AVAHO

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

TOPLINE:

Paramagnetic seeds work just as well as standard guidewires for breast tumor localization and are easier for surgeons, radiologists, and operating room planners to use.

METHODOLOGY:

• Paramagnetic seeds have shown promise over standard guidewire localization, but the two methods of tagging breast lesions for surgical removal have never been compared head-to-head in a randomized trial.
• Paramagnetic seeds are magnetic markers smaller than a grain of rice that are injected into the lesion under ultrasound or x-ray guidance. While traditional guidewires are placed on the day of surgery, seeds can be placed up to 4 weeks ahead of time.
• In the current study, investigators at three hospitals in Sweden randomized 426 women undergoing breast-conserving surgery for early breast cancer to either paramagnetic seed (Magseed, Endomag, Cambridge, UK) or guidewire localization.
• Sentinel lymph nodes were also marked magnetically for removal by superparamagnetic iron oxide (Magtrace, Endomag, Cambridge, UK ) injected into the breast before surgery. This approach — an alternative to traditional radioisotopes and blue dye — can be done days before surgery.

TAKEAWAY:

• The investigators found no significant difference in re-excision rates (2.84% vs 2.87%), sentinel lymph node detection (98.1% vs 99.0%), or resection ratios — a metric of surgical precision — between the guidewire and seed approaches.
• The rate of failed localizations was significantly higher in the guidewire group (10.1% vs 1.9%; P < .001).
• Median operative time was significantly shorter in the seed localization group (69 min vs 75.5 min; P = .03).
• Surgery coordinators reported greater ease of planning with the seeds, radiologists reported easier preoperative localization, and surgeons reported easier detection of marked tumors during surgery.

IN PRACTICE:

Overall, the randomized trial found that “a paramagnetic marker was equivalent to the guidewire in re-excisions and excised specimen volumes, with advantages of shorter operative time, safer localization, and preferable logistics,” the authors concluded.

Another advantage of paramagnetic seeds: Surgical staff and patients were not confined to the same-day “restrictions posed by guidewire localization or radioisotope-based methods, making it an attractive alternative for numerous and diverse clinical settings,” the authors added.

SOURCE:

The work, led by Eirini Pantiora, MD, of Uppsala University, Sweden, was published in JAMA Surgery .

LIMITATIONS:

The investigators don’t yet know whether the benefits of implementing seed localization outweigh the costs.

DISCLOSURES:

The work was funded by Uppsala University, the Swedish Breast Cancer Association, and others. The senior investigator reported receiving grants from Endomag, the maker of the technology tested in the trial.

A version of this article appeared on Medscape.com.

Seventeen years ago, Philip Segal, a retired accountant from suburban Toronto, Canada, was diagnosed with prostate cancer in a private clinic. After rejecting brachytherapy recommended by an oncologist, he went on active surveillance to watch, but not treat, the Gleason 6 (grade group 1) tumor. As he approaches his 80th birthday later this year, Mr. Segal said he plans to maintain the status quo. “It definitely brings me some peace of mind. I’d rather do that than not follow it and kick myself if there was a serious change,” he said.

Meanwhile, 2 years ago and 200 miles away in suburban Detroit, Bruno Barrey, a robotics engineer, was diagnosed with three cores of Gleason 6 and went on active surveillance.

Six months after the original diagnosis, however, Mr. Barrey, 57, underwent a follow-up biopsy. This time, all 16 cores were positive, with a mix of low-risk Gleason 6 and more advanced Gleason 3 + 4 lesions. His tumor was so large he underwent radiation therapy in 2023, ending his brief stint on the monitoring approach.

The two cases illustrate the complicated truth of active surveillance. For some men, the strategy can prove to be short-lived, perhaps 5 years or less, or a life-long approach lasting until the man dies from another cause.

Which kind of race a man will run depends on a wide range of factors: His comfort level living with a cancer, or at least a tumor that might well evolve into an aggressive malignancy, changes in his prostate-specific antigen (PSA) level and results of a magnetic resonance imaging test, the volume of his cancer, results of genetic testing of the patient himself and his lesion, and his urologist’s philosophy about surveillance. Where a patient lives matters, too, because variations in surveillance levels exist in different geographic areas, domestically and internationally.

“Active surveillance is a strategy of monitoring until it is necessary to be treated. For some people, it is very short, and for others, essentially indefinite,” said Michael Leapman, MD, clinical lead at Yale Cancer Center in New Haven, Connecticut. “While there are differences, I think they are mainly about who is the ideal patient.”

Most studies show that roughly half of men in the United States who go on active surveillance abandon it within 5 years of diagnosis. Rashid Sayyid, MD, a clinical fellow at the University of Toronto, Canada, found in a paper presented to the American Urological Association in 2022 that the number leaving active surveillance increased to nearly two thirds at 10 years.

Peter Carroll, MD, a urologist at the University of California, San Francisco, and a pioneer in the active surveillance in the late 1990s, said the major reason men abandon the strategy is because monitoring reveals the presence of a more aggressive cancer, typically a grade group 2 (Gleason 3 + 4) lesion. But other reasons include anxiety and other emotional distress and upgrades in blood levels of PSA and increases in the rating scale for MRI for the likelihood of the presence of clinically significant prostate cancer.

Laurence Klotz, MD, of the University of Toronto, Toronto, Ontario, who coined the term active surveillance strategy in 1997 and published the first studies in the early 2000s, said it is important to consider when the data on surveillance were collected.

Since 2013, when MRI began to be adopted as a surveillance modality for men with prostate cancer, the dropout rate began declining. The reason? According to Dr. Klotz, MRIs and targeted biopsies result in greater accuracy in staging the disease, determining which patients need to be biopsied, which helps some men avoid being diagnosed to begin with.

Dr. Klotz cited as an example of the emerging change a 2020 study in the Journal of Urology, which found a 24% dropout rate for surveillance at 5 years, 36% at 10 years, and 42% at 15 years in a series of 2664 grade group 1 patients on active surveillance at Memorial Sloan Kettering Cancer Center in New York City from 2000 to 2017.

Dr. Leapman cited a 2023 study in JNCI Cancer Spectrum using the National Cancer Database that found a decline in the percentage of patients who had grade group 1 in biopsies from 45% in 2010 to 25% in 2019.

“There is more judicious use of PSA testing and biopsy in individuals who are more likely to have significant prostate cancer,” Dr. Leapman told this news organization. “And MRI could also play a role by finding more high-grade cancers that would have otherwise been hidden.”

The changing statistics of prostate cancer also may reflect decreases in screening in response to a 2012 statement from the US Preventive Services Task Force advising against PSA testing. The American Cancer Society in January 2023 said that statement could be driving more diagnoses of late-stage disease, which has been surging for the first time in two decades, especially among Black men.

Dr. Sayyid said patients must be selected carefully for active surveillance. And he said urologists should not promise their active surveillance patients that they will avoid treatment. “There are numerous factors at stake that influence the ultimate outcome,” he said.

Progression of Gleason scores is estimated at 1%-2% per year, Dr. Sayyid added. When active surveillance fails in the short to medium term — 5-10 years — the reason usually is that higher-grade cancers with Gleason 3 + 4 or above were initially missed.

Dr. Sayyid said he counsels patients aged 70 years and older differently than those in their 50s, telling younger patients they are more likely to need treatment eventually than the older patients.

Factors that can affect the longevity of active surveillance include the presence or absence of germline mutations and the overall health and life expectancy and comorbidities such as heart disease and diabetes in a given patient, he said.

Urologists hold varying philosophies here, especially involving younger patients and the presence of any level of Gleason 4 cancer.

William Catalona, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, who developed the concept of mass screening with PSA testing, originally opposed active surveillance. In recent years, he has modified his views but still takes a more conservative approach.

“I consider active surveillance a foolish strategy or, at best, a short-term strategy for young, otherwise healthy men, especially those having any Gleason pattern 4 disease.”

“More than half will ultimately convert to active treatment, some too late, and will require multiple treatments with multiple side effects. Some will develop metastases, and some will die of prostate cancer.”

Dr. Sayyid takes a more liberal approach. “I would counsel an eligible patient considering active surveillance that at the current time, I see no strong reason why you should be subjected to treatment and the associated side effects,” he said. “And as long as your overall disease ‘state’ [the combination of grade, volume, PSA, and imaging tests] remains relatively stable, there should be no reason for us to ‘jump ship’. In my practice, another term for active surveillance is ‘active partnership’ — working together to decide if this is a sprint or a lifelong marathon.”

Dr. Carroll reported research funding from the National Institutes of Health.

A version of this article appeared on Medscape.com.

Seventeen years ago, Philip Segal, a retired accountant from suburban Toronto, Canada, was diagnosed with prostate cancer in a private clinic. After rejecting brachytherapy recommended by an oncologist, he went on active surveillance to watch, but not treat, the Gleason 6 (grade group 1) tumor. As he approaches his 80th birthday later this year, Mr. Segal said he plans to maintain the status quo. “It definitely brings me some peace of mind. I’d rather do that than not follow it and kick myself if there was a serious change,” he said.

Meanwhile, 2 years ago and 200 miles away in suburban Detroit, Bruno Barrey, a robotics engineer, was diagnosed with three cores of Gleason 6 and went on active surveillance.

Six months after the original diagnosis, however, Mr. Barrey, 57, underwent a follow-up biopsy. This time, all 16 cores were positive, with a mix of low-risk Gleason 6 and more advanced Gleason 3 + 4 lesions. His tumor was so large he underwent radiation therapy in 2023, ending his brief stint on the monitoring approach.

The two cases illustrate the complicated truth of active surveillance. For some men, the strategy can prove to be short-lived, perhaps 5 years or less, or a life-long approach lasting until the man dies from another cause.

Which kind of race a man will run depends on a wide range of factors: His comfort level living with a cancer, or at least a tumor that might well evolve into an aggressive malignancy, changes in his prostate-specific antigen (PSA) level and results of a magnetic resonance imaging test, the volume of his cancer, results of genetic testing of the patient himself and his lesion, and his urologist’s philosophy about surveillance. Where a patient lives matters, too, because variations in surveillance levels exist in different geographic areas, domestically and internationally.

“Active surveillance is a strategy of monitoring until it is necessary to be treated. For some people, it is very short, and for others, essentially indefinite,” said Michael Leapman, MD, clinical lead at Yale Cancer Center in New Haven, Connecticut. “While there are differences, I think they are mainly about who is the ideal patient.”

Most studies show that roughly half of men in the United States who go on active surveillance abandon it within 5 years of diagnosis. Rashid Sayyid, MD, a clinical fellow at the University of Toronto, Canada, found in a paper presented to the American Urological Association in 2022 that the number leaving active surveillance increased to nearly two thirds at 10 years.

Peter Carroll, MD, a urologist at the University of California, San Francisco, and a pioneer in the active surveillance in the late 1990s, said the major reason men abandon the strategy is because monitoring reveals the presence of a more aggressive cancer, typically a grade group 2 (Gleason 3 + 4) lesion. But other reasons include anxiety and other emotional distress and upgrades in blood levels of PSA and increases in the rating scale for MRI for the likelihood of the presence of clinically significant prostate cancer.

Laurence Klotz, MD, of the University of Toronto, Toronto, Ontario, who coined the term active surveillance strategy in 1997 and published the first studies in the early 2000s, said it is important to consider when the data on surveillance were collected.

Since 2013, when MRI began to be adopted as a surveillance modality for men with prostate cancer, the dropout rate began declining. The reason? According to Dr. Klotz, MRIs and targeted biopsies result in greater accuracy in staging the disease, determining which patients need to be biopsied, which helps some men avoid being diagnosed to begin with.

Dr. Klotz cited as an example of the emerging change a 2020 study in the Journal of Urology, which found a 24% dropout rate for surveillance at 5 years, 36% at 10 years, and 42% at 15 years in a series of 2664 grade group 1 patients on active surveillance at Memorial Sloan Kettering Cancer Center in New York City from 2000 to 2017.

Dr. Leapman cited a 2023 study in JNCI Cancer Spectrum using the National Cancer Database that found a decline in the percentage of patients who had grade group 1 in biopsies from 45% in 2010 to 25% in 2019.

“There is more judicious use of PSA testing and biopsy in individuals who are more likely to have significant prostate cancer,” Dr. Leapman told this news organization. “And MRI could also play a role by finding more high-grade cancers that would have otherwise been hidden.”

The changing statistics of prostate cancer also may reflect decreases in screening in response to a 2012 statement from the US Preventive Services Task Force advising against PSA testing. The American Cancer Society in January 2023 said that statement could be driving more diagnoses of late-stage disease, which has been surging for the first time in two decades, especially among Black men.

Dr. Sayyid said patients must be selected carefully for active surveillance. And he said urologists should not promise their active surveillance patients that they will avoid treatment. “There are numerous factors at stake that influence the ultimate outcome,” he said.

Progression of Gleason scores is estimated at 1%-2% per year, Dr. Sayyid added. When active surveillance fails in the short to medium term — 5-10 years — the reason usually is that higher-grade cancers with Gleason 3 + 4 or above were initially missed.

Dr. Sayyid said he counsels patients aged 70 years and older differently than those in their 50s, telling younger patients they are more likely to need treatment eventually than the older patients.

Factors that can affect the longevity of active surveillance include the presence or absence of germline mutations and the overall health and life expectancy and comorbidities such as heart disease and diabetes in a given patient, he said.

Urologists hold varying philosophies here, especially involving younger patients and the presence of any level of Gleason 4 cancer.

William Catalona, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, who developed the concept of mass screening with PSA testing, originally opposed active surveillance. In recent years, he has modified his views but still takes a more conservative approach.

“I consider active surveillance a foolish strategy or, at best, a short-term strategy for young, otherwise healthy men, especially those having any Gleason pattern 4 disease.”

“More than half will ultimately convert to active treatment, some too late, and will require multiple treatments with multiple side effects. Some will develop metastases, and some will die of prostate cancer.”

Dr. Sayyid takes a more liberal approach. “I would counsel an eligible patient considering active surveillance that at the current time, I see no strong reason why you should be subjected to treatment and the associated side effects,” he said. “And as long as your overall disease ‘state’ [the combination of grade, volume, PSA, and imaging tests] remains relatively stable, there should be no reason for us to ‘jump ship’. In my practice, another term for active surveillance is ‘active partnership’ — working together to decide if this is a sprint or a lifelong marathon.”

Dr. Carroll reported research funding from the National Institutes of Health.

A version of this article appeared on Medscape.com.

Seventeen years ago, Philip Segal, a retired accountant from suburban Toronto, Canada, was diagnosed with prostate cancer in a private clinic. After rejecting brachytherapy recommended by an oncologist, he went on active surveillance to watch, but not treat, the Gleason 6 (grade group 1) tumor. As he approaches his 80th birthday later this year, Mr. Segal said he plans to maintain the status quo. “It definitely brings me some peace of mind. I’d rather do that than not follow it and kick myself if there was a serious change,” he said.

Meanwhile, 2 years ago and 200 miles away in suburban Detroit, Bruno Barrey, a robotics engineer, was diagnosed with three cores of Gleason 6 and went on active surveillance.

Six months after the original diagnosis, however, Mr. Barrey, 57, underwent a follow-up biopsy. This time, all 16 cores were positive, with a mix of low-risk Gleason 6 and more advanced Gleason 3 + 4 lesions. His tumor was so large he underwent radiation therapy in 2023, ending his brief stint on the monitoring approach.

The two cases illustrate the complicated truth of active surveillance. For some men, the strategy can prove to be short-lived, perhaps 5 years or less, or a life-long approach lasting until the man dies from another cause.

Which kind of race a man will run depends on a wide range of factors: His comfort level living with a cancer, or at least a tumor that might well evolve into an aggressive malignancy, changes in his prostate-specific antigen (PSA) level and results of a magnetic resonance imaging test, the volume of his cancer, results of genetic testing of the patient himself and his lesion, and his urologist’s philosophy about surveillance. Where a patient lives matters, too, because variations in surveillance levels exist in different geographic areas, domestically and internationally.

“Active surveillance is a strategy of monitoring until it is necessary to be treated. For some people, it is very short, and for others, essentially indefinite,” said Michael Leapman, MD, clinical lead at Yale Cancer Center in New Haven, Connecticut. “While there are differences, I think they are mainly about who is the ideal patient.”

Most studies show that roughly half of men in the United States who go on active surveillance abandon it within 5 years of diagnosis. Rashid Sayyid, MD, a clinical fellow at the University of Toronto, Canada, found in a paper presented to the American Urological Association in 2022 that the number leaving active surveillance increased to nearly two thirds at 10 years.

Peter Carroll, MD, a urologist at the University of California, San Francisco, and a pioneer in the active surveillance in the late 1990s, said the major reason men abandon the strategy is because monitoring reveals the presence of a more aggressive cancer, typically a grade group 2 (Gleason 3 + 4) lesion. But other reasons include anxiety and other emotional distress and upgrades in blood levels of PSA and increases in the rating scale for MRI for the likelihood of the presence of clinically significant prostate cancer.

Laurence Klotz, MD, of the University of Toronto, Toronto, Ontario, who coined the term active surveillance strategy in 1997 and published the first studies in the early 2000s, said it is important to consider when the data on surveillance were collected.

Since 2013, when MRI began to be adopted as a surveillance modality for men with prostate cancer, the dropout rate began declining. The reason? According to Dr. Klotz, MRIs and targeted biopsies result in greater accuracy in staging the disease, determining which patients need to be biopsied, which helps some men avoid being diagnosed to begin with.

Dr. Klotz cited as an example of the emerging change a 2020 study in the Journal of Urology, which found a 24% dropout rate for surveillance at 5 years, 36% at 10 years, and 42% at 15 years in a series of 2664 grade group 1 patients on active surveillance at Memorial Sloan Kettering Cancer Center in New York City from 2000 to 2017.

Dr. Leapman cited a 2023 study in JNCI Cancer Spectrum using the National Cancer Database that found a decline in the percentage of patients who had grade group 1 in biopsies from 45% in 2010 to 25% in 2019.

“There is more judicious use of PSA testing and biopsy in individuals who are more likely to have significant prostate cancer,” Dr. Leapman told this news organization. “And MRI could also play a role by finding more high-grade cancers that would have otherwise been hidden.”

The changing statistics of prostate cancer also may reflect decreases in screening in response to a 2012 statement from the US Preventive Services Task Force advising against PSA testing. The American Cancer Society in January 2023 said that statement could be driving more diagnoses of late-stage disease, which has been surging for the first time in two decades, especially among Black men.

Dr. Sayyid said patients must be selected carefully for active surveillance. And he said urologists should not promise their active surveillance patients that they will avoid treatment. “There are numerous factors at stake that influence the ultimate outcome,” he said.

Progression of Gleason scores is estimated at 1%-2% per year, Dr. Sayyid added. When active surveillance fails in the short to medium term — 5-10 years — the reason usually is that higher-grade cancers with Gleason 3 + 4 or above were initially missed.

Dr. Sayyid said he counsels patients aged 70 years and older differently than those in their 50s, telling younger patients they are more likely to need treatment eventually than the older patients.

Factors that can affect the longevity of active surveillance include the presence or absence of germline mutations and the overall health and life expectancy and comorbidities such as heart disease and diabetes in a given patient, he said.

Urologists hold varying philosophies here, especially involving younger patients and the presence of any level of Gleason 4 cancer.

William Catalona, MD, of Northwestern University Feinberg School of Medicine in Chicago, Illinois, who developed the concept of mass screening with PSA testing, originally opposed active surveillance. In recent years, he has modified his views but still takes a more conservative approach.

“I consider active surveillance a foolish strategy or, at best, a short-term strategy for young, otherwise healthy men, especially those having any Gleason pattern 4 disease.”

“More than half will ultimately convert to active treatment, some too late, and will require multiple treatments with multiple side effects. Some will develop metastases, and some will die of prostate cancer.”

Dr. Sayyid takes a more liberal approach. “I would counsel an eligible patient considering active surveillance that at the current time, I see no strong reason why you should be subjected to treatment and the associated side effects,” he said. “And as long as your overall disease ‘state’ [the combination of grade, volume, PSA, and imaging tests] remains relatively stable, there should be no reason for us to ‘jump ship’. In my practice, another term for active surveillance is ‘active partnership’ — working together to decide if this is a sprint or a lifelong marathon.”

Dr. Carroll reported research funding from the National Institutes of Health.

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

TOPLINE:

Imposing a new prior authorization requirement increased the likelihood that older patients with cancer will delay or stop filling their prescription for oral anticancer drugs, a new study showed.

METHODOLOGY:

• Prior authorization requirements, especially in oncology, continue to increase, but how these policies affect patients’ access to care remains less clear.
• Researchers analyzed Medicare Part D claims from 2010 to 2020 to assess the effects of prior authorization changes on prescriptions fills for 1 of 11 oral anticancer drugs.
• The study included 2495 patients filling a prescription for these medications prior to their health plan imposing a new prior authorization policy and 22,641 patients filling prescriptions for the same drugs with no change in prior authorization policy (control).
• Beneficiaries had at least three 30-day fills in the 120 days before the new prior authorization policy was established on January 1 and continued to be enrolled in the same plan 120 days after the policy change.
• The researchers focused on how often patients discontinued their therapy within 120 days following a prior authorization policy change, as well as the time to fill a prescription after this change.

TAKEAWAY:

• Patients subjected to a new prior authorization policy on an established drug had a sevenfold higher likelihood of stopping the drug within 120 days than those who had no change in prior authorization requirements (adjusted odds ratio, 7.1).
• The adjusted probability of discontinuing an oral cancer regimen within 120 days after an index date of January 1 (when most health plan policy changes occur) was 5.8% for those with a new prior authorization policy vs 1.4% for the control group.
• A new prior authorization requirement was also associated with an average 10-day delay to refill the first prescription following the policy change (P < .001).
• The probability of a delay of more than 30 days was 22% after a policy change vs 7% after no policy change.

IN PRACTICE:

“Our results suggest concerns about delayed and foregone care related to prior authorization are warranted,” the authors said. Overall, this study found that “prior authorization wasted time and undermined the policy priorities of access to care and oral anticancer drug adherence for patients who were regular users of a particular medication.”

SOURCE:

The study by Michael Anna Kyle, PhD, RN, and Nancy Keating, MD, MPH, with Harvard Medical School, Boston, was published online in the Journal of Clinical Oncology.

LIMITATIONS:

The study did not look at patients starting new oral anticancer drugs, which may come with more complex prior authorization processes and create more significant access issues. The results are also limited to patients taking 1 of 11 oral anticancer agents in Medicare Part D.

DISCLOSURES:

Funding for the study was provided by the National Cancer Institute. The authors reported no relevant conflicts of interest.

A version of this article appeared on Medscape.com.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

Mark Lewis, MD, saw the pain in his patient’s body. The man’s gastrointestinal tumor had metastasized to his bones. Even breathing had become agonizing.

It was a Friday afternoon. Dr. Lewis could see his patient would struggle to make it through the weekend without some pain relief.

When this happens, “the clock is ticking,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Health in Salt Lake City, Utah. “A patient, especially one with more advanced disease, only has so much time to wait for care.”

Dr. Lewis sent in an electronic request for an opioid prescription to help ease his patient’s pain through the weekend. Once the prescription had gone through, Dr. Lewis told his patient the medication should be ready to pick up at his local pharmacy.

Dr. Lewis left work that Friday feeling a little lighter, knowing the pain medication would help his patient over the weekend.

Moments after walking into the clinic on Monday morning, Dr. Lewis received an unexpected message: “Your patient is in the hospital.”

The events of the weekend soon unfolded.

Dr. Lewis learned that when his patient went to the pharmacy to pick up his pain medication, the pharmacist told him the prescription required prior authorization.

The patient left the pharmacy empty-handed. Hours later, he was in the emergency room (ER) in extreme pain — the exact situation Dr. Lewis had been trying to avoid.

Dr. Lewis felt a sense of powerlessness in that moment.

“I had been left in the dark,” he said. The oncologist-patient relationship is predicated on trust and “that trust is eroded when I can’t give my patients the care they need,” he explained. “I can’t stand overpromising and underdelivering to them.”

Dr. Lewis had received no communication from the insurer that the prescription required prior authorization, no red flag that the request had been denied, and no notification to call the insurer.

Although physicians may need to tread carefully when prescribing opioids over the long term, “this was simply a prescription for 2-3 days of opioids for the exact patient who the drugs were developed to benefit,” Dr. Lewis said. But instead, “he ended up in ER with a pain crisis.”

Prior authorization delays like this often mean patients pay the price.

“These delays are not trivial,” Dr. Lewis said.

A recent study, presented at the ASCO Quality Care Symposium in October, found that among 3304 supportive care prescriptions requiring prior authorization, insurance companies denied 8% of requests, with final denials taking as long as 78 days. Among approved prescriptions, about 40% happened on the same day, while the remaining took anywhere from 1 to 54 days.

Denying or delaying necessary and cost-effective care, even briefly, can harm patients and lead to higher costs. A 2022 survey from the American Medical Association found that instead of reducing low-value care as insurance companies claim, prior authorization often leads to higher overall use of healthcare resources. More specifically, almost half of physicians surveyed said that prior authorization led to an ER visit or need for immediate care.

In this patient’s case, filling the opioid prescription that Friday would have cost no more than $300, possibly as little as $30. The ER visit to manage the patient’s pain crisis costs thousands.

The major issue overall, Dr. Lewis said, is the disconnect between the time spent waiting for prior authorization approvals and the necessity of these treatments. Dr. Lewis says even standard chemotherapy often requires prior authorization.

“The currency we all share is time,” Dr. Lewis said. “But it often feels like there’s very little urgency on insurance company side to approve a treatment, which places a heavy weight on patients and physicians.”

“It just shouldn’t be this hard,” he said.

A version of this article appeared on Medscape.com as part of the Gatekeepers of Care series on issues oncologists and people with cancer face navigating health insurance company requirements. Read more about the series here. Please email [email protected] to share experiences with prior authorization or other challenges receiving care.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

TOPLINE:

Women with estrogen receptor (ER)–positive, human epidermal growth factor receptor 2 (HER2)–negative invasive lobular carcinoma who are treated with endocrine therapy do not derive any additional survival benefit from neoadjuvant or adjuvant chemotherapy.

METHODOLOGY:

• Studies evaluating the long-term effects of chemotherapy in patients with invasive lobular carcinoma are limited and often “show inconclusive results,” the authors explained.
• Female patients diagnosed with ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy were identified from the breast cancer database at Erasmus Medical Center, Rotterdam, the Netherlands.
• Linked information on patient and tumor characteristics, vital status, and treatment were then obtained from the Netherlands Cancer Registry.
• Patients also had to have an indication for chemotherapy based on lymph node status, tumor size, histologic tumor grade, and hormone receptor status, in line with national guidelines.
• Among 716 patients with ER-positive, HER2-negative invasive lobular carcinoma, 520 who had an indication for chemotherapy were included. Of those, 379 received chemotherapy and 141 did not.

TAKEAWAY:

• Patients who received chemotherapy were younger at diagnosis than those who did not (51 vs 61 years), had an earlier average year of diagnosis (2010 vs 2015), and had longer follow-up (7.8 years vs 5.2 years).
• Chemotherapy recipients were more likely to have T3+ disease (33% vs 14%) and positive lymph node involvement (80% vs 49%), and less likely to undergo breast-conserving surgery (31% vs 43%).
• Researchers, however, found no difference between the chemotherapy and no-chemotherapy groups in terms of recurrence-free survival (hazard ratio [HR], 1.20; 95% CI, 0.63-2.31), breast cancer–specific survival (HR, 1.24; 95% CI, 0.60-2.58), and overall survival (HR, 0.97; 95% CI, 0.56-1.66) after adjustment for confounders.

IN PRACTICE:

The authors “observed no evidence for added value of chemotherapy” for ER-positive, HER2-negative invasive lobular carcinoma who received endocrine therapy. “In view of the adverse effects of chemotherapy, our study takes an important step in answering a valuable question from the patient’s perspective,” the researchers wrote.

SOURCE:

The study, conducted by Bernadette A.M. Heemskerk-Gerritsen, PhD, from Erasmus Medical Center Cancer Institute, Rotterdam, the Netherlands, was published in Cancer on November 20, 2023.

LIMITATIONS:

The retrospective design means that there is a risk for residual confounding from factors not recorded in the database. The researchers believe that some patients did not receive chemotherapy owing to having comorbidities or patient preference, which could have influenced the results. Moreover, the duration of endocrine therapy was not recorded.

DISCLOSURES:

No funding was declared. One author declares relationships with GlaxoSmithKline, Pfizer, Menarini Silicon Biosystems, and Novartis. No other relevant financial relationships were declared.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

SAN ANTONIO — Axillary lymph node dissection may be unnecessary if breast cancer patients with one or two positive sentinel lymph nodes plan to have adjuvant nodal radiation, according to a major Scandinavian trial presented at the San Antonio Breast Cancer Symposium.

“It means that you don’t need to dissect the axilla if you” are going to “radiate the axilla.” “For the U.S., that’s the conclusion because there are still centers that do both, and that’s out,” lead investigator Jana de Boniface, MD, PhD, a breast cancer surgeon at the Karolinska Institutet, Stockholm, said in an interview.

The study added to a persistent theme at this year’s meeting, protecting breast cancer patients from doing too much and causing unnecessary harm. Some even wondered if 5 years of endocrine therapy is necessary.

Dr. Boniface shared her thoughts after presenting the Scandinavian trial, SENOMAC, which she led.

SENOMAC randomized 1,204 patients with one or two positive sentinel lymph nodes to axillary dissection; 1,335 with the same finding were randomized to no dissection.

Subjects had clinically T1-3, N0 primary breast cancer. About 89% in both arms went on to adjuvant radiation, including nodal radiation, and almost all also went on to systemic therapy, which included endocrine therapy in over 90%. Only about 2% of subjects had neoadjuvant therapy.

At a median follow-up of nearly 4 years, recurrence-free survival was virtually identical in both groups, with 8% of patients in the dissection arm and 7.1% in the no-dissection group having recurrences. Estimated 5-year recurrence-free survival was just shy of 90% in both groups. Skipping dissection was strongly non-inferior to having one (P < .001).

SENOMAC “clearly shows that you don’t need to dissect the axilla if you have one to two positive sentinel lymph nodes” so long as patients have adjuvant nodal radiation. Recurrence-free survival “curves practically overlap, and we cannot see any difference between the two groups,” Dr. Boniface said.

Meanwhile, the dissection group fared worse on patient reported outcomes. Overall survival outcomes, the primary endpoint of the trial, are expected within 2 years.

The goal of the trial, the largest to date to look into the issue, was to fill gaps in the literature. Similar outcomes were reported around a decade ago in patients with low sentinel lymph node burdens, but the extensive exclusion criteria raised questions about general applicability.

In contrast, SENOMAC was widely inclusive. Over a third of patients had mastectomies, over a third had sentinel lymph node extracapsular extension, almost 6% had T3 disease, almost 20% had lobular carcinoma, 40% were 65 years or older, and tumors were as large as 15.5 cm.

The findings held regardless of those and other factors on subgroup analyses, including estrogen receptor and HER2 status and the number of additional positive nodes retrieved in the dissection group.

Andrea V. Barrio, MD, the study discussant and a breast cancer surgeon at Memorial Sloan Kettering Cancer Center, New York, agreed with the message from SENOMAC.

“Based on this, ALND [axillary lymph node dissection] should not be considered standard in patients with clinical T1-3, N0 breast cancer with one to two positive sentinel nodes, with or without microscopic extracapsular extension, undergoing lumpectomy or mastectomy,” provided nodal adjuvant radiotherapy is indicated, she said.

Although adjuvant nodal radiation for patients with one to three positive sentinel nodes is standard of care in Denmark and Sweden, where most of the patients in SENOMAC were located, practices vary widely in the United States. If adjuvant radiation isn’t used, “then ALND [is still] indicated,” Dr. Barrio said, but in either case, “only one is needed.”

In keeping with the de-escalation theme at the 2023 symposium, both Dr. Boniface and Dr. Barrio noted that trials are now underway to find patients who can avoid any axillary treatment at all if they have just one or two positive sentinel lymph nodes.

Preoperative axillary ultrasound was mandatory in SENOMAC and patients with non-palpable suspicious axillary lymph nodes were enrolled.

Thirty-six were positive on fine needle aspiration and randomized into the study, but when asked, Dr. Boniface didn’t have the data immediately at hand on how they fared.

The work was funded by the Swedish Research Council, Nordic Cancer Union, and others. Dr. Boniface and Dr. Barrio didn’t have any disclosures.

Highlights in diffuse large B-cell lymphoma (DLBCL) from the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition that are particularly relevant to Veterans Health Administration (VHA) patients are reported by Dr Nicholas Burwick of Puget Sound VA Health Care System. 

Dr Burwick begins with a large VHA study examining racial disparities in DLBCL outcomes among veterans. Importantly, overall survival was not significantly different across racial groups.  

He next covers two studies in the DLBCL frontline setting. The first examines the efficacy of standard-dose R-CHOP; reduced-intensity R-CHOP; and an anthracycline alternative regimen among older patients. Standard-dose R-CHOP yielded superior results in patients aged 70- to 79-years but not for those older than 80 years, a group that merits further study. 

The second frontline study focused on the chemotherapy-free regimen mosunetuzumab plus the antibody-drug conjugate polatuzumab vedotin (pola) in patients who are older and unfit for chemotherapy. The combination showed good preliminary efficacy. 

Turning to relapsed/refractory patients, Dr Burwick discusses a real-world study examining response rates to tafasitamab in White vs Black/African American patients and non-Hispanic vs Hispanic patients. Differences between the two groups proved minimal. 

Finally, he discusses a study of the bispecific antibody glofitamab and pola in heavily pretreated patients that showed promising results in this population. 

--

Nicholas R. Burwick, MD, Associate Professor, Department of Medicine, Division of Hematology, University of Washington; Staff Physician, Department of Medicine, Division of Hematology, Puget Sound VA Health Care System, Seattle, Washington  

Nicholas R. Burwick, MD, has disclosed no relevant financial relationships 

Highlights in diffuse large B-cell lymphoma (DLBCL) from the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition that are particularly relevant to Veterans Health Administration (VHA) patients are reported by Dr Nicholas Burwick of Puget Sound VA Health Care System. 

Dr Burwick begins with a large VHA study examining racial disparities in DLBCL outcomes among veterans. Importantly, overall survival was not significantly different across racial groups.  

He next covers two studies in the DLBCL frontline setting. The first examines the efficacy of standard-dose R-CHOP; reduced-intensity R-CHOP; and an anthracycline alternative regimen among older patients. Standard-dose R-CHOP yielded superior results in patients aged 70- to 79-years but not for those older than 80 years, a group that merits further study. 

The second frontline study focused on the chemotherapy-free regimen mosunetuzumab plus the antibody-drug conjugate polatuzumab vedotin (pola) in patients who are older and unfit for chemotherapy. The combination showed good preliminary efficacy. 

Turning to relapsed/refractory patients, Dr Burwick discusses a real-world study examining response rates to tafasitamab in White vs Black/African American patients and non-Hispanic vs Hispanic patients. Differences between the two groups proved minimal. 

Finally, he discusses a study of the bispecific antibody glofitamab and pola in heavily pretreated patients that showed promising results in this population. 

--

Nicholas R. Burwick, MD, Associate Professor, Department of Medicine, Division of Hematology, University of Washington; Staff Physician, Department of Medicine, Division of Hematology, Puget Sound VA Health Care System, Seattle, Washington  

Nicholas R. Burwick, MD, has disclosed no relevant financial relationships 

Highlights in diffuse large B-cell lymphoma (DLBCL) from the 2023 American Society of Hematology (ASH) Annual Meeting and Exposition that are particularly relevant to Veterans Health Administration (VHA) patients are reported by Dr Nicholas Burwick of Puget Sound VA Health Care System. 

Dr Burwick begins with a large VHA study examining racial disparities in DLBCL outcomes among veterans. Importantly, overall survival was not significantly different across racial groups.  

He next covers two studies in the DLBCL frontline setting. The first examines the efficacy of standard-dose R-CHOP; reduced-intensity R-CHOP; and an anthracycline alternative regimen among older patients. Standard-dose R-CHOP yielded superior results in patients aged 70- to 79-years but not for those older than 80 years, a group that merits further study. 

The second frontline study focused on the chemotherapy-free regimen mosunetuzumab plus the antibody-drug conjugate polatuzumab vedotin (pola) in patients who are older and unfit for chemotherapy. The combination showed good preliminary efficacy. 

Turning to relapsed/refractory patients, Dr Burwick discusses a real-world study examining response rates to tafasitamab in White vs Black/African American patients and non-Hispanic vs Hispanic patients. Differences between the two groups proved minimal. 

Finally, he discusses a study of the bispecific antibody glofitamab and pola in heavily pretreated patients that showed promising results in this population. 

--

Nicholas R. Burwick, MD, Associate Professor, Department of Medicine, Division of Hematology, University of Washington; Staff Physician, Department of Medicine, Division of Hematology, Puget Sound VA Health Care System, Seattle, Washington  

Nicholas R. Burwick, MD, has disclosed no relevant financial relationships 

Healthcare costs for patients undergoing common surgical procedures are significantly higher when the surgery is performed by a male surgeon rather than a female surgeon, data suggested.

A retrospective, population-based cohort study that included more than 1 million adults undergoing any of 25 common surgical procedures found that total healthcare costs assessed at 1 year following surgery were more than $6000 higher when the surgery was performed by a male surgeon. Costs were also higher at 30 and 90 days for patients treated by male surgeons.

“As a male surgeon, I think our results should cause me and my colleagues to pause and consider why this may be,” said lead author Christopher J. D. Wallis, MD, PhD, assistant professor of surgery at the University of Toronto.

“None of us believe that the presence of a Y chromosome in surgeons means there are worse outcomes, it’s just that generally speaking, men and women, as we have known for decades, practice medicine a little differently. Things like communication style, time they spend with their patients, and even things like guideline adherence are different, and understanding how those differences translate into patient outcomes is the goal of this whole body of work,” said Wallis.

The study was published online November 29 in JAMA Surgery.

Explanation Is Elusive

In earlier work, Dr. Wallis and his team reported that patients treated by female surgeons had a small but statistically significant decrease in 30-day mortality, were less likely to be readmitted to the hospital, and had fewer complications than those treated by male surgeons. In another study, they found worse outcomes among female patients treated by male surgeons.

In the current study, the researchers examined the association between surgeon sex and healthcare costs among patients undergoing various surgical procedures, including coronary artery bypass grafting, appendectomy, hysterectomy, anterior spinal decompression, and knee replacement. They included all adult patients who underwent these procedures at hospitals in Ontario, Canada, between January 2007 and December 2019 in their analysis.

The study sample included 1,165,711 patients. Of this group, 151,054 patients were treated by a female surgeon, and 1,014,657 were treated by a male surgeon.

After adjusting for patient-, surgeon-, anesthesiologist-, and hospital-related factors, they found that 1-year total healthcare costs were $24,882 for patients treated by male surgeons vs $18,517 for patients treated by female surgeons. Healthcare costs were also higher at 30 days (adjusted absolute difference, $3115) and at 90 days (adjusted absolute difference, $4228).

“This translates into a 9%-10% higher risk of costs with male surgeons compared with women surgeons at these time points,” said Dr. Wallis.

“This study cannot provide a specific answer as to why these differences are occurring,” Dr. Wallis said.

“We are currently undertaking more research to better understand the reasons. Our previous studies have shown that patients treated by male physicians have higher rates of death, readmission, and complications. Managing these adverse postoperative events is costly and likely contributes to these differences. Given the size of our study and similar training pathways, we do not think there are technical differences between male and female surgeons. Rather, we are hypothesizing that there may be differences in how physicians practice, make decisions, and consult with patients,” he said.

Ultimately, Dr. Wallis said he would like his research to prompt “a moment of introspection” among his surgical colleagues.

“Hopefully, these data will provide the impetus for further efforts to make surgery, and medicine in general, a field that is welcoming to women,” he said.

Potential Confounding Factors

This study expands the evidence suggesting significant practice differences between male and female surgeons, Ursula Adams, MD, a resident; Caprice C. Greenberg, MD, MPH, chair; and Jared Gallaher, MD, MPH, adjunct assistant professor, all from the Department of Surgery at the University of North Carolina in Chapel Hill, wrote in an accompanying editorial.

They cautioned, however, that “there are many potential confounding factors and possible explanatory mechanisms associated with surgeon sex that make it challenging to untangle influences on costs. Sex may be an easily captured data point, but is understanding the mechanism by which it affects cost the right next step? Surgeons control how and where they practice; they do not have control over their own demographics.”

The editorialists added that while recruiting and retaining women in surgery is important, it is not a solution to controlling costs.

“We must provide surgeons with better data to understand how practice approach and decisions affect cost and support for practice improvement. Only with these insights will we ensure patients of male surgeons receive care that is just as cost-effective as that provided by female surgeons, while also helping to bend the cost curve and improve the quality of surgical care,” they concluded.

‘Admirable’ Data Use

Commenting on the findings, Oluwadamilola “Lola” Fayanju, MD, chief of breast surgery at Penn Medicine in Philadelphia, said, “It is interesting that the study was performed in Canada with its different healthcare system.” Dr. Fayanju did not participate in the study.

“They used administrative data from a national database, and it is admirable that they were able to do that. These data allow us to make large-scale geographical assessments, although they are subject to errors and unmeasured confounders,” said Dr. Fayanju.

Women surgeons may do things that result in better outcomes, she suggested. “In this study, the women were younger and so perhaps were more up to date. They might have optimized management of their patients in the pre-op phase, including better patient selection, which led to better costs. Or in the post-op phase, they might have made themselves readily accessible. For instance, I remove all barriers about getting in touch with me, and I tell my students to make sure the patient can reach you easily,” said Dr. Fayanju.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care, and the Data Sciences Institute at the University of Toronto. Dr. Wallis, Dr. Adams, Dr. Greenberg, Dr. Gallaher, and Dr. Fayanju reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Healthcare costs for patients undergoing common surgical procedures are significantly higher when the surgery is performed by a male surgeon rather than a female surgeon, data suggested.

A retrospective, population-based cohort study that included more than 1 million adults undergoing any of 25 common surgical procedures found that total healthcare costs assessed at 1 year following surgery were more than $6000 higher when the surgery was performed by a male surgeon. Costs were also higher at 30 and 90 days for patients treated by male surgeons.

“As a male surgeon, I think our results should cause me and my colleagues to pause and consider why this may be,” said lead author Christopher J. D. Wallis, MD, PhD, assistant professor of surgery at the University of Toronto.

“None of us believe that the presence of a Y chromosome in surgeons means there are worse outcomes, it’s just that generally speaking, men and women, as we have known for decades, practice medicine a little differently. Things like communication style, time they spend with their patients, and even things like guideline adherence are different, and understanding how those differences translate into patient outcomes is the goal of this whole body of work,” said Wallis.

The study was published online November 29 in JAMA Surgery.

Explanation Is Elusive

In earlier work, Dr. Wallis and his team reported that patients treated by female surgeons had a small but statistically significant decrease in 30-day mortality, were less likely to be readmitted to the hospital, and had fewer complications than those treated by male surgeons. In another study, they found worse outcomes among female patients treated by male surgeons.

In the current study, the researchers examined the association between surgeon sex and healthcare costs among patients undergoing various surgical procedures, including coronary artery bypass grafting, appendectomy, hysterectomy, anterior spinal decompression, and knee replacement. They included all adult patients who underwent these procedures at hospitals in Ontario, Canada, between January 2007 and December 2019 in their analysis.

The study sample included 1,165,711 patients. Of this group, 151,054 patients were treated by a female surgeon, and 1,014,657 were treated by a male surgeon.

After adjusting for patient-, surgeon-, anesthesiologist-, and hospital-related factors, they found that 1-year total healthcare costs were $24,882 for patients treated by male surgeons vs $18,517 for patients treated by female surgeons. Healthcare costs were also higher at 30 days (adjusted absolute difference, $3115) and at 90 days (adjusted absolute difference, $4228).

“This translates into a 9%-10% higher risk of costs with male surgeons compared with women surgeons at these time points,” said Dr. Wallis.

“This study cannot provide a specific answer as to why these differences are occurring,” Dr. Wallis said.

“We are currently undertaking more research to better understand the reasons. Our previous studies have shown that patients treated by male physicians have higher rates of death, readmission, and complications. Managing these adverse postoperative events is costly and likely contributes to these differences. Given the size of our study and similar training pathways, we do not think there are technical differences between male and female surgeons. Rather, we are hypothesizing that there may be differences in how physicians practice, make decisions, and consult with patients,” he said.

Ultimately, Dr. Wallis said he would like his research to prompt “a moment of introspection” among his surgical colleagues.

“Hopefully, these data will provide the impetus for further efforts to make surgery, and medicine in general, a field that is welcoming to women,” he said.

Potential Confounding Factors

This study expands the evidence suggesting significant practice differences between male and female surgeons, Ursula Adams, MD, a resident; Caprice C. Greenberg, MD, MPH, chair; and Jared Gallaher, MD, MPH, adjunct assistant professor, all from the Department of Surgery at the University of North Carolina in Chapel Hill, wrote in an accompanying editorial.

They cautioned, however, that “there are many potential confounding factors and possible explanatory mechanisms associated with surgeon sex that make it challenging to untangle influences on costs. Sex may be an easily captured data point, but is understanding the mechanism by which it affects cost the right next step? Surgeons control how and where they practice; they do not have control over their own demographics.”

The editorialists added that while recruiting and retaining women in surgery is important, it is not a solution to controlling costs.

“We must provide surgeons with better data to understand how practice approach and decisions affect cost and support for practice improvement. Only with these insights will we ensure patients of male surgeons receive care that is just as cost-effective as that provided by female surgeons, while also helping to bend the cost curve and improve the quality of surgical care,” they concluded.

‘Admirable’ Data Use

Commenting on the findings, Oluwadamilola “Lola” Fayanju, MD, chief of breast surgery at Penn Medicine in Philadelphia, said, “It is interesting that the study was performed in Canada with its different healthcare system.” Dr. Fayanju did not participate in the study.

“They used administrative data from a national database, and it is admirable that they were able to do that. These data allow us to make large-scale geographical assessments, although they are subject to errors and unmeasured confounders,” said Dr. Fayanju.

Women surgeons may do things that result in better outcomes, she suggested. “In this study, the women were younger and so perhaps were more up to date. They might have optimized management of their patients in the pre-op phase, including better patient selection, which led to better costs. Or in the post-op phase, they might have made themselves readily accessible. For instance, I remove all barriers about getting in touch with me, and I tell my students to make sure the patient can reach you easily,” said Dr. Fayanju.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care, and the Data Sciences Institute at the University of Toronto. Dr. Wallis, Dr. Adams, Dr. Greenberg, Dr. Gallaher, and Dr. Fayanju reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

Healthcare costs for patients undergoing common surgical procedures are significantly higher when the surgery is performed by a male surgeon rather than a female surgeon, data suggested.

A retrospective, population-based cohort study that included more than 1 million adults undergoing any of 25 common surgical procedures found that total healthcare costs assessed at 1 year following surgery were more than $6000 higher when the surgery was performed by a male surgeon. Costs were also higher at 30 and 90 days for patients treated by male surgeons.

“As a male surgeon, I think our results should cause me and my colleagues to pause and consider why this may be,” said lead author Christopher J. D. Wallis, MD, PhD, assistant professor of surgery at the University of Toronto.

“None of us believe that the presence of a Y chromosome in surgeons means there are worse outcomes, it’s just that generally speaking, men and women, as we have known for decades, practice medicine a little differently. Things like communication style, time they spend with their patients, and even things like guideline adherence are different, and understanding how those differences translate into patient outcomes is the goal of this whole body of work,” said Wallis.

The study was published online November 29 in JAMA Surgery.

Explanation Is Elusive

In earlier work, Dr. Wallis and his team reported that patients treated by female surgeons had a small but statistically significant decrease in 30-day mortality, were less likely to be readmitted to the hospital, and had fewer complications than those treated by male surgeons. In another study, they found worse outcomes among female patients treated by male surgeons.

In the current study, the researchers examined the association between surgeon sex and healthcare costs among patients undergoing various surgical procedures, including coronary artery bypass grafting, appendectomy, hysterectomy, anterior spinal decompression, and knee replacement. They included all adult patients who underwent these procedures at hospitals in Ontario, Canada, between January 2007 and December 2019 in their analysis.

The study sample included 1,165,711 patients. Of this group, 151,054 patients were treated by a female surgeon, and 1,014,657 were treated by a male surgeon.

After adjusting for patient-, surgeon-, anesthesiologist-, and hospital-related factors, they found that 1-year total healthcare costs were $24,882 for patients treated by male surgeons vs $18,517 for patients treated by female surgeons. Healthcare costs were also higher at 30 days (adjusted absolute difference, $3115) and at 90 days (adjusted absolute difference, $4228).

“This translates into a 9%-10% higher risk of costs with male surgeons compared with women surgeons at these time points,” said Dr. Wallis.

“This study cannot provide a specific answer as to why these differences are occurring,” Dr. Wallis said.

“We are currently undertaking more research to better understand the reasons. Our previous studies have shown that patients treated by male physicians have higher rates of death, readmission, and complications. Managing these adverse postoperative events is costly and likely contributes to these differences. Given the size of our study and similar training pathways, we do not think there are technical differences between male and female surgeons. Rather, we are hypothesizing that there may be differences in how physicians practice, make decisions, and consult with patients,” he said.

Ultimately, Dr. Wallis said he would like his research to prompt “a moment of introspection” among his surgical colleagues.

“Hopefully, these data will provide the impetus for further efforts to make surgery, and medicine in general, a field that is welcoming to women,” he said.

Potential Confounding Factors

This study expands the evidence suggesting significant practice differences between male and female surgeons, Ursula Adams, MD, a resident; Caprice C. Greenberg, MD, MPH, chair; and Jared Gallaher, MD, MPH, adjunct assistant professor, all from the Department of Surgery at the University of North Carolina in Chapel Hill, wrote in an accompanying editorial.

They cautioned, however, that “there are many potential confounding factors and possible explanatory mechanisms associated with surgeon sex that make it challenging to untangle influences on costs. Sex may be an easily captured data point, but is understanding the mechanism by which it affects cost the right next step? Surgeons control how and where they practice; they do not have control over their own demographics.”

The editorialists added that while recruiting and retaining women in surgery is important, it is not a solution to controlling costs.

“We must provide surgeons with better data to understand how practice approach and decisions affect cost and support for practice improvement. Only with these insights will we ensure patients of male surgeons receive care that is just as cost-effective as that provided by female surgeons, while also helping to bend the cost curve and improve the quality of surgical care,” they concluded.

‘Admirable’ Data Use

Commenting on the findings, Oluwadamilola “Lola” Fayanju, MD, chief of breast surgery at Penn Medicine in Philadelphia, said, “It is interesting that the study was performed in Canada with its different healthcare system.” Dr. Fayanju did not participate in the study.

“They used administrative data from a national database, and it is admirable that they were able to do that. These data allow us to make large-scale geographical assessments, although they are subject to errors and unmeasured confounders,” said Dr. Fayanju.

Women surgeons may do things that result in better outcomes, she suggested. “In this study, the women were younger and so perhaps were more up to date. They might have optimized management of their patients in the pre-op phase, including better patient selection, which led to better costs. Or in the post-op phase, they might have made themselves readily accessible. For instance, I remove all barriers about getting in touch with me, and I tell my students to make sure the patient can reach you easily,” said Dr. Fayanju.

The study was supported by ICES, which is funded by an annual grant from the Ontario Ministry of Health and the Ministry of Long-Term Care, and the Data Sciences Institute at the University of Toronto. Dr. Wallis, Dr. Adams, Dr. Greenberg, Dr. Gallaher, and Dr. Fayanju reported no relevant financial relationships.

A version of this article appeared on Medscape.com.

SAN DIEGO — Two proposed new multiple myeloma staging systems offer similar prognostic accuracy compared with the standard staging system, but the new systems provide more refined risk classifications across different disease stages. 

The findings should encourage greater use of these newer staging systems in routine clinical practice, first author Manni Mohyuddin, MD, said during a presentation at the American Society of Hematology annual meeting.

Dr. Mohyuddin and his colleagues retrospectively compared the standard Revised International Staging System (R-ISS) with two newer systems, the Second Revision of the R-ISS (R2-ISS) and the Mayo Additive Staging System (MASS), using real-world data from nearly 500 patients with newly diagnosed multiple myeloma.

The R-ISS, the most common multiple myeloma staging system, incorporates a range of prognostic features, including high-risk genetic markers assessed using fluorescence in situ hybridization as well as levels of lactate dehydrogenase, albumin, and beta-2 microglobulin, explained Dr. Mohyuddin, assistant professor at the Huntsman Cancer Institute, University of Utah, Salt Lake City.

R2-ISS and MASS include additional factors that reflect experts’ growing understanding of multiple myeloma. Specifically, the systems also evaluate a gain of chromosome 1q, in which patients have an extra copy of chromosome 1q, as well as the additive effects of multiple high-risk cytogenetic abnormalities, both of which indicate worse prognosis in multiple myeloma, Dr. Mohyuddin said in an interview.

To compare the three staging systems, the investigators used information on newly diagnosed patients in the Flatiron Health EHR–derived deidentified database, which includes data from cancer clinics across the United States. Patients were followed from first-line treatment initiation until death, the end of the study period, or last recorded activity.

The patients from the database had a median age of 70 years, and most had not received a transplant. The most common cytogenetic abnormality was gain 1q, present in about one third of patients. 

Given that the R2-ISS originated from patients in clinical trials, Dr. Mohyuddin noted the importance of assessing how the system would perform in a real-world setting. 

Of the 497 patients in the analysis, the R-ISS staging system classified 24% as stage I, 63% as stage II, and 13% as stage III. Overall survival differed across these R-ISS stages, indicating the system was prognostic for survival. Median overall survival was not reached for those with stage I disease, was 62.9 months for those with stage II disease, and 37.6 months for those with stage III disease.

Because the R-ISS doesn’t consider the additive effect of multiple cytogenetic abnormalities, many patients end up in the R-ISS stage II category but ultimately may have vastly different outcomes, Dr. Mohyuddin said.

The R2-ISS includes four risk categories, which provide more granularity to the stage II classification: Stage I is low risk, stage II is low-intermediate, stage III is intermediate, and stage IV is high risk. Using this staging system, 20% of patients were stage I, 25% were stage II, 46% were stage III, and 9% were stage IV.

The R2-ISS was also prognostic for survival, which generally worsened from stage I to stage IV: Median overall survival was not reached in stage I patients, was 69.3 months for stage II, 50.0 months for stage III, and 50.6 months for stage IV patients. However, Dr. Mohyuddin noted that there was some overlap in the survival curves for stages I and II and for stages III and IV.

When applying MASS, 34% of patients were categorized as stage I, 35% as stage II, and 31% as stage III disease. This system was prognostic for survival as well, with median overall survival of 76.9 months for stage I, 61.2 months for stage II, and 45.0 months for stage III.

With R2-ISS, many of those in R-ISS stage II are moved into stage I and III. With MASS, the R-ISS stage II patients are more evenly distributed across stages I, II, and III.

In other words, “we show that both these newer staging systems basically recategorize patients into different stages,” essentially “decreasing the number of people in the large, ambiguous (R-ISS) stage II category,” said Dr. Mohyuddin. 

Dr. Mohyuddin and colleagues also evaluated the staging systems in fully adjusted analyses that controlled for age, race/ethnicity, sex, practice type, and diagnosis year. 

Using R2-ISS, stage I patients had a similar risk for death compared with stage II patients (hazard ratio [HR], 1.2). Compared with stage I patients, stage III and IV patients had comparable risks for death, both about 2.5-fold higher than in those with stage I disease (HR, 2.4 and 2.6, respectively). 

Compared with stage I MASS patients, those with stage II had a twofold higher risk for death (HR, 2.0), and those with stage III had an almost threefold higher risk (HR, 2.7). 

Although no system considers all factors associated with myeloma outcomes, R2-ISS and MASS do offer a benefit over R-ISS, Dr. Mohyuddin said.

He added that the R2-ISS and MASS are similar from a statistical standpoint, but he gave MASS a slight edge for use in clinical practice.

MASS “more cleanly demarcated [patients] into prognostic subsets,” plus it is “a little easier to remember by heart,” he explained. MASS also puts more emphasis on the presence of multiple high-risk cytogenetic abnormalities, which is a worse prognostic in this era of quadruplet therapy for multiple myeloma, he added.

Because the study largely took place in an era when triplet therapy dominated, “we would be curious to see, with longer follow-up and more use of quadruplets, how these staging systems would perform,” he said. 

Despite the benefits of these newer staging systems, many factors play a role in multiple myeloma outcomes, Dr. Mohyuddin explained. Staging systems are “only a piece of the puzzle.”

Dr. Mohyuddin reported having no financial interests to disclose.
 

A version of this article appeared on Medscape.com.

SAN DIEGO — Two proposed new multiple myeloma staging systems offer similar prognostic accuracy compared with the standard staging system, but the new systems provide more refined risk classifications across different disease stages. 

The findings should encourage greater use of these newer staging systems in routine clinical practice, first author Manni Mohyuddin, MD, said during a presentation at the American Society of Hematology annual meeting.

Dr. Mohyuddin and his colleagues retrospectively compared the standard Revised International Staging System (R-ISS) with two newer systems, the Second Revision of the R-ISS (R2-ISS) and the Mayo Additive Staging System (MASS), using real-world data from nearly 500 patients with newly diagnosed multiple myeloma.

The R-ISS, the most common multiple myeloma staging system, incorporates a range of prognostic features, including high-risk genetic markers assessed using fluorescence in situ hybridization as well as levels of lactate dehydrogenase, albumin, and beta-2 microglobulin, explained Dr. Mohyuddin, assistant professor at the Huntsman Cancer Institute, University of Utah, Salt Lake City.

R2-ISS and MASS include additional factors that reflect experts’ growing understanding of multiple myeloma. Specifically, the systems also evaluate a gain of chromosome 1q, in which patients have an extra copy of chromosome 1q, as well as the additive effects of multiple high-risk cytogenetic abnormalities, both of which indicate worse prognosis in multiple myeloma, Dr. Mohyuddin said in an interview.

To compare the three staging systems, the investigators used information on newly diagnosed patients in the Flatiron Health EHR–derived deidentified database, which includes data from cancer clinics across the United States. Patients were followed from first-line treatment initiation until death, the end of the study period, or last recorded activity.

The patients from the database had a median age of 70 years, and most had not received a transplant. The most common cytogenetic abnormality was gain 1q, present in about one third of patients. 

Given that the R2-ISS originated from patients in clinical trials, Dr. Mohyuddin noted the importance of assessing how the system would perform in a real-world setting. 

Of the 497 patients in the analysis, the R-ISS staging system classified 24% as stage I, 63% as stage II, and 13% as stage III. Overall survival differed across these R-ISS stages, indicating the system was prognostic for survival. Median overall survival was not reached for those with stage I disease, was 62.9 months for those with stage II disease, and 37.6 months for those with stage III disease.

Because the R-ISS doesn’t consider the additive effect of multiple cytogenetic abnormalities, many patients end up in the R-ISS stage II category but ultimately may have vastly different outcomes, Dr. Mohyuddin said.

The R2-ISS includes four risk categories, which provide more granularity to the stage II classification: Stage I is low risk, stage II is low-intermediate, stage III is intermediate, and stage IV is high risk. Using this staging system, 20% of patients were stage I, 25% were stage II, 46% were stage III, and 9% were stage IV.

The R2-ISS was also prognostic for survival, which generally worsened from stage I to stage IV: Median overall survival was not reached in stage I patients, was 69.3 months for stage II, 50.0 months for stage III, and 50.6 months for stage IV patients. However, Dr. Mohyuddin noted that there was some overlap in the survival curves for stages I and II and for stages III and IV.

When applying MASS, 34% of patients were categorized as stage I, 35% as stage II, and 31% as stage III disease. This system was prognostic for survival as well, with median overall survival of 76.9 months for stage I, 61.2 months for stage II, and 45.0 months for stage III.

With R2-ISS, many of those in R-ISS stage II are moved into stage I and III. With MASS, the R-ISS stage II patients are more evenly distributed across stages I, II, and III.

In other words, “we show that both these newer staging systems basically recategorize patients into different stages,” essentially “decreasing the number of people in the large, ambiguous (R-ISS) stage II category,” said Dr. Mohyuddin. 

Dr. Mohyuddin and colleagues also evaluated the staging systems in fully adjusted analyses that controlled for age, race/ethnicity, sex, practice type, and diagnosis year. 

Using R2-ISS, stage I patients had a similar risk for death compared with stage II patients (hazard ratio [HR], 1.2). Compared with stage I patients, stage III and IV patients had comparable risks for death, both about 2.5-fold higher than in those with stage I disease (HR, 2.4 and 2.6, respectively). 

Compared with stage I MASS patients, those with stage II had a twofold higher risk for death (HR, 2.0), and those with stage III had an almost threefold higher risk (HR, 2.7). 

Although no system considers all factors associated with myeloma outcomes, R2-ISS and MASS do offer a benefit over R-ISS, Dr. Mohyuddin said.

He added that the R2-ISS and MASS are similar from a statistical standpoint, but he gave MASS a slight edge for use in clinical practice.

MASS “more cleanly demarcated [patients] into prognostic subsets,” plus it is “a little easier to remember by heart,” he explained. MASS also puts more emphasis on the presence of multiple high-risk cytogenetic abnormalities, which is a worse prognostic in this era of quadruplet therapy for multiple myeloma, he added.

Because the study largely took place in an era when triplet therapy dominated, “we would be curious to see, with longer follow-up and more use of quadruplets, how these staging systems would perform,” he said. 

Despite the benefits of these newer staging systems, many factors play a role in multiple myeloma outcomes, Dr. Mohyuddin explained. Staging systems are “only a piece of the puzzle.”

Dr. Mohyuddin reported having no financial interests to disclose.
 

A version of this article appeared on Medscape.com.

SAN DIEGO — Two proposed new multiple myeloma staging systems offer similar prognostic accuracy compared with the standard staging system, but the new systems provide more refined risk classifications across different disease stages. 

The findings should encourage greater use of these newer staging systems in routine clinical practice, first author Manni Mohyuddin, MD, said during a presentation at the American Society of Hematology annual meeting.

Dr. Mohyuddin and his colleagues retrospectively compared the standard Revised International Staging System (R-ISS) with two newer systems, the Second Revision of the R-ISS (R2-ISS) and the Mayo Additive Staging System (MASS), using real-world data from nearly 500 patients with newly diagnosed multiple myeloma.

The R-ISS, the most common multiple myeloma staging system, incorporates a range of prognostic features, including high-risk genetic markers assessed using fluorescence in situ hybridization as well as levels of lactate dehydrogenase, albumin, and beta-2 microglobulin, explained Dr. Mohyuddin, assistant professor at the Huntsman Cancer Institute, University of Utah, Salt Lake City.

R2-ISS and MASS include additional factors that reflect experts’ growing understanding of multiple myeloma. Specifically, the systems also evaluate a gain of chromosome 1q, in which patients have an extra copy of chromosome 1q, as well as the additive effects of multiple high-risk cytogenetic abnormalities, both of which indicate worse prognosis in multiple myeloma, Dr. Mohyuddin said in an interview.

To compare the three staging systems, the investigators used information on newly diagnosed patients in the Flatiron Health EHR–derived deidentified database, which includes data from cancer clinics across the United States. Patients were followed from first-line treatment initiation until death, the end of the study period, or last recorded activity.

The patients from the database had a median age of 70 years, and most had not received a transplant. The most common cytogenetic abnormality was gain 1q, present in about one third of patients. 

Given that the R2-ISS originated from patients in clinical trials, Dr. Mohyuddin noted the importance of assessing how the system would perform in a real-world setting. 

Of the 497 patients in the analysis, the R-ISS staging system classified 24% as stage I, 63% as stage II, and 13% as stage III. Overall survival differed across these R-ISS stages, indicating the system was prognostic for survival. Median overall survival was not reached for those with stage I disease, was 62.9 months for those with stage II disease, and 37.6 months for those with stage III disease.

Because the R-ISS doesn’t consider the additive effect of multiple cytogenetic abnormalities, many patients end up in the R-ISS stage II category but ultimately may have vastly different outcomes, Dr. Mohyuddin said.

The R2-ISS includes four risk categories, which provide more granularity to the stage II classification: Stage I is low risk, stage II is low-intermediate, stage III is intermediate, and stage IV is high risk. Using this staging system, 20% of patients were stage I, 25% were stage II, 46% were stage III, and 9% were stage IV.

The R2-ISS was also prognostic for survival, which generally worsened from stage I to stage IV: Median overall survival was not reached in stage I patients, was 69.3 months for stage II, 50.0 months for stage III, and 50.6 months for stage IV patients. However, Dr. Mohyuddin noted that there was some overlap in the survival curves for stages I and II and for stages III and IV.

When applying MASS, 34% of patients were categorized as stage I, 35% as stage II, and 31% as stage III disease. This system was prognostic for survival as well, with median overall survival of 76.9 months for stage I, 61.2 months for stage II, and 45.0 months for stage III.

With R2-ISS, many of those in R-ISS stage II are moved into stage I and III. With MASS, the R-ISS stage II patients are more evenly distributed across stages I, II, and III.

In other words, “we show that both these newer staging systems basically recategorize patients into different stages,” essentially “decreasing the number of people in the large, ambiguous (R-ISS) stage II category,” said Dr. Mohyuddin. 

Dr. Mohyuddin and colleagues also evaluated the staging systems in fully adjusted analyses that controlled for age, race/ethnicity, sex, practice type, and diagnosis year. 

Using R2-ISS, stage I patients had a similar risk for death compared with stage II patients (hazard ratio [HR], 1.2). Compared with stage I patients, stage III and IV patients had comparable risks for death, both about 2.5-fold higher than in those with stage I disease (HR, 2.4 and 2.6, respectively). 

Compared with stage I MASS patients, those with stage II had a twofold higher risk for death (HR, 2.0), and those with stage III had an almost threefold higher risk (HR, 2.7). 

Although no system considers all factors associated with myeloma outcomes, R2-ISS and MASS do offer a benefit over R-ISS, Dr. Mohyuddin said.

He added that the R2-ISS and MASS are similar from a statistical standpoint, but he gave MASS a slight edge for use in clinical practice.

MASS “more cleanly demarcated [patients] into prognostic subsets,” plus it is “a little easier to remember by heart,” he explained. MASS also puts more emphasis on the presence of multiple high-risk cytogenetic abnormalities, which is a worse prognostic in this era of quadruplet therapy for multiple myeloma, he added.

Because the study largely took place in an era when triplet therapy dominated, “we would be curious to see, with longer follow-up and more use of quadruplets, how these staging systems would perform,” he said. 

Despite the benefits of these newer staging systems, many factors play a role in multiple myeloma outcomes, Dr. Mohyuddin explained. Staging systems are “only a piece of the puzzle.”

Dr. Mohyuddin reported having no financial interests to disclose.
 

A version of this article appeared on Medscape.com.

SAN ANTONIO — Low-dose tamoxifen, sometimes called “baby TAM,” is gaining traction as an alternative to full-dose tamoxifen for use in breast cancer prevention. The drug can reduce incidence of breast cancer in high-risk individuals, but side effects that mimic menopause have led to low rates of uptake. Lower-dose tamoxifen aims to reduce those side effects, but there remains some uncertainty about the minimum dose required to maintain efficacy.

The TAM-01 study, first published in 2019, demonstrated that a 5-mg dose of tamoxifen led to a reduction in recurrence of invasive breast cancer or ductal carcinoma in situ (DCIS). At the San Antonio Breast Cancer Symposium, two studies were presented that provided insight into dose efficacy and likelihood of medication adherence in women taking baby TAM.

“We all know that women who are at increased risk for breast cancer may benefit from the use of tamoxifen to help lower their risk, although historical uptake to tamoxifen in the prevention setting has been quite low,” said Lauren Cornell, MD, during a presentation. Her team investigated the impact of patient counseling on how well they understood their risk, as well as their likelihood of adherence to the medication.

The study included 41 women, and 31 completed follow-up at 1 year. “We saw that 90% of our patients reported good or complete understanding of their breast cancer risk after the consultation, emphasizing the benefit of that consult, and 73% reported that the availability of baby tamoxifen helped in their decision to consider a preventative medication,” said Dr. Cornell during her presentation. After 1 year of follow-up, 74% said that they had initiated baby tamoxifen, and 78% of those who started taking the drug were still taking it at 1 year.

Participants who continued to take baby TAM at 1 year had a higher estimated breast cancer risk (IBIS 10-year risk, 12.7% vs 7.6%; P = .027) than those who discontinued. “We saw that uptake to baby TAM after informed discussion in patients who qualify is high, especially in those patients with high risk and intraepithelial lesions or DCIS, and adherence and tolerability at 1 year follow up is improved, compared to what we would expect with traditional dosing of tamoxifen. It’s important to note that the NCCN guidelines and the ASCO clinical practice update now include low-dose tamoxifen as an option for select women, and future randomized control trials on de-escalation of tamoxifen and high-risk patients based on their risk model assessment still need to be done. Future study should also focus on markers to identify candidates best suited for low versus standard dose of tamoxifen,” said Dr. Cornell, who is an assistant professor of medicine at Mayo Clinic Florida in Jacksonville.

At another SABCS session, Per Hall, MD, PhD, discussed findings from the previously published KARISMA-2 study, which examined efficacy of various doses of tamoxifen. A total of 1440 participants, 240 in each arm, received tamoxifen doses of 20 mg, 10 mg, 5 mg, 2.5 mg, 1 mg, or placebo. During his talk, Dr. Hall pointed out that measuring outcomes would take a very large number of participants to identify small differences in breast cancer rates. Therefore, the researchers examined breast density changes as a proxy. As a noninferiority outcome, the researchers used the proportion of women in each arm who achieved the median decrease in breast density seen at 20 mg of tamoxifen, which is 10.1%.

The women underwent mammograms at baseline and again at 6 months to determine change in breast density. Among all women in the study, the proportion of patients who had a similar breast density reduction as the 20-mg dose were very similar in the 10 mg (50.0%; P = .002), 5 mg (49.3%; P < .001), and 2.5 mg (52.5%; P < .001) groups. The 1 mg group had a proportion of 39.5% (P = .138), while the placebo group had 38.9% (P = .161). However, the results were driven by premenopausal women, where the values were 63.3%, 70.7%, 74.4%, and 69.7% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, respectively, and 32.9% at 1 mg and 29.7% on placebo. In postmenopausal women, the values were 41.9%, 36.7%, 33.3%, and 41.9% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, with values of 44.2% in the 1-mg group and 43.8% in the placebo group.

The median density change was 18.5% in premenopausal women and 4.0% in postmenopausal women.

“We didn’t see anything in the postmenopausal women. The decrease for those on 20 milligrams and those on placebo were exactly the same. Why this is, we still don’t know because we do know that tamoxifen in the adjuvant setting could be used for postmenopausal women. It could be that 6 months is too short of a time [to see a benefit]. We don’t know,” said Dr. Hall, who is a medical epidemiologist and biostatistician at Karolinska Institutet, Stockholm, Sweden.

Severe vasomotor side effects like hot flashes, cold flashes, and night sweats were reduced by about 50% in the lower tamoxifen doses, compared with 20 mg.

Dr. Hall also pointed out that tamoxifen is a prodrug. The CYP2D6 enzyme produces a range of metabolites, with endoxifen having the strongest affinity to the estrogen receptor and being present at the highest plasma concentration. He showed a table of endoxifen plasma levels at various tamoxifen doses in women of various metabolizer status, ranging from poor to ultrafast. Among intermediate, normal, and ultrarapid metabolizers, 5- and 10-mg doses produced plasma endoxifen levels ranging from 2.4 to 6.2 ng/mL, which represents a good therapeutic window. “For intermediate and normal metabolizers, it could be that 5 mg [of tamoxifen] is enough, but I want to underline that we didn’t use breast cancer incidence or recurrence in this study, we used density change, so we should be careful when we use these results,” said Dr. Hall. His group is now conducting the KARISMA Endoxifen trial, which will test endoxifen directly at doses of 1 and 2 mg.

Dr. Cornell has no relevant financial disclosures. Dr. Hall is a member of the scientific advisory board for Atossa Therapeutics.

SAN ANTONIO — Low-dose tamoxifen, sometimes called “baby TAM,” is gaining traction as an alternative to full-dose tamoxifen for use in breast cancer prevention. The drug can reduce incidence of breast cancer in high-risk individuals, but side effects that mimic menopause have led to low rates of uptake. Lower-dose tamoxifen aims to reduce those side effects, but there remains some uncertainty about the minimum dose required to maintain efficacy.

The TAM-01 study, first published in 2019, demonstrated that a 5-mg dose of tamoxifen led to a reduction in recurrence of invasive breast cancer or ductal carcinoma in situ (DCIS). At the San Antonio Breast Cancer Symposium, two studies were presented that provided insight into dose efficacy and likelihood of medication adherence in women taking baby TAM.

“We all know that women who are at increased risk for breast cancer may benefit from the use of tamoxifen to help lower their risk, although historical uptake to tamoxifen in the prevention setting has been quite low,” said Lauren Cornell, MD, during a presentation. Her team investigated the impact of patient counseling on how well they understood their risk, as well as their likelihood of adherence to the medication.

The study included 41 women, and 31 completed follow-up at 1 year. “We saw that 90% of our patients reported good or complete understanding of their breast cancer risk after the consultation, emphasizing the benefit of that consult, and 73% reported that the availability of baby tamoxifen helped in their decision to consider a preventative medication,” said Dr. Cornell during her presentation. After 1 year of follow-up, 74% said that they had initiated baby tamoxifen, and 78% of those who started taking the drug were still taking it at 1 year.

Participants who continued to take baby TAM at 1 year had a higher estimated breast cancer risk (IBIS 10-year risk, 12.7% vs 7.6%; P = .027) than those who discontinued. “We saw that uptake to baby TAM after informed discussion in patients who qualify is high, especially in those patients with high risk and intraepithelial lesions or DCIS, and adherence and tolerability at 1 year follow up is improved, compared to what we would expect with traditional dosing of tamoxifen. It’s important to note that the NCCN guidelines and the ASCO clinical practice update now include low-dose tamoxifen as an option for select women, and future randomized control trials on de-escalation of tamoxifen and high-risk patients based on their risk model assessment still need to be done. Future study should also focus on markers to identify candidates best suited for low versus standard dose of tamoxifen,” said Dr. Cornell, who is an assistant professor of medicine at Mayo Clinic Florida in Jacksonville.

At another SABCS session, Per Hall, MD, PhD, discussed findings from the previously published KARISMA-2 study, which examined efficacy of various doses of tamoxifen. A total of 1440 participants, 240 in each arm, received tamoxifen doses of 20 mg, 10 mg, 5 mg, 2.5 mg, 1 mg, or placebo. During his talk, Dr. Hall pointed out that measuring outcomes would take a very large number of participants to identify small differences in breast cancer rates. Therefore, the researchers examined breast density changes as a proxy. As a noninferiority outcome, the researchers used the proportion of women in each arm who achieved the median decrease in breast density seen at 20 mg of tamoxifen, which is 10.1%.

The women underwent mammograms at baseline and again at 6 months to determine change in breast density. Among all women in the study, the proportion of patients who had a similar breast density reduction as the 20-mg dose were very similar in the 10 mg (50.0%; P = .002), 5 mg (49.3%; P < .001), and 2.5 mg (52.5%; P < .001) groups. The 1 mg group had a proportion of 39.5% (P = .138), while the placebo group had 38.9% (P = .161). However, the results were driven by premenopausal women, where the values were 63.3%, 70.7%, 74.4%, and 69.7% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, respectively, and 32.9% at 1 mg and 29.7% on placebo. In postmenopausal women, the values were 41.9%, 36.7%, 33.3%, and 41.9% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, with values of 44.2% in the 1-mg group and 43.8% in the placebo group.

The median density change was 18.5% in premenopausal women and 4.0% in postmenopausal women.

“We didn’t see anything in the postmenopausal women. The decrease for those on 20 milligrams and those on placebo were exactly the same. Why this is, we still don’t know because we do know that tamoxifen in the adjuvant setting could be used for postmenopausal women. It could be that 6 months is too short of a time [to see a benefit]. We don’t know,” said Dr. Hall, who is a medical epidemiologist and biostatistician at Karolinska Institutet, Stockholm, Sweden.

Severe vasomotor side effects like hot flashes, cold flashes, and night sweats were reduced by about 50% in the lower tamoxifen doses, compared with 20 mg.

Dr. Hall also pointed out that tamoxifen is a prodrug. The CYP2D6 enzyme produces a range of metabolites, with endoxifen having the strongest affinity to the estrogen receptor and being present at the highest plasma concentration. He showed a table of endoxifen plasma levels at various tamoxifen doses in women of various metabolizer status, ranging from poor to ultrafast. Among intermediate, normal, and ultrarapid metabolizers, 5- and 10-mg doses produced plasma endoxifen levels ranging from 2.4 to 6.2 ng/mL, which represents a good therapeutic window. “For intermediate and normal metabolizers, it could be that 5 mg [of tamoxifen] is enough, but I want to underline that we didn’t use breast cancer incidence or recurrence in this study, we used density change, so we should be careful when we use these results,” said Dr. Hall. His group is now conducting the KARISMA Endoxifen trial, which will test endoxifen directly at doses of 1 and 2 mg.

Dr. Cornell has no relevant financial disclosures. Dr. Hall is a member of the scientific advisory board for Atossa Therapeutics.

SAN ANTONIO — Low-dose tamoxifen, sometimes called “baby TAM,” is gaining traction as an alternative to full-dose tamoxifen for use in breast cancer prevention. The drug can reduce incidence of breast cancer in high-risk individuals, but side effects that mimic menopause have led to low rates of uptake. Lower-dose tamoxifen aims to reduce those side effects, but there remains some uncertainty about the minimum dose required to maintain efficacy.

The TAM-01 study, first published in 2019, demonstrated that a 5-mg dose of tamoxifen led to a reduction in recurrence of invasive breast cancer or ductal carcinoma in situ (DCIS). At the San Antonio Breast Cancer Symposium, two studies were presented that provided insight into dose efficacy and likelihood of medication adherence in women taking baby TAM.

“We all know that women who are at increased risk for breast cancer may benefit from the use of tamoxifen to help lower their risk, although historical uptake to tamoxifen in the prevention setting has been quite low,” said Lauren Cornell, MD, during a presentation. Her team investigated the impact of patient counseling on how well they understood their risk, as well as their likelihood of adherence to the medication.

The study included 41 women, and 31 completed follow-up at 1 year. “We saw that 90% of our patients reported good or complete understanding of their breast cancer risk after the consultation, emphasizing the benefit of that consult, and 73% reported that the availability of baby tamoxifen helped in their decision to consider a preventative medication,” said Dr. Cornell during her presentation. After 1 year of follow-up, 74% said that they had initiated baby tamoxifen, and 78% of those who started taking the drug were still taking it at 1 year.

Participants who continued to take baby TAM at 1 year had a higher estimated breast cancer risk (IBIS 10-year risk, 12.7% vs 7.6%; P = .027) than those who discontinued. “We saw that uptake to baby TAM after informed discussion in patients who qualify is high, especially in those patients with high risk and intraepithelial lesions or DCIS, and adherence and tolerability at 1 year follow up is improved, compared to what we would expect with traditional dosing of tamoxifen. It’s important to note that the NCCN guidelines and the ASCO clinical practice update now include low-dose tamoxifen as an option for select women, and future randomized control trials on de-escalation of tamoxifen and high-risk patients based on their risk model assessment still need to be done. Future study should also focus on markers to identify candidates best suited for low versus standard dose of tamoxifen,” said Dr. Cornell, who is an assistant professor of medicine at Mayo Clinic Florida in Jacksonville.

At another SABCS session, Per Hall, MD, PhD, discussed findings from the previously published KARISMA-2 study, which examined efficacy of various doses of tamoxifen. A total of 1440 participants, 240 in each arm, received tamoxifen doses of 20 mg, 10 mg, 5 mg, 2.5 mg, 1 mg, or placebo. During his talk, Dr. Hall pointed out that measuring outcomes would take a very large number of participants to identify small differences in breast cancer rates. Therefore, the researchers examined breast density changes as a proxy. As a noninferiority outcome, the researchers used the proportion of women in each arm who achieved the median decrease in breast density seen at 20 mg of tamoxifen, which is 10.1%.

The women underwent mammograms at baseline and again at 6 months to determine change in breast density. Among all women in the study, the proportion of patients who had a similar breast density reduction as the 20-mg dose were very similar in the 10 mg (50.0%; P = .002), 5 mg (49.3%; P < .001), and 2.5 mg (52.5%; P < .001) groups. The 1 mg group had a proportion of 39.5% (P = .138), while the placebo group had 38.9% (P = .161). However, the results were driven by premenopausal women, where the values were 63.3%, 70.7%, 74.4%, and 69.7% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, respectively, and 32.9% at 1 mg and 29.7% on placebo. In postmenopausal women, the values were 41.9%, 36.7%, 33.3%, and 41.9% in the 20-mg, 10-mg, 5-mg, and 2.5-mg groups, with values of 44.2% in the 1-mg group and 43.8% in the placebo group.

The median density change was 18.5% in premenopausal women and 4.0% in postmenopausal women.

“We didn’t see anything in the postmenopausal women. The decrease for those on 20 milligrams and those on placebo were exactly the same. Why this is, we still don’t know because we do know that tamoxifen in the adjuvant setting could be used for postmenopausal women. It could be that 6 months is too short of a time [to see a benefit]. We don’t know,” said Dr. Hall, who is a medical epidemiologist and biostatistician at Karolinska Institutet, Stockholm, Sweden.

Severe vasomotor side effects like hot flashes, cold flashes, and night sweats were reduced by about 50% in the lower tamoxifen doses, compared with 20 mg.

Dr. Hall also pointed out that tamoxifen is a prodrug. The CYP2D6 enzyme produces a range of metabolites, with endoxifen having the strongest affinity to the estrogen receptor and being present at the highest plasma concentration. He showed a table of endoxifen plasma levels at various tamoxifen doses in women of various metabolizer status, ranging from poor to ultrafast. Among intermediate, normal, and ultrarapid metabolizers, 5- and 10-mg doses produced plasma endoxifen levels ranging from 2.4 to 6.2 ng/mL, which represents a good therapeutic window. “For intermediate and normal metabolizers, it could be that 5 mg [of tamoxifen] is enough, but I want to underline that we didn’t use breast cancer incidence or recurrence in this study, we used density change, so we should be careful when we use these results,” said Dr. Hall. His group is now conducting the KARISMA Endoxifen trial, which will test endoxifen directly at doses of 1 and 2 mg.

Dr. Cornell has no relevant financial disclosures. Dr. Hall is a member of the scientific advisory board for Atossa Therapeutics.