AVAHO

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

Many of the persistent problems that breast cancer survivors experience after treatment are not part of the conversation with oncologists during treatment, said Patricia A. Ganz, MD, during a presentation at the European Society for Medical Oncology Breast Cancer annual congress.

Several studies suggest that many breast cancer patients are not well prepared to move forward after a breast cancer diagnosis and subsequent treatments, continued Dr. Ganz, who works at the UCLA Jonsson Comprehensive Cancer Center, Los Angeles.

Meeting the survivorship needs of breast cancer patients requires addressing both their physical and psychosocial needs, Dr. Ganz said. She explained how to achieve that, but first pointed to research elaborating on what's missing from some breast cancer survivors' care and barriers to these patients having their variety of health-related needs met.

In a 2021 study published in the Journal of Cancer Survivorship, Dr. Ganz and colleagues conducted a survey of approximately 200 medical oncologists in the United States. They determined that less than 50% provide survivorship care plans to patients at the end of treatment or communicate with patients’ other physicians about follow-up care.

In a secondary analysis of data from the same survey published in 2022 in Breast Cancer Research and Treatment, Dr. Ganz and colleagues examined medical oncologists’ perceived barriers to addressing both physical and psychosocial long-term effects in breast cancer survivors. For both, lack of time was the greatest perceived barrier, cited by nearly two-thirds of oncologists. Other barriers to addressing physical effects included lack of evidence-based, effective interventions, lack of clinical algorithms to guide care, and ambiguity regarding professional responsibility at the end of treatment. Other top barriers to addressing psychosocial issues included lack of mental health providers, lack of psychosocial resources, and lack of clinician knowledge and skills.

Data from additional studies suggest that, overall, cancer patients with greater physical burdens, such as more complex and lengthy treatment regimens, also have greater psychosocial needs, Dr. Ganz noted. Plus, approximately 15%-20% of cancer survivors have ongoing anxiety and depressive symptoms.

Shift to primary care

As more breast cancer and other cancer patients survive for longer periods, more care will likely occur in general medical settings, Dr. Ganz said. Issues to be addressed will include the potential increased risk of comorbid conditions for these survivors, and whether survivorship interventions earlier in the disease trajectory will impact survivorship. For cancer patients who achieve remission after treatment, the first 5 years after a diagnosis involves treatment and short-term surveillance for late effects. Beyond 5 years, care for cancer survivors mainly involves primary care and management of any comorbid conditions, as well as surveillance for late effects and recurrences, and awareness of new research.

A patient consultation early in the process after diagnosis is the start of a continuum of care, Dr. Ganz said. A patient consultation should address symptoms related to initial treatments, such as neuropathy, pain, fatigue, and insomnia, as well as the psychological symptoms of anxiety and depression. An early consultation also should evaluate adherence to endocrine therapy and management of symptoms, if needed, with the larger goal of preparing patients for recovery and the transition to survivorship, and what to expect for long-term follow-up.
 

Delivering the three P’s

The “Three P’s” of survivor care for breast cancer patients are palliation, prevention, and promotion of health, according to Dr. Ganz .

The first “P,” for palliative, is a key part of survivorship care, said Dr. Ganz. Palliative care is defined as care that focuses on reducing symptom severity and improving quality of life. The biological effects of cancer treatment can be associated with physical effects, such as functional limitations and frailty, and behavioral/cognitive effects such as depression, fatigue, and cognitive deficits, she said. To manage these effects and provide palliative care, consultation is needed with specialists in relevant areas including mental health, pain management, physical medicine/rehabilitation, endocrinology, cardiology, and neurology.

The second “P,” which is for prevention in survivorship care, refers to ongoing follow-up screening to identify any potentially serious late-onset complications such as osteoporosis or cardiac disease so they can be addressed, said Dr. Ganz. Other considerations include chemoprevention if available and genetic counseling for patients with hereditary cancers. Prevention also includes counseling patients about lifestyle modifications to help prevent additional cancer.

The goal of the third “P,” which is for health promotion, is to promote risk reduction for the health problems associated with accelerated aging that may arise in cancer survivors, said Dr. Ganz.

Health promotion strategies include maintaining a healthy weight, increasing physical activity, and avoiding harmful exposures, she said. Healthy lifestyle interventions can also reduce the risk of other chronic diseases such as diabetes and heart disease.

To that end, Dr. Ganz outlined several behavioral interventions that may mitigate the effects of cancer treatment on the accelerated aging process, including stress reduction in the form of meditation or yoga, cognitive behavioral therapy, improving sleep, increasing physical activity, reducing obesity, and decreasing tobacco and alcohol use. These interventions may help reduce inflammation and promote tissue repair and healing.

For cancer survivors, the life span may be longer than the health span, and these patients may benefit from an integrated model of care, with systematic screening and consolidated appointments, rather than a fragmented model in which departments and referrals are siloed, which may result in conflicting advice or redundancy, said Dr. Ganz.

Looking ahead, more research is needed to explore models of care delivery, as requirements for survivor care will vary among patients and care settings, Dr. Ganz said.

However, regardless of setting, treatment plans and shared decision-making can help reduce potential long-term or late-emerging effects, she said. Developing a survivorship care plan can help patients learn how to enhance their recovery.

During a question and answer session, Dr. Ganz was asked about whether hormone therapy could be used for patients with hormone negative breast cancer. “I think vaginal estrogen can be used if someone is on tamoxifen,” she said. However, “we need to be cautious” in case there are remaining estrogen positive cells, in order to avoid potential metastases, and use of hormone therapy in breast cancer survivors is an individualized decision based in part on quality of life.
 

Engaging a patient’s partner early can be helpful

If possible, engage the patient’s partner in survivorship discussions, said Luzia Travado, PhD, head of psycho-oncology at the Champalimaud Foundation, Lisbon, who presented on the topic of sexuality and commented on survivorship during the discussion. For those women with partners, engaging the partner early in treatment often means they are more likely to play a larger role in the post treatment and long term by providing stability and emotional support.

“Make sure partners are engaged and understand that they have a role, and that this role is valued,” she said. Unfortunately, there are a lot of divorced women with breast cancer, as the disease can take a toll on relationships. However, remember “sexuality is not just sex; it is caring, loving, and intimacy.”

“To end on a positive note, it is important to empower patients, and to give them self-management skills so they can make things even better in their survivorship,” said Dr. Ganz. In spite of discussing difficulties and challenges, one of the goals of the session was to offer potential solutions and answers.

Dr. Ganz disclosed serving as editor of the cancer survivorship section on Up-to-Date, and serving as a consultant for Blue Note Therapeutics, GRAIL, InformedDNA, and Roche-Genentech. Dr. Travado had no relevant financial conflicts to disclose.

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

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

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

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

A new study urges people to continue wearing protective masks in medical settings, even though the U.S. public health emergency declaration around COVID-19 has expired.

Masks continue to lower the risk of catching the virus during medical visits, according to the study, published in Annals of Internal Medicine. And there was not much difference between wearing surgical masks and N95 respirators in health care settings.

The researchers reviewed 3 randomized trials and 21 observational studies to compare the effectiveness of those and cloth masks in reducing COVID-19 transmission.

“Masking in interactions between patients and health care personnel should continue to receive serious consideration as a patient safety measure,” Tara N. Palmore, MD, of George Washington University, Washington, and David K. Henderson, MD, of the National Institutes of Health, Bethesda, Md., wrote in an opinion article accompanying the study.

“In our enthusiasm to return to the appearance and feeling of normalcy, and as institutions decide which mitigation strategies to discontinue, we strongly advocate not discarding this important lesson learned for the sake of our patients’ safety,” Dr. Palmore and Dr. Henderson wrote.

Surgical masks limit the spread of aerosols and droplets from people who have the flu, coronaviruses or other respiratory viruses, CNN reported. And while masks are not 100% effective, they substantially lower the amount of virus put into the air via coughing and talking.

The study said one reason people should wear masks to medical settings is because “health care personnel are notorious for coming to work while ill.” Transmission from patient to staff and staff to patient is still possible, but rare, when both are masked.

The review authors reported no conflicts of interest. Dr. Palmore has received grants from the NIH, Rigel, Gilead, and AbbVie, and Dr. Henderson is a past president of the Society for Healthcare Epidemiology of America.

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

“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

“What am I allowed to do?” radiation oncologist Vivek Kavadi, MD, asked the business manager at Texas Oncology in Sugar Land, Tex.

Dr. Kavadi wanted to give his patient with early-stage breast cancer a standard radiation treatment – hypofractionated 3D conformal radiation therapy – following her lumpectomy.

But his hands were tied.

Dr. Kavadi had submitted a prior authorization request, but the patient’s health insurance was dragging its feet. And without prior authorization, Dr. Kavadi couldn’t schedule his patient’s first treatment.

“I chose the most cost-effective, standard treatment, but nothing could begin without the insurance company’s permission,” he said.

One of the most challenging aspects of the delay was explaining to his patient why he couldn’t schedule her treatment. “We would love to start, but your insurance company has not given us approval. The best I can do is give you a tentative appointment,” he recalled telling her.

After a few days with no word, calls to the insurance company began. “My patient called, I called, my office called,” Dr. Kavadi said. “It was a week or more of aggravation, stress, and time wasted for my patient and my team.”

This type of delay has become increasingly common in radiation oncology. One recent analysis estimated that 97% of radiation oncology services now require prior authorization under Medicare Advantage. And another analysis found that almost all radiation oncologists said prior authorization delays life-saving care for their patients.

The rise of prior authorization requirements may boil down to the fact that prior authorization is no longer reserved for uncertain or high-cost care. Terrence Cunningham, director of administrative simplification policy for the American Hospital Association, told this news organization last year that “prior authorization used to be applied only to new, costly, or high-risk services,” but now “many insurers require authorizations for even routine care, which is inappropriate.”

The growth of prior authorization requirements has forced many doctors, nurses, and pharmacists to dedicate part of their workday to handling requests and appealing denials and has forced many practices to hire staff exclusively for prior authorizations.

This additional work is costly.

One recent study found that the radiation oncology department of Vanderbilt University, Nashville, Tenn., spent nearly $500,000 annually in employee time to obtain prior authorization for radiation therapy treatments. Extrapolated nationally, the researchers estimated that physicians’ annual compensation for prior authorization duties came to an estimated $46 million. Overall, 86% of these costs were for treatments that were ultimately approved, the majority on initial request and some on appeal.

Dr. Kavadi has five full-time employees dedicated to managing prior authorization requests and challenges.

And after a week of delays and hours on the phone with the insurer, his patient’s radiation treatment was ultimately approved.

Dr. Kavadi wondered why something so simple needed to be so onerous.

Stretching out an approval for a standard radiation treatment “feels like a means of intentionally delaying care,” Dr. Kavadi said. “This is an example of a process that has run so far amok. It’s just a burden across the board.”

And even with his 30 years of experience, “I still have to ask my business supervisor what I am allowed to do,” he said. “I can’t just proceed with what’s best for my patient, what the patient has consented to, and what also happens to be the least expensive option.”

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

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

While poly (ADP-ribose) polymerase (PARP) inhibitors clearly show benefit in certain kinds of breast cancer, questions persist about ideal drug targets and the value of combining them with other medications, oncologists explained at the European Society for Medical Oncology Breast Cancer annual congress.

For now, the drugs are only approved in high-risk germline BRCA mutation (gBRCAmut) early breast cancer, oncologist Kevin Punie, MD, of Saint Augustine Hospital in Wilrijk, Belgium, said during a session at the meeting. Combining the drugs with chemotherapy “has not yet demonstrated significant benefits, and this is irrespective whether platinum was part of the chemotherapy backbone.”

PARP is a kind of enzyme that repairs damaged DNA in cells, especially cancerous ones. PARP inhibitors block the enzyme, potentially leading more cancer cells to die, the Dana-Farber Cancer Institute states.

In a separate presentation during the same session, oncologist Andrew Tutt, MBChB, PhD, noted that a study he led – a phase 3, double-blinded, randomized 2021 trial – found that patients with BRCA1- or BRCA2-mutated breast cancer who took the PARP inhibitor olarapib (Lynparza) versus placebo had improved outcomes on several measures, including 3-year invasive disease-free survival (85.9% vs. 77.1%, P < .001). However, the study noted that “olaparib had limited effects on global patient-reported quality of life.”

Dr. Tutt, of the Institute of Cancer Research, London, and Kings College London, said 57% of patients who took olarapib suffered nausea versus 24% of those who took placebo, and fatigue and anemia were also more common in the olarapib group. Anemia can be severe and lead to transfusions in some cases.

As Dr. Punie explained, there are many reasons to consider combining PARP inhibitors with other treatments such as chemotherapy, immunotherapy, and radiotherapy. The combinations may have synergetic effects, and they could have potential in both the neoadjuvant and adjuvant settings.

The combination of the PARP inhibitor olaparib and endocrine therapy is now approved by the European Medicines Agency for the adjuvant treatment of certain patients with germline BRCA1/2 mutations who have HER2-negative, high-risk early breast cancer, Dr. Punie noted.

The 2021 study led by Dr. Tutt reported that treatment or safety differences were found in those who received both olaparib and endocrine therapy versus those who only received olarapib.

So far, Dr. Punie said, “we not yet have enough clinical evidence to say that there’s really synergy between PNP inhibitors and other anticancer therapies.” According to the National Institutes of Health, medical synergy “describes the interaction of two or more drugs when their combined effect is greater than the sum of the effects seen when each drug is given alone.”

In regard to chemotherapy, it makes sense that PARP inhibitors would be helpful in combination, Dr. Punie said. DNA damage to cancer cells accumulates during chemotherapy, he said, and they’re more depending on PARP for repair.

Study results so far have been mixed. A 2022 study, for example, found that adding the experimental PARP inhibitor veliparib to the chemotherapy regimen carboplatin-paclitaxel didn’t improve outcomes, he said. A similar study examining the addition of olaparib to carboplatin-paclitaxel is ongoing.

As for combining radiotherapy and PARP inhibitors, Dr. Punie said that preclinical findings are promising, and research is underway. There’s also ongoing research into combining PARP inhibitors with immunotherapy.

Off-label use of olaparib with immunotherapy or sequential treatment may be appropriate in the setting of adjuvant gBRCAmut triple-negative breast cancer with residual disease, he said.

During his presentation, Dr. Tutt called for researchers to investigate the use of PARP inhibitors in the de-escalation of treatment in lower-risk gBRCAmut disease.

“Clearly, some patients require chemotherapy, and we know patients respond very well to neoadjuvant chemotherapy if they have a BRCA mutation, but we don’t yet know who we can de-escalate in,” he said.

He also highlighted the need to reduce anemia in patients on PARP inhibitors, “particularly if we’re moving into lower-risk populations or possibly considering prevention trials.

“The study of PARP inhibitor resistance ... is now urgent, so that we can address it,” he said.

Dr. Punie disclosed financial relationships with AstraZeneca, Eli Lilly, Exact Sciences, Focus Patient, Medscape, MSD, Mundi Pharma, Need, Novartis, Pierre Fabre, Pfizer, F. Hoffmann–La Roche, Sanofi, Seagen, and PharmaMar. Dr. Tutt disclosed financial relationships with Artios, Gilead, MD Anderson, Merck KGaA, Pfizer, Vertex, AstraZeneca, EM Partners, Medscape Education, CRUK, Inbiomotion, Myriad Genetics, and Breast Cancer Now.

Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

Mailing do-it-yourself sampling kits to test for cervical cancer doubled the rate of screening in a population of low-income and under-screened women, researchers say. 

The self-sampling kits, which detect human papillomavirus (HPV), are available only for use in clinical trials, but the researchers hope that eventually these kits will be approved for use by the general public. 

The researchers, from the University of North Carolina, explored use of these kits in the My Body, My Test-3 study, which was published online in The Lancet Public Health.

In a commentary published with the study, Runzhi Wang, MD, and Jennell Coleman, MD, MPH, both of Johns Hopkins University, Baltimore, said it “provides the required evidence that ... self-collected samples can be an effective strategy for hard-to-reach populations.”

The study involved 665 women (aged 25-64) in North Carolina who were either uninsured or enrolled in Medicaid or Medicare. The patients had low-income backgrounds and lived in urban areas. More than half self-reported as Black or Hispanic (55%), uninsured (78%) or unemployed (57%). None had a Pap smear in at least 4 years or a high-risk HPV test in the last 6 years. 

Two-thirds of the women were mailed an HPV self-collection kit and received assistance with scheduling an in-person screening appointment. The kit included a Viba-Brush device, which is inserted into the vagina like a tampon to collect the sample.

The other third of women, the control group, only received scheduling assistance.

The team found that mailing the self-collection tests along with helping women book in-clinic appointments improved screening rates twofold, compared with just assisting patients to schedule an appointment. 

Screening success among those who received the at-home collection kit was 72%, compared with 37% in the control group. 

Of those who received the kits, 78% returned them. This is “impressive,” said Dr. Wang and Dr. Coleman, as previous studies have reported return rates of only 8%-20%.

University of North Carolina

About 23% of eligible women are overdue for cervical cancer screening by at least a year, according to the National Cancer Institute. Jennifer Smith, PhD, MPH, professor of epidemiology at the University of North Carolina at Chapel Hill and an author of the study, believes every woman deserves equal access to cervical screening.

“I think we really need to make efforts to increase cervical cancer screening among women who are overdue for screening by a year or more from the recommended guidelines,” Dr. Smith said. “We’ve proven along with the wide evidence both in the U.S. and globally that self-collection intervention works well and can motivate screening uptake by breaking down barriers for populations that have less access to care.”

“We’re hoping this research in combination with all of the extensive evidence on the positive performance of HPV self-collection will provide additional information to be considered by the FDA for approval of the kits for primary screening,” Dr. Smith said. 

University of North Carolina

“Government approval of at-home HPV tests would have a huge impact,” said coauthor Noel Brewer, PhD, also of UNC Chapel Hill. “We could better reach those in rural areas where cervical cancer screening is hard to come by.”

Dr. Smith has received research grants, supply donations, and consultancies for Hologic and BD Diagnostics. Dr. Brewer, Dr. Wang, and Dr. Coleman reported no conflicts of interest.

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

Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

Having a fatty liver raises a patient’s risk of colorectal cancer liver metastasis via an immunosuppressive tumor microenvironment, yes-associated protein (YAP) signaling, and extracellular vesicle-microRNAs, according to the authors of new research.

These findings support the previously reported link between fatty liver and colorectal cancer (CRC) liver metastasis, and suggest that CRC patients with nonalcoholic fatty liver disease (NAFLD) may respond differently to treatment than CRC patients without NAFLD, wrote lead author Zhijun Wang, MD, PhD, of Cedars-Sinai Medical Center, Los Angeles, and colleagues, in their paper.

“Obesity and NAFLD are the significant risk factors for CRC,” the investigators explained, in Cell Metabolism. “A growing body of epidemiological evidence indicates that fatty liver increases the occurrence of CRC liver metastasis and the local recurrence after resection of CRC liver metastases, thereby worsening prognosis ... There is an urgent need to understand the molecular mechanisms of metastasis in patients with fatty liver to manage those patients effectively.”

To this end, Dr. Wang and colleagues conducted a series of experiments involving mice, cell cultures, and human sera. They found that fatty liver increases risk of CRC liver metastasis via extracellular vesicles (EVs) that contain procarcinogenic miRNAs. As these EVs transfer microRNAs from fatty liver hepatocytes to metastatic cancer cells, YAP activity increases, which, in turn, suppresses immune activity within the tumor microenvironment, promoting growth of CRC metastasis.

Beyond the increased risk of liver metastasis presented by fatty liver, the investigators suggested that NAFLD may cause “more complex” metastatic tumor microenvironments, potentially explaining “diverse responses” to cancer therapies among patients with CRC and liver metastases.

“In summary, our study demonstrates that the pre- and prometastatic liver environment of fatty liver is induced by procarcinogenic EVs and results in an immunosuppressive tumor microenvironemnt, in which YAP plays an important role,” the investigators concluded. “Our study provides new insight into [the] distinct liver tumor microenvironment in patients with fatty liver and without fatty liver, which may contribute to the aggressiveness of metastatic tumors and weak responses to anticancer therapy in patients with fatty liver. Additional studies are warranted to develop precision medicine for treating patients with CRC and liver metastasis.”

One of the study authors disclosed relationships with Altimmune, Cytodyn, Novo Nordisk, and others. The other investigators had no relevant financial disclosures.

CHICAGO – Preoperative clinical diagnoses of pancreatic cystic neoplasms (PCNs) are frequently found to be in error when patients go to surgery as recommended under international guidelines, data from a retrospective study show.

An analysis of all pancreatic resections performed for presumed PCN at the Verona Pancreas Institute, Italy, from 2011 through 2020 showed a high degree of discrepancy between the preoperative clinical diagnosis and the final postoperative pathology, with some lesions being misdiagnosed in nearly two-thirds of cases, reported Anna Burelli, MD, of the department of general and pancreatic surgery at the University of Verona.

“Diagnostic errors are still common for resected PCNs. Morphological and clinical information alone still poorly frame actual targets for surgery, and hopefully the development of new reliable biomarkers will represent the next evolution in pancreatic cystic neoplasm management,” she said in an oral abstract session at the annual Digestive Disease Week^® (DDW).

Diagnostic errors are significant issues in care of patients with PCN, because clinicians must balance the need for prompt, definitive treatment when necessary with the need for avoiding the significant morbidity of pancreatic resection for patients with lesions that turn out to be nonmalignant.

The investigators define “misdiagnosis” as a discrepancy between the preoperative clinical diagnosis and the postoperative pathology, and “mismatch” as a discrepancy between the preoperative suspicion of malignant or benign disease and the final pathology.
 

Checkered history

In previous cases series from Massachusetts General Hospital in Boston (2010) and the Verona Pancreas Institute (2012) – both experienced, high-volume centers – PCN misdiagnosis rates were 30% and 21%, respectively, and results from the current study show that things haven’t changed much since then, Dr. Burelli said.

PCNs are divided into neoplastic and nonneoplastic categories, with mucin-producing subtypes considered to be precancerous lesions that require accurate diagnosis and close monitoring.

Examples of neoplastic PCNs are intraductal papillary mucinous neoplasms (IPMNs) of the main pancreatic duct or side branch and mucinous cystadenomas. In contrast, serous cystadenomas, considered nonneoplastic, are mostly benign lesions discovered incidentally during abdominal imaging for another indication. It is very difficult, however, to distinguish between the two PCN subtypes clinically.

For example, Dr. Burelli showed images from a patient who received a preoperative diagnosis of mixed IPMN that was in fact found to be chronic pancreatitis on postoperative pathology.

Dr. Burelli noted that AGA and joint European guidelines for management of PCNs have been updated over the past decade, with the latest AGA iteration in 2015.

A 2017 study evaluating the 2015 AGA guidelines for management of asymptomatic PCNs found that following the guidelines in a large multicenter cohort “would have resulted in 60 % fewer patients being referred for surgical resection, and accurately recommended surveillance in 95% of patients with asymptomatic PCNs.”

Misdiagnosis and mismatch common

In the current study, Dr. Burelli and colleagues reviewed all pancreatic resections performed for PCNs at their center from 2011 through 2020.

Of 601 patients included in the retrospective study, 301 underwent endoscopic ultrasound (EUS).

The investigators identified misdiagnosis in 19% of cases and mismatch in 34%, and there was no significant improvement in diagnostic accuracy among the 50% of patients who underwent EUS.

The most frequently misdiagnosed lesions were cystic neuroendocrine tumors, in 61% of cases. The least misdiagnosed lesions were pseudopapillary tumors, in 6% of cases.

Many of the diagnostic errors were clinically important. For example, seven cases presumed to be serous cystic neoplasms (an almost always benign lesion) were found on final pathology to have a different, malignant histology.

Mismatch examples included 50 IPMNs with high-risk stigmata that were presumed to be malignant before surgery but were nonmalignant on final pathology, and 38 IPMNs without high-risk stigmata which were thought on clinical examination to be benign but turned out to be malignant on final pathology.

“Our results are in line with the current literature,” Dr. Burelli said, citing a recent meta-analysis showing that among 3,292 patients who underwent resection for mucinous cystic neoplasms (MCNs), the pooled rate of malignancy was 16.1%, yet the 2012 International Association of Pancreatology guidelines recommend surgery for all fit patients with MCNs, and joint European evidence-based guidelines from 2018 recommend surgery for MCNs 40 mm or larger, those with mural nodules, and for patients who are symptomatic.

The 16.1% pooled malignancy rate suggests “that there is space for surveillance in most cases of MCNs,” she said.

In addition, morphologic and clinical evaluation for IPMN with high-risk stigmata have been shown to have low specificity and low sensitivity, “so should guideline recommendations be revised?” Dr. Burelli said.

She pointed to a recent multi-institutional study in Gastroenterology showing that real-time next-generation sequencing of pancreatic cyst fluid “is sensitive and specific for various pancreatic cyst types and advanced neoplasia arising from mucinous cysts, but also reveals the diversity of genomic alterations seen in pancreatic cysts and their clinical significance.”

“This is not the future; this is the present,” she concluded.

Invited discussant R. Matthew Walsh, MD, a surgeon specializing in pancreatic and cancer surgery at the Cleveland Clinic, complimented the contributions of her group.

“The patient that you showed with chronic pancreatitis could have very well benefited from the operation regardless of the diagnosis if they were symptomatic,” he said, addressing Dr. Burelli. “So what is the group that is the regrettable surgical patients, and where are you aiming your studies? Is it really the 24% with high-risk features in IPMN that have low-grade dysplasia, or is it the 58% who we’re not sure why they were operated on because they didn’t have high-grade features who had low-grade dysplasia?”

She replied that “the goal here is to avoid surgery for benign entities, and we know that the only true benign entities are serous cystic neoplasms, and all the others have a malignant potential, but we think at Verona Pancreas Institute there is no reason to operate on low-grade dysplasia free patients. This is what we really would like to avoid.”

Dr. Walsh also asked, given their finding that EUS did not appear to offer a benefit to patients or change decision making, which patients should still get EUS.

“I think that only patients in which the diagnosis is uncertain or in which there are some worrisome features or high-risk stigmata should undergo EUS before surgery, and also to continue follow-up,” Dr. Burelli said. “I don’t think that the conclusion is that EUS is not useful, but it’s not useful in all.”

For example, large, microcystic lesions can be readily identified radiographically, but other, more complex cases may still require EUS to help nail down or refine a diagnosis, she said.

The study was internally funded. Dr. Burelli and Dr. Walsh reported having no conflicts of interest.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – Preoperative clinical diagnoses of pancreatic cystic neoplasms (PCNs) are frequently found to be in error when patients go to surgery as recommended under international guidelines, data from a retrospective study show.

An analysis of all pancreatic resections performed for presumed PCN at the Verona Pancreas Institute, Italy, from 2011 through 2020 showed a high degree of discrepancy between the preoperative clinical diagnosis and the final postoperative pathology, with some lesions being misdiagnosed in nearly two-thirds of cases, reported Anna Burelli, MD, of the department of general and pancreatic surgery at the University of Verona.

“Diagnostic errors are still common for resected PCNs. Morphological and clinical information alone still poorly frame actual targets for surgery, and hopefully the development of new reliable biomarkers will represent the next evolution in pancreatic cystic neoplasm management,” she said in an oral abstract session at the annual Digestive Disease Week^® (DDW).

Diagnostic errors are significant issues in care of patients with PCN, because clinicians must balance the need for prompt, definitive treatment when necessary with the need for avoiding the significant morbidity of pancreatic resection for patients with lesions that turn out to be nonmalignant.

The investigators define “misdiagnosis” as a discrepancy between the preoperative clinical diagnosis and the postoperative pathology, and “mismatch” as a discrepancy between the preoperative suspicion of malignant or benign disease and the final pathology.
 

Checkered history

In previous cases series from Massachusetts General Hospital in Boston (2010) and the Verona Pancreas Institute (2012) – both experienced, high-volume centers – PCN misdiagnosis rates were 30% and 21%, respectively, and results from the current study show that things haven’t changed much since then, Dr. Burelli said.

PCNs are divided into neoplastic and nonneoplastic categories, with mucin-producing subtypes considered to be precancerous lesions that require accurate diagnosis and close monitoring.

Examples of neoplastic PCNs are intraductal papillary mucinous neoplasms (IPMNs) of the main pancreatic duct or side branch and mucinous cystadenomas. In contrast, serous cystadenomas, considered nonneoplastic, are mostly benign lesions discovered incidentally during abdominal imaging for another indication. It is very difficult, however, to distinguish between the two PCN subtypes clinically.

For example, Dr. Burelli showed images from a patient who received a preoperative diagnosis of mixed IPMN that was in fact found to be chronic pancreatitis on postoperative pathology.

Dr. Burelli noted that AGA and joint European guidelines for management of PCNs have been updated over the past decade, with the latest AGA iteration in 2015.

A 2017 study evaluating the 2015 AGA guidelines for management of asymptomatic PCNs found that following the guidelines in a large multicenter cohort “would have resulted in 60 % fewer patients being referred for surgical resection, and accurately recommended surveillance in 95% of patients with asymptomatic PCNs.”

Misdiagnosis and mismatch common

In the current study, Dr. Burelli and colleagues reviewed all pancreatic resections performed for PCNs at their center from 2011 through 2020.

Of 601 patients included in the retrospective study, 301 underwent endoscopic ultrasound (EUS).

The investigators identified misdiagnosis in 19% of cases and mismatch in 34%, and there was no significant improvement in diagnostic accuracy among the 50% of patients who underwent EUS.

The most frequently misdiagnosed lesions were cystic neuroendocrine tumors, in 61% of cases. The least misdiagnosed lesions were pseudopapillary tumors, in 6% of cases.

Many of the diagnostic errors were clinically important. For example, seven cases presumed to be serous cystic neoplasms (an almost always benign lesion) were found on final pathology to have a different, malignant histology.

Mismatch examples included 50 IPMNs with high-risk stigmata that were presumed to be malignant before surgery but were nonmalignant on final pathology, and 38 IPMNs without high-risk stigmata which were thought on clinical examination to be benign but turned out to be malignant on final pathology.

“Our results are in line with the current literature,” Dr. Burelli said, citing a recent meta-analysis showing that among 3,292 patients who underwent resection for mucinous cystic neoplasms (MCNs), the pooled rate of malignancy was 16.1%, yet the 2012 International Association of Pancreatology guidelines recommend surgery for all fit patients with MCNs, and joint European evidence-based guidelines from 2018 recommend surgery for MCNs 40 mm or larger, those with mural nodules, and for patients who are symptomatic.

The 16.1% pooled malignancy rate suggests “that there is space for surveillance in most cases of MCNs,” she said.

In addition, morphologic and clinical evaluation for IPMN with high-risk stigmata have been shown to have low specificity and low sensitivity, “so should guideline recommendations be revised?” Dr. Burelli said.

She pointed to a recent multi-institutional study in Gastroenterology showing that real-time next-generation sequencing of pancreatic cyst fluid “is sensitive and specific for various pancreatic cyst types and advanced neoplasia arising from mucinous cysts, but also reveals the diversity of genomic alterations seen in pancreatic cysts and their clinical significance.”

“This is not the future; this is the present,” she concluded.

Invited discussant R. Matthew Walsh, MD, a surgeon specializing in pancreatic and cancer surgery at the Cleveland Clinic, complimented the contributions of her group.

“The patient that you showed with chronic pancreatitis could have very well benefited from the operation regardless of the diagnosis if they were symptomatic,” he said, addressing Dr. Burelli. “So what is the group that is the regrettable surgical patients, and where are you aiming your studies? Is it really the 24% with high-risk features in IPMN that have low-grade dysplasia, or is it the 58% who we’re not sure why they were operated on because they didn’t have high-grade features who had low-grade dysplasia?”

She replied that “the goal here is to avoid surgery for benign entities, and we know that the only true benign entities are serous cystic neoplasms, and all the others have a malignant potential, but we think at Verona Pancreas Institute there is no reason to operate on low-grade dysplasia free patients. This is what we really would like to avoid.”

Dr. Walsh also asked, given their finding that EUS did not appear to offer a benefit to patients or change decision making, which patients should still get EUS.

“I think that only patients in which the diagnosis is uncertain or in which there are some worrisome features or high-risk stigmata should undergo EUS before surgery, and also to continue follow-up,” Dr. Burelli said. “I don’t think that the conclusion is that EUS is not useful, but it’s not useful in all.”

For example, large, microcystic lesions can be readily identified radiographically, but other, more complex cases may still require EUS to help nail down or refine a diagnosis, she said.

The study was internally funded. Dr. Burelli and Dr. Walsh reported having no conflicts of interest.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

CHICAGO – Preoperative clinical diagnoses of pancreatic cystic neoplasms (PCNs) are frequently found to be in error when patients go to surgery as recommended under international guidelines, data from a retrospective study show.

An analysis of all pancreatic resections performed for presumed PCN at the Verona Pancreas Institute, Italy, from 2011 through 2020 showed a high degree of discrepancy between the preoperative clinical diagnosis and the final postoperative pathology, with some lesions being misdiagnosed in nearly two-thirds of cases, reported Anna Burelli, MD, of the department of general and pancreatic surgery at the University of Verona.

“Diagnostic errors are still common for resected PCNs. Morphological and clinical information alone still poorly frame actual targets for surgery, and hopefully the development of new reliable biomarkers will represent the next evolution in pancreatic cystic neoplasm management,” she said in an oral abstract session at the annual Digestive Disease Week^® (DDW).

Diagnostic errors are significant issues in care of patients with PCN, because clinicians must balance the need for prompt, definitive treatment when necessary with the need for avoiding the significant morbidity of pancreatic resection for patients with lesions that turn out to be nonmalignant.

The investigators define “misdiagnosis” as a discrepancy between the preoperative clinical diagnosis and the postoperative pathology, and “mismatch” as a discrepancy between the preoperative suspicion of malignant or benign disease and the final pathology.
 

Checkered history

In previous cases series from Massachusetts General Hospital in Boston (2010) and the Verona Pancreas Institute (2012) – both experienced, high-volume centers – PCN misdiagnosis rates were 30% and 21%, respectively, and results from the current study show that things haven’t changed much since then, Dr. Burelli said.

PCNs are divided into neoplastic and nonneoplastic categories, with mucin-producing subtypes considered to be precancerous lesions that require accurate diagnosis and close monitoring.

Examples of neoplastic PCNs are intraductal papillary mucinous neoplasms (IPMNs) of the main pancreatic duct or side branch and mucinous cystadenomas. In contrast, serous cystadenomas, considered nonneoplastic, are mostly benign lesions discovered incidentally during abdominal imaging for another indication. It is very difficult, however, to distinguish between the two PCN subtypes clinically.

For example, Dr. Burelli showed images from a patient who received a preoperative diagnosis of mixed IPMN that was in fact found to be chronic pancreatitis on postoperative pathology.

Dr. Burelli noted that AGA and joint European guidelines for management of PCNs have been updated over the past decade, with the latest AGA iteration in 2015.

A 2017 study evaluating the 2015 AGA guidelines for management of asymptomatic PCNs found that following the guidelines in a large multicenter cohort “would have resulted in 60 % fewer patients being referred for surgical resection, and accurately recommended surveillance in 95% of patients with asymptomatic PCNs.”

Misdiagnosis and mismatch common

In the current study, Dr. Burelli and colleagues reviewed all pancreatic resections performed for PCNs at their center from 2011 through 2020.

Of 601 patients included in the retrospective study, 301 underwent endoscopic ultrasound (EUS).

The investigators identified misdiagnosis in 19% of cases and mismatch in 34%, and there was no significant improvement in diagnostic accuracy among the 50% of patients who underwent EUS.

The most frequently misdiagnosed lesions were cystic neuroendocrine tumors, in 61% of cases. The least misdiagnosed lesions were pseudopapillary tumors, in 6% of cases.

Many of the diagnostic errors were clinically important. For example, seven cases presumed to be serous cystic neoplasms (an almost always benign lesion) were found on final pathology to have a different, malignant histology.

Mismatch examples included 50 IPMNs with high-risk stigmata that were presumed to be malignant before surgery but were nonmalignant on final pathology, and 38 IPMNs without high-risk stigmata which were thought on clinical examination to be benign but turned out to be malignant on final pathology.

“Our results are in line with the current literature,” Dr. Burelli said, citing a recent meta-analysis showing that among 3,292 patients who underwent resection for mucinous cystic neoplasms (MCNs), the pooled rate of malignancy was 16.1%, yet the 2012 International Association of Pancreatology guidelines recommend surgery for all fit patients with MCNs, and joint European evidence-based guidelines from 2018 recommend surgery for MCNs 40 mm or larger, those with mural nodules, and for patients who are symptomatic.

The 16.1% pooled malignancy rate suggests “that there is space for surveillance in most cases of MCNs,” she said.

In addition, morphologic and clinical evaluation for IPMN with high-risk stigmata have been shown to have low specificity and low sensitivity, “so should guideline recommendations be revised?” Dr. Burelli said.

She pointed to a recent multi-institutional study in Gastroenterology showing that real-time next-generation sequencing of pancreatic cyst fluid “is sensitive and specific for various pancreatic cyst types and advanced neoplasia arising from mucinous cysts, but also reveals the diversity of genomic alterations seen in pancreatic cysts and their clinical significance.”

“This is not the future; this is the present,” she concluded.

Invited discussant R. Matthew Walsh, MD, a surgeon specializing in pancreatic and cancer surgery at the Cleveland Clinic, complimented the contributions of her group.

“The patient that you showed with chronic pancreatitis could have very well benefited from the operation regardless of the diagnosis if they were symptomatic,” he said, addressing Dr. Burelli. “So what is the group that is the regrettable surgical patients, and where are you aiming your studies? Is it really the 24% with high-risk features in IPMN that have low-grade dysplasia, or is it the 58% who we’re not sure why they were operated on because they didn’t have high-grade features who had low-grade dysplasia?”

She replied that “the goal here is to avoid surgery for benign entities, and we know that the only true benign entities are serous cystic neoplasms, and all the others have a malignant potential, but we think at Verona Pancreas Institute there is no reason to operate on low-grade dysplasia free patients. This is what we really would like to avoid.”

Dr. Walsh also asked, given their finding that EUS did not appear to offer a benefit to patients or change decision making, which patients should still get EUS.

“I think that only patients in which the diagnosis is uncertain or in which there are some worrisome features or high-risk stigmata should undergo EUS before surgery, and also to continue follow-up,” Dr. Burelli said. “I don’t think that the conclusion is that EUS is not useful, but it’s not useful in all.”

For example, large, microcystic lesions can be readily identified radiographically, but other, more complex cases may still require EUS to help nail down or refine a diagnosis, she said.

The study was internally funded. Dr. Burelli and Dr. Walsh reported having no conflicts of interest.

DDW is sponsored by the American Association for the Study of Liver Diseases, the American Gastroenterological Association, the American Society for Gastrointestinal Endoscopy, and the Society for Surgery of the Alimentary Tract.

Adding the immunotherapy cemiplimab to chemotherapy for patients with advanced non–small cell lung cancer (NSCLC) not only improved overall survival but also led to quality-of-life benefits, new data show.

In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.

Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.

The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.

The research was published online May 8 in Cancer.

Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.

In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.

The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.

In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.

Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).

Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).

Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).

The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.

No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.

As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”

Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.

The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
 

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

Adding the immunotherapy cemiplimab to chemotherapy for patients with advanced non–small cell lung cancer (NSCLC) not only improved overall survival but also led to quality-of-life benefits, new data show.

In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.

Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.

The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.

The research was published online May 8 in Cancer.

Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.

In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.

The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.

In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.

Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).

Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).

Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).

The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.

No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.

As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”

Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.

The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
 

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

Adding the immunotherapy cemiplimab to chemotherapy for patients with advanced non–small cell lung cancer (NSCLC) not only improved overall survival but also led to quality-of-life benefits, new data show.

In the trial, patients who received the PD-1 inhibitor plus platinum-doublet chemotherapy in the first-line setting reported significant improvements in pain symptoms and delay in time to deterioration, as well as improvements in disease-related symptoms, such as dyspnea, constipation, nausea, and vomiting.

Overall, “the findings support the concept that the superior efficacy and favorable safety profile of cemiplimab plus chemotherapy translate to better patient-reported outcomes compared with chemotherapy alone in patients with advanced non–small cell lung cancer, “ corresponding author Tamta Makharadze, MD, of LTD High Technology Hospital Med Center in Batumi, Georgia, said in a press release.

The delays reported in time to definitive clinically meaningful deterioration “are particularly pertinent, given the anticipated continued improvements in cancer survivorship among patients with advanced NSCLC,” the authors explained.

The research was published online May 8 in Cancer.

Quality of life is especially important for patients with advanced NSCLC, for whom the benefits of improved survival must be weighed against the potential drawbacks of treatment toxicities, which can severely impact quality of life, the authors noted.

In the initial multinational phase 3 EMPOWER-Lung 3 trial, Dr. Makharadze and colleagues randomly assigned 466 patients with stage IIIB, IIIC, or stage IV NSCLC to receive either 350 mg of cemiplimab (Libtayo, Regeneron Pharmaceuticals) every 3 weeks along with investigator’s choice of platinum‐doublet chemotherapy or placebo plus chemotherapy. Investigator’s choice of chemotherapy was either paclitaxel plus carboplatin or cisplatin, pemetrexed plus carboplatin, or cisplatin.

The researchers found that the addition of cemiplimab to chemotherapy was associated with a significant, almost 9-month improvement in overall survival. While the trial also highlighted significant improvements in quality of life, functioning, and most symptoms with cemiplimab in comparison with placebo, the current study provides more details on these patient-reported quality-of-life outcomes.

In the latest analysis, Dr. Makharadze and colleagues evaluated data on the 312 patients in the cemiplimab arm and the 154 in the placebo arm. The median age of the patients was 63 years, and most (83.9%) were men.

Patients in the cemiplimab arm reported significant improvements in pain symptoms from baseline, as measured with the European Organization for Research and Treatment of Cancer (EORTC) Quality of Life–Core 30 (QLQ‐C30) score (–4.98; P = .004).

Patients who were treated with cemiplimab also reported a significant delay in time to definitive clinically meaningful deterioration (hazard ratio [HR], 0.39; P < .0001).

Significant delays in the time to deterioration in other functioning and symptom scales favored the cemiplimab group, including dyspnea (HR, 0.54), nausea/vomiting (HR, 0.39), and constipation (HR, 0.48).

The cemiplimab group also reported significantly delayed time to deterioration in physical (HR, 0.62) and emotional functioning (HR, 0.52) compared with the placebo arm as well as significant overall improvements from baseline in global health status/quality of life scores.

No significant improvements in patient-reported outcomes favoring the placebo group were observed on any quality-of-life metric evaluated using the symptom scales.

As for study limitations, the authors said that although about 86% of patients in both arms completed at least one question at baseline and post baseline, “the results may have overrepresented the patients who did well in both treatment arms because patients who progressed no longer completed the questionnaires.”

Nevertheless, the results “show that the favorable efficacy achieved with cemiplimab plus chemotherapy over placebo plus chemotherapy is accompanied by significant overall improvement in pain and significant delay in [time to definitive clinically meaningful deterioration] in multiple patient‐reported cancer‐related and lung cancer–specific functions and symptoms,” the authors concluded.

The study was sponsored by Regeneron Pharmaceuticals and Sanofi.
 

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

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

The results from a prognostic genomic assay called HER2DX convinced a group of Spanish oncologists to change treatment plans for 56% of 89 patients with HER2-positive (HER2+) early breast cancer, according to new research.

The prospective pilot study is small, and the researchers didn’t report on how the patients fared, according to a poster presented at the European Society for Medical Oncology (ESMO) Breast Cancer annual congress. Plus, the test itself hasn’t been analyzed prospectively. But the study’s lead author, Olga Martínez-Sáez, MD, PhD, said in an interview that the 56% number is significant.

“We consider this percentage to be clinically very relevant,” said Dr. Martínez-Sáez, an oncologist at Hospital Clinic of Barcelona and the University of Barcelona. “HER2DX can change practice.”

Also in an interview, Kent Hoskins, MD, associate chief of hematology/oncology at University of Illinois at Chicago, described HER2DX as a next-generation genomic test that builds on assays developed 2 decades ago to help identify patients who would benefit – or not – from adjuvant chemotherapy.

Dr. Hoskins, who isn’t connected to the new study but has studied genomic tests for breast cancer, said the HER2DX test seeks to provide guidance to oncologists about which of several treatments are most effective in treating patients with HER2+ breast cancer.

“The overall trend in the HER2+ space is escalating therapy, and the cure rates have improved quite substantially,” he said. “But do they all need that much therapy? That’s the clinical question that this assay is addressing.”

The assay examines clinical features and the expression of 4 gene signatures, Dr. Martínez-Sáez said. It provides a risk score estimating the likelihood of recurrence plus a score that estimates the likelihood of achieving pathological complete response (pCR) with trastuzumab-based neoadjuvant therapy and an ERBB2 mRNA score.

In a retrospective 2022 study published in eBioMedicine, researchers reported that the assay “predicts response following neoadjuvant letrozole in combination with dual HER2 blockade with trastuzumab and pertuzumab in early-stage HER2-positive/hormone receptor–positive breast cancer.”

In the 2022 study, researchers wrote that assay results and other scores “might help better tailor systemic therapy in this context and identify candidates for avoiding chemotherapy, a therapy associated with short- and long-term toxicities and impact in quality of life.”

For the new study, a decision-impact analysis, researchers tracked 89 patients with HER2+ breast cancer (median age = 53 years, range 30-79, and 52% postmenopausal), the poster says. Most had T1-2 tumors (87%), negative nodes (64%), grade 2 (56%) or 3 (41%) tumors, and ductal histology (87%). And most were hormone receptor positive (65%). Seventy-eight percent of patients received neoadjuvant therapy (NAT), and 22% underwent upfront surgery.

In 56% of cases, oncologists changed their treatment decisions after getting the results of the HER2DX assays. In 59% of these cases, oncologists de-escalated therapy; in 41%, they escalated therapy, opting for more intense chemotherapy 65% of the time, according to the poster.

Clinician confidence in their decisions improved in 67% of cases, the researchers reported in their poster. Among 56 patients treated with neoadjuvant therapy who could be evaluated, “HER2DX pCR score was significantly associated with pCR (81% in pCR-medium/high and 32% in pCR-low; odds ratio=9.3, P = 0.001) independently of the rest of variables.”

Dr. Hoskins said the new report suggests that the assay can change treatment decisions, although he cautioned that “this study does not in itself establish its place in standard of care.” Large, prospective, randomized research is still needed, he said.

Dr. Martínez-Sáez said, in an interview, that the HER2DX assay should cost about as much as genomic assays for other breast cancer subtypes. These kinds of tests have cost several thousand dollars each in recent years.

What’s next? The decision impact study is ongoing. As for research into the assay itself, “prospective clinical trials are planned to demonstrate its clinical utility to de-escalate and guide therapy,” Dr. Martínez-Sáez said.

No funding is reported. Reveal Genomics is the developer of the HER2DX assay. Dr. Martinez- Saez reports financial relationships with Novartis, Eisai, Roche, and Reveal Genomics. Other study authors report multiple disclosures. Dr. Hoskins discloses non-financial research support from Agendia, which makes the MammaPrint early-breast-cancer assay.

Diffuse large B-cell lymphoma (DLBCL) made headlines earlier this year with the high-profile case of prominent U.S. Congressman Jamie Raskin (D-MD). Yet, until very recently, progress in treating this most common form of lymphoma has been stalled for more than 2 decades.

Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.

“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.

University of California, San Francisco

“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.

R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.

“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.

Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.

“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”

Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.

“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.

Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”

Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”

MD Anderson Cancer Center

Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.

The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.

Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.

Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”

The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.

Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.

Diffuse large B-cell lymphoma (DLBCL) made headlines earlier this year with the high-profile case of prominent U.S. Congressman Jamie Raskin (D-MD). Yet, until very recently, progress in treating this most common form of lymphoma has been stalled for more than 2 decades.

Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.

“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.

University of California, San Francisco

“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.

R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.

“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.

Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.

“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”

Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.

“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.

Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”

Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”

MD Anderson Cancer Center

Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.

The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.

Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.

Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”

The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.

Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.

Diffuse large B-cell lymphoma (DLBCL) made headlines earlier this year with the high-profile case of prominent U.S. Congressman Jamie Raskin (D-MD). Yet, until very recently, progress in treating this most common form of lymphoma has been stalled for more than 2 decades.

Significant breakthroughs have come in just the past few weeks and months, through the use of CAR T-cell and immunotherapies and with the approval in April by the Food and Drug Administration of polatuzumab for frontline DLBCL.

“Until the publishing of data from the POLARIX study (NCT03274492), which led to the approval of polatuzumab vedotin plus rituximab-cyclophosphamide, doxorubicin, and prednisone (pola + R-CHP), we had not had a breakthrough in frontline DLBCL therapies since the addition of rituximab 22 years ago,” said Dr. Charalambos Andreadis, MD, of the University of California at San Francisco’s Helen Diller Family Comprehensive Cancer Center.

University of California, San Francisco

“Pola + R-CHP is an improvement over the standard-of-care treatment, R-CHOP (rituximab-cyclophosphamide, doxorubicin, vincristine, and prednisone), giving treatment naive patients an increase in PFS without an increase in side effects,” Dr. Andreadis said.

R-CHP-polatuzumab was approved only for patients with an International Prognostic Indices score between 2 and 5, leaving patients with IPI scores of 0 or 1 with the frontline standard of care (SoC) treatment of R-CHOP, which has a cure rate of between 60% and 70%.

“The highest likelihood of relapse is in the first year following treatment. After 2 years in remission, patients’ chance of relapsing is the same as the general populations’ chance of getting DLBCL for the first time. This is why even a slight increase in the progression-free survival rate with the addition of pola is so significant,” Dr. Andreadis noted.

Historically, patients with relapsed or refractory (RR) DLBCL who did not respond to R-CHOP or who experienced disease relapse less than a year after primary intervention were treated with alternative chemotherapy regimens, often followed by autologous stem cell transplants (ASCT). Randomized control studies have shown that CAR T-cell therapies yield higher success rates than chemotherapy and ASCT, leading to the SoC in RR patients being CAR-T cell therapy directly following failed primary treatment.

“There are many new CAR T-cell platforms in development, as well as novel combination strategies that aim to target critical genetic pathways,” Kieron Dunleavy, MD, professor of medicine at the Lombardi Comprehensive Cancer Center at Georgetown University Hospital, said in an interview. “While access to CAR T-cell therapies is becoming easier and more feasible in many centers, fast access continues to be an issue for many patients, often depending on geography and socioeconomic factors.”

Asked about the latest breakthroughs in treating DLBCL, Dr. Dunleavy said, “A significant proportion of patients with relapsed or refractory DLBCL do not have easy access to CAR T-cell therapies, so this needs to be addressed and improved. Sometimes the rapidity of clinical progression in DLBCL can make these therapies challenging to deliver, considering logistical issues like apheresis and insurance approvals, which are frequently complex. This highlights the need for alternative and ‘easier to deliver’ CAR-T cells and our continued prioritization of developing alternative effective agents for DLBCL.

“Currently, commercially approved CAR T-cells in DLBCL target the CD-19 marker on lymphoma cells but CAR T-cells targeting other and more than one antigen as well as alternative anti CD19 agents like loncastuximab and tafasitamab are similarly FDA approved and available for patients,” Dr. Dunleavy concluded.

Dr. Dunleavy is affiliated with the MedStar Georgetown Lymphoma group, where Rep. Raskin publicly announced that he had completed 4 months of chemotherapy treatment for DLBCL. On April 27, in an open letter to the U.S. public, he wrote that he rang the bell at MedStar to mark his preliminary diagnosis of being “in remission,” with a “90% prognosis of no relapse.”

Interviewed about the latest advances in treating DLBCL, Jason Westin, MD, associate professor of lymphoma and myeloma at the MD Anderson Cancer Center in Houston, said that even with improvements in overall survival possible with CAR T-cell therapies, “usually, a clinical trial should be considered strongly, as it is often the best option for patients, both in a newly diagnosed or in a relapsed setting, as they allow access to tomorrow’s breakthrough therapies today.”

MD Anderson Cancer Center

Dr. Westin cited the example of bispecific T-cell engagers (BITE) as a promising therapy that is available to patients in clinical trials. These agents bind to one side to the lymphoma cell, but they also have a binding arm for T-cells, so they activate a patient’s own immune cells to kill lymphoma cells, in some cases offering a cure when CAR T-cell therapy has failed.

The first BITE to be approved, mosunetuzumab, is authorized only for the treatment of follicular lymphoma. However, data from a recent clinical study indicated that the agent yields complete responses in 24% of heavily pretreated patients with RR DLBCL.

Another BITE, glofitamab, was approved in Canada in March 2023 for use in RR DLBCL. Based on its high efficacy, it soon may be approved elsewhere.

Dr. Andreadis noted, “We are finally at a point where for both treatment naive and RR DLBCL patients, there are several promising options on the horizon that don’t involve ASCT. Furthermore, these breakthroughs reinforce each other, as there are studies in which therapies like BITE are being brought to the front line and pola to RR cases.”

The growing field of new frontline and RR DLBCL therapies lend credence to the optimism of specialists who treat DLBCL – and to the sanguine note that Congressman Raskin struck in published comments about his treatment for DLBCL.

Dr. Andreadis reported ties with BMS, Novartis, Roche, Genmab, Merck, Gilead, AbbVie, and J&J. Dr. Dunleavy disclosed relationships with ONO Pharmaceuticals, Kymera, Merck, Genentech, AstraZeneca, Amgen, ADC Therapeutics, MorphoSys and Incyte, Kite/Gilead, Cellectar. Dr. Westin reported ties with Kite/Gilead, BMS, Novartis, Genentech, AstraZeneca, Morphosys/Incyte, ADC Therapeutics, Kymera, Nurix, and MonteRosa.