwent imaging with ¹⁷⁷Lu-SPECT/CT after each dose. After the second dose, investigators used the composite of PSA and ¹⁷⁷Lu SPECT/CT response to determine which patients had a partial response, which had stable disease, and which had progressive disease.

The men were divided into three groups on the basis of their level of response. Group 1, which included 35% of participants, achieved a significant reduction in PSA levels and a partial response on ¹⁷⁷Lu-SPECT. These patients were advised to discontinue treatment until PSA levels increased. This treatment holiday lasted a median of about 6 months.

Group 2, which represented 34% of the cohort, had stable or reduced PSA levels as well as stable disease on SPECT imaging. For these patients, the treatment regimen continued.

Group 3 demonstrated rising PSA levels and progressive disease on SPECT imaging. These men were offered an alternative therapy.

Overall, median PSA progression-free survival was 12.1 months in group 1, 6.1 months in group 2, and 2.6 months in group 3. Median overall survival was also significantly better among patients who showed early responses to therapy: 19.2 months in group 1, 13.2 months in group 2, and 11. 2 months in group 3.

Dr. Nguyen noted several limitations to the findings, including the study’s retrospective nature and the fact that some patients in group 1 chose not to resume further treatment after their PSA levels rose.

“Personalizing dosing intervals using early-response biomarkers with ¹⁷⁷Lu-PSMA has the potential to achieve similar overall treatment responses to that published for continuous dosing, while allowing treatment holidays in responders and early crossover to potentially more effective therapies in nonresponders,” the authors conclude.

Given the effectiveness of this strategy, Dr. Nguyen says his team “now routinely uses these composite biomarkers when treating clinical patients.”

A version of this article appeared on Medscape.com.

Monitoring early-response biomarkers in patients receiving lutetium-177 (¹⁷⁷Lu)–PSMA-617 for metastatic castrate-resistant prostate cancer may allow physicians to personalize dosing intervals and improve patient outcomes, new research suggests.

The findings indicate that implementing a personalized dosing strategy with the radioligand therapy “allowed for treatment holidays in excellent responders, continuous 6-weekly treatments in moderate responders, and [allowed us] to consider changing or adding treatment in limited responders,” said study author Andrew Nguyen, MBBS, FRACP, AANMS, senior staff specialist in the department of theranostics and nuclear medicine at St. Vincent’s Hospital in Sydney.

The research was presented at the annual meeting of the Society of Nuclear Medicine and Molecular Imaging.

Although clinical trials have demonstrated that ¹⁷⁷Lu-PSMA is an effective treatment for metastatic castration-resistant prostate cancer, the question remains: Can patient outcomes be improved through the use of biomarkers and by escalating or deescalating treatment as appropriate? asked Dr. Nguyen, who presented the findings at the meeting.

Clinical trials use standardized dosing intervals. Adjusting treatment intervals through the use of early-biomarker responses could give some patients a break from treatment and improve overall survival outcomes, Dr. Nguyen explained. For example, the 2021 REALITY study showed that overall survival was significantly better for patients who received ¹⁷⁷Lu-PSMA plus standard care, compared with patients who received standard care alone (median, 15.3 vs. 11.3 months), and that overall survival was better among patients with early prostate-specific antigen (PSA) responses.

In the current study, Dr. Nguyen and colleagues used composite early biomarkers of PSA, imaging with 1⁷⁷Lu-PSMA SPECT, and diagnostic CT to guide a personalized dosing interval strategy for patients with metastatic castration-resistant prostate cancer receiving ¹⁷⁷Lu-PSMA. The team evaluated progression-free survival and overall survival among these patients to determine whether personalizing dosing on the basis of early biomarker levels was associated with survival outcomes.

The cohort included 125 men who received six weekly doses of ¹⁷⁷Lu-PSMA and who underwent imaging with ¹⁷⁷Lu-SPECT/CT after each dose. After the second dose, investigators used the composite of PSA and ¹⁷⁷Lu SPECT/CT response to determine which patients had a partial response, which had stable disease, and which had progressive disease.

The men were divided into three groups on the basis of their level of response. Group 1, which included 35% of participants, achieved a significant reduction in PSA levels and a partial response on ¹⁷⁷Lu-SPECT. These patients were advised to discontinue treatment until PSA levels increased. This treatment holiday lasted a median of about 6 months.

Group 2, which represented 34% of the cohort, had stable or reduced PSA levels as well as stable disease on SPECT imaging. For these patients, the treatment regimen continued.

Group 3 demonstrated rising PSA levels and progressive disease on SPECT imaging. These men were offered an alternative therapy.

Overall, median PSA progression-free survival was 12.1 months in group 1, 6.1 months in group 2, and 2.6 months in group 3. Median overall survival was also significantly better among patients who showed early responses to therapy: 19.2 months in group 1, 13.2 months in group 2, and 11. 2 months in group 3.

Dr. Nguyen noted several limitations to the findings, including the study’s retrospective nature and the fact that some patients in group 1 chose not to resume further treatment after their PSA levels rose.

“Personalizing dosing intervals using early-response biomarkers with ¹⁷⁷Lu-PSMA has the potential to achieve similar overall treatment responses to that published for continuous dosing, while allowing treatment holidays in responders and early crossover to potentially more effective therapies in nonresponders,” the authors conclude.

Given the effectiveness of this strategy, Dr. Nguyen says his team “now routinely uses these composite biomarkers when treating clinical patients.”

A version of this article appeared on Medscape.com.