Oncology Practice

Should 5 mg of tamoxifen — known as “baby TAM” — or the usual 20 mg dose be standard of care for breast cancer prevention in high-risk women?

Research to date clearly shows that tamoxifen can reduce the risk for breast cancer in high-risk individuals by 30%-50%. Recent evidence also indicates that this chemoprevention approach can reduce the risk of dying from breast cancer by as much as 57%.

In 2019, the US Preventive Services Task Force issued updated recommendations that clinicians offer risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women at an increased risk for breast cancer and a low risk for adverse medication effects.

However, this prophylactic strategy remains underused.

A major roadblock: The drugs’ side effects, which include venous thromboembolic events and endometrial cancer as well as symptoms of menopause, such as hot flashes and sexual issues, have made uptake and adherence a challenge.

Offering women a lower dose of tamoxifen could allay fears about toxicities and improve uptake as well as reduce side effects and boost long-term adherence among those receiving baby TAM.

However, experts remain uncertain about whether patients need the standard dose to experience the full prevention benefit.
 

The Debate

Years ago, Andrea De Censi, MD, a breast cancer researcher at the Galliera Hospital in Genova, Italy, and his colleagues reasoned that, because tamoxifen is a competitive estrogen receptor inhibitor, it may indeed have a minimal effective dose below 20 mg/d.

The fruits of that line of thought were presented to the world in the TAM-01 trial, first published in 2019, which pitted tamoxifen 5 mg/d for 3 years against placebo in 500 women with high-risk lesions, including lobular and ductal carcinoma in situ.

Dr. De Censi and colleagues found that baby TAM reduced the risk for invasive breast cancer by 52% and the risk for contralateral breast cancer by 75%.

Treatment adherence was slightly higher in the baby TAM group at 65% vs 61% in the placebo group.

A recent 10-year follow-up showed ongoing benefits associated with baby TAM vs placebo — a 42% reduction in breast cancer and a 64% drop in contralateral lesions.

The baby TAM group vs placebo experienced a slight increase in hot flashes but no significant increase in other common side effects.

Regarding serious adverse events, the baby TAM arm had one case of stage 1 endometrial cancer (0.4% of patients) and 20 cases of endometrial polyps (5%) vs 13 cases of endometrial polyps in the placebo arm. But there were no significant differences in thrombosis, cataracts, bone fractures, and other serious events.

Dr. De Censi said he’s surprised the baby TAM vs tamoxifen topic is still being debated. “Baby TAM, in my opinion, is a new standard of care for endocrine prevention of breast cancer in high-risk [women],” and baby TAM over 3 years is enough, said Dr. De Censi during a debate on the topic at the 2024 European Society for Medical Oncology Breast Cancer Congress in Berlin.

Gareth Evans, MD, a cancer genetics and prevention specialist at the University of Manchester, Manchester, England, however, isn’t convinced.

During the debate, Dr. Evans explained that  his main concern was that the baby TAM trial was limited to women with high-risk lesions, not other common reasons for tamoxifen prophylaxis, such as a positive family history or BRCA mutations.

“In Manchester, we have put over a thousand women on tamoxifen who have a family history or other risk factors, not high-risk lesions,” and there simply isn’t definitive evidence for baby TAM in these women, Dr. Evans said.

The vast weight of evidence for tamoxifen prophylaxis, he added, is in trials involving tens of thousands of women, followed in some cases for 20 years, who received the 20 mg dose for 5 years.

As a result, women in Manchester are started on 20 mg and dropped down to 5 mg only for side effects. That way, Evans explained, we are not taking away the benefit among women who can tolerate 20 mg.

Meanwhile, there’s no evidence that baby TAM improves medication adherence, he noted. Trials have reported similar adherence rates to baby TAM and standard dose tamoxifen as well as no definitive evidence that the risk for cancer and thrombosis is less with baby TAM, he said.

In fact, Dr. Evans noted, “many women take tamoxifen 20 mg for 5 years with no side effects.”

Overall, “I don’t think we’ve got the evidence yet to drop” dosages, particularly in women without high-risk lesions, Dr. Evans said. A real concern, he added, is poor metabolizers for whom 5 mg won’t be enough to have a preventive effect.

Dr. De Censi noted, however, that there will likely never be a definitive answer to the question of baby TAM vs standard dosing because industry has no financial incentive to do a head-to-head trial; tamoxifen went off patent over 30 years ago.

Still, a poll of the audience favored Evans’ approach — 80% said they would start high-risk women on 20 mg for breast cancer prophylaxis and reduce for side effects as needed.

Dr. De Censi didn’t have any disclosures. Dr. Evans is a consultant/advisor for AstraZeneca, SpringWorks, Recursion, Everything Genetic, and Syantra.

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

Should 5 mg of tamoxifen — known as “baby TAM” — or the usual 20 mg dose be standard of care for breast cancer prevention in high-risk women?

Research to date clearly shows that tamoxifen can reduce the risk for breast cancer in high-risk individuals by 30%-50%. Recent evidence also indicates that this chemoprevention approach can reduce the risk of dying from breast cancer by as much as 57%.

In 2019, the US Preventive Services Task Force issued updated recommendations that clinicians offer risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women at an increased risk for breast cancer and a low risk for adverse medication effects.

However, this prophylactic strategy remains underused.

A major roadblock: The drugs’ side effects, which include venous thromboembolic events and endometrial cancer as well as symptoms of menopause, such as hot flashes and sexual issues, have made uptake and adherence a challenge.

Offering women a lower dose of tamoxifen could allay fears about toxicities and improve uptake as well as reduce side effects and boost long-term adherence among those receiving baby TAM.

However, experts remain uncertain about whether patients need the standard dose to experience the full prevention benefit.
 

The Debate

Years ago, Andrea De Censi, MD, a breast cancer researcher at the Galliera Hospital in Genova, Italy, and his colleagues reasoned that, because tamoxifen is a competitive estrogen receptor inhibitor, it may indeed have a minimal effective dose below 20 mg/d.

The fruits of that line of thought were presented to the world in the TAM-01 trial, first published in 2019, which pitted tamoxifen 5 mg/d for 3 years against placebo in 500 women with high-risk lesions, including lobular and ductal carcinoma in situ.

Dr. De Censi and colleagues found that baby TAM reduced the risk for invasive breast cancer by 52% and the risk for contralateral breast cancer by 75%.

Treatment adherence was slightly higher in the baby TAM group at 65% vs 61% in the placebo group.

A recent 10-year follow-up showed ongoing benefits associated with baby TAM vs placebo — a 42% reduction in breast cancer and a 64% drop in contralateral lesions.

The baby TAM group vs placebo experienced a slight increase in hot flashes but no significant increase in other common side effects.

Regarding serious adverse events, the baby TAM arm had one case of stage 1 endometrial cancer (0.4% of patients) and 20 cases of endometrial polyps (5%) vs 13 cases of endometrial polyps in the placebo arm. But there were no significant differences in thrombosis, cataracts, bone fractures, and other serious events.

Dr. De Censi said he’s surprised the baby TAM vs tamoxifen topic is still being debated. “Baby TAM, in my opinion, is a new standard of care for endocrine prevention of breast cancer in high-risk [women],” and baby TAM over 3 years is enough, said Dr. De Censi during a debate on the topic at the 2024 European Society for Medical Oncology Breast Cancer Congress in Berlin.

Gareth Evans, MD, a cancer genetics and prevention specialist at the University of Manchester, Manchester, England, however, isn’t convinced.

During the debate, Dr. Evans explained that  his main concern was that the baby TAM trial was limited to women with high-risk lesions, not other common reasons for tamoxifen prophylaxis, such as a positive family history or BRCA mutations.

“In Manchester, we have put over a thousand women on tamoxifen who have a family history or other risk factors, not high-risk lesions,” and there simply isn’t definitive evidence for baby TAM in these women, Dr. Evans said.

The vast weight of evidence for tamoxifen prophylaxis, he added, is in trials involving tens of thousands of women, followed in some cases for 20 years, who received the 20 mg dose for 5 years.

As a result, women in Manchester are started on 20 mg and dropped down to 5 mg only for side effects. That way, Evans explained, we are not taking away the benefit among women who can tolerate 20 mg.

Meanwhile, there’s no evidence that baby TAM improves medication adherence, he noted. Trials have reported similar adherence rates to baby TAM and standard dose tamoxifen as well as no definitive evidence that the risk for cancer and thrombosis is less with baby TAM, he said.

In fact, Dr. Evans noted, “many women take tamoxifen 20 mg for 5 years with no side effects.”

Overall, “I don’t think we’ve got the evidence yet to drop” dosages, particularly in women without high-risk lesions, Dr. Evans said. A real concern, he added, is poor metabolizers for whom 5 mg won’t be enough to have a preventive effect.

Dr. De Censi noted, however, that there will likely never be a definitive answer to the question of baby TAM vs standard dosing because industry has no financial incentive to do a head-to-head trial; tamoxifen went off patent over 30 years ago.

Still, a poll of the audience favored Evans’ approach — 80% said they would start high-risk women on 20 mg for breast cancer prophylaxis and reduce for side effects as needed.

Dr. De Censi didn’t have any disclosures. Dr. Evans is a consultant/advisor for AstraZeneca, SpringWorks, Recursion, Everything Genetic, and Syantra.

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

Should 5 mg of tamoxifen — known as “baby TAM” — or the usual 20 mg dose be standard of care for breast cancer prevention in high-risk women?

Research to date clearly shows that tamoxifen can reduce the risk for breast cancer in high-risk individuals by 30%-50%. Recent evidence also indicates that this chemoprevention approach can reduce the risk of dying from breast cancer by as much as 57%.

In 2019, the US Preventive Services Task Force issued updated recommendations that clinicians offer risk-reducing medications, such as tamoxifen, raloxifene, or aromatase inhibitors, to women at an increased risk for breast cancer and a low risk for adverse medication effects.

However, this prophylactic strategy remains underused.

A major roadblock: The drugs’ side effects, which include venous thromboembolic events and endometrial cancer as well as symptoms of menopause, such as hot flashes and sexual issues, have made uptake and adherence a challenge.

Offering women a lower dose of tamoxifen could allay fears about toxicities and improve uptake as well as reduce side effects and boost long-term adherence among those receiving baby TAM.

However, experts remain uncertain about whether patients need the standard dose to experience the full prevention benefit.
 

The Debate

Years ago, Andrea De Censi, MD, a breast cancer researcher at the Galliera Hospital in Genova, Italy, and his colleagues reasoned that, because tamoxifen is a competitive estrogen receptor inhibitor, it may indeed have a minimal effective dose below 20 mg/d.

The fruits of that line of thought were presented to the world in the TAM-01 trial, first published in 2019, which pitted tamoxifen 5 mg/d for 3 years against placebo in 500 women with high-risk lesions, including lobular and ductal carcinoma in situ.

Dr. De Censi and colleagues found that baby TAM reduced the risk for invasive breast cancer by 52% and the risk for contralateral breast cancer by 75%.

Treatment adherence was slightly higher in the baby TAM group at 65% vs 61% in the placebo group.

A recent 10-year follow-up showed ongoing benefits associated with baby TAM vs placebo — a 42% reduction in breast cancer and a 64% drop in contralateral lesions.

The baby TAM group vs placebo experienced a slight increase in hot flashes but no significant increase in other common side effects.

Regarding serious adverse events, the baby TAM arm had one case of stage 1 endometrial cancer (0.4% of patients) and 20 cases of endometrial polyps (5%) vs 13 cases of endometrial polyps in the placebo arm. But there were no significant differences in thrombosis, cataracts, bone fractures, and other serious events.

Dr. De Censi said he’s surprised the baby TAM vs tamoxifen topic is still being debated. “Baby TAM, in my opinion, is a new standard of care for endocrine prevention of breast cancer in high-risk [women],” and baby TAM over 3 years is enough, said Dr. De Censi during a debate on the topic at the 2024 European Society for Medical Oncology Breast Cancer Congress in Berlin.

Gareth Evans, MD, a cancer genetics and prevention specialist at the University of Manchester, Manchester, England, however, isn’t convinced.

During the debate, Dr. Evans explained that  his main concern was that the baby TAM trial was limited to women with high-risk lesions, not other common reasons for tamoxifen prophylaxis, such as a positive family history or BRCA mutations.

“In Manchester, we have put over a thousand women on tamoxifen who have a family history or other risk factors, not high-risk lesions,” and there simply isn’t definitive evidence for baby TAM in these women, Dr. Evans said.

The vast weight of evidence for tamoxifen prophylaxis, he added, is in trials involving tens of thousands of women, followed in some cases for 20 years, who received the 20 mg dose for 5 years.

As a result, women in Manchester are started on 20 mg and dropped down to 5 mg only for side effects. That way, Evans explained, we are not taking away the benefit among women who can tolerate 20 mg.

Meanwhile, there’s no evidence that baby TAM improves medication adherence, he noted. Trials have reported similar adherence rates to baby TAM and standard dose tamoxifen as well as no definitive evidence that the risk for cancer and thrombosis is less with baby TAM, he said.

In fact, Dr. Evans noted, “many women take tamoxifen 20 mg for 5 years with no side effects.”

Overall, “I don’t think we’ve got the evidence yet to drop” dosages, particularly in women without high-risk lesions, Dr. Evans said. A real concern, he added, is poor metabolizers for whom 5 mg won’t be enough to have a preventive effect.

Dr. De Censi noted, however, that there will likely never be a definitive answer to the question of baby TAM vs standard dosing because industry has no financial incentive to do a head-to-head trial; tamoxifen went off patent over 30 years ago.

Still, a poll of the audience favored Evans’ approach — 80% said they would start high-risk women on 20 mg for breast cancer prophylaxis and reduce for side effects as needed.

Dr. De Censi didn’t have any disclosures. Dr. Evans is a consultant/advisor for AstraZeneca, SpringWorks, Recursion, Everything Genetic, and Syantra.

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

An elderly gentleman was truly suffering, so his doctor decided to try something new.

“He’d had a number of cumulative side effects after almost two years of IV chemotherapy for his metastatic colon cancer,” said Anuj Patel, MD, a senior physician at Dana-Farber Cancer Institute in Boston, recalling his patient. “When we switched him to combination treatment with trifluridine/tipiracil and bevacizumab, he constantly remarked on how well he now felt. He described no side effects from this new regimen.”

Nearly a year after the US Food and Drug Administration (FDA) approved trifluridine/tipiracil combined with bevacizumab for refractory mCRC, the tremendous value of its results in practice are clear.

Trifluridine/tipiracil (Lonsurf) had been used to treat advanced gastric cancer, while bevacizumab had been therapeutic for a wider range of diseases, including cervical, brain, liver, kidney, gynecological and lung cancers. Used together for treating refractory mCRC, well-known initial findings about their effectiveness have been proven true over time.

“Patients taking both drugs can experience, on average, a life extension of three months,” said Richard M. Goldberg, MD, professor emeritus of the West Virginia University Cancer Institute and director of Fight Colorectal Cancer.
 

The History of the Combined Therapy’s Approval

The FDA originally approved trifluridine/tipiracil in September 2015 for use in patients with metastatic colorectal cancer. Patients eligible to take it had to have been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and—if RAS wild-type—an anti-epidermal growth factor receptor (EGFR) therapy, according to data published by the National Center for Biotechnology Information. The FDA’s August 2023 approval of the trifluridine/tipiracil and bevacizumab combination regimen is for patients meeting the same eligibility requirements.

Another drug, regorafenib, had already been approved by the FDA in September 2012 to treat mCRC. The drug has a wide range of potential side effects, however, including complications relating to the limbs.

“One of my patients tried regorafenib as his initial third- line treatment,” Dr. Goldberg said. “I checked in on him at his farm, and he was sitting in the barn near his tractor.

He had such severe hand-foot syndrome that he could barely walk.”

Trifluridine/tipiracil alone proved to be very helpful in this case. “We switched him to it, and he tolerated it well,” Dr. Goldberg continued. “He got his fields plowed and was on it for months before he passed away. We both felt it kept him going longer.”

A new research review confirms the regimen’s success, determining that trifluridine/tipiracil plus bevacizumab was associated with improved outcomes compared to therapy solely with trifluridine/tipiracil.
 

A True Practice Changer

Now that the regimen has been on the market for more than half a year, there are longer-term data available.

Patients on average live within the same timeframe as the patients in the SUNLIGHT study, and many feel physically better on the therapy. “The combination has very quickly shifted the standard of care,” Dr. Goldberg said.

The regimen can also provide significant psychological benefits to patients.

“As patients can maintain good performance status for longer with the combination, it increases the perception of quality of life,” said Jacobo Hincapie-Echeverri, MD, a GI and geriatric oncologist at Orlando Health Cancer Institute in Orlando, Florida.

The regimen is unique too, in that it can help doctors plan additional treatment strategies.

“This current approval, for the combination of trifluridine/tipiracil and bevacizumab, is practice-changing in that it helps clarify the sequence for later treatments for patients with mCRC,” said Dr. Patel, who is also clinical director of the Center for Esophageal and Gastric Cancer and assistant professor of medicine at Harvard Medical School, Boston. “Previously, it had been difficult to decide between trifluridine/tipiracil and regorafenib in this setting.”

The fact that the regimen has been shown to give time and improved quality of life to patients in ways regorafenib does not is clarifying. “Now, with the improved outcomes seen, I do think that trifluridine/tipiracil plus bevacizumab is the better option for most mCRC patients after IV chemotherapies,” Dr. Patel added.

When it comes to his specific experience with prescribing the regimen for his patients, Dr. Patel reported that it’s easier on his patients than other therapies.

“I find that it is generally well tolerated,” he elaborated. “As an oral agent, it is also usually somewhat easier to take (than other delivery methods of medication). These factors are critical for patients who have likely already had at least 2 or 3 prior lines of chemotherapy. I have had many patients with mCRC who, after disease progression on prior IV chemotherapy regimens, have had periods of meaningful disease control – often with fewer and manageable side effects.”

Dr. Goldberg mentioned another benefit.

“The nice thing about the combination of trifluridine/tipiracil and bevacizumab is that in terms of toxicity, there’s very little difference compared to the toxicity of trifluridine/tipiracil used alone.”
 

Are There Downsides to the Regimen?

The pros are obvious, but the regimen has some cons as well. Medically, patients should have a platelet count over 75,000/mm³ and absolute neutrophil count (ANC) over 1,500/mm³ prior to the start of each cycle, and their liver and renal function should be monitored.

Patients with metastatic colorectal cancer must be also carefully monitored for hematologic adverse events (AEs) , including chemotherapy-associated neutropenia. Biweekly treatments may reduce the risk of AEs as a whole, however, according to research.

The regimen is also expensive – an approximate cost of $8,191 for a 28-day supply. According to a new study, patients managing both AE expenses along with the cost of trifluridine/tipiracil-bevacizumab face a monthly bill of about $17,179.

Some very good news, though: 100% of Medicare drug plans cover trifluridine/tipiracil, with an average copay of $57-$292. Bevacizumab is also covered by Medicare, with a copay as low as $0-$25.

Private insurers do cover the drugs, depending on a patient’s specific plan. However, if a patient’s claim is denied, financial assistance for trifluridine/tipiracil through the drug’s manufacturers may be available for some patients, reducing prescriptions to a zero cost in some cases. Bevacizumab can be made available to patients who may not have health insurance at all, too. Patients can use a financial assistance tool through the drug’s manufacturer to receive up to $25,000 in yearly copay assistance.
 

What Does the Latest Research on the Regimen Indicate?

In May 2024, two abstracts were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) that explored expanded possible use of trifluridine/tipiracil plus bevacizumab as a treatment for metastatic colorectal cancer.

The first abstract studied trifluridine/tipiracil plus bevacizumab as upfront treatment for mCRC, adding capecitabine to the regimen.

“It’s a phase 1 study looking at dose findings for the three-drug combination, where the active drug is a chemotherapy agent classified as a fluoropyrimidine ... I would characterize this as a study combining two [fluoropyrimidines] with a single targeted therapy,” Dr. Goldberg said.

“Combining two fluoropyrimidines is an unusual approach, because they tend to have overlapping side effects, and the potential is there for either innate drug resistance to the class of drugs or that the combination of two agents that work by a similar mechanism of action could hasten the development of acquired drug resistance. There is apparently a signal that combining the two chemotherapy agents enhances each other’s activity in cell culture and animal models,” he added.

Ultimately, Dr. Goldberg said he thinks more evidence is needed to prove the regimen’s effectiveness.

“This is a very early study and really provides no information about its potential given that no response data was presented,” he added. “While this is an interesting idea, it is unclear if it will pan out until we see the data on the Phase II study in progress.”

The other abstract looked at the impact of colorectal liver metastases in patients with mCRC who in phase 3 of the SUNLIGHT trial received trifluridine/tipiracil with or without bevacizumab.

“There is not much that is novel here,” Dr. Goldberg said. “The retrospective analysis shows that trifluridine/tipiracil plus bevacizumab is better than trifluridine/tipiracil alone in the subset of patients with liver metastases, as it was shown to be in the entire patient population. While this is reassuring, it’s not unexpected, especially since the vast majority of people enrolled in the SUNLIGHT trial had liver metastases.”

The Bottom Line

In the future, the potential exists for trifluridine/tipiracil combined with bevacizumab to work in first-line and second-line patients.

“Seventy percent of colorectal cancer patients reach second line treatment right now, but only 30% reach third line treatment — either they become too sick to continue, or choose not to,” Dr. Goldberg said. “The hope is that using these drugs earlier can help more patients reach and prolong treatment.”

It’s also possible that the regimen can be applied in new ways.

“Further research combining trifluridine/tipiracil and bevacizumab with other targeted therapies could yield additional advances for refractory mCRC patients,” Dr. Hincapie-Echeverri said. “The survival benefit of this therapy reinforces the importance of continuing to develop new therapies to improve outcomes in the refractory mCRC setting.”

Dr. Patel’s patient felt lucky to simply live a longer life.

Because of the regimen, “his cancer remained stable for approximately 8 months. Upon its progression, he chose not to pursue any further chemotherapy. He instead expressed his gratitude at having been able to feel more like himself for nearly a year.”

Dr. Patel received research funding in 2017 from Taiho, which manufactures trifluridine/tipiracil. He receives no current funding from Taiho and has no additional conflicts of interest. Dr. Goldberg helped represent Taiho in a patent law dispute regarding Lonsurf for which he was paid, but he is no longer paid by the company. Dr. Hincapie-Echeverri is a speaker for Astellas Pharma, which does not manufacture trifluridine/tipiracil or bevacizumab, and he has no additional conflicts of interest.

An elderly gentleman was truly suffering, so his doctor decided to try something new.

“He’d had a number of cumulative side effects after almost two years of IV chemotherapy for his metastatic colon cancer,” said Anuj Patel, MD, a senior physician at Dana-Farber Cancer Institute in Boston, recalling his patient. “When we switched him to combination treatment with trifluridine/tipiracil and bevacizumab, he constantly remarked on how well he now felt. He described no side effects from this new regimen.”

Nearly a year after the US Food and Drug Administration (FDA) approved trifluridine/tipiracil combined with bevacizumab for refractory mCRC, the tremendous value of its results in practice are clear.

Trifluridine/tipiracil (Lonsurf) had been used to treat advanced gastric cancer, while bevacizumab had been therapeutic for a wider range of diseases, including cervical, brain, liver, kidney, gynecological and lung cancers. Used together for treating refractory mCRC, well-known initial findings about their effectiveness have been proven true over time.

“Patients taking both drugs can experience, on average, a life extension of three months,” said Richard M. Goldberg, MD, professor emeritus of the West Virginia University Cancer Institute and director of Fight Colorectal Cancer.
 

The History of the Combined Therapy’s Approval

The FDA originally approved trifluridine/tipiracil in September 2015 for use in patients with metastatic colorectal cancer. Patients eligible to take it had to have been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and—if RAS wild-type—an anti-epidermal growth factor receptor (EGFR) therapy, according to data published by the National Center for Biotechnology Information. The FDA’s August 2023 approval of the trifluridine/tipiracil and bevacizumab combination regimen is for patients meeting the same eligibility requirements.

Another drug, regorafenib, had already been approved by the FDA in September 2012 to treat mCRC. The drug has a wide range of potential side effects, however, including complications relating to the limbs.

“One of my patients tried regorafenib as his initial third- line treatment,” Dr. Goldberg said. “I checked in on him at his farm, and he was sitting in the barn near his tractor.

He had such severe hand-foot syndrome that he could barely walk.”

Trifluridine/tipiracil alone proved to be very helpful in this case. “We switched him to it, and he tolerated it well,” Dr. Goldberg continued. “He got his fields plowed and was on it for months before he passed away. We both felt it kept him going longer.”

A new research review confirms the regimen’s success, determining that trifluridine/tipiracil plus bevacizumab was associated with improved outcomes compared to therapy solely with trifluridine/tipiracil.
 

A True Practice Changer

Now that the regimen has been on the market for more than half a year, there are longer-term data available.

Patients on average live within the same timeframe as the patients in the SUNLIGHT study, and many feel physically better on the therapy. “The combination has very quickly shifted the standard of care,” Dr. Goldberg said.

The regimen can also provide significant psychological benefits to patients.

“As patients can maintain good performance status for longer with the combination, it increases the perception of quality of life,” said Jacobo Hincapie-Echeverri, MD, a GI and geriatric oncologist at Orlando Health Cancer Institute in Orlando, Florida.

The regimen is unique too, in that it can help doctors plan additional treatment strategies.

“This current approval, for the combination of trifluridine/tipiracil and bevacizumab, is practice-changing in that it helps clarify the sequence for later treatments for patients with mCRC,” said Dr. Patel, who is also clinical director of the Center for Esophageal and Gastric Cancer and assistant professor of medicine at Harvard Medical School, Boston. “Previously, it had been difficult to decide between trifluridine/tipiracil and regorafenib in this setting.”

The fact that the regimen has been shown to give time and improved quality of life to patients in ways regorafenib does not is clarifying. “Now, with the improved outcomes seen, I do think that trifluridine/tipiracil plus bevacizumab is the better option for most mCRC patients after IV chemotherapies,” Dr. Patel added.

When it comes to his specific experience with prescribing the regimen for his patients, Dr. Patel reported that it’s easier on his patients than other therapies.

“I find that it is generally well tolerated,” he elaborated. “As an oral agent, it is also usually somewhat easier to take (than other delivery methods of medication). These factors are critical for patients who have likely already had at least 2 or 3 prior lines of chemotherapy. I have had many patients with mCRC who, after disease progression on prior IV chemotherapy regimens, have had periods of meaningful disease control – often with fewer and manageable side effects.”

Dr. Goldberg mentioned another benefit.

“The nice thing about the combination of trifluridine/tipiracil and bevacizumab is that in terms of toxicity, there’s very little difference compared to the toxicity of trifluridine/tipiracil used alone.”
 

Are There Downsides to the Regimen?

The pros are obvious, but the regimen has some cons as well. Medically, patients should have a platelet count over 75,000/mm³ and absolute neutrophil count (ANC) over 1,500/mm³ prior to the start of each cycle, and their liver and renal function should be monitored.

Patients with metastatic colorectal cancer must be also carefully monitored for hematologic adverse events (AEs) , including chemotherapy-associated neutropenia. Biweekly treatments may reduce the risk of AEs as a whole, however, according to research.

The regimen is also expensive – an approximate cost of $8,191 for a 28-day supply. According to a new study, patients managing both AE expenses along with the cost of trifluridine/tipiracil-bevacizumab face a monthly bill of about $17,179.

Some very good news, though: 100% of Medicare drug plans cover trifluridine/tipiracil, with an average copay of $57-$292. Bevacizumab is also covered by Medicare, with a copay as low as $0-$25.

Private insurers do cover the drugs, depending on a patient’s specific plan. However, if a patient’s claim is denied, financial assistance for trifluridine/tipiracil through the drug’s manufacturers may be available for some patients, reducing prescriptions to a zero cost in some cases. Bevacizumab can be made available to patients who may not have health insurance at all, too. Patients can use a financial assistance tool through the drug’s manufacturer to receive up to $25,000 in yearly copay assistance.
 

What Does the Latest Research on the Regimen Indicate?

In May 2024, two abstracts were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) that explored expanded possible use of trifluridine/tipiracil plus bevacizumab as a treatment for metastatic colorectal cancer.

The first abstract studied trifluridine/tipiracil plus bevacizumab as upfront treatment for mCRC, adding capecitabine to the regimen.

“It’s a phase 1 study looking at dose findings for the three-drug combination, where the active drug is a chemotherapy agent classified as a fluoropyrimidine ... I would characterize this as a study combining two [fluoropyrimidines] with a single targeted therapy,” Dr. Goldberg said.

“Combining two fluoropyrimidines is an unusual approach, because they tend to have overlapping side effects, and the potential is there for either innate drug resistance to the class of drugs or that the combination of two agents that work by a similar mechanism of action could hasten the development of acquired drug resistance. There is apparently a signal that combining the two chemotherapy agents enhances each other’s activity in cell culture and animal models,” he added.

Ultimately, Dr. Goldberg said he thinks more evidence is needed to prove the regimen’s effectiveness.

“This is a very early study and really provides no information about its potential given that no response data was presented,” he added. “While this is an interesting idea, it is unclear if it will pan out until we see the data on the Phase II study in progress.”

The other abstract looked at the impact of colorectal liver metastases in patients with mCRC who in phase 3 of the SUNLIGHT trial received trifluridine/tipiracil with or without bevacizumab.

“There is not much that is novel here,” Dr. Goldberg said. “The retrospective analysis shows that trifluridine/tipiracil plus bevacizumab is better than trifluridine/tipiracil alone in the subset of patients with liver metastases, as it was shown to be in the entire patient population. While this is reassuring, it’s not unexpected, especially since the vast majority of people enrolled in the SUNLIGHT trial had liver metastases.”

The Bottom Line

In the future, the potential exists for trifluridine/tipiracil combined with bevacizumab to work in first-line and second-line patients.

“Seventy percent of colorectal cancer patients reach second line treatment right now, but only 30% reach third line treatment — either they become too sick to continue, or choose not to,” Dr. Goldberg said. “The hope is that using these drugs earlier can help more patients reach and prolong treatment.”

It’s also possible that the regimen can be applied in new ways.

“Further research combining trifluridine/tipiracil and bevacizumab with other targeted therapies could yield additional advances for refractory mCRC patients,” Dr. Hincapie-Echeverri said. “The survival benefit of this therapy reinforces the importance of continuing to develop new therapies to improve outcomes in the refractory mCRC setting.”

Dr. Patel’s patient felt lucky to simply live a longer life.

Because of the regimen, “his cancer remained stable for approximately 8 months. Upon its progression, he chose not to pursue any further chemotherapy. He instead expressed his gratitude at having been able to feel more like himself for nearly a year.”

Dr. Patel received research funding in 2017 from Taiho, which manufactures trifluridine/tipiracil. He receives no current funding from Taiho and has no additional conflicts of interest. Dr. Goldberg helped represent Taiho in a patent law dispute regarding Lonsurf for which he was paid, but he is no longer paid by the company. Dr. Hincapie-Echeverri is a speaker for Astellas Pharma, which does not manufacture trifluridine/tipiracil or bevacizumab, and he has no additional conflicts of interest.

An elderly gentleman was truly suffering, so his doctor decided to try something new.

“He’d had a number of cumulative side effects after almost two years of IV chemotherapy for his metastatic colon cancer,” said Anuj Patel, MD, a senior physician at Dana-Farber Cancer Institute in Boston, recalling his patient. “When we switched him to combination treatment with trifluridine/tipiracil and bevacizumab, he constantly remarked on how well he now felt. He described no side effects from this new regimen.”

Nearly a year after the US Food and Drug Administration (FDA) approved trifluridine/tipiracil combined with bevacizumab for refractory mCRC, the tremendous value of its results in practice are clear.

Trifluridine/tipiracil (Lonsurf) had been used to treat advanced gastric cancer, while bevacizumab had been therapeutic for a wider range of diseases, including cervical, brain, liver, kidney, gynecological and lung cancers. Used together for treating refractory mCRC, well-known initial findings about their effectiveness have been proven true over time.

“Patients taking both drugs can experience, on average, a life extension of three months,” said Richard M. Goldberg, MD, professor emeritus of the West Virginia University Cancer Institute and director of Fight Colorectal Cancer.
 

The History of the Combined Therapy’s Approval

The FDA originally approved trifluridine/tipiracil in September 2015 for use in patients with metastatic colorectal cancer. Patients eligible to take it had to have been treated with fluoropyrimidine-, oxaliplatin-, and irinotecan-based chemotherapy, an anti-vascular endothelial growth factor (VEGF) biological therapy, and—if RAS wild-type—an anti-epidermal growth factor receptor (EGFR) therapy, according to data published by the National Center for Biotechnology Information. The FDA’s August 2023 approval of the trifluridine/tipiracil and bevacizumab combination regimen is for patients meeting the same eligibility requirements.

Another drug, regorafenib, had already been approved by the FDA in September 2012 to treat mCRC. The drug has a wide range of potential side effects, however, including complications relating to the limbs.

“One of my patients tried regorafenib as his initial third- line treatment,” Dr. Goldberg said. “I checked in on him at his farm, and he was sitting in the barn near his tractor.

He had such severe hand-foot syndrome that he could barely walk.”

Trifluridine/tipiracil alone proved to be very helpful in this case. “We switched him to it, and he tolerated it well,” Dr. Goldberg continued. “He got his fields plowed and was on it for months before he passed away. We both felt it kept him going longer.”

A new research review confirms the regimen’s success, determining that trifluridine/tipiracil plus bevacizumab was associated with improved outcomes compared to therapy solely with trifluridine/tipiracil.
 

A True Practice Changer

Now that the regimen has been on the market for more than half a year, there are longer-term data available.

Patients on average live within the same timeframe as the patients in the SUNLIGHT study, and many feel physically better on the therapy. “The combination has very quickly shifted the standard of care,” Dr. Goldberg said.

The regimen can also provide significant psychological benefits to patients.

“As patients can maintain good performance status for longer with the combination, it increases the perception of quality of life,” said Jacobo Hincapie-Echeverri, MD, a GI and geriatric oncologist at Orlando Health Cancer Institute in Orlando, Florida.

The regimen is unique too, in that it can help doctors plan additional treatment strategies.

“This current approval, for the combination of trifluridine/tipiracil and bevacizumab, is practice-changing in that it helps clarify the sequence for later treatments for patients with mCRC,” said Dr. Patel, who is also clinical director of the Center for Esophageal and Gastric Cancer and assistant professor of medicine at Harvard Medical School, Boston. “Previously, it had been difficult to decide between trifluridine/tipiracil and regorafenib in this setting.”

The fact that the regimen has been shown to give time and improved quality of life to patients in ways regorafenib does not is clarifying. “Now, with the improved outcomes seen, I do think that trifluridine/tipiracil plus bevacizumab is the better option for most mCRC patients after IV chemotherapies,” Dr. Patel added.

When it comes to his specific experience with prescribing the regimen for his patients, Dr. Patel reported that it’s easier on his patients than other therapies.

“I find that it is generally well tolerated,” he elaborated. “As an oral agent, it is also usually somewhat easier to take (than other delivery methods of medication). These factors are critical for patients who have likely already had at least 2 or 3 prior lines of chemotherapy. I have had many patients with mCRC who, after disease progression on prior IV chemotherapy regimens, have had periods of meaningful disease control – often with fewer and manageable side effects.”

Dr. Goldberg mentioned another benefit.

“The nice thing about the combination of trifluridine/tipiracil and bevacizumab is that in terms of toxicity, there’s very little difference compared to the toxicity of trifluridine/tipiracil used alone.”
 

Are There Downsides to the Regimen?

The pros are obvious, but the regimen has some cons as well. Medically, patients should have a platelet count over 75,000/mm³ and absolute neutrophil count (ANC) over 1,500/mm³ prior to the start of each cycle, and their liver and renal function should be monitored.

Patients with metastatic colorectal cancer must be also carefully monitored for hematologic adverse events (AEs) , including chemotherapy-associated neutropenia. Biweekly treatments may reduce the risk of AEs as a whole, however, according to research.

The regimen is also expensive – an approximate cost of $8,191 for a 28-day supply. According to a new study, patients managing both AE expenses along with the cost of trifluridine/tipiracil-bevacizumab face a monthly bill of about $17,179.

Some very good news, though: 100% of Medicare drug plans cover trifluridine/tipiracil, with an average copay of $57-$292. Bevacizumab is also covered by Medicare, with a copay as low as $0-$25.

Private insurers do cover the drugs, depending on a patient’s specific plan. However, if a patient’s claim is denied, financial assistance for trifluridine/tipiracil through the drug’s manufacturers may be available for some patients, reducing prescriptions to a zero cost in some cases. Bevacizumab can be made available to patients who may not have health insurance at all, too. Patients can use a financial assistance tool through the drug’s manufacturer to receive up to $25,000 in yearly copay assistance.
 

What Does the Latest Research on the Regimen Indicate?

In May 2024, two abstracts were presented at the annual meeting of the American Society of Clinical Oncology (ASCO) that explored expanded possible use of trifluridine/tipiracil plus bevacizumab as a treatment for metastatic colorectal cancer.

The first abstract studied trifluridine/tipiracil plus bevacizumab as upfront treatment for mCRC, adding capecitabine to the regimen.

“It’s a phase 1 study looking at dose findings for the three-drug combination, where the active drug is a chemotherapy agent classified as a fluoropyrimidine ... I would characterize this as a study combining two [fluoropyrimidines] with a single targeted therapy,” Dr. Goldberg said.

“Combining two fluoropyrimidines is an unusual approach, because they tend to have overlapping side effects, and the potential is there for either innate drug resistance to the class of drugs or that the combination of two agents that work by a similar mechanism of action could hasten the development of acquired drug resistance. There is apparently a signal that combining the two chemotherapy agents enhances each other’s activity in cell culture and animal models,” he added.

Ultimately, Dr. Goldberg said he thinks more evidence is needed to prove the regimen’s effectiveness.

“This is a very early study and really provides no information about its potential given that no response data was presented,” he added. “While this is an interesting idea, it is unclear if it will pan out until we see the data on the Phase II study in progress.”

The other abstract looked at the impact of colorectal liver metastases in patients with mCRC who in phase 3 of the SUNLIGHT trial received trifluridine/tipiracil with or without bevacizumab.

“There is not much that is novel here,” Dr. Goldberg said. “The retrospective analysis shows that trifluridine/tipiracil plus bevacizumab is better than trifluridine/tipiracil alone in the subset of patients with liver metastases, as it was shown to be in the entire patient population. While this is reassuring, it’s not unexpected, especially since the vast majority of people enrolled in the SUNLIGHT trial had liver metastases.”

The Bottom Line

In the future, the potential exists for trifluridine/tipiracil combined with bevacizumab to work in first-line and second-line patients.

“Seventy percent of colorectal cancer patients reach second line treatment right now, but only 30% reach third line treatment — either they become too sick to continue, or choose not to,” Dr. Goldberg said. “The hope is that using these drugs earlier can help more patients reach and prolong treatment.”

It’s also possible that the regimen can be applied in new ways.

“Further research combining trifluridine/tipiracil and bevacizumab with other targeted therapies could yield additional advances for refractory mCRC patients,” Dr. Hincapie-Echeverri said. “The survival benefit of this therapy reinforces the importance of continuing to develop new therapies to improve outcomes in the refractory mCRC setting.”

Dr. Patel’s patient felt lucky to simply live a longer life.

Because of the regimen, “his cancer remained stable for approximately 8 months. Upon its progression, he chose not to pursue any further chemotherapy. He instead expressed his gratitude at having been able to feel more like himself for nearly a year.”

Dr. Patel received research funding in 2017 from Taiho, which manufactures trifluridine/tipiracil. He receives no current funding from Taiho and has no additional conflicts of interest. Dr. Goldberg helped represent Taiho in a patent law dispute regarding Lonsurf for which he was paid, but he is no longer paid by the company. Dr. Hincapie-Echeverri is a speaker for Astellas Pharma, which does not manufacture trifluridine/tipiracil or bevacizumab, and he has no additional conflicts of interest.

TOPLINE:

Compared with the general population, patients with urticaria had a 49% higher risk of developing cancer in the first year following diagnosis, which decreased to 6% in subsequent years, in a cohort study using Danish healthcare databases.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from Danish healthcare registries and compared the incident cancer risk between patients with urticaria and the risk in the general population.
• They identified 87,507 patients (58% women) with a primary or secondary first-time hospital outpatient clinic, emergency room, or inpatient diagnosis of urticaria between 1980 and 2022, who were followed for a median of 10.1 years.
• Incident cancers, including nonmelanoma skin cancer, were identified using the Danish Cancer Registry and classified by the extent of spread at the time of diagnosis.
• This study computed the absolute cancer risk within the first year of an urticaria diagnosis and standardized incidence ratios (SIRs), with 95% CIs standardized to Danish national cancer rates.

TAKEAWAY:

• For the first year of follow-up, the absolute risk for all cancer types was 0.7%, and it was 29.5% for subsequent years. The overall SIR for all types of cancer was 1.09 (95% CI, 1.06-1.11), which was based on 7788 observed cancer cases compared with 7161 cases expected over the entire follow-up period.
• Within the first year of follow-up, 588 patients with urticaria were diagnosed with cancer, for an SIR of 1.49 (95% CI, 1.38-1.62) for all cancer types.
• After the first year, the SIR for all cancer sites decreased and stabilized at 1.06 (95% CI, 1.04-1.09), with 7200 observed cancer cases.
• The risk was highest for hematological cancers in the first year, particularly Hodgkin lymphoma (SIR, 5.35; 95% CI, 2.56-9.85).

IN PRACTICE:

“Our study suggests that urticaria may be a marker of occult cancer and that it is associated with a slightly increased long-term cancer risk,” the authors wrote.

SOURCE:

The study was led by Sissel B.T. Sørensen, departments of dermatology and rheumatology, Aarhus University Hospital, Aarhus, Denmark. It was published online on June 27, 2024, in the British Journal of Dermatology.

LIMITATIONS:

The study is limited by its observational design and reliance on registry data, which may be subject to misclassification or incomplete information. In addition, the study could not assess individual patient factors such as lifestyle or genetic predispositions that may influence cancer risk, and the results may not be generalizable to other populations. Finally, the exact biologic mechanisms linking urticaria and cancer remain unclear, warranting further investigation.

DISCLOSURES:

The study did not receive any funding. The authors reported that they had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Compared with the general population, patients with urticaria had a 49% higher risk of developing cancer in the first year following diagnosis, which decreased to 6% in subsequent years, in a cohort study using Danish healthcare databases.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from Danish healthcare registries and compared the incident cancer risk between patients with urticaria and the risk in the general population.
• They identified 87,507 patients (58% women) with a primary or secondary first-time hospital outpatient clinic, emergency room, or inpatient diagnosis of urticaria between 1980 and 2022, who were followed for a median of 10.1 years.
• Incident cancers, including nonmelanoma skin cancer, were identified using the Danish Cancer Registry and classified by the extent of spread at the time of diagnosis.
• This study computed the absolute cancer risk within the first year of an urticaria diagnosis and standardized incidence ratios (SIRs), with 95% CIs standardized to Danish national cancer rates.

TAKEAWAY:

• For the first year of follow-up, the absolute risk for all cancer types was 0.7%, and it was 29.5% for subsequent years. The overall SIR for all types of cancer was 1.09 (95% CI, 1.06-1.11), which was based on 7788 observed cancer cases compared with 7161 cases expected over the entire follow-up period.
• Within the first year of follow-up, 588 patients with urticaria were diagnosed with cancer, for an SIR of 1.49 (95% CI, 1.38-1.62) for all cancer types.
• After the first year, the SIR for all cancer sites decreased and stabilized at 1.06 (95% CI, 1.04-1.09), with 7200 observed cancer cases.
• The risk was highest for hematological cancers in the first year, particularly Hodgkin lymphoma (SIR, 5.35; 95% CI, 2.56-9.85).

IN PRACTICE:

“Our study suggests that urticaria may be a marker of occult cancer and that it is associated with a slightly increased long-term cancer risk,” the authors wrote.

SOURCE:

The study was led by Sissel B.T. Sørensen, departments of dermatology and rheumatology, Aarhus University Hospital, Aarhus, Denmark. It was published online on June 27, 2024, in the British Journal of Dermatology.

LIMITATIONS:

The study is limited by its observational design and reliance on registry data, which may be subject to misclassification or incomplete information. In addition, the study could not assess individual patient factors such as lifestyle or genetic predispositions that may influence cancer risk, and the results may not be generalizable to other populations. Finally, the exact biologic mechanisms linking urticaria and cancer remain unclear, warranting further investigation.

DISCLOSURES:

The study did not receive any funding. The authors reported that they had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

TOPLINE:

Compared with the general population, patients with urticaria had a 49% higher risk of developing cancer in the first year following diagnosis, which decreased to 6% in subsequent years, in a cohort study using Danish healthcare databases.

METHODOLOGY:

• Researchers conducted a retrospective cohort study using data from Danish healthcare registries and compared the incident cancer risk between patients with urticaria and the risk in the general population.
• They identified 87,507 patients (58% women) with a primary or secondary first-time hospital outpatient clinic, emergency room, or inpatient diagnosis of urticaria between 1980 and 2022, who were followed for a median of 10.1 years.
• Incident cancers, including nonmelanoma skin cancer, were identified using the Danish Cancer Registry and classified by the extent of spread at the time of diagnosis.
• This study computed the absolute cancer risk within the first year of an urticaria diagnosis and standardized incidence ratios (SIRs), with 95% CIs standardized to Danish national cancer rates.

TAKEAWAY:

• For the first year of follow-up, the absolute risk for all cancer types was 0.7%, and it was 29.5% for subsequent years. The overall SIR for all types of cancer was 1.09 (95% CI, 1.06-1.11), which was based on 7788 observed cancer cases compared with 7161 cases expected over the entire follow-up period.
• Within the first year of follow-up, 588 patients with urticaria were diagnosed with cancer, for an SIR of 1.49 (95% CI, 1.38-1.62) for all cancer types.
• After the first year, the SIR for all cancer sites decreased and stabilized at 1.06 (95% CI, 1.04-1.09), with 7200 observed cancer cases.
• The risk was highest for hematological cancers in the first year, particularly Hodgkin lymphoma (SIR, 5.35; 95% CI, 2.56-9.85).

IN PRACTICE:

“Our study suggests that urticaria may be a marker of occult cancer and that it is associated with a slightly increased long-term cancer risk,” the authors wrote.

SOURCE:

The study was led by Sissel B.T. Sørensen, departments of dermatology and rheumatology, Aarhus University Hospital, Aarhus, Denmark. It was published online on June 27, 2024, in the British Journal of Dermatology.

LIMITATIONS:

The study is limited by its observational design and reliance on registry data, which may be subject to misclassification or incomplete information. In addition, the study could not assess individual patient factors such as lifestyle or genetic predispositions that may influence cancer risk, and the results may not be generalizable to other populations. Finally, the exact biologic mechanisms linking urticaria and cancer remain unclear, warranting further investigation.

DISCLOSURES:

The study did not receive any funding. The authors reported that they had no relevant conflicts of interest.

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article first appeared on Medscape.com.

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

On any given day, oncologist Mark Lewis, MD, feels like he’s seesawing between two eras of technology. 

One minute, he’s working on sequencing a tumor genome. The next, he’s sifting through pages of disorganized data from a device that has been around for decades: the fax machine. 

“If two doctors’ offices aren’t on the same electronic medical record, one of the main ways to transfer records is still by fax,” said Dr. Lewis, director of gastrointestinal oncology at Intermountain Healthcare in Murray, Utah. “I can go from cutting-edge innovation to relying on, at best, 1980s information technology. It just boggles my mind.”

Dr. Lewis, who has posted about his frustration with fax machines, is far from alone. Oncologists are among the many specialists across the country at the mercy of telecopiers. 

According to a 2021 report by the Office of the National Coordinator for Health Information Technology, fax and mail continue to be the most common methods for hospitals and health systems to exchange care record summaries. In 2019, nearly 8 in 10 hospitals used mail or fax to send and receive health information, the report found. 

Fax machines are still commonplace across the healthcare spectrum, said Robert Havasy, MS, senior director for informatics strategy at the Healthcare Information and Management Systems Society (HIMSS). Inertia, cost, and more pressing priorities for hospitals and medical institutions contribute to the technology sticking around, he explained. 

“Post-COVID, my guess is we’re still at over 50% of healthcare practices using fax for some reason, on a daily basis,” Mr. Havasy said in an interview. “A lot of hospitals just don’t have the time, the money, or the staff to fix that problem because there’s always something a little higher up the priority chain they need to focus on.” 

If, for instance, “you’re going to do a process redesign to reduce hospital total acquired infections, your fax machine replacement might be 10th or 12th on the list. It just never gets up to 1 or 2 because it’s ‘not that much of a problem,’ ” he added.

Or is it?

Administrators may not view fax machines as a top concern, but clinicians who deal with the machines daily see it differently. 

“What worries me is we’re taking records out of an electronic storehouse [and] converting them to a paper medium,” Dr. Lewis said. “And then we are scanning into another electronic storehouse. The more steps, the more can be lost.”

And when information is lost, patient care can be compromised. 

Slower Workflows, Care Concerns

Although there are no published data on fax machine use in oncology specifically, this outdated technology does come into play in a variety of ways along the cancer care continuum. 

Radiation oncologist David R. Penberthy, MD, said patients often seek his cancer center’s expertise for second opinions, and that requires collecting patient records from many different practices. 

“Ideally, it would come electronically, but sometimes it does come by fax,” said Dr. Penberthy, program director of radiation oncology at the University of Virginia School of Medicine in Charlottesville. “The quality of the fax is not always the best. Sometimes it’s literally a fax of a fax. You’re reading something that’s very difficult to read.” 

Orders for new tests are also typically sent and received via fax temporarily while IT teams work to integrate them into the electronic health record (EHR), Dr. Penberthy said. 

Insurers and third-party laboratories often send test results back by fax as well.

“Even if I haven’t actually sent my patient out of our institution, this crucial result may only be entered back into the record as a scanned document from a fax, which is not great because it can get lost in the other results that are reported electronically,” Dr. Lewis said. The risk here is that an ordering physician won’t see these results, which can lead to delayed or overlooked care for patients, he explained.

“To me, it’s like a blind spot,” Dr. Lewis said. “Every time we use a fax, I see it actually as an opportunity for oversight and missed opportunity to collect data.”

Dr. Penberthy said faxing can slow things down at his practice, particularly if he faxes a document to another office but receives no confirmation and has to track down what happened. 

As for cybersecurity, data that are in transit during faxing are generally considered secure and compliant with the Health Insurance Portability and Accountability Act (HIPAA), said Mr. Havasy of HIMSS. However, the Privacy Rule also requires that data remain secure while at rest, which isn’t always possible, he added. 

“That’s where faxes fall down, because generally fax machines are in public, if you will, or open areas in a hospital,” he said. “They just sit on a desk. I don’t know that the next nurse who comes up and looks through that stack was the nurse who was treating the patient.” 

Important decisions or results can also be missed when sent by fax, creating headaches for physicians and care problems for patients. 

Dr. Lewis recently experienced an insurance-related fax mishap over Memorial Day weekend. He believed his patient had access to the antinausea medication he had prescribed. When Dr. Lewis happened to check the fax machine over the weekend, he found a coverage denial for the medication from the insurer but, at that point, had no recourse to appeal because it was a long holiday weekend. 

“Had the denial been sent by an electronic means that was quicker and more readily available, it would have been possible to appeal before the holiday weekend,” he said. 

Hematologist Aaron Goodman, MD, encountered a similar problem after an insurer denied coverage of an expensive cancer drug for a patient and faxed over its reason for the denial. Dr. Goodman was not directly notified that the information arrived and didn’t learn about the denial for a week, he said. 

“There’s no ‘ding’ in my inbox if something is faxed over and scanned,” said Dr. Goodman, associate professor of medicine at UC San Diego Health. “Once I realized it was denied, I was able to rectify it, but it wasted a week of a patient not getting a drug that I felt would be beneficial for them.”

Broader Health Policy Impacts

The use of outdated technology, such as fax machines, also creates ripple effects that burden the health system, health policy experts say. 

Duplicate testing and unnecessary care are top impacts, said Julia Adler-Milstein, PhD, professor of medicine and chief of the division of clinical informatics and digital transformation at the University of California, San Francisco.

Studies show that 20%-30% of the $65 billion spent annually on lab tests is used on unnecessary duplicate tests, and another estimated $30 billion is spent each year on unnecessary duplicate medical imaging. These duplicate tests may be mitigated if hospitals adopt certified EHR technology, research shows.

Still, without EHR interoperability between institutions, new providers may be unaware that tests or past labs for patients exist, leading to repeat tests, said Dr. Adler-Milstein, who researches health IT policy with a focus on EHRs. Patients can sometimes fill in the gaps, but not always. 

“Fax machines only help close information gaps if the clinician is aware of where to seek out the information and there is someone at the other organization to locate and transmit the information in a timely manner,” Dr. Adler-Milstein said. 

Old technology and poor interoperability also greatly affect data collection for disease surveillance and monitoring, said Janet Hamilton, MPH, executive director for the Council of State and Territorial Epidemiologists. This issue was keenly demonstrated during the pandemic, Ms. Hamilton said. 

“It was tragic, quite honestly,” she said. “There was such an immense amount of data that needed to be moved quickly, and that’s when computers are at their best.”

But, she said, “we didn’t have the level of systems in place to do it well.”

Specifically, the lack of electronic case reporting in place during the pandemic — where diagnoses are documented in the record and then immediately sent to the public health system — led to reports that were delayed, not made, or had missing or incomplete information, such as patients’ race and ethnicity or other health conditions, Ms. Hamilton said. 

Incomplete or missing data hampered the ability of public health officials and researchers to understand how the virus might affect different patients.

“If you had a chronic condition like cancer, you were less likely to have a positive outcome with COVID,” Ms. Hamilton said. “But because electronic case reporting was not in place, we didn’t get some of those additional pieces of information. We didn’t have people’s underlying oncology status to then say, ‘Here are individuals with these types of characteristics, and these are the things that happen if they also have a cancer.’” 

Slow, but Steady, Improvements

Efforts at the state and federal levels have targeted improved health information exchange, but progress takes time, Dr. Adler-Milstein said.

Most states have some form of health information exchange, such as statewide exchanges, regional health information organizations, or clinical data registries. Maryland is often held up as a notable example for its health information exchange, Dr. Adler-Milstein noted.

According to Maryland law, all hospitals under the jurisdiction of the Maryland Health Care Commission are required to electronically connect to the state-designated health information exchange. In 2012, Maryland became the first state to connect all its 46 acute care hospitals in the sharing of real-time data. 

The Health Information Technology for Economic and Clinical Health (HITECH) Act provided federal-enhanced Medicaid matching funds to states through 2021 to support efforts to advance electronic exchange. Nearly all states used these funds, and most have identified other sources to sustain the efforts, according to a recent US Government Accountability Office (GAO) report. However, GAO found that small and rural providers are less likely to have the financial and technological resources to participate in or maintain electronic exchange capabilities.

Nationally, several recent initiatives have targeted health data interoperability, including for cancer care. The Centers for Disease Control and Prevention’s Data Modernization Initiative is a multiyear, multi–billion-dollar effort to improve data sharing across the federal and state public health landscape. 

Meanwhile, in March 2024, the Biden-Harris administration launched United States Core Data for Interoperability Plus Cancer. The program will define a recommended minimum set of cancer-related data to be included in a patient’s EHR to enhance data exchange for research and clinical care. 

EHR vendors are also key to improving the landscape, said Dr. Adler-Milstein. Vendors such as Epic have developed strong sharing capabilities for transmitting health information from site to site, but of course, that only helps if providers have Epic, she said. 

“That’s where these national frameworks should help, because we don’t want it to break down by what EHR vendor you have,” she said. “It’s a patchwork. You can go to some places and hear success stories because they have Epic or a state health information exchange, but it’s very heterogeneous. In some places, they have nothing and are using a fax machine.”

Mr. Havasy believes fax machines will ultimately go extinct, particularly as a younger, more digitally savvy generation enters the healthcare workforce. He also foresees that the growing use of artificial intelligence will help eradicate the outdated technology. 

But, Ms. Hamilton noted, “unless we have consistent, ongoing, sustained funding, it is very hard to move off [an older] technology that can work. That’s one of the biggest barriers.” 

“Public health is about protecting the lives of every single person everywhere,” Ms. Hamilton said, “but when we don’t have the data that comes into the system, we can’t achieve our mission.”
 

A version of this article appeared on Medscape.com.

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

Results from the latest survey by the National Comprehensive Cancer Network (NCCN) showed that numerous critical systemic anticancer therapies, primarily generic drugs, are currently in shortage.

Nearly 90% of the 28 NCCN member centers who responded to the survey, conducted between May 28 and June 11, said they were experiencing a shortage of at least one drug.

“Many drugs that are currently in shortage form the backbones of effective multiagent regimens across both curative and palliative treatment settings,” NCCN’s CEO Crystal S. Denlinger, MD, said in an interview.

The good news is that carboplatin and cisplatin shortages have fallen dramatically since 2023. At the peak of the shortage in 2023, 93% of centers surveyed reported experiencing a shortage of carboplatin and 70% were experiencing a shortage of cisplatin, whereas in 2024, only 11% reported a carboplatin shortage and 7% reported a cisplatin shortage.

“Thankfully, the shortages for carboplatin and cisplatin are mostly resolved at this time,” Dr. Denlinger said.

However, all three NCCN surveys conducted in the past year, including the most recent one, have found shortages of various chemotherapies and supportive care medications, which suggests this is an ongoing issue affecting a significant spectrum of generic drugs.

“The acute crisis associated with the shortage of carboplatin and cisplatin was a singular event that brought the issue into the national spotlight,” but it’s “important to note that the current broad drug shortages found on this survey are not new,” said Dr. Denlinger.

In the latest survey, 89% of NCCN centers continue to report shortages of one or more drugs, and 75% said they are experiencing shortages of two or more drugs.

Overall, 57% of centers are short on vinblastine, 46% are short on etoposide, and 43% are short on topotecan. Other common chemotherapy and supportive care agents in short supply include dacarbazine (18% of centers) as well as 5-fluorouracil (5-FU) and methotrexate (14% of centers).

In 2023, however, shortages of methotrexate and 5-FU were worse, with 67% of centers reporting shortages of methotrexate and 26% of 5-FU.

In the current survey, 75% of NCCN centers also noted they were aware of drug shortages within community practices in their area, and more than one in four centers reported treatment delays requiring additional prior authorization.

Cancer drug shortages impact not only routine treatments but also clinical trials. The recent survey found that 43% of respondents said drug shortages disrupted clinical trials at their center. The biggest issues centers flagged included greater administrative burdens, lower patient enrollment, and fewer open trials.

How are centers dealing with ongoing supply issues?

Top mitigation strategies include reducing waste, limiting use of current stock, and adjusting the timing and dosage within evidence-based ranges.

“The current situation underscores the need for sustainable, long-term solutions that ensure a stable supply of high-quality cancer medications,” Alyssa Schatz, MSW, NCCN senior director of policy and advocacy, said in a news release.

Three-quarters (75%) of survey respondents said they would like to see economic incentives put in place to encourage the high-quality manufacturing of medications, especially generic versions that are often in short supply. Nearly two-thirds (64%) cited a need for a broader buffer stock payment, and the same percentage would like to see more information on user experiences with various generic suppliers to help hospitals contract with those engaging in high-quality practices.

The NCCN also continues to work with federal regulators, agencies, and lawmakers to implement long-term solutions to cancer drug shortages.

“The federal government has a key role to play in addressing this issue,” Ms. Schatz said. “Establishing economic incentives, such as tax breaks or manufacturing grants for generic drugmakers, will help support a robust and resilient supply chain — ultimately safeguarding care for people with cancer across the country.”

A version of this article appeared on Medscape.com.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

Patients with small melanoma in situ (MIS) on low-risk body sites managed with 5-mm margins had a local recurrence rate of 0.9%, results from a retrospective case series from a single dermatology practice in Australia showed. This approach has the potential to reduce morbidity and cost associated with treatment “without compromising patient outcomes in a selected population of lesions,” the authors say. 

“Currently, there is uncertainty regarding the optimal excision margin for MIS, with different guidelines recommending a range between 5 and 10 mm,” corresponding author Cong Sun, MD, of Mater Hospital Brisbane Raymond Terrace, South Brisbane, Queensland, Australia, and colleagues wrote in the study, which was published in JAMA Dermatology. “In addition, studies using the Mohs micrographic surgery technique have suggested that wider margins, up to 18 mm, may be required for MIS in some settings.”

[embed:render:related:node:269549]

To further examine the use of 5-mm margins for excision of small MIS on low-risk sites, the researchers retrospectively evaluated 351 MIS lesions diagnosed in 292 patients between January 1, 2011, and November 30, 2018. Lesions were eligible for analysis if a 5-mm excisional margin was documented on the operation report and if there was more than 5 years of site-specific follow-up after wide local excision. Lesions with undocumented margins were excluded from analysis, as were those with fewer than 5 years of follow-up, and those that required more than one wide local excision.

The mean age of patients was 60.3 years, 55.5% were female, and the mean dimensions of the lesions was 6 × 5 mm. The most common subtype of melanoma diagnosed was superficial spreading melanoma (50.4% of lesions), followed by lentigo maligna (30.5%) and lentiginous MIS (19.1%). Nearly half of the lesions were on the trunk (47.9%), followed by the upper limb (27.4%), lower limb (16.8%), neck (4%), face (3.4%), and scalp (0.6%). As for the size of lesions, 78.1% were < 10 mm long and 88.9% were < 10 mm wide. 

Nearly 71% (248) of the lesions were treated with an initial excisional biopsy, and 29.3% (103) underwent an initial shave excision. Median follow-up was 7 years.

Only three of the 351 lesions (0.9%) had a local recurrence, with no regional recurrence or metastatic spread, and 99.1% had no recurrence. The recurrences were reexcised “with clear margins” and after at least 5 years of follow-up, no further recurrences were reported, the authors said. 

In Mohs surgery studies, reported recurrence rates for MIS have been “between 0.26% and 1.1%, with excisional margins between 6 and 12 mm required,” the authors noted. “This study demonstrated a comparable 0.9% recurrence rate achieved with a conservative 5-mm excisional margin. This shows that using a 5-mm margin for MIS of smaller size (< 10 mm) may reduce morbidity and cost associated with treatment without compromising patient outcomes in a selected population of lesions.” 

The researchers recommended additional studies to confirm their findings and acknowledged certain limitations of their analysis, including its retrospective, single-center design and the predominantly small sizes of the lesions. 

In an accompanying editorial, John A. Zitelli, MD, of the University of Pittsburgh, Pittsburgh, Pennsylvania, said that the margin measurement used by the researchers was another limitation. “Before the excision with a 5-mm margin was performed, the diagnosis of MIS was obtained by shave biopsy or excisional biopsy with a 2- to 3-mm margin of clinically normal skin,” Dr. Zitelli wrote. “Therefore, in patients without a 2- to 3-mm biopsy margin, a minimum surgical margin of 7-8 mm would be required to achieve a similar true negative excision margin.” 

Also, he continued, the exclusion of lesions with wide subclinical extension that required wider margins “weakens the conclusion that 5 mm would be an effective treatment for all MIS.” 

Hugh Greenway, MD, head of Mohs micrographic surgery and director of cutaneous oncology at Scripps Cancer Center, San Diego, who was asked to comment on the study, said that clinicians continue to search for the optimum smaller surgical margin for MIS. “This can be challenging with the variability of MIS based on location and other factors,” Dr. Greenway told this news organization. “This Australian retrospective study notes that for selected, well-defined 6 × 5 mm lesions of low-risk body sites (mainly torso and limbs), a 5-mm surgical margin can provide a high cure rate. The authors note further studies are indicated. Thus, for selected lesions in selected locations, the 5-mm surgical margin may be appropriate for MIS.”

The study authors, Dr. Zitelli, and Dr. Greenway reported no financial disclosures.

A version of this article appeared on Medscape.com.

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

TOPLINE:

The incidence of dermatofibrosarcoma protuberans (DFSP) is twice as high in Black individuals as in White individuals, according to a study that also found that larger tumor size and older age were associated with survival outcomes.

[embed:render:related:node:269548]

METHODOLOGY:

• Researchers used the National Cancer Institute’s Surveillance, Epidemiology, and End Results (SEER) registry from 2000 through 2018 to provide a comprehensive report on the incidence of DFSP, a rare, low-grade cutaneous soft tissue sarcoma, and factors associated with metastatic progression, overall survival (OS), and cancer-specific survival.
• A total of 7748 patients (mean age, 43.5 years; 53.3% women; 52% non-Hispanic White) were diagnosed with histologically confirmed DFSP of the skin and connective tissue and were included in the study.
• DFSP incidence was reported as cases per million person-years and age-adjusted to the 2000 US Standard Population, and factors influencing metastasis were assessed.

TAKEAWAY:

• The overall DFSP incidence rate was 6.25 cases per million person-years, with a higher incidence in Black individuals than in White individuals (8.74 vs 4.53).
• The 5-year OS rate was 95.8%. Older age (≥ 60 years; hazard ratio [HR], 6.66), male gender assigned at birth (HR, 1.79), and larger tumor size (≥ 3 cm; HR, 2.02) were associated with poorer OS (P < .001 for all).
• The 1-year and 5-year DFSP-specific survival rates were 99.9% and 99.2%, respectively. Older age (HR, 3.47; P < .001) and larger tumor size (≥ 3 cm; HR, 5.34; P = .002) were associated with significantly worse cancer-specific survival.
• Large tumor size (odds ratio [OR], 2.24) and DFSP located on the head and neck (OR, 4.88), or genitalia (OR, 3.16) were significantly associated with increased metastasis risk. Higher socioeconomic status was linked to a lower risk for metastasis.

IN PRACTICE:

“Our findings highlight the increased incidence rates of DFSP among Black patients. We demonstrate the interplay between patient demographics and clinical factors in influencing DFSP metastasis, OS, and cancer-specific survival,” the authors wrote. The results, they added, “may be useful for further evaluation of proposed causes, which will ultimately lead to further understanding and prevention of this disease.”
 

SOURCE:

The study was led by Jalal Maghfour, MD, Department of Dermatology, Henry Ford Health, Detroit, and was published online on June 20 in the Journal of the American Academy of Dermatology.
 

LIMITATIONS:

Details on specific cases in the SEER registry are limited. For 1752 patients, tumor size was not included, increasing the risk for misclassification bias. Because specific pathology reports were not available, the analysis did not address histologic grade.
 

DISCLOSURES:

The study did not receive any funding support. The authors declared no conflicts of interest.
 

This article was created using several editorial tools, including AI, as part of the process. Human editors reviewed this content before publication. A version of this article appeared on Medscape.com.

At its June 27 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations for four cancer therapies. 

Balversa

The CHMP endorsed the approval of Balversa (erdafitinib, Janssen-Cilag International N.V.), intended for the treatment of urothelial carcinoma, a type of cancer affecting the bladder and urinary system.

As a monotherapy, Balversa is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations. These patients must have previously received at least one line of therapy containing a programmed death receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting.

Urothelial carcinoma is the most common form of bladder cancer, the ninth most frequently diagnosed cancer worldwide. In 2022, there were approximately 614,000 new cases of bladder cancer and 220,000 deaths globally. 

The highest incidence rates in both men and women are found in Southern Europe. Greece had 5800 new cases and 1537 deaths in 2018. Spain has the highest incidence rate in men globally. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing among women in certain European countries. 

The CHMP recommendation is based on data from cohort 1 of the phase 3 THOR trial, which compared erdafitinib with standard-of-care chemotherapy (investigator’s choice of docetaxel or vinflunine). Cohort 1 included 266 adults with advanced urothelial cancer harboring selected FGFR3 alterations. 

All patients had disease progression after one or two prior treatments, at least one of which included a PD-1 or PD-L1 inhibitor. The major efficacy endpoints were overall survival, progression free survival, and objective response rate (ORR).

Treatment with erdafitinib reduced the risk for death by 36% compared with chemotherapy (hazard ratio [HR], 0.64; P = .005). Median overall survival was 12.1 months in the erdafitinib arm vs 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm vs 2.7 months in the chemotherapy arm (HR, 0.58; P = .0002). ORR was 35.3% with erdafitinib compared with 8.5% with chemotherapy.

Balversa will be available as 3-mg, 4-mg, and 5-mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor (FGFR) tyrosine kinases. Deregulation of FGFR3 signaling is implicated in the pathogenesis of urothelial cancer, and FGFR inhibition has demonstrated antitumor activity in FGFR-expressing cells.
 

Ordspono 

The committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as a monotherapy for the treatment of adult patients with: 

• Relapsed or refractory follicular lymphoma (rrFL), after two or more lines of systemic therapy.
• Relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), after two or more lines of systemic therapy.

The approval recommendation is based on phase 2 trials (NCT02290951, NCT03888105), which demonstrated high ORRs in patients with rrFL and rrDLBCL.

In the DLBCL cohort, a 49% ORR was achieved in heavily pretreated patients who had not received chimeric antigen receptor T-cell therapy. A total of 31% achieved a complete response. 

The FL cohort showed an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a complete response.

Ordspono will be available as a 2-mg, 80-mg, and 320-mg concentrate for solution for infusion. The active substance of Ordspono is odronextamab, a bispecific antibody that targets CD20-expressing B cells and CD3-expressing T cells. By binding to both, it induces T-cell activation and generates a polyclonal cytotoxic T-cell response, leading to the lysis of malignant B cells. 
 

Generics

The panel also adopted positive opinions for two generic cancer medicines.

Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:

• As monotherapy or with androgen-deprivation therapy for high-risk biochemical recurrent nonmetastatic hormone-sensitive prostate cancer in men unsuitable for salvage-radiotherapy.
• In combination with androgen-deprivation therapy for metastatic hormone-sensitive prostate cancer.
• For high-risk nonmetastatic castration-resistant prostate cancer (CRPC).
• For metastatic CRPC in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy, where chemotherapy is not yet indicated.
• For metastatic CRPC in men whose disease has progressed on or after docetaxel therapy.

Enzalutamide Viatris is a generic version of Xtandi, authorized in the European Union since June 2013. Studies have confirmed the satisfactory quality and bioequivalence of Enzalutamide Viatris to Xtandi.

Enzalutamide Viatris will be available as 40-mg and 80-mg film-coated tablets. The active substance of Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor–signaling pathway.

Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome–positive chronic myelogenous leukemia (CML).

It is used in adult and pediatric patients with newly diagnosed CML in the chronic phase, adult patients with chronic phase and accelerated phase CML with resistance or intolerance to prior therapy including imatinib, and pediatric patients with CML with resistance or intolerance to prior therapy including imatinib.

Nilotinib Accord is a generic of Tasigna, authorized in the European Union since November 2007. Studies have demonstrated the satisfactory quality and bioequivalence of Nilotinib Accord to Tasigna.

Nilotinib Accord will be available as 50-mg, 150-mg, and 200-mg hard capsules. The active substance of Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.

A version of this article appeared on Medscape.com.

At its June 27 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations for four cancer therapies. 

Balversa

The CHMP endorsed the approval of Balversa (erdafitinib, Janssen-Cilag International N.V.), intended for the treatment of urothelial carcinoma, a type of cancer affecting the bladder and urinary system.

As a monotherapy, Balversa is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations. These patients must have previously received at least one line of therapy containing a programmed death receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting.

Urothelial carcinoma is the most common form of bladder cancer, the ninth most frequently diagnosed cancer worldwide. In 2022, there were approximately 614,000 new cases of bladder cancer and 220,000 deaths globally. 

The highest incidence rates in both men and women are found in Southern Europe. Greece had 5800 new cases and 1537 deaths in 2018. Spain has the highest incidence rate in men globally. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing among women in certain European countries. 

The CHMP recommendation is based on data from cohort 1 of the phase 3 THOR trial, which compared erdafitinib with standard-of-care chemotherapy (investigator’s choice of docetaxel or vinflunine). Cohort 1 included 266 adults with advanced urothelial cancer harboring selected FGFR3 alterations. 

All patients had disease progression after one or two prior treatments, at least one of which included a PD-1 or PD-L1 inhibitor. The major efficacy endpoints were overall survival, progression free survival, and objective response rate (ORR).

Treatment with erdafitinib reduced the risk for death by 36% compared with chemotherapy (hazard ratio [HR], 0.64; P = .005). Median overall survival was 12.1 months in the erdafitinib arm vs 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm vs 2.7 months in the chemotherapy arm (HR, 0.58; P = .0002). ORR was 35.3% with erdafitinib compared with 8.5% with chemotherapy.

Balversa will be available as 3-mg, 4-mg, and 5-mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor (FGFR) tyrosine kinases. Deregulation of FGFR3 signaling is implicated in the pathogenesis of urothelial cancer, and FGFR inhibition has demonstrated antitumor activity in FGFR-expressing cells.
 

Ordspono 

The committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as a monotherapy for the treatment of adult patients with: 

• Relapsed or refractory follicular lymphoma (rrFL), after two or more lines of systemic therapy.
• Relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), after two or more lines of systemic therapy.

The approval recommendation is based on phase 2 trials (NCT02290951, NCT03888105), which demonstrated high ORRs in patients with rrFL and rrDLBCL.

In the DLBCL cohort, a 49% ORR was achieved in heavily pretreated patients who had not received chimeric antigen receptor T-cell therapy. A total of 31% achieved a complete response. 

The FL cohort showed an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a complete response.

Ordspono will be available as a 2-mg, 80-mg, and 320-mg concentrate for solution for infusion. The active substance of Ordspono is odronextamab, a bispecific antibody that targets CD20-expressing B cells and CD3-expressing T cells. By binding to both, it induces T-cell activation and generates a polyclonal cytotoxic T-cell response, leading to the lysis of malignant B cells. 
 

Generics

The panel also adopted positive opinions for two generic cancer medicines.

Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:

• As monotherapy or with androgen-deprivation therapy for high-risk biochemical recurrent nonmetastatic hormone-sensitive prostate cancer in men unsuitable for salvage-radiotherapy.
• In combination with androgen-deprivation therapy for metastatic hormone-sensitive prostate cancer.
• For high-risk nonmetastatic castration-resistant prostate cancer (CRPC).
• For metastatic CRPC in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy, where chemotherapy is not yet indicated.
• For metastatic CRPC in men whose disease has progressed on or after docetaxel therapy.

Enzalutamide Viatris is a generic version of Xtandi, authorized in the European Union since June 2013. Studies have confirmed the satisfactory quality and bioequivalence of Enzalutamide Viatris to Xtandi.

Enzalutamide Viatris will be available as 40-mg and 80-mg film-coated tablets. The active substance of Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor–signaling pathway.

Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome–positive chronic myelogenous leukemia (CML).

It is used in adult and pediatric patients with newly diagnosed CML in the chronic phase, adult patients with chronic phase and accelerated phase CML with resistance or intolerance to prior therapy including imatinib, and pediatric patients with CML with resistance or intolerance to prior therapy including imatinib.

Nilotinib Accord is a generic of Tasigna, authorized in the European Union since November 2007. Studies have demonstrated the satisfactory quality and bioequivalence of Nilotinib Accord to Tasigna.

Nilotinib Accord will be available as 50-mg, 150-mg, and 200-mg hard capsules. The active substance of Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.

A version of this article appeared on Medscape.com.

At its June 27 meeting, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) recommended granting marketing authorizations for four cancer therapies. 

Balversa

The CHMP endorsed the approval of Balversa (erdafitinib, Janssen-Cilag International N.V.), intended for the treatment of urothelial carcinoma, a type of cancer affecting the bladder and urinary system.

As a monotherapy, Balversa is indicated for the treatment of adult patients with unresectable or metastatic urothelial carcinoma harboring susceptible FGFR3 genetic alterations. These patients must have previously received at least one line of therapy containing a programmed death receptor 1 (PD-1) or programmed death-ligand 1 (PD-L1) inhibitor in the unresectable or metastatic treatment setting.

Urothelial carcinoma is the most common form of bladder cancer, the ninth most frequently diagnosed cancer worldwide. In 2022, there were approximately 614,000 new cases of bladder cancer and 220,000 deaths globally. 

The highest incidence rates in both men and women are found in Southern Europe. Greece had 5800 new cases and 1537 deaths in 2018. Spain has the highest incidence rate in men globally. Since the 1990s, bladder cancer incidence trends have diverged by sex, with rates decreasing or stabilizing in men but increasing among women in certain European countries. 

The CHMP recommendation is based on data from cohort 1 of the phase 3 THOR trial, which compared erdafitinib with standard-of-care chemotherapy (investigator’s choice of docetaxel or vinflunine). Cohort 1 included 266 adults with advanced urothelial cancer harboring selected FGFR3 alterations. 

All patients had disease progression after one or two prior treatments, at least one of which included a PD-1 or PD-L1 inhibitor. The major efficacy endpoints were overall survival, progression free survival, and objective response rate (ORR).

Treatment with erdafitinib reduced the risk for death by 36% compared with chemotherapy (hazard ratio [HR], 0.64; P = .005). Median overall survival was 12.1 months in the erdafitinib arm vs 7.8 months in the chemotherapy arm. Median progression-free survival was 5.6 months in the erdafitinib arm vs 2.7 months in the chemotherapy arm (HR, 0.58; P = .0002). ORR was 35.3% with erdafitinib compared with 8.5% with chemotherapy.

Balversa will be available as 3-mg, 4-mg, and 5-mg film-coated tablets. Erdafitinib, the active substance in Balversa, is an antineoplastic protein kinase inhibitor that suppresses fibroblast growth factor receptor (FGFR) tyrosine kinases. Deregulation of FGFR3 signaling is implicated in the pathogenesis of urothelial cancer, and FGFR inhibition has demonstrated antitumor activity in FGFR-expressing cells.
 

Ordspono 

The committee adopted a positive opinion for Ordspono (odronextamab, Regeneron Ireland Designated Activity Company), indicated as a monotherapy for the treatment of adult patients with: 

• Relapsed or refractory follicular lymphoma (rrFL), after two or more lines of systemic therapy.
• Relapsed or refractory diffuse large B-cell lymphoma (rrDLBCL), after two or more lines of systemic therapy.

The approval recommendation is based on phase 2 trials (NCT02290951, NCT03888105), which demonstrated high ORRs in patients with rrFL and rrDLBCL.

In the DLBCL cohort, a 49% ORR was achieved in heavily pretreated patients who had not received chimeric antigen receptor T-cell therapy. A total of 31% achieved a complete response. 

The FL cohort showed an 82% response rate in patients with grades I-IIIA disease, with 75% of the overall population achieving a complete response.

Ordspono will be available as a 2-mg, 80-mg, and 320-mg concentrate for solution for infusion. The active substance of Ordspono is odronextamab, a bispecific antibody that targets CD20-expressing B cells and CD3-expressing T cells. By binding to both, it induces T-cell activation and generates a polyclonal cytotoxic T-cell response, leading to the lysis of malignant B cells. 
 

Generics

The panel also adopted positive opinions for two generic cancer medicines.

Enzalutamide Viatris (enzalutamide) is indicated for the treatment of adult men with prostate cancer in several scenarios:

• As monotherapy or with androgen-deprivation therapy for high-risk biochemical recurrent nonmetastatic hormone-sensitive prostate cancer in men unsuitable for salvage-radiotherapy.
• In combination with androgen-deprivation therapy for metastatic hormone-sensitive prostate cancer.
• For high-risk nonmetastatic castration-resistant prostate cancer (CRPC).
• For metastatic CRPC in men who are asymptomatic or mildly symptomatic after failure of androgen-deprivation therapy, where chemotherapy is not yet indicated.
• For metastatic CRPC in men whose disease has progressed on or after docetaxel therapy.

Enzalutamide Viatris is a generic version of Xtandi, authorized in the European Union since June 2013. Studies have confirmed the satisfactory quality and bioequivalence of Enzalutamide Viatris to Xtandi.

Enzalutamide Viatris will be available as 40-mg and 80-mg film-coated tablets. The active substance of Enzalutamide Viatris is enzalutamide, a hormone antagonist that blocks multiple steps in the androgen receptor–signaling pathway.

Nilotinib Accord (nilotinib) is indicated for the treatment of Philadelphia chromosome–positive chronic myelogenous leukemia (CML).

It is used in adult and pediatric patients with newly diagnosed CML in the chronic phase, adult patients with chronic phase and accelerated phase CML with resistance or intolerance to prior therapy including imatinib, and pediatric patients with CML with resistance or intolerance to prior therapy including imatinib.

Nilotinib Accord is a generic of Tasigna, authorized in the European Union since November 2007. Studies have demonstrated the satisfactory quality and bioequivalence of Nilotinib Accord to Tasigna.

Nilotinib Accord will be available as 50-mg, 150-mg, and 200-mg hard capsules. The active substance of Nilotinib Accord is nilotinib, an antineoplastic protein kinase inhibitor that targets BCR-ABL kinase and other oncogenic kinases.

A version of this article appeared on Medscape.com.

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

The Food and Drug Administration (FDA) has issued new draft guidance that does not require additional switching studies for biosimilars seeking interchangeability. These studies were previously recommended to demonstrate that switching between the biosimilar and its reference product showed no greater risk than using the reference product alone.

“The recommendations in today’s draft guidance, when finalized, will provide clarity and transparency about the FDA’s thinking and align the review and approval process with existing and emerging science,” said Sarah Yim, MD, director of the FDA’s Office of Therapeutic Biologics and Biosimilars in a statement on June 20. “We have gained valuable experience reviewing both biosimilar and interchangeable biosimilar medications over the past 10 years. Both biosimilars and interchangeable biosimilars meet the same high standard of biosimilarity for FDA approval and both are as safe and effective as the reference product.”

An interchangeable status allows a biosimilar product to be swapped with the reference product without involvement from the prescribing provider, depending on state law.

While switching studies were not required under previous FDA guidance, the 2019 document did state that the agency “expects that applications generally will include data from a switching study or studies in one or more appropriate conditions of use.”

However, of the 13 biosimilars that received interchangeability status, 9 did not include switching study data.

“Experience has shown that, for the products approved as biosimilars to date, the risk in terms of safety or diminished efficacy is insignificant following single or multiple switches between a reference product and a biosimilar product,” the FDA stated. The agency’s investigators also conducted a systematic review of switching studies, which found no differences in risk for death, serious adverse events, and treatment discontinuations in participants switched between biosimilars and reference products and those that remained on reference products.

“Additionally, today’s analytical tools can accurately evaluate the structure and effects [of] biologic products, both in the lab (in vitro) and in living organisms (in vivo) with more precision and sensitivity than switching studies,” the agency noted.

The FDA is now calling for commentary on these draft recommendations to be submitted by Aug. 20, 2024.

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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

Two hospitals in California in recent months have been cited by state inspectors for allowing certified registered nurse anesthetists (CRNAs) to practice beyond their scope, leading to one hospital temporarily stopping use of CRNAs in surgeries.

In one case, a CRNA changed a physician’s order from general anesthesia to spinal anesthesia for a patient who later became unresponsive and had to be transferred to another hospital, according to The Modesto Bee.

The unusual situation highlights the ongoing, often contentious debate about the proper role of CRNAs in surgery amid widely varying state scope of practice laws.

Elizabeth Bamgbose, CRNA, past president of the California Association of Nurse Anesthetists (CANA), said that the absence of CRNAs at Doctors Medical Center (DMC) in Modesto, California, had led to the cancellation of hundreds of procedures. It was an unnecessary step, she said.

“It’s unfortunate that a single surveyor has taken it upon themselves to reinterpret state regulations and redefine a practice that was efficient and safe,” said Ms. Bamgbose, a member of the CANA practice committee.

In late May, the California Department of Public Health (CDPH) issued an “immediate jeopardy” warning about DMC of Modesto. The state agency, like its counterparts in other states, acts on behalf of the Centers for Medicare and Medicaid Services (CMS) in surveying healthcare facilities. CMS defines immediate jeopardy as “a situation in which entity noncompliance has placed the health and safety of recipients in its care at risk for serious injury, serious harm, serious impairment, or death.”

The administrative warning comes with fines and requires the facility to submit an action plan to remediate the situation. The state determines through a follow-up survey whether the plan is sufficient for the facility to avoid being dropped from participation in Medicare and Medicaid.

Before the immediate jeopardy action was taken against DMC, the state had issued three previous such warnings in 2024, according to the CDPH enforcement actions dashboard.
 

CRNA Claims to Be in Charge

Stanislaus Surgical Hospital in Modesto, California, was the first facility to attract CDPH attention. It reportedly was cited in August 2023 and January 2024 surveys for a number of violations of the CMS conditions of participation, including allowing nurse anesthetists to practice beyond their scope.

According to The Modesto Bee, CDPH issued an “immediate jeopardy” order for Stanislaus in January.

The paper reported that state regulators took issue with a CRNA claiming to be the lead manager of the hospital’s anesthesia group, referring to herself as the “chief CRNA.”

Jennifer Banek, MSN, CRNA, a member of the American Association of Nurse Anesthesiology board, declined comment on the Stanislaus hospital but said that “it would not be unusual for a nurse anesthetist to serve as a leader, especially (for a) rural or underserved population.”

In April, CMS informed Stanislaus it was being terminated from Medicare, but several Congressional representatives from the Modesto area asked CMS to reconsider. The agency eventually reversed the sanction, The Modesto Bee reported.

CDPH subsequently cited DMC for CRNA scope of practice issues. A department spokesman said that CDPH teams went to DMC “to investigate practices that may not be compliant with state and federal requirements.” The agency declined to comment further until its investigations were complete.

CDPH is monitoring DMC to ensure the hospital complies with state requirements and will return for an unannounced follow-up survey “so it can provide safe, high-quality care to patients that need it,” the spokesperson said.

Although DMC would not confirm it on the record, the immediate jeopardy order led to the removal of all CRNAs, according to Ms. Banek, Ms. Bamgbose, and The Modesto Bee.

The hospital said in a statement that it is working with CDPH to address its concerns and will await a follow-up survey. “Our hospital will continue to fully participate in the Medicare and Medicaid programs during this process.”
 

Scope of Practice Confusion?

Federal and state laws and hospital bylaws all prescribe what falls within the scope of practice for a CRNA, but uncertainty remains.

Twenty-five states — including California — have legally opted out of the federal CMS requirement that a physician supervise CRNAs.

But that does not supersede state laws or hospital bylaws governing practice, said American Society of Anesthesiologists (ASA) president Ronald Harter, MD.

Five states — Alaska, Delaware, Montana, New Hampshire, and Oregon — have laws that allow nurse anesthetists to practice without physician oversight or involvement, said Dr. Harter, professor of anesthesiology at The Ohio State University Wexner Medical Center in Columbus, Ohio.

“There’s a lot of various opinions on what exactly constitutes scope of practice of a nurse anesthetist,” Dr. Harter said. “The vast majority of them work under the direction of an anesthesiologist, and in those settings, it’s typically very clear to everybody who performs what tasks within the care team,” he said.

It’s less common for nurse anesthetists to work totally independent of physician oversight, he said.

Ms. Bamgbose, however, said there is no California statute requiring physician supervision of CRNAs.

The ASA maintains that CRNAs should always be under the supervision of a physician, which can be an anesthesiologist, obstetrician, gastroenterologist, surgeon, or other physician conducting a procedure. An anesthesiologist does not necessarily have to be physically on site, but in those circumstances, the physician conducting the procedure would be, said Dr. Harter.

Nurse anesthetists are “excellent advanced practice nurses,” Dr. Harter said. “But they haven’t been to medical school; they haven’t conducted a residency in anesthesiology. [They] don’t have the medical knowledge and skills that are required to manage the medical problems that patients either bring to the OR with them or that can arise during the time that they’re under anesthesia.”
 

Filling a Gap

Nurse anesthetists see things differently.

CRNAs, by virtue of their certification, can “practice to the full extent and to the full scope, which is complete service of anesthesia,” said Ms. Bamgbose. “You can practice independently of anyone, any type of supervision,” she said.

She acknowledges that “the bylaws of any institution will govern the scope at which any healthcare professional can practice at that institution.”

Most nurse anesthetists see themselves as independent practitioners.

Seventy-five percent of CRNAs who responded to a 2023 Medscape Medical News survey said they practice independently. But even Ms. Banek said that often, the meaning of “independent” is in the eye of the beholder. “It could mean different things to various providers, especially depending on the state that they are residing in,” she said.

Ms. Banek and Ms. Bamgbose said that CRNAs can help fill a gap in anesthesiology services in underserved areas.

The Bureau of Labor Statistics estimates there are currently 32,530 anesthesiologists in the United States, with California employing the largest number, at about 5300. The Association of American Medical Colleges estimated the number at 42,263 in 2022. But the federal Health Resources and Services Administration projects a shortage of 6300 anesthesiologists over the next 15 years.

Some 61,000 CRNAs are currently practicing, with 2400 graduating each year. They are required to be board-certified and are recredentialed every 4 years. By 2025, all will be required to have a doctoral degree. Most have already achieved that status, said Ms. Banek.

“Nurse anesthetists provide care predominantly to rural and underserved areas,” she said, adding, “In many rural hospitals across the country and in all three branches of the military, CRNAs practice autonomously.”

There are 3000 CRNAs in California, said Ms. Bamgbose. Nurse anesthetists are the only anesthesiology professionals in four of 58 California counties, she said.

Ms. Banek said she had heard that some 200 cases were canceled in 1 week at DMC due to the lack of CRNAs. Having physician supervision, which she called redundant, “is really creating a barrier to care,” she said.

“We have countless state and national studies that show the safety and efficacy of our practice,” said Ms. Bamgbose. “To interrupt that care ... is incredibly disruptive to the system.”

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