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Surgeons, intensivists earn more than do colleagues from private insurance
General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.
On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.
None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.
The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.
Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.
This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.
The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.
The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:
- Anesthesiology: $1,665,510
- Cardiology: $1,703,013
- Critical Care (intensivist): $3,338,656
- Dermatology: $729,107
- Family medicine: $697,094
- Gastroenterology: $2,765,110
- Internal medicine: $1,297,200
- Neurology: $1,390,181
- Obstetrician/gynecology: $1,880,888
- Otolaryngology: $2,095,277
- Pediatrics: $661,552
- Psychiatry: $1,348,730
- Pulmonology: $1,561,617
- Radiology: $1,015,750
- Rheumatology: $1,705,140
- General surgery: $5,834,508
- Orthopedic surgery: $4,904,757
- Urology: $2,943,381
Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.
The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.
Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.
The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.
The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.
The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”
A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.
AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.
A version of this article originally appeared on Medscape.com.
General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.
On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.
None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.
The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.
Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.
This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.
The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.
The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:
- Anesthesiology: $1,665,510
- Cardiology: $1,703,013
- Critical Care (intensivist): $3,338,656
- Dermatology: $729,107
- Family medicine: $697,094
- Gastroenterology: $2,765,110
- Internal medicine: $1,297,200
- Neurology: $1,390,181
- Obstetrician/gynecology: $1,880,888
- Otolaryngology: $2,095,277
- Pediatrics: $661,552
- Psychiatry: $1,348,730
- Pulmonology: $1,561,617
- Radiology: $1,015,750
- Rheumatology: $1,705,140
- General surgery: $5,834,508
- Orthopedic surgery: $4,904,757
- Urology: $2,943,381
Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.
The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.
Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.
The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.
The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.
The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”
A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.
AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.
A version of this article originally appeared on Medscape.com.
General and orthopedic surgeons and intensivists earn the highest net reimbursements from private U.S. insurers, a new report estimates.
On average in 2021, they were paid $5.8 million, $4.9 million, and $3.3 million, respectively, according to figures compiled by AMN Healthcare, a Dallas-based health staffing company.
None of 15 other physician specialties topped $3 million in net reimbursement on average, and three – dermatology, pediatrics, and family medicine – didn’t reach $1 million.
The report doesn’t include data about reimbursement from Medicare and Medicaid, and its numbers assume that 50% of insurance claims are denied. Denial rates differ from practice to practice.
Still, the findings offer a “benchmark tool” to help clinicians understand how they rank against their peers, Linda Murphy, president of AMN Healthcare’s Revenue Cycle Solutions division, said in an interview.
This is the first year that the company has calculated physician reimbursement levels by using claim and clearinghouse data, Ms. Murphy said. Previously, a division of the firm compiled data by surveying chief financial officers from hospitals.
The report’s estimate that insurers deny 50% of claims is “conservative,” Ms. Murphy said. Miscoding is a significant factor behind that number.
The estimated 2021 net private insurance reimbursements by specialty for direct services, assuming a 50% denial rate:
- Anesthesiology: $1,665,510
- Cardiology: $1,703,013
- Critical Care (intensivist): $3,338,656
- Dermatology: $729,107
- Family medicine: $697,094
- Gastroenterology: $2,765,110
- Internal medicine: $1,297,200
- Neurology: $1,390,181
- Obstetrician/gynecology: $1,880,888
- Otolaryngology: $2,095,277
- Pediatrics: $661,552
- Psychiatry: $1,348,730
- Pulmonology: $1,561,617
- Radiology: $1,015,750
- Rheumatology: $1,705,140
- General surgery: $5,834,508
- Orthopedic surgery: $4,904,757
- Urology: $2,943,381
Among 18 physician specialties overall, the report estimated that the average net reimbursement in 2021 was $1.9 million.
The report also estimated that the net reimbursement amounts at $875,140 for certified registered nurse anesthetists and $388,696 for nurse practitioners.
Surprisingly, Ms. Murphy said, there’s “a really large swing” among reimbursement levels for individual specialties. The quartile of cardiologists with the lowest level of reimbursement, for example, submitted $2.1 million in claims in 2021, netting about $1 million at a 50% denial rate versus the $7.3 million made by those in the highest quartile, netting about $3.6 million.
The gap seems to be due to regional variations, she said, adding that a rural cardiologist will have different billing practices than does one practicing in New York City.
The quartile of general surgeons with the highest reimbursement levels billed for $21.1 million on average in 2021, making about $10.5 million at a 50% denial rate. The lowest quartile billed for $5.5 million, making about $2.7 million at a 50% denial rate.
The report noted that primary care physicians – that is, family medicine, internal medicine, and pediatrics specialists – have much lower levels of reimbursement, compared with most other specialties. But the work of primary care physicians “may lead to considerable ‘downstream revenue’ through the hospital admissions, tests and treatment they order.”
A previous analysis by a division of AMN Healthcare found that primary care physicians, on average, generate $2,113,273 a year in net annual revenue for their affiliated hospitals, nearing the $2,446,429 in net annual hospital revenue generated by specialists.
AMN Healthcare is preparing another report that will examine Medicare reimbursements, Ms. Murphy said. According to the new report, payments by nonprivate insurers amount to about one-third of the total amount of reimbursement by commercial insurers.
A version of this article originally appeared on Medscape.com.
From Beirut to frontline hematology research
“If we start treatment earlier, in the smoldering phase, maybe there is a chance of actually curing the disease and completely getting rid of it,” said Dr. Mouhieddine, 31, a research fellow at the Icahn School of Medicine at Mount Sinai, in New York. “We haven’t proven that yet, and it’s going to take years before we’re able to prove it. I’m hoping to be one of those spearheading the initiative.”
As he develops clinical trials, the young physician scientist has another focus: A deeply personal connection to the very disease he’s trying to cure. Last year Dr. Mouhieddine diagnosed his aunt back in Lebanon with multiple myeloma. “I have always been close to her, and I’m like her son,” he said, and her situation is especially scary because she lives in a country where treatment options are limited.
Dr. Mouhieddine was born and raised in Beirut, the son of a sports journalist father and a mother who worked in a bank. Lebanon’s civil war ended in 1990, shortly before his birth, but political instability returned when he was a child.
“Everything was a disaster,” he recalled. “There was a period of time when there were bombs throughout the city because certain politicians were being targeted. I remember when groups of people would have gunfights in the street.”
Dr. Mouhieddine attended the American University of Beirut, then after college and medical school there, he headed to the United States.
“I wanted to make a difference in medicine. And I knew that if I stayed back home, I wouldn’t be able to,” he said. Fortunately, “everybody has made me feel that I really belong here, and I’ve never felt like I’m an outsider.”
Early on, as he went through fellowships and residency, he developed an interest in multiple myeloma.
Ajai Chari, MD, a colleague of Dr. Mouhieddine’s at Icahn School of Medicine, said in an interview, “I remember meeting him at a conference before he had even started an internal medicine residency, let alone a hematology oncology fellowship. He was already certain he wanted to work in multiple myeloma, due to his work at Dana-Farber Cancer Institute.”
Myeloma was especially intriguing to Dr. Mouhieddine because of the rapid rate of progress in treating the disease. “Over the past 10 years, the myeloma field has advanced at such an extremely fast pace, more than any other cancer,” he said. “Maybe 15 years ago, you would tell someone with newly diagnosed myeloma that they had a chance for an average of another 2 years. Now, we tell patients they have 10 years to live on average, which means you could live 15 or 20 years. That alone was astounding to me and piqued my interest in myeloma.”
At the same time, smoldering myeloma – which can be discovered during routine blood work – remains little understood. As the National Cancer Institute explains, “smoldering myeloma is a precancerous condition that alters certain proteins in blood and/or increases plasma cells in bone marrow, but it does not cause symptoms of disease. About half of those diagnosed with the condition, however, will develop multiple myeloma within 5 years.”
“If we understand what drives smoldering myeloma, we may be able to prevent it from progressing to its active form,” said hematologist oncologist Samir Parekh, MD, who works with Dr. Mouhieddine at Icahn School of Medicine. “Or at the minimum, we could better predict who will progress so we can tailor therapy for high-risk patients and minimize toxicity by not overtreating patients who may not need therapy.”
Dr. Mouhieddine’s current work is focusing on developing clinical trials to test whether immunotherapy can snuff out myeloma when it’s at the smoldering stage, “before anything bad happens.
“If a myeloma patient comes in with renal failure, and we treat the myeloma at that stage, it doesn’t mean that the patient’s kidneys are gonna go back to normal. A lot of the damage can be permanent,” he said. “Even when you treat multiple myeloma, and it goes into remission, it ends up coming back. And you just have to go from one therapy to the other.”
In contrast, a successful treatment for smoldering myeloma would prevent progression to the full disease. In other words, it would be a cure – which is now elusive.
Specifically, Dr. Mouhieddine hopes to test whether bispecific antibodies, a type of immunotherapy that enlists the body’s T cells to kill myeloma cells, will be effective in the smoldering phase. Bispecific antibodies are now being explored as treatments for full multiple myeloma when the immune system is weaker, he said, and they may be even more effective earlier, when the body is better equipped to fight off the disease.
Dr. Mouhieddine hopes better treatments for multiple myeloma itself will help save his 64-year-old aunt Hassana, back in Beirut. He diagnosed her in 2022 after she told him that she felt tired all the time and underwent various tests. The woman he calls his “second mom” is doing well, despite struggles to buy medication due to the lack of access to bank funds in Lebanon.
“I’m always going to be afraid that the disease is going to progress or come back at some point,” he said. “Lebanon doesn’t have as many options as people in the U.S. do. Once you exhaust your first option, and maybe your second option, then you don’t have any other options. Here, we have outpatients who exhaust option number 15 and go to option number 16. That’s definitely not the case over there.”
For now, Dr. Mouhieddine is treating patients and working to launch clinical trials into smoldering myeloma. “His work ethic is incredible,” said his colleague, Dr. Chari. “He has seen multiple projects to publication, and he develops deep connections with his patients and follows up on their care whether or not he is in clinic on a particular day.”
Dr. Parekh, another colleague, said Dr. Mouhieddine can even be a role model. “Other trainees may benefit from thinking about their career early on and exploring both lab and clinical research projects, so that they can develop the necessary experience to be competitive in academia later on.”
His workload can a burden for Dr. Mouhieddine, who is Muslim. He expressed regret that his busy schedule does not always permit him to fast during Ramadan. On a nonmedical front, his recent efforts have paid off. In March 2023 Dr. Mouhieddine became a U.S. citizen.
“It’s surreal,” he said, “but also a dream come true. I feel very grateful, like it’s like an appreciation of who I am, what I’ve done, and what I can do for this country.”
“If we start treatment earlier, in the smoldering phase, maybe there is a chance of actually curing the disease and completely getting rid of it,” said Dr. Mouhieddine, 31, a research fellow at the Icahn School of Medicine at Mount Sinai, in New York. “We haven’t proven that yet, and it’s going to take years before we’re able to prove it. I’m hoping to be one of those spearheading the initiative.”
As he develops clinical trials, the young physician scientist has another focus: A deeply personal connection to the very disease he’s trying to cure. Last year Dr. Mouhieddine diagnosed his aunt back in Lebanon with multiple myeloma. “I have always been close to her, and I’m like her son,” he said, and her situation is especially scary because she lives in a country where treatment options are limited.
Dr. Mouhieddine was born and raised in Beirut, the son of a sports journalist father and a mother who worked in a bank. Lebanon’s civil war ended in 1990, shortly before his birth, but political instability returned when he was a child.
“Everything was a disaster,” he recalled. “There was a period of time when there were bombs throughout the city because certain politicians were being targeted. I remember when groups of people would have gunfights in the street.”
Dr. Mouhieddine attended the American University of Beirut, then after college and medical school there, he headed to the United States.
“I wanted to make a difference in medicine. And I knew that if I stayed back home, I wouldn’t be able to,” he said. Fortunately, “everybody has made me feel that I really belong here, and I’ve never felt like I’m an outsider.”
Early on, as he went through fellowships and residency, he developed an interest in multiple myeloma.
Ajai Chari, MD, a colleague of Dr. Mouhieddine’s at Icahn School of Medicine, said in an interview, “I remember meeting him at a conference before he had even started an internal medicine residency, let alone a hematology oncology fellowship. He was already certain he wanted to work in multiple myeloma, due to his work at Dana-Farber Cancer Institute.”
Myeloma was especially intriguing to Dr. Mouhieddine because of the rapid rate of progress in treating the disease. “Over the past 10 years, the myeloma field has advanced at such an extremely fast pace, more than any other cancer,” he said. “Maybe 15 years ago, you would tell someone with newly diagnosed myeloma that they had a chance for an average of another 2 years. Now, we tell patients they have 10 years to live on average, which means you could live 15 or 20 years. That alone was astounding to me and piqued my interest in myeloma.”
At the same time, smoldering myeloma – which can be discovered during routine blood work – remains little understood. As the National Cancer Institute explains, “smoldering myeloma is a precancerous condition that alters certain proteins in blood and/or increases plasma cells in bone marrow, but it does not cause symptoms of disease. About half of those diagnosed with the condition, however, will develop multiple myeloma within 5 years.”
“If we understand what drives smoldering myeloma, we may be able to prevent it from progressing to its active form,” said hematologist oncologist Samir Parekh, MD, who works with Dr. Mouhieddine at Icahn School of Medicine. “Or at the minimum, we could better predict who will progress so we can tailor therapy for high-risk patients and minimize toxicity by not overtreating patients who may not need therapy.”
Dr. Mouhieddine’s current work is focusing on developing clinical trials to test whether immunotherapy can snuff out myeloma when it’s at the smoldering stage, “before anything bad happens.
“If a myeloma patient comes in with renal failure, and we treat the myeloma at that stage, it doesn’t mean that the patient’s kidneys are gonna go back to normal. A lot of the damage can be permanent,” he said. “Even when you treat multiple myeloma, and it goes into remission, it ends up coming back. And you just have to go from one therapy to the other.”
In contrast, a successful treatment for smoldering myeloma would prevent progression to the full disease. In other words, it would be a cure – which is now elusive.
Specifically, Dr. Mouhieddine hopes to test whether bispecific antibodies, a type of immunotherapy that enlists the body’s T cells to kill myeloma cells, will be effective in the smoldering phase. Bispecific antibodies are now being explored as treatments for full multiple myeloma when the immune system is weaker, he said, and they may be even more effective earlier, when the body is better equipped to fight off the disease.
Dr. Mouhieddine hopes better treatments for multiple myeloma itself will help save his 64-year-old aunt Hassana, back in Beirut. He diagnosed her in 2022 after she told him that she felt tired all the time and underwent various tests. The woman he calls his “second mom” is doing well, despite struggles to buy medication due to the lack of access to bank funds in Lebanon.
“I’m always going to be afraid that the disease is going to progress or come back at some point,” he said. “Lebanon doesn’t have as many options as people in the U.S. do. Once you exhaust your first option, and maybe your second option, then you don’t have any other options. Here, we have outpatients who exhaust option number 15 and go to option number 16. That’s definitely not the case over there.”
For now, Dr. Mouhieddine is treating patients and working to launch clinical trials into smoldering myeloma. “His work ethic is incredible,” said his colleague, Dr. Chari. “He has seen multiple projects to publication, and he develops deep connections with his patients and follows up on their care whether or not he is in clinic on a particular day.”
Dr. Parekh, another colleague, said Dr. Mouhieddine can even be a role model. “Other trainees may benefit from thinking about their career early on and exploring both lab and clinical research projects, so that they can develop the necessary experience to be competitive in academia later on.”
His workload can a burden for Dr. Mouhieddine, who is Muslim. He expressed regret that his busy schedule does not always permit him to fast during Ramadan. On a nonmedical front, his recent efforts have paid off. In March 2023 Dr. Mouhieddine became a U.S. citizen.
“It’s surreal,” he said, “but also a dream come true. I feel very grateful, like it’s like an appreciation of who I am, what I’ve done, and what I can do for this country.”
“If we start treatment earlier, in the smoldering phase, maybe there is a chance of actually curing the disease and completely getting rid of it,” said Dr. Mouhieddine, 31, a research fellow at the Icahn School of Medicine at Mount Sinai, in New York. “We haven’t proven that yet, and it’s going to take years before we’re able to prove it. I’m hoping to be one of those spearheading the initiative.”
As he develops clinical trials, the young physician scientist has another focus: A deeply personal connection to the very disease he’s trying to cure. Last year Dr. Mouhieddine diagnosed his aunt back in Lebanon with multiple myeloma. “I have always been close to her, and I’m like her son,” he said, and her situation is especially scary because she lives in a country where treatment options are limited.
Dr. Mouhieddine was born and raised in Beirut, the son of a sports journalist father and a mother who worked in a bank. Lebanon’s civil war ended in 1990, shortly before his birth, but political instability returned when he was a child.
“Everything was a disaster,” he recalled. “There was a period of time when there were bombs throughout the city because certain politicians were being targeted. I remember when groups of people would have gunfights in the street.”
Dr. Mouhieddine attended the American University of Beirut, then after college and medical school there, he headed to the United States.
“I wanted to make a difference in medicine. And I knew that if I stayed back home, I wouldn’t be able to,” he said. Fortunately, “everybody has made me feel that I really belong here, and I’ve never felt like I’m an outsider.”
Early on, as he went through fellowships and residency, he developed an interest in multiple myeloma.
Ajai Chari, MD, a colleague of Dr. Mouhieddine’s at Icahn School of Medicine, said in an interview, “I remember meeting him at a conference before he had even started an internal medicine residency, let alone a hematology oncology fellowship. He was already certain he wanted to work in multiple myeloma, due to his work at Dana-Farber Cancer Institute.”
Myeloma was especially intriguing to Dr. Mouhieddine because of the rapid rate of progress in treating the disease. “Over the past 10 years, the myeloma field has advanced at such an extremely fast pace, more than any other cancer,” he said. “Maybe 15 years ago, you would tell someone with newly diagnosed myeloma that they had a chance for an average of another 2 years. Now, we tell patients they have 10 years to live on average, which means you could live 15 or 20 years. That alone was astounding to me and piqued my interest in myeloma.”
At the same time, smoldering myeloma – which can be discovered during routine blood work – remains little understood. As the National Cancer Institute explains, “smoldering myeloma is a precancerous condition that alters certain proteins in blood and/or increases plasma cells in bone marrow, but it does not cause symptoms of disease. About half of those diagnosed with the condition, however, will develop multiple myeloma within 5 years.”
“If we understand what drives smoldering myeloma, we may be able to prevent it from progressing to its active form,” said hematologist oncologist Samir Parekh, MD, who works with Dr. Mouhieddine at Icahn School of Medicine. “Or at the minimum, we could better predict who will progress so we can tailor therapy for high-risk patients and minimize toxicity by not overtreating patients who may not need therapy.”
Dr. Mouhieddine’s current work is focusing on developing clinical trials to test whether immunotherapy can snuff out myeloma when it’s at the smoldering stage, “before anything bad happens.
“If a myeloma patient comes in with renal failure, and we treat the myeloma at that stage, it doesn’t mean that the patient’s kidneys are gonna go back to normal. A lot of the damage can be permanent,” he said. “Even when you treat multiple myeloma, and it goes into remission, it ends up coming back. And you just have to go from one therapy to the other.”
In contrast, a successful treatment for smoldering myeloma would prevent progression to the full disease. In other words, it would be a cure – which is now elusive.
Specifically, Dr. Mouhieddine hopes to test whether bispecific antibodies, a type of immunotherapy that enlists the body’s T cells to kill myeloma cells, will be effective in the smoldering phase. Bispecific antibodies are now being explored as treatments for full multiple myeloma when the immune system is weaker, he said, and they may be even more effective earlier, when the body is better equipped to fight off the disease.
Dr. Mouhieddine hopes better treatments for multiple myeloma itself will help save his 64-year-old aunt Hassana, back in Beirut. He diagnosed her in 2022 after she told him that she felt tired all the time and underwent various tests. The woman he calls his “second mom” is doing well, despite struggles to buy medication due to the lack of access to bank funds in Lebanon.
“I’m always going to be afraid that the disease is going to progress or come back at some point,” he said. “Lebanon doesn’t have as many options as people in the U.S. do. Once you exhaust your first option, and maybe your second option, then you don’t have any other options. Here, we have outpatients who exhaust option number 15 and go to option number 16. That’s definitely not the case over there.”
For now, Dr. Mouhieddine is treating patients and working to launch clinical trials into smoldering myeloma. “His work ethic is incredible,” said his colleague, Dr. Chari. “He has seen multiple projects to publication, and he develops deep connections with his patients and follows up on their care whether or not he is in clinic on a particular day.”
Dr. Parekh, another colleague, said Dr. Mouhieddine can even be a role model. “Other trainees may benefit from thinking about their career early on and exploring both lab and clinical research projects, so that they can develop the necessary experience to be competitive in academia later on.”
His workload can a burden for Dr. Mouhieddine, who is Muslim. He expressed regret that his busy schedule does not always permit him to fast during Ramadan. On a nonmedical front, his recent efforts have paid off. In March 2023 Dr. Mouhieddine became a U.S. citizen.
“It’s surreal,” he said, “but also a dream come true. I feel very grateful, like it’s like an appreciation of who I am, what I’ve done, and what I can do for this country.”
Study gives new insight into timing of combo treatment in metastatic NSCLC
However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.
While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.
The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”
Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.
Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”
But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”
For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.
The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.
Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).
Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).
However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).
There wasn’t a statistically significant difference in overall survival.
The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.
As for adverse effects, she said a preliminary analysis didn’t turn up any.
It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.
In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.
Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.
No funding was reported. The study authors and Dr. Campbell reported no disclosures.
However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.
While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.
The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”
Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.
Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”
But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”
For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.
The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.
Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).
Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).
However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).
There wasn’t a statistically significant difference in overall survival.
The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.
As for adverse effects, she said a preliminary analysis didn’t turn up any.
It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.
In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.
Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.
No funding was reported. The study authors and Dr. Campbell reported no disclosures.
However, patients still fared poorly on average since overall survival remained low and didn’t change significantly.
While not conclusive, the new research – released at European Lung Cancer Congress 2023 – offers early insight into the best timing for the experimental combination treatment, study coauthor Yanyan Lou, MD, PhD, an oncologist at Mayo Clinic in Jacksonville, Fla., said in an interview.
The wide availability of radiation therapy could also allow the therapy to be administered even in regions with poor access to sophisticated medical care, she said. “Radiation is a very feasible approach that pretty much everybody in your community can get.”
Radiotherapy is typically not added to immunotherapy in patients with non–small cell lung cancer. But “there has been recent interest in the combination: Would tumor necrosis from radiation enhance the immunogenicity of the tumor and thus enhance the effect of immunotherapy?” oncologist Toby Campbell, MD, of University of Wisconsin–Madison, said in an interview.
Research has indeed suggested that the treatments may have a synergistic effect, he said, and it’s clear that “strategies to try and increase immunogenicity are an important area to investigate.”
But he cautioned that “we have a long way to go to understanding how immunogenicity works and how the gut microbiome, tumor, immunotherapy, and the immune system interact with one another.”
For the new study, researchers retrospectively analyzed cases of 225 patients with metastatic non–small cell lung cancer (male = 56%, median age = 68, 79% adenocarcinoma) who were treated with immunotherapy at Mayo Clinic–Jacksonville from 2011 to 2022. The study excluded those who received targeted therapy or prior concurrent chemoradiotherapy and durvalumab.
The most common metastases were bone and central nervous system types (41% and 25%, respectively). Fifty-six percent of patients received radiotherapy before or during immunotherapy. Another 27% never received radiotherapy, and 17% received it after immunotherapy was discontinued.
Common types of immunotherapy included pembrolizumab (78%), nivolumab (14%), and atezolizumab (12%).
Overall, the researchers found no statistically significant differences in various outcomes between patients who received radiotherapy before or during immunotherapy compared with those who didn’t get radiotherapy (progression-free survival: 5.9 vs. 5.5 months, P = .66; overall survival: 16.9 vs. 13.1 months, P = .84; immune-related adverse events: 26.2% vs. 34.4%, P = .24).
However, the researchers found that progression-free survival was significantly higher in one group: Those who received radiotherapy 1-12 months before immunotherapy vs. those who received it less than 1 month before (12.6 vs. 4.2 months, hazard ratio [HR], 0.46, 95% confidence interval [CI], 0.26-0.83, P = .005,) and those who never received radiotherapy (12.6 vs. 5.5 months, HR, 0.56, 95% CI, 0.36-0.89, P = .0197).
There wasn’t a statistically significant difference in overall survival.
The small number of subjects and the variation in treatment protocols may have prevented the study from revealing a survival benefit, Dr. Lou said.
As for adverse effects, she said a preliminary analysis didn’t turn up any.
It’s not clear why a 1- to 12-month gap between radiotherapy and immunotherapy may be most effective, she said. Moving forward, “we need validate this in a large cohort,” she noted.
In regard to cost, immunotherapy is notoriously expensive. Pembrolizumab, for example, has a list price of $10,897 per 200-mg dose given every 3 weeks, and patients may take the drug for a year or two.
Dr. Campbell, who didn’t take part in the new study, said it suggests that research into radiation-immunotherapy combination treatment may be worthwhile.
No funding was reported. The study authors and Dr. Campbell reported no disclosures.
FROM ELCC 2023
Long-term heavy smoking quadruples likelihood of lung cancer vs. less heavy smoking
People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.
The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.
The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.
By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.
The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”
For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).
Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).
“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.
As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”
The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.
In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”
No study funding is reported. The study authors and Dr. Volk reported no disclosures.
*This article was updated on 4/17/23.
People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.
The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.
The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.
By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.
The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”
For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).
Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).
“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.
As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”
The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.
In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”
No study funding is reported. The study authors and Dr. Volk reported no disclosures.
*This article was updated on 4/17/23.
People who have smoked an average of 1 pack a day for 20-39 years tripled their tumor risk versus less-heavy smokers and 30-fold versus those who never smoked. For those who smoked the equivalent of 1 pack for 40-60 years, or 2 packs for 20-30 years, the risk levels grew by fourfold and 40-fold, respectively. For those who’ve smoked even more, the likelihood of developing lung cancer is high, but the risk remains stable and doesn’t grow more over time, according to the analysis.
The report, released at the annual European Lung Cancer Congress 2023 meeting, and an earlier related study “underscore the importance of smoking abstinence and early smoking cessation,” said study lead author J. Anthony Nations, MD, MBA, in an interview.
The earlier study, published in JAMA Oncology, relied on a “pack-year” analysis to evaluate the risk of lung cancer in smokers. A pack-year refers to the cigarette use of a person who smoked a pack a day for 1 year. It’s the equivalent of smoking half a pack for 2 years or 2 packs for 6 months.
By this measure, a smoker with 20 pack-years of cigarette use smoked the equivalent of a pack a day for 20 years or 2 packs a day for 10 years. U.S. guidelines recommend annual low-dose CT lung cancer screening in adults who are aged 50-80, have more than 20 pack-years of tobacco exposure, and either currently smoke or quit within the last 15 years.
The JAMA Oncology report “showed that, compared with never-smokers, current heavy and nonheavy smokers had [a] 40 and 10 times higher risk of lung cancer, respectively,” said Dr. Nations, who is also a pulmonologist with Washington D.C. Veterans Affairs Medical Center. “A smoking history of greater than 20 pack-years was considered heavy, but current heavy smokers had a median pack-year smoking history of 50 pack-years. This observation prompted us to want to look more closely at pack-year smoking history.”
For the new analysis, researchers tracked 2,505 older adults (mean age, 73 ± 5.7 years; 69% women, 17% African American) in the Cardiovascular Health Study. Of those, 532 were current smokers (18% less than 20 pack-years, 30% 20-39 pack-years, 34% 40–59 pack-years, and 18% greater than 60 pack-years).
Lung cancer occurred in 0.5% of those who never smoked, 5% of those who smoked less than 20 pack-years, 14.6% of those who smoked 20-39 pack-years, 17.7% of those who smoked 40-59 pack-years, and 16.0% for those who smoked more than 60 pack-years. In an analysis adjusted for age, sex, race, and competing risk of death, researchers found that those who smoked less than 20 pack-years were 9.73 times more likely to develop lung cancer than those who never smoked (hazard ratio, 9.73). The HRs of lung cancer versus never-smokers for the other groups were 30.33 (20-39 pack-years), 42.97 (40-59 pack-years), and 46.02 (greater than 60 pack-years.).
“While it was not surprising that the risk of lung cancer in current heavy smokers would be proportionately greater in smokers with higher pack-year smoking history, we were surprised to see that the risk almost plateaued in the heaviest current smokers,” Dr. Nations said.
As for the clinical message from the findings, Dr. Nations said they reveal that quitting smoking makes a difference in lung cancer risk, even after many years of heavy smoking. “Smokers who quit after a 30–pack-year smoking history will not incur the higher risk of those with a 40– or 50–pack-year smoking history.”
The previous JAMA Oncology paper also showed that quitting pays dividends by reducing lung cancer risk. Subjects with at least 20 pack-years of smoking who quit less than 15 years ago nearly halved their excess risk of lung cancer, compared with similar current smokers who didn’t quit.
In an interview, cancer researcher Robert J. Volk, PhD, of the University of Texas MD Anderson Cancer Center, Houston, praised the new analysis but noted that it has limitations: “The sample is fairly small – 532 adults who currently smoke – and the subgroups based on pack-years are even smaller.”
No study funding is reported. The study authors and Dr. Volk reported no disclosures.
*This article was updated on 4/17/23.
FROM ELCC 2023
First target doesn’t affect survival in NSCLC with brain metastases
“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.
The study was released at European Lung Cancer Congress 2023.
According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.
“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”
However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”
For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.
There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)
“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.
He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”
Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”
He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”
No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.
“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.
The study was released at European Lung Cancer Congress 2023.
According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.
“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”
However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”
For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.
There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)
“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.
He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”
Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”
He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”
No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.
“The findings of our study highlight the importance of adopting a personalized, case-based approach when treating each patient” instead of always treating the brain or lung first, lead author Arvind Kumar, a medical student at Icahn School of Medicine at Mount Sinai, New York, said in an interview.
The study was released at European Lung Cancer Congress 2023.
According to the author, current guidelines recommend treating the brain first in patients with non–small cell lung cancer and a tumor that has spread to the brain.
“Determining whether the brain or body gets treated first depends on where the symptoms are coming from, how severe the symptoms are, how bulky the disease is, and how long the treatment to each is expected to take,” radiation oncologist Henry S. Park, MD, MPH, chief of the thoracic radiotherapy program at Yale University, New Haven, Conn., said in an interview. “Often the brain is treated first since surgery is used for both diagnosis of metastatic disease as well as removal of the brain metastasis, especially if it is causing symptoms. The radiosurgery that follows tends to occur within a day or a few days.”
However, he said, “if the brain disease is small and not causing symptoms, and the lung disease is more problematic, then we will often treat the body first and fit in the brain treatment later.”
For the new study, researchers identified 1,044 patients in the National Cancer Database with non–small cell lung cancer and brain metastases who received systemic therapy plus surgery, brain stereotactic radiosurgery, or lung radiation. All were treated from 2010 to 2019; 79.0% received brain treatment first, and the other 21.0% received lung treatment first.
There was no statistically significant difference in overall survival between those whose brains were treated first and those whose lungs were treated first (hazard ratio, 1.24, 95% confidence interval [CI], 0.91-1.70, P = .17). A propensity score–matched analysis turned up no difference in 5-year survival (38.2% of those whose brains were treated first, 95% CI, 27.5-34.4, vs. 38.0% of those whose lungs were treated first, 95% CI, 29.9-44.7, P = .32.)
“These results were consistent regardless of which combination of treatment modalities the patient received – neurosurgery versus brain stereotactic radiosurgery, thoracic surgery versus thoracic radiation,” the author said.
He cautioned that “our study only included patients who were considered candidates for either surgery or radiation to both the brain and lung. The results of our study should therefore be cautiously interpreted for patients who may have contraindications to such treatment.”
Dr. Park, who didn’t take part in the study, said “the results are consistent with what I would generally expect.”
He added: “The take-home message for clinicians should be that there is no one correct answer in how to manage non–small cell lung cancer with synchronous limited metastatic disease in only the brain. If the brain disease is bulky and/or causes symptoms while the body disease isn’t – or if a biopsy or surgery is required to prove that the patient in fact has metastatic disease – then the brain disease should be treated first. On the other hand, if the body disease is bulky and/or causing symptoms while the brain disease isn’t – and there is no need for surgery but rather only a biopsy of the brain – then the body disease can be treated first.”
No funding was reported. The study authors and Dr. Park reported no financial conflicts or other disclosures.
FROM ELCC 2023
New coalition aims to revolutionize stalled lupus research
Clinical research into lupus has long been hampered by failures of medications that initially seemed promising. Now, a coalition of drugmakers, federal regulators, and activists has come together to forge a path toward better-designed studies and – potentially – groundbreaking new drugs.
“We have an opportunity to work collaboratively in lupus to address the challenges in drug development,” Teodora Staeva, PhD, vice president and chief scientific officer of the Lupus Research Alliance, said in an interview.
The alliance held a press conference on March 29 to announce the formation of the public-private Lupus Accelerating Breakthroughs Consortium. Coalition members include several major drugmakers, lupus organizations such as the LRA, the American College of Rheumatology, the Food and Drug Administration, and other federal agencies. Academic researchers, people living with lupus, caregivers and family members, and other members of the lupus community are also on board.
As Dr. Staeva explained, research into lupus has been marked by a high rate of failure. “Often, phase 2 trial successes have not translated into phase 3 successes,” she said.
But researchers, she said, don’t tend to think this is because the drugs themselves are useless.
Instead, it appears that “trial designs are not adequate to capture meaningful readouts of the drug effects, and that may have contributed to the multiple failures,” she said.
According to her, this may because the trials aren’t yet designed to fully detect whether drugs are useful. This is difficult to accomplish since patients have so many manifestations of the disease and trial participants already take a variety of existing drugs.
“Another major limitation has been the lack of integration of the patient’s voice and needs in the drug development process,” she said. It’s also challenging to recruit patients with the most severe lupus to participate in studies, especially since the trials often last 52 weeks.
The new coalition will not directly develop or favor specific drugs. Instead, it will focus on clinical research priorities. “It’s all open and collaborative,” Dr. Staeva explained, and a patient council will provide input. “We have a unique opportunity to bring the voice of people [living with lupus] to the table for the first time and be able to integrate their needs and priorities into the infrastructure.”
The new coalition was inspired by existing public-private partnerships such as the Kidney Health Initiative, she said. That initiative was founded in 2012 by the FDA and the American Society of Nephrology and has dozens of members, including multiple drugmakers and medical societies.
The leadership of the Lupus ABC coalition will include three nonvoting members from the FDA. They’ll offer guidance, Dr. Staeva said. At the press conference, Albert T. Roy, president and CEO of the LRA, said drug companies will appreciate the opportunity to speak with FDA representatives “in a space that is not competitive with respect to intellectual property or anything like that.”
The coalition will meet later in spring 2023, Dr. Staeva said. She hopes it will launch a couple of projects by the end of 2023 and be able to release preliminary results by the end of 2024.
One challenge will be figuring out how to stratify trial subjects so drug studies will more easily detect medications that may work in smaller populations of patients, Hoang Nguyen, PhD, director of scientific partnerships at the LRA, said in an interview. “Now we lump [patients] all together, and that’s not the optimal way to test drugs on patients who have a lot of differences.”
According to Dr. Staeva, the LRA funded the development of the coalition, and drugmakers will primarily provide financial support going forward. The pharmaceutical company members of the coalition are Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, GlaxoSmithKline, Merck, and Takeda.
Dr. Staeva, Dr. Nguyen, and Mr. Roy have no disclosures.
Clinical research into lupus has long been hampered by failures of medications that initially seemed promising. Now, a coalition of drugmakers, federal regulators, and activists has come together to forge a path toward better-designed studies and – potentially – groundbreaking new drugs.
“We have an opportunity to work collaboratively in lupus to address the challenges in drug development,” Teodora Staeva, PhD, vice president and chief scientific officer of the Lupus Research Alliance, said in an interview.
The alliance held a press conference on March 29 to announce the formation of the public-private Lupus Accelerating Breakthroughs Consortium. Coalition members include several major drugmakers, lupus organizations such as the LRA, the American College of Rheumatology, the Food and Drug Administration, and other federal agencies. Academic researchers, people living with lupus, caregivers and family members, and other members of the lupus community are also on board.
As Dr. Staeva explained, research into lupus has been marked by a high rate of failure. “Often, phase 2 trial successes have not translated into phase 3 successes,” she said.
But researchers, she said, don’t tend to think this is because the drugs themselves are useless.
Instead, it appears that “trial designs are not adequate to capture meaningful readouts of the drug effects, and that may have contributed to the multiple failures,” she said.
According to her, this may because the trials aren’t yet designed to fully detect whether drugs are useful. This is difficult to accomplish since patients have so many manifestations of the disease and trial participants already take a variety of existing drugs.
“Another major limitation has been the lack of integration of the patient’s voice and needs in the drug development process,” she said. It’s also challenging to recruit patients with the most severe lupus to participate in studies, especially since the trials often last 52 weeks.
The new coalition will not directly develop or favor specific drugs. Instead, it will focus on clinical research priorities. “It’s all open and collaborative,” Dr. Staeva explained, and a patient council will provide input. “We have a unique opportunity to bring the voice of people [living with lupus] to the table for the first time and be able to integrate their needs and priorities into the infrastructure.”
The new coalition was inspired by existing public-private partnerships such as the Kidney Health Initiative, she said. That initiative was founded in 2012 by the FDA and the American Society of Nephrology and has dozens of members, including multiple drugmakers and medical societies.
The leadership of the Lupus ABC coalition will include three nonvoting members from the FDA. They’ll offer guidance, Dr. Staeva said. At the press conference, Albert T. Roy, president and CEO of the LRA, said drug companies will appreciate the opportunity to speak with FDA representatives “in a space that is not competitive with respect to intellectual property or anything like that.”
The coalition will meet later in spring 2023, Dr. Staeva said. She hopes it will launch a couple of projects by the end of 2023 and be able to release preliminary results by the end of 2024.
One challenge will be figuring out how to stratify trial subjects so drug studies will more easily detect medications that may work in smaller populations of patients, Hoang Nguyen, PhD, director of scientific partnerships at the LRA, said in an interview. “Now we lump [patients] all together, and that’s not the optimal way to test drugs on patients who have a lot of differences.”
According to Dr. Staeva, the LRA funded the development of the coalition, and drugmakers will primarily provide financial support going forward. The pharmaceutical company members of the coalition are Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, GlaxoSmithKline, Merck, and Takeda.
Dr. Staeva, Dr. Nguyen, and Mr. Roy have no disclosures.
Clinical research into lupus has long been hampered by failures of medications that initially seemed promising. Now, a coalition of drugmakers, federal regulators, and activists has come together to forge a path toward better-designed studies and – potentially – groundbreaking new drugs.
“We have an opportunity to work collaboratively in lupus to address the challenges in drug development,” Teodora Staeva, PhD, vice president and chief scientific officer of the Lupus Research Alliance, said in an interview.
The alliance held a press conference on March 29 to announce the formation of the public-private Lupus Accelerating Breakthroughs Consortium. Coalition members include several major drugmakers, lupus organizations such as the LRA, the American College of Rheumatology, the Food and Drug Administration, and other federal agencies. Academic researchers, people living with lupus, caregivers and family members, and other members of the lupus community are also on board.
As Dr. Staeva explained, research into lupus has been marked by a high rate of failure. “Often, phase 2 trial successes have not translated into phase 3 successes,” she said.
But researchers, she said, don’t tend to think this is because the drugs themselves are useless.
Instead, it appears that “trial designs are not adequate to capture meaningful readouts of the drug effects, and that may have contributed to the multiple failures,” she said.
According to her, this may because the trials aren’t yet designed to fully detect whether drugs are useful. This is difficult to accomplish since patients have so many manifestations of the disease and trial participants already take a variety of existing drugs.
“Another major limitation has been the lack of integration of the patient’s voice and needs in the drug development process,” she said. It’s also challenging to recruit patients with the most severe lupus to participate in studies, especially since the trials often last 52 weeks.
The new coalition will not directly develop or favor specific drugs. Instead, it will focus on clinical research priorities. “It’s all open and collaborative,” Dr. Staeva explained, and a patient council will provide input. “We have a unique opportunity to bring the voice of people [living with lupus] to the table for the first time and be able to integrate their needs and priorities into the infrastructure.”
The new coalition was inspired by existing public-private partnerships such as the Kidney Health Initiative, she said. That initiative was founded in 2012 by the FDA and the American Society of Nephrology and has dozens of members, including multiple drugmakers and medical societies.
The leadership of the Lupus ABC coalition will include three nonvoting members from the FDA. They’ll offer guidance, Dr. Staeva said. At the press conference, Albert T. Roy, president and CEO of the LRA, said drug companies will appreciate the opportunity to speak with FDA representatives “in a space that is not competitive with respect to intellectual property or anything like that.”
The coalition will meet later in spring 2023, Dr. Staeva said. She hopes it will launch a couple of projects by the end of 2023 and be able to release preliminary results by the end of 2024.
One challenge will be figuring out how to stratify trial subjects so drug studies will more easily detect medications that may work in smaller populations of patients, Hoang Nguyen, PhD, director of scientific partnerships at the LRA, said in an interview. “Now we lump [patients] all together, and that’s not the optimal way to test drugs on patients who have a lot of differences.”
According to Dr. Staeva, the LRA funded the development of the coalition, and drugmakers will primarily provide financial support going forward. The pharmaceutical company members of the coalition are Biogen, Bristol-Myers Squibb, Eli Lilly, EMD Serono, Genentech, Gilead, GlaxoSmithKline, Merck, and Takeda.
Dr. Staeva, Dr. Nguyen, and Mr. Roy have no disclosures.
B-cell cancers: Sparse insight into preventing infections
Researchers found just 22 randomized controlled studies into prophylactic strategies, with several of them conducted prior to 2000. According to the report, published in Blood Advances, the studies together only evaluated a few thousand participants.
Reliable findings are so sparse that study coauthor Zoe McQuilten, MBBS, PhD, MD, a hematologist at Monash University, Melbourne, said “we simply don’t know” which preventive strategy is most effective. This is especially worrisome because more patients will survive their cancers and “be at risk of infection or have significant cytopenias and will experience impaired quality of life as a result,” she said in an interview.
The study authors launched the analysis to better understand the evidence regarding infection prevention and to guide the development of clinical trials, study coauthor Robert Weinkove, MBBS, PhD, a hematologist at Malaghan Institute of Medical Research, Wellington, New Zealand, said in an interview.
As he explained, targeted therapies have revolutionized the treatment of some B-cell cancers. They also have boosted the number of patients who survive the diseases yet still have profound hypogammaglobulinemia.
“Indeed, we may soon reach the point at which infection, and not tumor progression, is the leading cause of death for patients with certain B-cell cancers,” he said. “The evidence base for managing hypogammaglobulinemia is largely based on randomized trials of immunoglobulin replacement conducted in the 1980s and early 1990s, before the advent of B cell–targeted therapies. Immunoglobulin replacement is a costly intervention, and many countries are facing a shortage of immunoglobulin.”
The report authors identified 22 total randomized controlled trials, including one led by Dr. McQuilten: 8 studies into prophylactic immunoglobulin (n = 370; all but 1 study published prior to 2000), 5 into prophylactic antibiotics (n = 1,587), 7 into vaccination (n = 3,996), and 1 comparing immunoglobulin versus antibiotics (n = 60).
No evidence was found to support a lowering of risk by prophylactic antibiotics, although they caused adverse events.
Prophylactic immunoglobulin also caused adverse events, but a meta-analysis found that it reduced the risk of clinically documented infection by 28% (n = 2 trials; relative risk, 0.72; 95% confidence interval, 0.54-0.96). Three trials reported adverse events and found a higher risk overall (RR, 2.23; 95% CI, 1.67-2.99).
Varicella zoster virus vaccination reduced the risk of one or more infections by 63% (n = 5 trials, RR, 0.37; 95% CI, 0.30-0.45, n = 3,515). Prophylactic antibiotics did not reduce the risk.
No intervention reduced all-cause mortality.
“Our findings should be interpreted with caution, Dr. McQuilten said, “because of the low number of patients, high risk of bias in the included studies, and lack of contemporary data applicable to the current standard of care for such patients.”
The lack of useful data is surprising, she said, especially considering “how commonly these interventions are used in current clinical practice and the cost and supply constraints for immunoglobulin. Given the variation in international guidelines, rising global demand and cost of immunoglobulin, and concerns regarding antimicrobial resistance, more evidence is needed to inform infection prevention strategies for this patient population.”
More data is expected soon. One ongoing study is examining intravenous immunoglobulin versus placebo in patients with CLL. It’s expected to be completed in September 2023.
What should clinicians do for now? “Given the lack of a proven survival benefit in favor of prophylactic immunoglobulin replacement, one strategy is to maximize use of vaccination and to educate both patients and clinicians regarding the need for early treatment of infections,” Dr. Weinkove said. “For people who have recurrent or severe infections despite these measures, both immunoglobulin replacement and prophylactic antibiotics are clinical options. It would be reasonable to take account of patient preference, logistical considerations, and reimbursement and availability in deciding between these options.”
He added that, “for people with severe hypogammaglobulinemia who experience recurrent or severe infections despite prophylactic antibiotics, switching to immunoglobulin replacement would be appropriate. We advocate enrollment in clinical trials, if possible.”
In an interview, Juthaporn Cowan, MD, PhD, an infectious disease physician with the University of Ottawa, said many patients with B-cell lymphomas develop acquired hypogammaglobulinemia. “Patients tend to get prolonged colds, frequent sinusitis, bronchitis, or pneumonia. Some can end up with severe infection. Many patients told me that, even though their cancer is cured or in remission, quality of life is still quite poor due to these infections and fatigue.”
Dr. Cowan said the new report is somewhat useful, although “concluding that vaccination reduces infection is misleading. Vaccination reduces the infection that patients were vaccinated against. Patients who received Shingrix will have less shingles but will continue to have bronchitis and other infections.”
As for advice for clinicians, she said preventing acquired hypogammaglobulinemia is difficult since it can be caused by the malignancies, by treatment, or both. “The other item to consider is that we do not know how long we should continue [immunoglobulin] treatment in these patients. I have a patient post CAR [chimeric antigen receptor] T therapy who still does not have B-cell 5-6 years after CAR T, while I have lymphoma patients who could safely discontinue [immunoglobulin] treatment in a few years.”
Dr. Cowan added that patients on immunoglobulin treatment can still get opportunistic infections from cytomegalovirus or herpes simplex virus “because the mechanism of host defense against these infections is different. Antimicrobial prophylaxis should still be considered as vaccination is not available for every single potential opportunistic infection.”
Australia funded the research through the National Blood Authority. Dr. McQuilten and Dr. Weinkove reported no disclosures. Other report authors disclosed ties with Aegros, CSL Behring, Janssen, AbbVie, and BeiGene. Monash University has received funding for unrelated projects from CSL Behring. Dr. Cowan reports honoraria from Takeda, CSL Behring, Octapharma, GlaxoSmithKline, Merck, and AstraZeneca.
Researchers found just 22 randomized controlled studies into prophylactic strategies, with several of them conducted prior to 2000. According to the report, published in Blood Advances, the studies together only evaluated a few thousand participants.
Reliable findings are so sparse that study coauthor Zoe McQuilten, MBBS, PhD, MD, a hematologist at Monash University, Melbourne, said “we simply don’t know” which preventive strategy is most effective. This is especially worrisome because more patients will survive their cancers and “be at risk of infection or have significant cytopenias and will experience impaired quality of life as a result,” she said in an interview.
The study authors launched the analysis to better understand the evidence regarding infection prevention and to guide the development of clinical trials, study coauthor Robert Weinkove, MBBS, PhD, a hematologist at Malaghan Institute of Medical Research, Wellington, New Zealand, said in an interview.
As he explained, targeted therapies have revolutionized the treatment of some B-cell cancers. They also have boosted the number of patients who survive the diseases yet still have profound hypogammaglobulinemia.
“Indeed, we may soon reach the point at which infection, and not tumor progression, is the leading cause of death for patients with certain B-cell cancers,” he said. “The evidence base for managing hypogammaglobulinemia is largely based on randomized trials of immunoglobulin replacement conducted in the 1980s and early 1990s, before the advent of B cell–targeted therapies. Immunoglobulin replacement is a costly intervention, and many countries are facing a shortage of immunoglobulin.”
The report authors identified 22 total randomized controlled trials, including one led by Dr. McQuilten: 8 studies into prophylactic immunoglobulin (n = 370; all but 1 study published prior to 2000), 5 into prophylactic antibiotics (n = 1,587), 7 into vaccination (n = 3,996), and 1 comparing immunoglobulin versus antibiotics (n = 60).
No evidence was found to support a lowering of risk by prophylactic antibiotics, although they caused adverse events.
Prophylactic immunoglobulin also caused adverse events, but a meta-analysis found that it reduced the risk of clinically documented infection by 28% (n = 2 trials; relative risk, 0.72; 95% confidence interval, 0.54-0.96). Three trials reported adverse events and found a higher risk overall (RR, 2.23; 95% CI, 1.67-2.99).
Varicella zoster virus vaccination reduced the risk of one or more infections by 63% (n = 5 trials, RR, 0.37; 95% CI, 0.30-0.45, n = 3,515). Prophylactic antibiotics did not reduce the risk.
No intervention reduced all-cause mortality.
“Our findings should be interpreted with caution, Dr. McQuilten said, “because of the low number of patients, high risk of bias in the included studies, and lack of contemporary data applicable to the current standard of care for such patients.”
The lack of useful data is surprising, she said, especially considering “how commonly these interventions are used in current clinical practice and the cost and supply constraints for immunoglobulin. Given the variation in international guidelines, rising global demand and cost of immunoglobulin, and concerns regarding antimicrobial resistance, more evidence is needed to inform infection prevention strategies for this patient population.”
More data is expected soon. One ongoing study is examining intravenous immunoglobulin versus placebo in patients with CLL. It’s expected to be completed in September 2023.
What should clinicians do for now? “Given the lack of a proven survival benefit in favor of prophylactic immunoglobulin replacement, one strategy is to maximize use of vaccination and to educate both patients and clinicians regarding the need for early treatment of infections,” Dr. Weinkove said. “For people who have recurrent or severe infections despite these measures, both immunoglobulin replacement and prophylactic antibiotics are clinical options. It would be reasonable to take account of patient preference, logistical considerations, and reimbursement and availability in deciding between these options.”
He added that, “for people with severe hypogammaglobulinemia who experience recurrent or severe infections despite prophylactic antibiotics, switching to immunoglobulin replacement would be appropriate. We advocate enrollment in clinical trials, if possible.”
In an interview, Juthaporn Cowan, MD, PhD, an infectious disease physician with the University of Ottawa, said many patients with B-cell lymphomas develop acquired hypogammaglobulinemia. “Patients tend to get prolonged colds, frequent sinusitis, bronchitis, or pneumonia. Some can end up with severe infection. Many patients told me that, even though their cancer is cured or in remission, quality of life is still quite poor due to these infections and fatigue.”
Dr. Cowan said the new report is somewhat useful, although “concluding that vaccination reduces infection is misleading. Vaccination reduces the infection that patients were vaccinated against. Patients who received Shingrix will have less shingles but will continue to have bronchitis and other infections.”
As for advice for clinicians, she said preventing acquired hypogammaglobulinemia is difficult since it can be caused by the malignancies, by treatment, or both. “The other item to consider is that we do not know how long we should continue [immunoglobulin] treatment in these patients. I have a patient post CAR [chimeric antigen receptor] T therapy who still does not have B-cell 5-6 years after CAR T, while I have lymphoma patients who could safely discontinue [immunoglobulin] treatment in a few years.”
Dr. Cowan added that patients on immunoglobulin treatment can still get opportunistic infections from cytomegalovirus or herpes simplex virus “because the mechanism of host defense against these infections is different. Antimicrobial prophylaxis should still be considered as vaccination is not available for every single potential opportunistic infection.”
Australia funded the research through the National Blood Authority. Dr. McQuilten and Dr. Weinkove reported no disclosures. Other report authors disclosed ties with Aegros, CSL Behring, Janssen, AbbVie, and BeiGene. Monash University has received funding for unrelated projects from CSL Behring. Dr. Cowan reports honoraria from Takeda, CSL Behring, Octapharma, GlaxoSmithKline, Merck, and AstraZeneca.
Researchers found just 22 randomized controlled studies into prophylactic strategies, with several of them conducted prior to 2000. According to the report, published in Blood Advances, the studies together only evaluated a few thousand participants.
Reliable findings are so sparse that study coauthor Zoe McQuilten, MBBS, PhD, MD, a hematologist at Monash University, Melbourne, said “we simply don’t know” which preventive strategy is most effective. This is especially worrisome because more patients will survive their cancers and “be at risk of infection or have significant cytopenias and will experience impaired quality of life as a result,” she said in an interview.
The study authors launched the analysis to better understand the evidence regarding infection prevention and to guide the development of clinical trials, study coauthor Robert Weinkove, MBBS, PhD, a hematologist at Malaghan Institute of Medical Research, Wellington, New Zealand, said in an interview.
As he explained, targeted therapies have revolutionized the treatment of some B-cell cancers. They also have boosted the number of patients who survive the diseases yet still have profound hypogammaglobulinemia.
“Indeed, we may soon reach the point at which infection, and not tumor progression, is the leading cause of death for patients with certain B-cell cancers,” he said. “The evidence base for managing hypogammaglobulinemia is largely based on randomized trials of immunoglobulin replacement conducted in the 1980s and early 1990s, before the advent of B cell–targeted therapies. Immunoglobulin replacement is a costly intervention, and many countries are facing a shortage of immunoglobulin.”
The report authors identified 22 total randomized controlled trials, including one led by Dr. McQuilten: 8 studies into prophylactic immunoglobulin (n = 370; all but 1 study published prior to 2000), 5 into prophylactic antibiotics (n = 1,587), 7 into vaccination (n = 3,996), and 1 comparing immunoglobulin versus antibiotics (n = 60).
No evidence was found to support a lowering of risk by prophylactic antibiotics, although they caused adverse events.
Prophylactic immunoglobulin also caused adverse events, but a meta-analysis found that it reduced the risk of clinically documented infection by 28% (n = 2 trials; relative risk, 0.72; 95% confidence interval, 0.54-0.96). Three trials reported adverse events and found a higher risk overall (RR, 2.23; 95% CI, 1.67-2.99).
Varicella zoster virus vaccination reduced the risk of one or more infections by 63% (n = 5 trials, RR, 0.37; 95% CI, 0.30-0.45, n = 3,515). Prophylactic antibiotics did not reduce the risk.
No intervention reduced all-cause mortality.
“Our findings should be interpreted with caution, Dr. McQuilten said, “because of the low number of patients, high risk of bias in the included studies, and lack of contemporary data applicable to the current standard of care for such patients.”
The lack of useful data is surprising, she said, especially considering “how commonly these interventions are used in current clinical practice and the cost and supply constraints for immunoglobulin. Given the variation in international guidelines, rising global demand and cost of immunoglobulin, and concerns regarding antimicrobial resistance, more evidence is needed to inform infection prevention strategies for this patient population.”
More data is expected soon. One ongoing study is examining intravenous immunoglobulin versus placebo in patients with CLL. It’s expected to be completed in September 2023.
What should clinicians do for now? “Given the lack of a proven survival benefit in favor of prophylactic immunoglobulin replacement, one strategy is to maximize use of vaccination and to educate both patients and clinicians regarding the need for early treatment of infections,” Dr. Weinkove said. “For people who have recurrent or severe infections despite these measures, both immunoglobulin replacement and prophylactic antibiotics are clinical options. It would be reasonable to take account of patient preference, logistical considerations, and reimbursement and availability in deciding between these options.”
He added that, “for people with severe hypogammaglobulinemia who experience recurrent or severe infections despite prophylactic antibiotics, switching to immunoglobulin replacement would be appropriate. We advocate enrollment in clinical trials, if possible.”
In an interview, Juthaporn Cowan, MD, PhD, an infectious disease physician with the University of Ottawa, said many patients with B-cell lymphomas develop acquired hypogammaglobulinemia. “Patients tend to get prolonged colds, frequent sinusitis, bronchitis, or pneumonia. Some can end up with severe infection. Many patients told me that, even though their cancer is cured or in remission, quality of life is still quite poor due to these infections and fatigue.”
Dr. Cowan said the new report is somewhat useful, although “concluding that vaccination reduces infection is misleading. Vaccination reduces the infection that patients were vaccinated against. Patients who received Shingrix will have less shingles but will continue to have bronchitis and other infections.”
As for advice for clinicians, she said preventing acquired hypogammaglobulinemia is difficult since it can be caused by the malignancies, by treatment, or both. “The other item to consider is that we do not know how long we should continue [immunoglobulin] treatment in these patients. I have a patient post CAR [chimeric antigen receptor] T therapy who still does not have B-cell 5-6 years after CAR T, while I have lymphoma patients who could safely discontinue [immunoglobulin] treatment in a few years.”
Dr. Cowan added that patients on immunoglobulin treatment can still get opportunistic infections from cytomegalovirus or herpes simplex virus “because the mechanism of host defense against these infections is different. Antimicrobial prophylaxis should still be considered as vaccination is not available for every single potential opportunistic infection.”
Australia funded the research through the National Blood Authority. Dr. McQuilten and Dr. Weinkove reported no disclosures. Other report authors disclosed ties with Aegros, CSL Behring, Janssen, AbbVie, and BeiGene. Monash University has received funding for unrelated projects from CSL Behring. Dr. Cowan reports honoraria from Takeda, CSL Behring, Octapharma, GlaxoSmithKline, Merck, and AstraZeneca.
FROM BLOOD ADVANCES
CLL and surgery are more compatible than ever
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
In the past decade, as targeted therapies have permitted better management of CLL, a new realm of possibilities has opened up for patients with this blood cancer.
“Previously, patients may not have been candidates for elective surgeries, such as hip replacements,” said hematologist-oncologist Helen Ma, MD, of the University of Irvine (Calif.) and VA Long Beach Healthcare System. She is the lead author of the report, which appeared in the British Journal of Hematology.
“Now that targeted therapies are controlling CLL well, patients may elect to have procedures that they may not have considered if their blood counts were very low or they felt too unwell to go through such invasive surgeries,” said Dr. Ma in an interview. In fact, the study authors noted that, “with currently available treatments, many patients with CLL are living considerably longer than the 1-year life expectancy threshold that proceduralists require.”
But extra surgical risks persist. “Both CLL and its treatment can increase the risk of complications during and after procedures, though available data are not consistently stratified by stage and whether patients are undergoing treatment,” the report authors noted.
Research has linked CLL to higher rates of blood transfusions in cardiac surgeries: One study, conducted partially in the era of targeted therapy, found that 87% of these surgery patients with CLL needed blood products vs. 65% of those who didn’t have CLL (P = .01). Studies didn’t find any extra risk of infections in patients with CLL, however, and there are conflicting findings about whether hospital mortality is higher.
Another study, also conducted partially in the era of targeted therapy, found that patients with CLL who had percutaneous coronary intervention procedures “developed higher rates of in-hospital mortality, any complication, bleeding and postoperative stroke compared to those seen in patients without leukemia.”
The authors of the new report noted that “patients with more advanced stage are at increased risk of bleeding and thromboembolic events relevant to their disease and invasive procedures.” Patients at more than minimal risk should undergo electrocardiograms prior to cardiac procedures, they wrote. Stress tests, coronary angiography, and percutaneous coronary intervention may also be warranted.
“To optimize evaluation and perioperative management, we strongly recommend the prospective collaborative inclusion of a multidisciplinary team including hematologists/oncologists, cardiologists (ideally cardio-oncologists), surgeons and anesthetists, as well as their ongoing involvement during the postoperative period,” the authors wrote.
As for medications, the researchers said that “generally, antibody therapy has no impact on surgery.” They added, “There is no evidence to hold treatment with anti-CD20 monoclonal antibodies prior to procedures unless the patient has cytopenias that may be a contra-indication. If that is the case, we recommend holding until counts recover to the parameters required for the procedure.”
In regard to Bruton’s tyrosine kinase inhibitors such as ibrutinib, “patients undergoing major surgeries with high risk of bleeding should hold Bruton’s tyrosine kinase inhibitors for a week prior to surgery to ensure adequate platelet function recovery given the disruption between collagen and platelet aggregation. Medications can be resumed 3-7 days after achieving postoperative hemostasis, depending on the type of surgery and risk of bleeding.”
As for venetoclax, “prior to surgery, patients should receive granulocyte colony-stimulating factor for neutropenia, blood transfusions for anemia, and platelet transfusions for thrombocytopenia to maintain procedural parameters.”
In the big picture, study lead author Dr. Ma said, “patients with CLL are doing well on continuous targeted treatments, and if there are otherwise no contraindications, they should be considered for procedures to improve their quality of life.”
In an interview, Stanford (Calif.) University surgeon Joe Forrester MD, MSc, who’s familiar with the report findings, said its conclusions are valid. “The nice thing is that a lot of the [CLL] therapies don’t have a lot of surgical side effects. Most should not preclude a patient from going to surgery.”
He advised colleagues to make sure to be open with patients about the heightened surgical risks due to CLL, such when they need emergency procedures. And it’s important to be realistic about whether patients will live long enough to benefit from the rare surgeries – such as weight-loss procedures – that won’t show major benefits for 5-10 years, he said.
The Lymphoma Research Foundation supported the study. Dr. Ma, several coauthors, and Dr. Forrester report no disclosures. One coauthor reports multiple relationships with industry.
FROM THE BRITISH JOURNAL OF HEMATOLOGY
Plant-based diet linked to better outcomes in prostate cancer
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
The findings, which were reported at the 2023 ASCO Genitourinary Cancers Symposium in February, are based on a study of 2,038 men (median age, 64 years) with prostate cancer at stage T1, T2, or T3a.
“Consuming a whole foods plant-based diet may be an option to decrease risk for recurrence and improve overall survivorship,” said Vivian N. Liu, a clinical research coordinator at the University of California, San Francisco, who presented the findings.
The patients were interviewed about their diets at about 31.5 months after diagnosis. The study group was broken down into four groups based on how much of their diet consisted of a plant-based diet. Men in the highest quintile group who consumed at least 2.4 servings daily of fruit, 4.2 servings of vegetables, 2.6 servings of dairy, and 1.2 servings of meat (not seafood), had a 52% lower risk of progression (hazard ratio, 0.48; 95% confidence interval, 0.36-0.65; P-trend < 0.001) and a 53% lower risk of recurrence (HR, 0.47; 95% CI, 0.32-0.68; P-trend < 0.001), which was statistically significant. This compares with men in the lowest quintile who consumed 0.8 servings a day of fruit, 2.1 servings of vegetables, 3.1 servings of dairy, and 1.4 servings of meat. The findings were adjusted for total caloric intake, race, and smoking status.
For men over 65 years old, researchers found that a plant-based diet was associated with lower risk of recurrence (HR, 0.41; 95% CI, 0.24-0.7; P-trend = 0.03). And for those who exercised daily – in this case walking at a fast pace more than 3 times a week – a plant-based diet had a 56% (HR, 0.33; 95% CI, 0.26-0.73) lower risk of progression in the highest quintile group and a 59% decrease in recurrence (HR, 0.41; 95% CI, 0.25-0.68).
A new analysis like this, Ms. Liu said, “could guide people to make better, more healthful choices across their whole diet rather than adding or removing select foods.”
The primary endpoint was progression including recurrence, secondary treatment, bone metastases, and death due to prostate cancer, and the secondary endpoint was recurrence (PSA > 0.2ng/mL at 2 consecutive follow-up visits or during secondary treatment). At 7.4 years follow-up, there were 204 cases of progression.
“Fruits and vegetables contain antioxidants and anti-inflammatory components as well as dietary fiber that improve glucose control and reduce inflammation,” Ms. Liu said. In contrast, she said, animal-based foods may increase insulin resistance and insulin levels and boost levels of insulin-like growth factor 1, which is associated with prostate cancer risk. More studies, especially randomized controlled trials, are needed to provide evidence whether healthful plant-based foods and prostate cancer progression are connected.
NYU Langone Health urologist Natasha Gupta, MD, published a systematic review in 2022 on the impact of a plant-based diet on prostate cancer.* The review, which included 5 interventional studies and 11 observational studies, found that consuming a plant-based diet was associated with improvements in general health for men with prostate cancer. The observational studies found either a lower risk of prostate cancer or no significant difference.
“Patients often ask if there is anything that they can do to reduce the risk of recurrence, and it is great to be able to tell patients that a healthy lifestyle including plant-based foods and physical activity is helpful,” Dr. Gupta said.
The review’s coauthor, Stacy Loeb, MD, also of NYU Langone Health, said the new study was “a well-done observational study by experts in nutritional epidemiology from UCSF. It adds to a large body of evidence showing that plant-based diets improve health outcomes.”
“In the short-term, purchasing plant-based protein sources, such as beans and lentils, is less expensive than buying meat. Plant-based diets also reduce the risk of obesity, diabetes, and cardiovascular disease, which are associated with hundreds of thousands of dollars over a lifetime,” she said.
Limitations of the new study included the small number of non-White participants and self-reporting of diet. The study doesn’t examine the cost of various diets or the availability of plant-based foods like fresh produce, which can be limited in some neighborhoods.
Ms. Liu and colleagues plan to conduct a study that examines postdiagnostic plant-based diets in relation to prostate cancer–specific mortality. She and her team will also examine the plant-based dietary indices in relation to prostate cancer–specific quality of life at 2, 5, and 10 years from baseline.
The study authors, Dr. Loeb, and Dr. Gupta report no disclosures.
Correction, 3/17/23: An earlier version of this article misstated the name of NYU Langone Health.
FROM ASCO GU 2023
Inclusive reminder: LGBTQ community may donate stem cells
In fact, gay men have been able to donate stem cells in the United States since 2015. That’s when National Marrow Donor Program’s Be the Match registry lifted restrictions on men who have sex with men (MSM).
Physicians say advocacy is still necessary, because LGBTQ people may assume they can’t donate or be wary of clinicians. “The LGBTQIA+ population in general has experienced a lot of issues with the medical-industrial complex in terms of discrimination and inappropriate care,” said UT Southwestern Medical Center pathologist Brian Adkins, MD, who manages the blood bank at Children’s Health in Dallas, in an interview. “There’s a weariness there that may produce some hesitancy to interact with the donation process.”
An estimated 6.8 million people give blood in the United States each year, and an estimated 9 million people are registered as potential stem cell donors. A total of 22,013 hematopoietic cell transplantation procedures were performed in 2020, according to the U.S. Health Resources and Services Administration.
Expanding the number of LGBTQ donors, especially those born as biological males, could pay major dividends. As Dr. Adkins noted, the ideal stem cell donor is young – Be the Match says doctors generally prefer donors aged 18-35 – and male. According to a 2021 Gallup Poll, 21% of those born from 1997 to 2003 (Generation Z) say they’re LGBTQ, as do 11% of those born from 1981 to 1996 (Millennials).
In North America, the most extensive outreach to the LGBTQ community about stem cell donation has been launched in Canada. There, an organization called Stem Cell Club focuses on encouraging college students and other young people to register as potential stem cell donors.
Stem Cell Club has several campaigns aimed at ethnic minority groups, and its Saving Lives With Pride project focuses on MSM. The project’s web page includes testimonials from a woman whose life was saved by an unrelated gay male donor and from a gay male nurse who recovered from blood cancer thanks to a stem cell donation. The site also includes videos about stem cell donation featuring LGBTQ young people and Canadian hematologists.
“Our specialized collection center will treat donors with the highest levels of respect and courtesy, indeed as heroes of their unselfish gift that can truly save a life,” says Ottawa Hospital transplant hematologist David Allan, MD, in one of the videos.
Stem Cell Club was founded by transplant hematologist Warren Fingrut, MD, a research fellow at Memorial Sloan Kettering Cancer Center. In an interview, he said the organization’s LGBTQ project has promoted stem cell donation at several annual gay pride events and will continue the outreach this coming summer. In 2018 and 2019, advocates recruited 354 potential stem-cell donors (40% male, 42 non-White) at five pride events, Dr. Fingrut and colleagues reported last year in the journal Bone Marrow Transplantation.
For a new study, researchers interviewed 37 gay and bisexual men from five Canadian provinces about stem cell donation. Dr. Fingrut and colleagues reported the findings in February in an abstract at the Transplantation & Cellular Therapy Meetings.
Most participants didn’t know they “are eligible to donate stem cells, with many confusing stem cell versus blood donor eligibility criteria,” the researchers reported. According to Dr. Fingrut, some of the men “felt they were treated as second-class citizens, and that translated into frustration and decreased motivation to donate. There were concerns that they would be treated as though they shouldn’t be there.”
Canada has allowed gay men to donate stem cells for at least 10 years, Dr. Fingrut said. In 2022, Canadian officials said blood banks would no longer require MSM donors to have been abstinent from sex for 3 months, the BBC reported. However, donors will be asked about high-risk sexual behaviors.
The United States, where HIV spread through the blood supply during the early years of the AIDS pandemic and killed thousands of hemophiliacs, has much been slower to change its policies. For decades, starting in the 1980s, both blood banks and stem cell donation programs chose to lower the risk by turning away MSM donors.
Policies only began to change in recent years. Be the Match’s registry led the way by welcoming MSM in 2015. Stem cell donations go through more extensive testing than blood donations, Dr. Adkins said, so it’s more likely that HIV will be screened out. Also, he said, officials probably realized “it was necessary to widen the donor pool in order to best serve the patients” because it’s so hard to find matched stem-cell donors.
Be the Match has also stepped up its outreach to the LGBTQ community. “During Pride Month in 2022, Be The Match sponsored booths at events in 12 major markets from coast to coast,” said Jamie Margolis, senior vice president of Donor Services. “These efforts enabled us to increase awareness among more than 500,000 festival attendees and added more than 2,000 new members to the Be The Match Registry. We also produced a social media awareness campaign featuring one of our own employees, who is a cofounder of the Pride Employee Resource Group at Be The Match and a recent blood stem cell donor.”
In 2020 as blood banks became desperate for donations during the early days of the COVID-19 pandemic, the FDA changed its policy and required MSM to be abstinent for 3 months instead of 1 year before giving blood. (Prior to December 2014, any man who’d had sex with a man, even once, was indefinitely banned from giving blood.)
The 3-month policy instituted in 2020 drew fire from critics such as the American Medical Association, which noted the regulation treated men differently if they had unprotected sex with a single man versus with multiple women.
Now, the FDA is proposing that it once again change the policy about blood donations: It is recommending that there be no special polices regarding MSM. “All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past 3 months would be deferred from donation.”
Under the proposal, anyone who’s ever had HIV will not be able to donate. (They can’t donate stem cells either.) And the FDA proposes restrictions on those who take pre-exposure prophylaxis or postexposure prophylaxis for HIV.
Margolis, of Be the Match, noted that some members of the LGBTQ community may not be able to donate to Be The Match BioTherapies, which works with cell and gene therapy developers worldwide to provide cellular starting material. “These therapies may have different requirements than those for blood stem-cell transplants. Men who have had sex with men in the past 5 years or women who have had sex with a man who has had sex with a man in the past 5 years may not be able to donate to Be The Match BioTherapies. While we understand this could be upsetting or frustrating for someone who desires to be a part of these therapies, we are committed to following medical guidelines and regulations, while also advocating for our donors and the LBGTQIA+ community as a whole.”
MSM aren’t the only target of outreach by proponents of stem cell donation. In 2019, UT Southwestern’s Dr. Adkins and colleagues wrote a commentary in Bone Marrow Transplantation that called for bone marrow donation centers to do more to be welcoming to transgender donors. “The largest age group identifying as transgender is 18-24 years of life, which overlaps considerably with the population of hematopoietic stem cell donors, which tend to be younger individuals,” the researchers wrote.
The transgender community was “simply overlooked,” Dr. Adkins said. Since then, as he pointed out, things have changed. Now, Be the Match’s website notes that “members of the LGBTQIA+ community CAN join the registry and donate.” The organization says that “for medical reasons, everyone is asked to provide their sex assigned at birth when they register. Should you be called as a match, pronouns and gender identity are respected throughout the process.”
In addition, the site says people on prescription hormone therapy are not excluded from joining the registry. Patients who have undergone surgery within the last 12 months, including sex-reassignment procedures, “will be asked about the current status of their recovery and whether they are still seeing a physician for follow-up in regards to the surgery.”
What’s next? Dr. Fingrut said he expects the lifting of strict rules about MSM and blood donation will boost stem cell donation in the community.
There seems to be plenty of room for more outreach. Cole Williams, founder of Pride & Plasma, which advocates for allowing gay men to give blood, suggested in an interview that advocates who want to increase stem cell donation in the LGBTQ community reach out to its community centers, health organizations, providers, and clinics.
So far, though, “I haven’t seen a big call for registration of any individuals unless they have a personal relation to bone marrow donation,” he said.
Dr. Fingrut and Dr. Adkins report no disclosures.
In fact, gay men have been able to donate stem cells in the United States since 2015. That’s when National Marrow Donor Program’s Be the Match registry lifted restrictions on men who have sex with men (MSM).
Physicians say advocacy is still necessary, because LGBTQ people may assume they can’t donate or be wary of clinicians. “The LGBTQIA+ population in general has experienced a lot of issues with the medical-industrial complex in terms of discrimination and inappropriate care,” said UT Southwestern Medical Center pathologist Brian Adkins, MD, who manages the blood bank at Children’s Health in Dallas, in an interview. “There’s a weariness there that may produce some hesitancy to interact with the donation process.”
An estimated 6.8 million people give blood in the United States each year, and an estimated 9 million people are registered as potential stem cell donors. A total of 22,013 hematopoietic cell transplantation procedures were performed in 2020, according to the U.S. Health Resources and Services Administration.
Expanding the number of LGBTQ donors, especially those born as biological males, could pay major dividends. As Dr. Adkins noted, the ideal stem cell donor is young – Be the Match says doctors generally prefer donors aged 18-35 – and male. According to a 2021 Gallup Poll, 21% of those born from 1997 to 2003 (Generation Z) say they’re LGBTQ, as do 11% of those born from 1981 to 1996 (Millennials).
In North America, the most extensive outreach to the LGBTQ community about stem cell donation has been launched in Canada. There, an organization called Stem Cell Club focuses on encouraging college students and other young people to register as potential stem cell donors.
Stem Cell Club has several campaigns aimed at ethnic minority groups, and its Saving Lives With Pride project focuses on MSM. The project’s web page includes testimonials from a woman whose life was saved by an unrelated gay male donor and from a gay male nurse who recovered from blood cancer thanks to a stem cell donation. The site also includes videos about stem cell donation featuring LGBTQ young people and Canadian hematologists.
“Our specialized collection center will treat donors with the highest levels of respect and courtesy, indeed as heroes of their unselfish gift that can truly save a life,” says Ottawa Hospital transplant hematologist David Allan, MD, in one of the videos.
Stem Cell Club was founded by transplant hematologist Warren Fingrut, MD, a research fellow at Memorial Sloan Kettering Cancer Center. In an interview, he said the organization’s LGBTQ project has promoted stem cell donation at several annual gay pride events and will continue the outreach this coming summer. In 2018 and 2019, advocates recruited 354 potential stem-cell donors (40% male, 42 non-White) at five pride events, Dr. Fingrut and colleagues reported last year in the journal Bone Marrow Transplantation.
For a new study, researchers interviewed 37 gay and bisexual men from five Canadian provinces about stem cell donation. Dr. Fingrut and colleagues reported the findings in February in an abstract at the Transplantation & Cellular Therapy Meetings.
Most participants didn’t know they “are eligible to donate stem cells, with many confusing stem cell versus blood donor eligibility criteria,” the researchers reported. According to Dr. Fingrut, some of the men “felt they were treated as second-class citizens, and that translated into frustration and decreased motivation to donate. There were concerns that they would be treated as though they shouldn’t be there.”
Canada has allowed gay men to donate stem cells for at least 10 years, Dr. Fingrut said. In 2022, Canadian officials said blood banks would no longer require MSM donors to have been abstinent from sex for 3 months, the BBC reported. However, donors will be asked about high-risk sexual behaviors.
The United States, where HIV spread through the blood supply during the early years of the AIDS pandemic and killed thousands of hemophiliacs, has much been slower to change its policies. For decades, starting in the 1980s, both blood banks and stem cell donation programs chose to lower the risk by turning away MSM donors.
Policies only began to change in recent years. Be the Match’s registry led the way by welcoming MSM in 2015. Stem cell donations go through more extensive testing than blood donations, Dr. Adkins said, so it’s more likely that HIV will be screened out. Also, he said, officials probably realized “it was necessary to widen the donor pool in order to best serve the patients” because it’s so hard to find matched stem-cell donors.
Be the Match has also stepped up its outreach to the LGBTQ community. “During Pride Month in 2022, Be The Match sponsored booths at events in 12 major markets from coast to coast,” said Jamie Margolis, senior vice president of Donor Services. “These efforts enabled us to increase awareness among more than 500,000 festival attendees and added more than 2,000 new members to the Be The Match Registry. We also produced a social media awareness campaign featuring one of our own employees, who is a cofounder of the Pride Employee Resource Group at Be The Match and a recent blood stem cell donor.”
In 2020 as blood banks became desperate for donations during the early days of the COVID-19 pandemic, the FDA changed its policy and required MSM to be abstinent for 3 months instead of 1 year before giving blood. (Prior to December 2014, any man who’d had sex with a man, even once, was indefinitely banned from giving blood.)
The 3-month policy instituted in 2020 drew fire from critics such as the American Medical Association, which noted the regulation treated men differently if they had unprotected sex with a single man versus with multiple women.
Now, the FDA is proposing that it once again change the policy about blood donations: It is recommending that there be no special polices regarding MSM. “All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past 3 months would be deferred from donation.”
Under the proposal, anyone who’s ever had HIV will not be able to donate. (They can’t donate stem cells either.) And the FDA proposes restrictions on those who take pre-exposure prophylaxis or postexposure prophylaxis for HIV.
Margolis, of Be the Match, noted that some members of the LGBTQ community may not be able to donate to Be The Match BioTherapies, which works with cell and gene therapy developers worldwide to provide cellular starting material. “These therapies may have different requirements than those for blood stem-cell transplants. Men who have had sex with men in the past 5 years or women who have had sex with a man who has had sex with a man in the past 5 years may not be able to donate to Be The Match BioTherapies. While we understand this could be upsetting or frustrating for someone who desires to be a part of these therapies, we are committed to following medical guidelines and regulations, while also advocating for our donors and the LBGTQIA+ community as a whole.”
MSM aren’t the only target of outreach by proponents of stem cell donation. In 2019, UT Southwestern’s Dr. Adkins and colleagues wrote a commentary in Bone Marrow Transplantation that called for bone marrow donation centers to do more to be welcoming to transgender donors. “The largest age group identifying as transgender is 18-24 years of life, which overlaps considerably with the population of hematopoietic stem cell donors, which tend to be younger individuals,” the researchers wrote.
The transgender community was “simply overlooked,” Dr. Adkins said. Since then, as he pointed out, things have changed. Now, Be the Match’s website notes that “members of the LGBTQIA+ community CAN join the registry and donate.” The organization says that “for medical reasons, everyone is asked to provide their sex assigned at birth when they register. Should you be called as a match, pronouns and gender identity are respected throughout the process.”
In addition, the site says people on prescription hormone therapy are not excluded from joining the registry. Patients who have undergone surgery within the last 12 months, including sex-reassignment procedures, “will be asked about the current status of their recovery and whether they are still seeing a physician for follow-up in regards to the surgery.”
What’s next? Dr. Fingrut said he expects the lifting of strict rules about MSM and blood donation will boost stem cell donation in the community.
There seems to be plenty of room for more outreach. Cole Williams, founder of Pride & Plasma, which advocates for allowing gay men to give blood, suggested in an interview that advocates who want to increase stem cell donation in the LGBTQ community reach out to its community centers, health organizations, providers, and clinics.
So far, though, “I haven’t seen a big call for registration of any individuals unless they have a personal relation to bone marrow donation,” he said.
Dr. Fingrut and Dr. Adkins report no disclosures.
In fact, gay men have been able to donate stem cells in the United States since 2015. That’s when National Marrow Donor Program’s Be the Match registry lifted restrictions on men who have sex with men (MSM).
Physicians say advocacy is still necessary, because LGBTQ people may assume they can’t donate or be wary of clinicians. “The LGBTQIA+ population in general has experienced a lot of issues with the medical-industrial complex in terms of discrimination and inappropriate care,” said UT Southwestern Medical Center pathologist Brian Adkins, MD, who manages the blood bank at Children’s Health in Dallas, in an interview. “There’s a weariness there that may produce some hesitancy to interact with the donation process.”
An estimated 6.8 million people give blood in the United States each year, and an estimated 9 million people are registered as potential stem cell donors. A total of 22,013 hematopoietic cell transplantation procedures were performed in 2020, according to the U.S. Health Resources and Services Administration.
Expanding the number of LGBTQ donors, especially those born as biological males, could pay major dividends. As Dr. Adkins noted, the ideal stem cell donor is young – Be the Match says doctors generally prefer donors aged 18-35 – and male. According to a 2021 Gallup Poll, 21% of those born from 1997 to 2003 (Generation Z) say they’re LGBTQ, as do 11% of those born from 1981 to 1996 (Millennials).
In North America, the most extensive outreach to the LGBTQ community about stem cell donation has been launched in Canada. There, an organization called Stem Cell Club focuses on encouraging college students and other young people to register as potential stem cell donors.
Stem Cell Club has several campaigns aimed at ethnic minority groups, and its Saving Lives With Pride project focuses on MSM. The project’s web page includes testimonials from a woman whose life was saved by an unrelated gay male donor and from a gay male nurse who recovered from blood cancer thanks to a stem cell donation. The site also includes videos about stem cell donation featuring LGBTQ young people and Canadian hematologists.
“Our specialized collection center will treat donors with the highest levels of respect and courtesy, indeed as heroes of their unselfish gift that can truly save a life,” says Ottawa Hospital transplant hematologist David Allan, MD, in one of the videos.
Stem Cell Club was founded by transplant hematologist Warren Fingrut, MD, a research fellow at Memorial Sloan Kettering Cancer Center. In an interview, he said the organization’s LGBTQ project has promoted stem cell donation at several annual gay pride events and will continue the outreach this coming summer. In 2018 and 2019, advocates recruited 354 potential stem-cell donors (40% male, 42 non-White) at five pride events, Dr. Fingrut and colleagues reported last year in the journal Bone Marrow Transplantation.
For a new study, researchers interviewed 37 gay and bisexual men from five Canadian provinces about stem cell donation. Dr. Fingrut and colleagues reported the findings in February in an abstract at the Transplantation & Cellular Therapy Meetings.
Most participants didn’t know they “are eligible to donate stem cells, with many confusing stem cell versus blood donor eligibility criteria,” the researchers reported. According to Dr. Fingrut, some of the men “felt they were treated as second-class citizens, and that translated into frustration and decreased motivation to donate. There were concerns that they would be treated as though they shouldn’t be there.”
Canada has allowed gay men to donate stem cells for at least 10 years, Dr. Fingrut said. In 2022, Canadian officials said blood banks would no longer require MSM donors to have been abstinent from sex for 3 months, the BBC reported. However, donors will be asked about high-risk sexual behaviors.
The United States, where HIV spread through the blood supply during the early years of the AIDS pandemic and killed thousands of hemophiliacs, has much been slower to change its policies. For decades, starting in the 1980s, both blood banks and stem cell donation programs chose to lower the risk by turning away MSM donors.
Policies only began to change in recent years. Be the Match’s registry led the way by welcoming MSM in 2015. Stem cell donations go through more extensive testing than blood donations, Dr. Adkins said, so it’s more likely that HIV will be screened out. Also, he said, officials probably realized “it was necessary to widen the donor pool in order to best serve the patients” because it’s so hard to find matched stem-cell donors.
Be the Match has also stepped up its outreach to the LGBTQ community. “During Pride Month in 2022, Be The Match sponsored booths at events in 12 major markets from coast to coast,” said Jamie Margolis, senior vice president of Donor Services. “These efforts enabled us to increase awareness among more than 500,000 festival attendees and added more than 2,000 new members to the Be The Match Registry. We also produced a social media awareness campaign featuring one of our own employees, who is a cofounder of the Pride Employee Resource Group at Be The Match and a recent blood stem cell donor.”
In 2020 as blood banks became desperate for donations during the early days of the COVID-19 pandemic, the FDA changed its policy and required MSM to be abstinent for 3 months instead of 1 year before giving blood. (Prior to December 2014, any man who’d had sex with a man, even once, was indefinitely banned from giving blood.)
The 3-month policy instituted in 2020 drew fire from critics such as the American Medical Association, which noted the regulation treated men differently if they had unprotected sex with a single man versus with multiple women.
Now, the FDA is proposing that it once again change the policy about blood donations: It is recommending that there be no special polices regarding MSM. “All prospective donors who report having a new sexual partner or more than one sexual partner and had anal sex in the past 3 months would be deferred from donation.”
Under the proposal, anyone who’s ever had HIV will not be able to donate. (They can’t donate stem cells either.) And the FDA proposes restrictions on those who take pre-exposure prophylaxis or postexposure prophylaxis for HIV.
Margolis, of Be the Match, noted that some members of the LGBTQ community may not be able to donate to Be The Match BioTherapies, which works with cell and gene therapy developers worldwide to provide cellular starting material. “These therapies may have different requirements than those for blood stem-cell transplants. Men who have had sex with men in the past 5 years or women who have had sex with a man who has had sex with a man in the past 5 years may not be able to donate to Be The Match BioTherapies. While we understand this could be upsetting or frustrating for someone who desires to be a part of these therapies, we are committed to following medical guidelines and regulations, while also advocating for our donors and the LBGTQIA+ community as a whole.”
MSM aren’t the only target of outreach by proponents of stem cell donation. In 2019, UT Southwestern’s Dr. Adkins and colleagues wrote a commentary in Bone Marrow Transplantation that called for bone marrow donation centers to do more to be welcoming to transgender donors. “The largest age group identifying as transgender is 18-24 years of life, which overlaps considerably with the population of hematopoietic stem cell donors, which tend to be younger individuals,” the researchers wrote.
The transgender community was “simply overlooked,” Dr. Adkins said. Since then, as he pointed out, things have changed. Now, Be the Match’s website notes that “members of the LGBTQIA+ community CAN join the registry and donate.” The organization says that “for medical reasons, everyone is asked to provide their sex assigned at birth when they register. Should you be called as a match, pronouns and gender identity are respected throughout the process.”
In addition, the site says people on prescription hormone therapy are not excluded from joining the registry. Patients who have undergone surgery within the last 12 months, including sex-reassignment procedures, “will be asked about the current status of their recovery and whether they are still seeing a physician for follow-up in regards to the surgery.”
What’s next? Dr. Fingrut said he expects the lifting of strict rules about MSM and blood donation will boost stem cell donation in the community.
There seems to be plenty of room for more outreach. Cole Williams, founder of Pride & Plasma, which advocates for allowing gay men to give blood, suggested in an interview that advocates who want to increase stem cell donation in the LGBTQ community reach out to its community centers, health organizations, providers, and clinics.
So far, though, “I haven’t seen a big call for registration of any individuals unless they have a personal relation to bone marrow donation,” he said.
Dr. Fingrut and Dr. Adkins report no disclosures.