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FDA approves glofitamab for DLBCL

Article Type
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The Food and Drug Administration has granted accelerated approval for glofitamab (Columvi) for use in certain types of lymphoma.

The indication is for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or with LBCL arising from follicular lymphoma who have received two or more lines of systemic therapy.

The product is a T cell–engaging bispecific antibody developed by Genentech, which has a similar product, mosunetuzumab-axgb (Lunsumio), for the treatment of follicular lymphoma. Lunsumio was approved in December 2022.

These drugs could be considered a first choice in the setting of third-line therapy, suggests an expert writing recently in The New England Journal of Medicine.

Nancy Bartlett, MD, from the Siteman Cancer Center, Washington University in St. Louis, is the author of an editorial that accompanied the publication of results with glofitamab in the pivotal trial that led to its approval.

“Bispecific agents will be an excellent option for the 60% of patients in whom second-line CAR [chimeric antigen receptor] T-cell therapy fails,” she wrote in her editorial.

Dr. Bartlett suggests that these agents may be preferred over CAR T cells. “If longer follow-up confirms that the majority of complete remissions with bispecific agents are durable, on the basis of the advantages of availability (including in the community setting) and more favorable immediate and late toxic-effect profiles, bispecific agents could be considered as the initial choice. ... CAR T-cell therapy could be held in reserve for patients who do not have a complete response or who have a relapse after a complete response.”
 

Most common form of non-Hodgkin’s lymphoma

DLBCL is the most common form of non-Hodgkin’s lymphoma in the United States, the company noted in a press release. While many people with DLBCL are responsive to treatment, the majority of those who experience relapse or whose condition is refractory to subsequent treatments have poor outcomes.

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” commented Krish Patel, MD, director of the lymphoma program at the Swedish Cancer Institute in Seattle, who is an investigator on the clinical trial that led to the product’s approval. He said that the results from trials suggest that glofitamab gives patients “a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”

The accelerated approval is based on response rate and durability of response results from the phase 1/2 NP30179 study.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This trial involved 132 patients with DLBCL who experienced relapse or whose condition was refractory to prior therapies. About one-third of patients (30%) had received prior CAR T-cell therapy. Additionally, for 83% of patients, the condition was refractory to their most recent therapy.

Glofitamab was given to all patients as a fixed course for 8.5 months.

More than half (56%) achieved an overall response, and 43% achieved a complete response. Over two-thirds (68.5%) of those who responded continued to respond for at least 9 months The median duration of response was 1.5 years.

The most common adverse events were cytokine release syndrome (CRS; 70%), which may be serious or life-threatening; musculoskeletal pain (21%); fatigue (20%); and rash (20%). CRS was generally of low grade (52% of patients experienced grade 1 CRS, and 14% experienced grade 2).

Results from the NP30179 trial were published in December 2022.

The complete response rates seen with glofitamab rivals the durable complete response that has been observed with CAR T-cell therapy, Dr. Bartlett noted in the accompanying editorial. “Although these results are promising, it is still too early to estimate the curative potential of glofitamab.”

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The Food and Drug Administration has granted accelerated approval for glofitamab (Columvi) for use in certain types of lymphoma.

The indication is for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or with LBCL arising from follicular lymphoma who have received two or more lines of systemic therapy.

The product is a T cell–engaging bispecific antibody developed by Genentech, which has a similar product, mosunetuzumab-axgb (Lunsumio), for the treatment of follicular lymphoma. Lunsumio was approved in December 2022.

These drugs could be considered a first choice in the setting of third-line therapy, suggests an expert writing recently in The New England Journal of Medicine.

Nancy Bartlett, MD, from the Siteman Cancer Center, Washington University in St. Louis, is the author of an editorial that accompanied the publication of results with glofitamab in the pivotal trial that led to its approval.

“Bispecific agents will be an excellent option for the 60% of patients in whom second-line CAR [chimeric antigen receptor] T-cell therapy fails,” she wrote in her editorial.

Dr. Bartlett suggests that these agents may be preferred over CAR T cells. “If longer follow-up confirms that the majority of complete remissions with bispecific agents are durable, on the basis of the advantages of availability (including in the community setting) and more favorable immediate and late toxic-effect profiles, bispecific agents could be considered as the initial choice. ... CAR T-cell therapy could be held in reserve for patients who do not have a complete response or who have a relapse after a complete response.”
 

Most common form of non-Hodgkin’s lymphoma

DLBCL is the most common form of non-Hodgkin’s lymphoma in the United States, the company noted in a press release. While many people with DLBCL are responsive to treatment, the majority of those who experience relapse or whose condition is refractory to subsequent treatments have poor outcomes.

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” commented Krish Patel, MD, director of the lymphoma program at the Swedish Cancer Institute in Seattle, who is an investigator on the clinical trial that led to the product’s approval. He said that the results from trials suggest that glofitamab gives patients “a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”

The accelerated approval is based on response rate and durability of response results from the phase 1/2 NP30179 study.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This trial involved 132 patients with DLBCL who experienced relapse or whose condition was refractory to prior therapies. About one-third of patients (30%) had received prior CAR T-cell therapy. Additionally, for 83% of patients, the condition was refractory to their most recent therapy.

Glofitamab was given to all patients as a fixed course for 8.5 months.

More than half (56%) achieved an overall response, and 43% achieved a complete response. Over two-thirds (68.5%) of those who responded continued to respond for at least 9 months The median duration of response was 1.5 years.

The most common adverse events were cytokine release syndrome (CRS; 70%), which may be serious or life-threatening; musculoskeletal pain (21%); fatigue (20%); and rash (20%). CRS was generally of low grade (52% of patients experienced grade 1 CRS, and 14% experienced grade 2).

Results from the NP30179 trial were published in December 2022.

The complete response rates seen with glofitamab rivals the durable complete response that has been observed with CAR T-cell therapy, Dr. Bartlett noted in the accompanying editorial. “Although these results are promising, it is still too early to estimate the curative potential of glofitamab.”

The Food and Drug Administration has granted accelerated approval for glofitamab (Columvi) for use in certain types of lymphoma.

The indication is for use in adult patients with relapsed/refractory diffuse large B-cell lymphoma (DLBCL) not otherwise specified or with LBCL arising from follicular lymphoma who have received two or more lines of systemic therapy.

The product is a T cell–engaging bispecific antibody developed by Genentech, which has a similar product, mosunetuzumab-axgb (Lunsumio), for the treatment of follicular lymphoma. Lunsumio was approved in December 2022.

These drugs could be considered a first choice in the setting of third-line therapy, suggests an expert writing recently in The New England Journal of Medicine.

Nancy Bartlett, MD, from the Siteman Cancer Center, Washington University in St. Louis, is the author of an editorial that accompanied the publication of results with glofitamab in the pivotal trial that led to its approval.

“Bispecific agents will be an excellent option for the 60% of patients in whom second-line CAR [chimeric antigen receptor] T-cell therapy fails,” she wrote in her editorial.

Dr. Bartlett suggests that these agents may be preferred over CAR T cells. “If longer follow-up confirms that the majority of complete remissions with bispecific agents are durable, on the basis of the advantages of availability (including in the community setting) and more favorable immediate and late toxic-effect profiles, bispecific agents could be considered as the initial choice. ... CAR T-cell therapy could be held in reserve for patients who do not have a complete response or who have a relapse after a complete response.”
 

Most common form of non-Hodgkin’s lymphoma

DLBCL is the most common form of non-Hodgkin’s lymphoma in the United States, the company noted in a press release. While many people with DLBCL are responsive to treatment, the majority of those who experience relapse or whose condition is refractory to subsequent treatments have poor outcomes.

“Patients with relapsed or refractory diffuse large B-cell lymphoma may experience rapid progression of their cancer and often urgently need an effective treatment option that can be administered without delay,” commented Krish Patel, MD, director of the lymphoma program at the Swedish Cancer Institute in Seattle, who is an investigator on the clinical trial that led to the product’s approval. He said that the results from trials suggest that glofitamab gives patients “a chance for complete remission with a fixed-duration immunotherapy and that such remissions can potentially be sustained after the end of their treatment.”

The accelerated approval is based on response rate and durability of response results from the phase 1/2 NP30179 study.

Continued approval for this indication may be contingent upon verification and description of clinical benefit in a confirmatory trial.

This trial involved 132 patients with DLBCL who experienced relapse or whose condition was refractory to prior therapies. About one-third of patients (30%) had received prior CAR T-cell therapy. Additionally, for 83% of patients, the condition was refractory to their most recent therapy.

Glofitamab was given to all patients as a fixed course for 8.5 months.

More than half (56%) achieved an overall response, and 43% achieved a complete response. Over two-thirds (68.5%) of those who responded continued to respond for at least 9 months The median duration of response was 1.5 years.

The most common adverse events were cytokine release syndrome (CRS; 70%), which may be serious or life-threatening; musculoskeletal pain (21%); fatigue (20%); and rash (20%). CRS was generally of low grade (52% of patients experienced grade 1 CRS, and 14% experienced grade 2).

Results from the NP30179 trial were published in December 2022.

The complete response rates seen with glofitamab rivals the durable complete response that has been observed with CAR T-cell therapy, Dr. Bartlett noted in the accompanying editorial. “Although these results are promising, it is still too early to estimate the curative potential of glofitamab.”

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‘Professional grief’ is a daily reality for oncologists

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Oncologists commonly suffer “professional grief” when a patient dies – in fact, it is a “familiar, daily reality for the oncology clinician,” says one – but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.

The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.  

Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.

The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.

Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.

One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.

“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.

“I love this idea,” she said. “The most important thing is to commemorate that person.”
 

Amplified during pandemic

Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.

This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.

If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.

The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.

“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”

Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
 

Teamwork intervention

The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.

The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.

Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.

It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.

After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.

The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.

They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.

Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.

So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.

They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.

The second was time-consuming electronic health record tasks.

Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.

“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”

“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.

“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
 

Tackling burnout

The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.

Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.

Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.

Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”

Initiatives such as virtual happy hours and game nights may be helpful, she suggested.

A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”

Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.

She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”

No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.

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

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Oncologists commonly suffer “professional grief” when a patient dies – in fact, it is a “familiar, daily reality for the oncology clinician,” says one – but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.

The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.  

Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.

The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.

Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.

One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.

“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.

“I love this idea,” she said. “The most important thing is to commemorate that person.”
 

Amplified during pandemic

Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.

This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.

If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.

The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.

“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”

Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
 

Teamwork intervention

The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.

The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.

Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.

It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.

After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.

The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.

They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.

Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.

So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.

They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.

The second was time-consuming electronic health record tasks.

Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.

“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”

“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.

“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
 

Tackling burnout

The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.

Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.

Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.

Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”

Initiatives such as virtual happy hours and game nights may be helpful, she suggested.

A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”

Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.

She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”

No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.

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

Oncologists commonly suffer “professional grief” when a patient dies – in fact, it is a “familiar, daily reality for the oncology clinician,” says one – but when it is also accompanied by a sense of emotional isolation, it can lead to reduced well-being and burnout.

The issue was discussed at a special session at the annual meeting of the American Society of Clinical Oncology, and several speakers offered solutions.  

Laurie Jean Lyckholm, MD, professor, Hematology/Oncology, West Virginia University School of Medicine, Morgantown, polled the audience to ask how they deal with patient-related loss and grief.

The responses showed that 44.4% said they talk with their colleagues, 16.7% said they talk about it with family and friends, but 22.2% said that they simply move on to the next patient.

Dr. Lyckholm noted that there are positive and negative ways of dealing with grief.

One example of a positive way comes from an oncologist who attended one of her talks and shared with her how his practice deals with the issue.

“At the end of every fourth Friday, he closes his community practice office early and all the oncologists, everyone, stays for a while, and they have a list of the people who have died,” Dr. Lyckholm explained. As a group, they go through the list and reminisce about the patients who died, recalling funny incidents or things that person had said.

“I love this idea,” she said. “The most important thing is to commemorate that person.”
 

Amplified during pandemic

Like many other issues, the problem of how to deal with “professional grief” was amplified during the COVID-19 pandemic. Many people were unable to see their dying relatives because of the restricted access to sealed-off, dedicated COVID-19 units. One oncologist who had developed a friendly relationship with a patient while treating them for cancer over several years was unable to visit the patient once they were ill with the disease and was left to communicate via an iPad. “It was the only way I could say ‘goodbye’ before she died. ... It still haunts me today, 2 years later,” the clinician recalled.

This anecdote illustrates “disenfranchised grief,” which occurs when an individual experiences a “significant loss and the resultant grief is not openly acknowledged, socially validated, or publicly mourned,” Dr. Lyckholm explained.

If this goes unrecognized, it can lead to shame, guilt, and organizational mistrust, resulting in reduced well-being and clinician burnout, she warned.

The pandemic also had an impact on clinicians directly. Dr. Lyckholm quoted one nurse practitioner who talked about coming back to a new “lonely normal” when returning to a Veterans Affairs hospital.

“I am still getting used to calling colleagues, and paging colleagues, and realizing that they just aren’t there,” the nurse practitioner said. “They aren’t there because they either left or died. I just didn’t expect that.”

Dr. Lyckholm said, “I don’t think we can ever stop acknowledging COVID, because it just had such a terrible impact on all of us.”
 

Teamwork intervention

The next speaker also polled the audience. Christopher Ryan Friese, PhD, RN, AOCN, Elizabeth Tone Hosmer Professor of Nursing, University of Michigan, Ann Arbor, asked the audience what strategy they would prioritize to reduce burnout, from the perspective of the entire cancer care team.

The response indicated that many (43.6%) would like to see team-based grief and bereavement sessions, while 31.1% thought it best to tackle low-value administrative work.

Dr. Friese drew on a teamwork intervention that researchers at the Dana-Farber Cancer Institute, Boston, with support from the National Cancer Institute, implemented to help identify opportunities to improve cancer care delivery services.

It began with a focus group of nurses who were invited to identify practice pain points, then six 2-hour sessions with all members of the clinical team to identify and develop service expectations and commitments across the various roles.

After these sessions, the researchers saw a decrease in missing orders from 30% to 2%, while patient satisfaction increased from 93% to 97% as a result. Interestingly, there was also a reported rise in efficiency, practice quality and safety, and respectful professional behaviors.

The pilot was then rolled out across the whole institution, and Dr. Friese and colleagues also implemented a version of the program at their community medical oncology practice.

They had a huge response from patients and clinicians alike (with participation rates of 90% and 78%, respectively), and the survey results led to changes in workflow and the standardization of communications.

Importantly for Dr. Friese, the clinicians who took part wanted to repeat the survey to evaluate any practice changes, which was not part of the study protocol and had not been envisaged by the researchers.

So they developed a survey for clinicians, using as an inspiration the Choosing Wisely campaign by the American Board of Internal Medicine Foundation to identify the best treatments to improve patient outcomes and those to deprioritize.

They used the survey on 373 clinicians at the University of Michigan Health System and found that “the number one thing was getting rid of the administrative work” – that it doesn’t have to be done specifically by physicians or other providers and that other people can do it.

The second was time-consuming electronic health record tasks.

Both of these have since been the focus of an elimination and reduction process to give clinicians more time to do what matters most to them and their patients.

“We have the opportunity to do this in a different way,” Dr. Friese said, “and I think it’s a really powerful opportunity.”

“We can retrofit the solution, which is the pizza parties, and the yoga apps, and the T-shirts ... [or] we could actually redesign the work that we’re asking clinicians to do on a daily basis,” he commented.

“We could make the work easier to do so that you have more time with patients and less time with administrative work and have more time to process grief or to celebrate successes,” he concluded.
 

Tackling burnout

The final speaker, Vicki A. Jackson, MD, MPH, chief of palliative care, Massachusetts General Hospital, emphasized that the recognition of grief by a cancer care provider is “imperative” for physician well-being and pointed out that that interventions to help “do exist,” including ASCO’s SafeHaven collection of physician well-being resources.

Oncology inherently carries with it “threats” to well-being, including uncertainty and doubt, isolation, fears over one’s usefulness, exhaustion, the witnessing of suffering, and moral distress, she noted.

Things that are necessary for well-being, in contrast, include a sense of connection and community, having boundaries between work and personal life, self-awareness, compassion, and empowerment, among others.

Dr. Jackson believes that in the current era community building within oncology must be “intentional” and not just based around “water cooler moments,” as the sense of isolation experienced by clinicians is “not fluff; this is critical.”

Initiatives such as virtual happy hours and game nights may be helpful, she suggested.

A colleague of hers likes to send out the dad joke of the day, “which made everybody groan, but let me tell you, it changed the affective tone before they started seeing all these really hard, sad patients.”

Setting boundaries, which was the topic of another session at ASCO 2023, is also an important way to address the “emotionally powerful” work of oncology, Dr. Jackson commented.

She underlined the need to channel or be “fully present when you are in the room” but emphasized the need to detach at the end of the day, commenting that “when you leave, you leave.”

No funding was declared. Dr. Friese reported relationships with Merck, NCCN/Pfizer, National Cancer Institute, Patient-Centered Outcomes Research Institute, and the Simms/Mann Foundation. No other speakers reported relevant financial relationships.

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

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FROM ASCO 2023

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ASCO 2023: Promising results in breast cancer from NATALEE and PHERGain

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This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

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This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

 

This transcript has been edited for clarity.

Hi. It’s Dr. Kathy Miller from Indiana University, coming to you today from the 2023 ASCO annual meeting in Chicago.

It’s been an exciting year for breast cancer news. I want to make sure that you hear about the two studies that I find the most impactful. One is the NATALEE study looking at ribociclib in adjuvant ER-positive patients at high risk for recurrence. You saw the press release a few weeks ago, and we now have the data. There is no doubt that this is a positive trial.

The details here are important. These were pre- or postmenopausal women, and men as well. Premenopausal women and men also had an LHRH agonist in addition to an aromatase inhibitor – that could have been either letrozole or anastrozole – then randomized to ribociclib or placebo.

The dose of ribociclib that you’re used to thinking about is 600 mg daily for 3 weeks and 7 days off. That’s the approved dose in the metastatic setting. In the adjuvant trial, they used 400 mg, and that was intentional to try to reduce some of the toxicity because the plan was for 3 years of therapy. Managing toxicity and really making this tolerable for patients was crucial.

We’ve now seen the efficacy results, with a roughly 3% reduction in the risk for recurrence; 90% disease-free survival in the ribociclib arm, 87% in the control arm, some patients still having prolongation of QTc but no serious arrhythmias; some patients still with myelosuppression, but risk for serious infections was really very low.

This is going to give you a question to ponder in your high-risk, ER-positive patients who are appropriate to consider for adjuvant cyclin-dependent kinase inhibitors. Are you now on team abemaciclib or team ribociclib? We have no head-to-head trials in any setting, and I doubt that our industry colleagues are going to be interested in a head-to-head setting.

We’re going to need to pay particular attention to long-term follow-up and to quality of life and toxicity data as to which our patients prefer. We may need to think about other ways of doing those direct comparisons with public funding, where we can get the answers our patients deserve.

I also want to think about the other end of the spectrum, those patients with HER2-positive disease. We saw fantastic results from the PHERGain study from our colleagues in Spain. This was a trial that took patients with predominantly stage II and III HER2-positive breast cancer. These are patients that we would treat with neoadjuvant chemotherapy, with dual HER2-targeted therapy.

Years ago, we saw results of some small, single-arm, phase 2 studies, suggesting that some of those patients may be so sensitive to biologic therapy that they have a pathologic complete response with HER2-targeted therapy – HER2-targeted therapy with endocrine therapy if they are positive – with no chemotherapy at all. Our question has always been how to identify those patients. Can we identify them well enough that we would be comfortable not treating them with chemotherapy? Importantly, If they didn’t get chemotherapy, what’s their long-term outcome?

The PHERGain trial lets us look at all those things. The PHERGain trial gave patients two cycles of dual HER2-targeted therapy, pertuzumab and trastuzumab, hormone therapy if also ER positive, and they got an FDG-PET scan after two cycles of therapy.

If they had a significant PET response, those patients were then randomized to switch to chemotherapy, standard TCHP, or continue biologic therapy alone for a total of six cycles. They then went to surgery. If they had a pathologic complete response, whether they had gotten chemotherapy or no chemotherapy, they completed the HER2-targeted therapy. If they still had residual disease, they got chemotherapy if chemotherapy had not been administered before, and they may have gotten other HER2-targeted therapies if they had already received chemotherapy.

There were over 300 patients in this trial, and my memory is that roughly two thirds of them had a PET response. About 86 patients randomized to continue biologic therapy had a pathologic complete response, so about one-third of those for whom the PET imaging said they were responding with biologic therapy only had a pathologic complete response.

They have now been followed for 3 years. The 3-year disease-free survival results look very reassuring. Of those 86 patients, one patient had a local recurrence and no patient had a distant recurrence.

This is what we’ve been waiting for. Can we identify those patients who have an excellent prognosis with biologic therapy alone so that we can avoid the toxicities? This is really where you’ll see the research over the coming years in breast cancer, looking at additional therapies in high-risk patients who don’t do so well with our standard therapies, and better stratification of patients who do so well with our standard therapies that we may be able to do less.

This is one of the ways that we’ll be able to do that. I look forward to sharing those results with you over coming years.

Kathy D. Miller, MD, is associate director of clinical research and codirector of the breast cancer program at the Melvin and Bren Simon Cancer Center at Indiana University, Indianapolis. She disclosed no relevant conflicts of interest.

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

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Low-carb, plant-rich diets tied to breast cancer survival?

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TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

  • The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
  • Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
  • Cox proportional hazards regression models adjusted for multiple potential confounding factors.
  • Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

  • Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
  • Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
  • Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
  • But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

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

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TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

  • The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
  • Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
  • Cox proportional hazards regression models adjusted for multiple potential confounding factors.
  • Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

  • Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
  • Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
  • Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
  • But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

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

 

TOPLINE:

A new analysis shows a significant association between plant-rich, low-carbohydrate diets and overall survival, but not breast cancer–specific survival, among women with stage I-III breast cancer.

METHODOLOGY:

  • The diets of 9,621 women with stage I-III breast cancer from two ongoing cohort studies – the Nurses’ Health Study and Nurses’ Health Study II – were evaluated.
  • Overall low-carb, animal-rich, and plant-rich low-carb diet scores were calculated using food frequency questionnaires after breast cancer diagnosis.
  • Cox proportional hazards regression models adjusted for multiple potential confounding factors.
  • Follow-up lasted for a median of 12.4 years after breast cancer diagnosis.

TAKEAWAY:

  • Overall, 1,269 deaths due to breast cancer and 3,850 all-cause deaths occurred during the follow-up period.
  • Researchers found that greater adherence to low-carb (hazard ratio, 0.82 for quintile 5 vs. 1) and plant-rich diet (HR, 0.73 Q5 vs. 1) was associated with a significantly lower risk for overall mortality but not breast cancer–specific mortality.
  • Overall, adhering to animal-rich, low-carb diets did not significantly influence all-cause or breast cancer–specific survival rates.
  • But replacing 3% of energy intake from available carbohydrates with fish protein was associated with 17% lower risk for breast cancer–specific mortality and 15% lower risk for all-cause mortality.

IN PRACTICE:

“The findings suggest that breast cancer survivors could benefit from limiting intake of carbohydrates, especially from fruit juice, sugar-sweetened beverages, and added sugar, and increasing the amount of protein and fat, in particular from plant sources,” the authors write.

STUDY DETAILS:

The study was led by Maryam Farvid, PhD, with the Data Statistics Group, Mission Viejo, Calif. It was published online in the journal Cancer and supported by National Institutes of Health and the University of Toronto.

LIMITATIONS:

Most women were non-Hispanic White and health professionals, so the results might not generalize to other sociodemographic groups. The authors also noted potential residual confounding, despite controlling for several breast cancer risk factors.

DISCLOSURES:

Dr. Farvid is a founder of the Institute for Cancer Prevention and Healing and the Data Statistics Group.

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

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Experts share their sun protection tips for children

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Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News
From left, panelists Dr. Lawrence F. Eichenfield, Dr. Moise Levy, Dr. Adelaide A. Hebert, and Dr. Jennifer Huang.

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.



Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

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Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News
From left, panelists Dr. Lawrence F. Eichenfield, Dr. Moise Levy, Dr. Adelaide A. Hebert, and Dr. Jennifer Huang.

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.



Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

Specific sun protection tips may vary by climate, but in San Diego, where the UV Index hovers in the moderate to high range on most days, Lawrence F. Eichenfield, MD, favors an aggressive approach.

“I basically say, ‘sun protection means clothing, shade, [considering the] time of day of exposure, and sunscreen if you are going to be otherwise exposed,’ ” Dr. Eichenfield, chief of pediatric and adolescent dermatology at Rady’s Children’s Hospital, San Diego, said during a panel discussion about sunscreen use at the Hawaii Dermatology Seminar provided by MedscapeLIVE! He recommends photoprotective gear such as rash guards for surfers and other water sport enthusiasts. When patients ask him if they should use sunscreen, he often replies with a question of his own.

Doug Brunk/MDedge News
From left, panelists Dr. Lawrence F. Eichenfield, Dr. Moise Levy, Dr. Adelaide A. Hebert, and Dr. Jennifer Huang.

“Do you brush your teeth?” he’ll ask.

“Yes, I do.”

“Well, you should put sunscreen on every day.”

Another panelist, Adelaide A. Hebert, MD, professor of dermatology and pediatrics and chief of pediatric dermatology at the University of Texas, Houston, said that she advises new parents to start sun protection efforts early. “Most sunscreens are not approved for use in children under the age of 6 months because testing has not been done in this age group, but I do recommend protective clothing. I also recommend wrap-around sunglasses, which offer 5% more protection from the sun than regular sunglasses.”

In her opinion, stick sunscreens are “a good add-on,” especially for under the eyes and the backs of the hands, but she is not a fan of spray sunscreens, which can leave large areas of skin unprotected if not applied properly.



Fellow panelist Jennifer Huang, MD, a pediatric dermatologist at Boston Children’s Hospital, who has a special interest in taking care of dermatologic conditions of children with cancer, generally recommends mineral-based sunscreens. “There is data to suggest that nonmineral sunscreens are less safe than mineral sunscreens for humans, and mineral sunscreens are considered to be better for the environment,” Dr. Huang said. “Plus, there are more elegant versions of mineral sunscreens that don’t make your skin pasty white.” However, for patients with darker skin tones, “it can be hard to apply a pasty white sunscreen, so I lean on some recommendations for tinted sunscreens, too, so there are options. I specifically recommend sunscreens that have iron oxides in them so that it can block physical rays and help with the cosmetic appearance.”

Moise Levy, MD, professor of internal medicine and pediatrics at the University of Texas at Austin, said that his approach to imparting sunscreen advice to children and their parents involves a mix of spoken information, printed information, and sunscreen samples for children to try in the office, in the presence of a parent. To help patients choose among different samples, be they ointments, gels, or lotions, he will often ask the child: “‘What do you like the feel of better?’ If the child says, ‘I like this one,’ I make sure the parent hears that,” Dr. Levy said.

Vesna Andjic/iStockphoto

Next, Dr. Eichenfield, who moderated the discussion, asked his fellow panelists how they would counsel someone who comes to their practice for evaluation of moles and has a family history of nonmelanoma skin cancer. “I think this is one of the easier counseling sessions, because there are enough kids who are asked about the moles on their skin when they’re at school,” Dr. Hebert said. “I think they’re very ready to wear sun protective clothing and I certainly don’t want any sun exposure that would pose an increased risk for their child.”

In addition to routine sun protection, Dr. Huang recommends annual mole checks for children who have a first-degree relative with a history of malignant melanoma. Other high-risk groups that should undergo annual skin exams include anyone who has received high doses of radiation, bone marrow transplants, prolonged use of voriconazole, or prolonged systemic immunosuppression. Without a known genetic predisposition syndrome, a family history of nonmelanoma skin cancer would not raise concern for melanoma in an otherwise healthy child.

Dr. Eichenfield added that freckling used to be the secondary risk factor for melanoma, “but it’s flipped over to a primary risk factor. A history of immunosuppression or prior cancer is a major risk factor in childhood and teenage years.”

Dr. Eichenfield disclosed that he is a consultant or adviser for numerous pharmaceutical companies. He has also received research funding from AbbVie, Bausch & Lomb, Galderma Laboratories, and Pfizer. Dr. Hebert disclosed that she is a consultant or adviser for AbbVie, Almirall, Amryt Pharma, Arcutis Biotherapeutics, Beiersdorf, Dermavant Sciences, Galderma Laboratories, L’Oreal, Novan, Ortho Dermatologics, Pfizer, and Verrica. Dr. Levy disclosed that he is consultant or adviser for Abeona, Castle Creek, Dusa Pharma, Krystal Bio, Novan, Regeneron, and Sanofi Genzyme. Dr. Huang disclosed that she is an adviser for EllaOla.

MedscapeLive! and this news organization are owned by the same parent company.
 

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Electronic nose may sniff out early lung cancer in COPD

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An electronic exhaled breath analyzer showed differences in breath profiles of patients with chronic obstructive pulmonary disease who did and did not develop lung cancer, based on data from a prospective study of approximately 800 individuals.

Lung cancer remains a major cause of death in patients with chronic obstructive pulmonary disease (COPD), but many cases may go undetected in the early stage because of lack of screening and lack of validated predictive biomarkers, wrote Rianne de Vries, PhD, of the University of Amsterdam, and colleagues.

Accurate, noninvasive tests to screen patients with COPD for lung cancer are needed, and molecular profiling of exhaled breath using electronic nose (eNose) technology has shown potential as a method of early detection by identifying patterns of exhaled volatile organic compounds (VOCs), they said.

In a study published in the journal Chest, the researchers reviewed data from 682 adults with COPD and 211 with lung cancer who were enrolled in BreathCloud, a multicenter, observational study of healthy controls and individuals with suspected or confirmed diagnosis of asthma, COPD, or lung cancer.

Patients’ breath profiles were collected at study enrollment, between May 2017 and November 2018, using a metal oxide semiconductor eNose (SpiroNose).

Data from the eNose included the highest sensor peak normalized to the most stable sensor and the ratio between sensor peak and breath hold point. These variables were combined into four principal components (PCs) that captured 78.4% of variance in the dataset, and training and validation sets were constructed for all subjects. The researchers calculated a receiver operating characteristic (ROC) curve, including the area under the curve (AUC).

All patients were treated with standard clinical care and were monitored for development of clinically diagnosed lung cancer for 2 years, confirmed via CT imaging. The mean age of the patients was 64 years, and demographics at baseline were similar for patients with and without lung cancer.

After exclusion of 116 patients with both COPD and lung cancer, the analysis showed an accuracy of 90% and a ROC-AUC of 0.95.

Within 2 years of study enrollment, 37 patients with COPD (5.4%) developed lung cancer. In training sets and validation sets, the principal components one, two, and three were significantly different in patients with COPD who developed lung cancer and those who did not, (P = .002, P < .001, P < .001, respectively). The ROC-AUCs of the testing and validation sets were 0.89 and 0.86, respectively.

“Interestingly, the VOC pattern associated with early development of lung cancer in COPD did not match to the pattern related to lung cancer stages, as the former was mainly captured by PC2 and the latter by PC3,” the researchers wrote in their discussion. “This suggests that early identification of upcoming clinically manifest lung cancer in patients with COPD by eNose is not driven by VOCs that are predominantly associated with a particular stage of the disease,” they said.

The findings were limited by several factors including the lack of CT scanning at baseline because of the real-world design, so the presence of any baseline tumors was unknown, although none of the COPD patients showed symptoms indicative of lung cancer at baseline, the researchers noted.

However, the results suggest that eNose technology can identify lung cancer-specific VOC patterns early in cancer development in COPD patients, which provides a possible opportunity for early intervention, they concluded.

The study received no outside funding. De Vries disclosed personal fees and a substantial interest in the start-up company Breathomix.

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

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An electronic exhaled breath analyzer showed differences in breath profiles of patients with chronic obstructive pulmonary disease who did and did not develop lung cancer, based on data from a prospective study of approximately 800 individuals.

Lung cancer remains a major cause of death in patients with chronic obstructive pulmonary disease (COPD), but many cases may go undetected in the early stage because of lack of screening and lack of validated predictive biomarkers, wrote Rianne de Vries, PhD, of the University of Amsterdam, and colleagues.

Accurate, noninvasive tests to screen patients with COPD for lung cancer are needed, and molecular profiling of exhaled breath using electronic nose (eNose) technology has shown potential as a method of early detection by identifying patterns of exhaled volatile organic compounds (VOCs), they said.

In a study published in the journal Chest, the researchers reviewed data from 682 adults with COPD and 211 with lung cancer who were enrolled in BreathCloud, a multicenter, observational study of healthy controls and individuals with suspected or confirmed diagnosis of asthma, COPD, or lung cancer.

Patients’ breath profiles were collected at study enrollment, between May 2017 and November 2018, using a metal oxide semiconductor eNose (SpiroNose).

Data from the eNose included the highest sensor peak normalized to the most stable sensor and the ratio between sensor peak and breath hold point. These variables were combined into four principal components (PCs) that captured 78.4% of variance in the dataset, and training and validation sets were constructed for all subjects. The researchers calculated a receiver operating characteristic (ROC) curve, including the area under the curve (AUC).

All patients were treated with standard clinical care and were monitored for development of clinically diagnosed lung cancer for 2 years, confirmed via CT imaging. The mean age of the patients was 64 years, and demographics at baseline were similar for patients with and without lung cancer.

After exclusion of 116 patients with both COPD and lung cancer, the analysis showed an accuracy of 90% and a ROC-AUC of 0.95.

Within 2 years of study enrollment, 37 patients with COPD (5.4%) developed lung cancer. In training sets and validation sets, the principal components one, two, and three were significantly different in patients with COPD who developed lung cancer and those who did not, (P = .002, P < .001, P < .001, respectively). The ROC-AUCs of the testing and validation sets were 0.89 and 0.86, respectively.

“Interestingly, the VOC pattern associated with early development of lung cancer in COPD did not match to the pattern related to lung cancer stages, as the former was mainly captured by PC2 and the latter by PC3,” the researchers wrote in their discussion. “This suggests that early identification of upcoming clinically manifest lung cancer in patients with COPD by eNose is not driven by VOCs that are predominantly associated with a particular stage of the disease,” they said.

The findings were limited by several factors including the lack of CT scanning at baseline because of the real-world design, so the presence of any baseline tumors was unknown, although none of the COPD patients showed symptoms indicative of lung cancer at baseline, the researchers noted.

However, the results suggest that eNose technology can identify lung cancer-specific VOC patterns early in cancer development in COPD patients, which provides a possible opportunity for early intervention, they concluded.

The study received no outside funding. De Vries disclosed personal fees and a substantial interest in the start-up company Breathomix.

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

An electronic exhaled breath analyzer showed differences in breath profiles of patients with chronic obstructive pulmonary disease who did and did not develop lung cancer, based on data from a prospective study of approximately 800 individuals.

Lung cancer remains a major cause of death in patients with chronic obstructive pulmonary disease (COPD), but many cases may go undetected in the early stage because of lack of screening and lack of validated predictive biomarkers, wrote Rianne de Vries, PhD, of the University of Amsterdam, and colleagues.

Accurate, noninvasive tests to screen patients with COPD for lung cancer are needed, and molecular profiling of exhaled breath using electronic nose (eNose) technology has shown potential as a method of early detection by identifying patterns of exhaled volatile organic compounds (VOCs), they said.

In a study published in the journal Chest, the researchers reviewed data from 682 adults with COPD and 211 with lung cancer who were enrolled in BreathCloud, a multicenter, observational study of healthy controls and individuals with suspected or confirmed diagnosis of asthma, COPD, or lung cancer.

Patients’ breath profiles were collected at study enrollment, between May 2017 and November 2018, using a metal oxide semiconductor eNose (SpiroNose).

Data from the eNose included the highest sensor peak normalized to the most stable sensor and the ratio between sensor peak and breath hold point. These variables were combined into four principal components (PCs) that captured 78.4% of variance in the dataset, and training and validation sets were constructed for all subjects. The researchers calculated a receiver operating characteristic (ROC) curve, including the area under the curve (AUC).

All patients were treated with standard clinical care and were monitored for development of clinically diagnosed lung cancer for 2 years, confirmed via CT imaging. The mean age of the patients was 64 years, and demographics at baseline were similar for patients with and without lung cancer.

After exclusion of 116 patients with both COPD and lung cancer, the analysis showed an accuracy of 90% and a ROC-AUC of 0.95.

Within 2 years of study enrollment, 37 patients with COPD (5.4%) developed lung cancer. In training sets and validation sets, the principal components one, two, and three were significantly different in patients with COPD who developed lung cancer and those who did not, (P = .002, P < .001, P < .001, respectively). The ROC-AUCs of the testing and validation sets were 0.89 and 0.86, respectively.

“Interestingly, the VOC pattern associated with early development of lung cancer in COPD did not match to the pattern related to lung cancer stages, as the former was mainly captured by PC2 and the latter by PC3,” the researchers wrote in their discussion. “This suggests that early identification of upcoming clinically manifest lung cancer in patients with COPD by eNose is not driven by VOCs that are predominantly associated with a particular stage of the disease,” they said.

The findings were limited by several factors including the lack of CT scanning at baseline because of the real-world design, so the presence of any baseline tumors was unknown, although none of the COPD patients showed symptoms indicative of lung cancer at baseline, the researchers noted.

However, the results suggest that eNose technology can identify lung cancer-specific VOC patterns early in cancer development in COPD patients, which provides a possible opportunity for early intervention, they concluded.

The study received no outside funding. De Vries disclosed personal fees and a substantial interest in the start-up company Breathomix.

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

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Cancer drug shortages spur worry, rationing, and tough choices

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– Oncologist Denise Yardley, MD, isn’t used to expressing uncertainty when she tells patients about what’s in store for them in terms of drug treatment. But things are dramatically different now amid a severe national shortage of carboplatin and cisplatin, two common and crucial cancer drugs.

“There’s a regimen I’m thinking about,” Dr. Yardley told a new patient recently, “but we’ll have to wait until you finish your staging evaluation to see whether I can deliver this. Another regimen that’s a little more toxic is my second choice.” And, she added, the alternative chemotherapy treatment – anthracycline instead of carboplatin – requires a longer treatment period.

This ambiguity is hardly ideal, said Dr. Yardley, of Tennessee Oncology and Sarah Cannon Research Institute in Nashville. “It’s another factor in being overwhelmed in a first-time visit and wanting to know the details about what your treatment is going to look like. You’re not walking out knowing exactly what you’re going to take or the exact timing so you can start mapping out your calendar and work schedule.”

This kind of scenario is becoming all too familiar this spring, according to oncologists who gathered at the annual meeting of the American Society of Clinical Oncology (ASCO). In interviews, these physicians said the limited supply of multiple cancer drugs – including the chemotherapies carboplatin and cisplatin – is having an unprecedented negative effect since their use is so widespread in cancer care.

“Every patient could get impacted. That’s why we need to address this sooner rather than later,” said oncologist Aditya Baria, MBBS, MPH, director of the Breast Cancer Research Program at Massachusetts General Hospital, Boston.

Shortages of cancer drugs are not unusual. Three-quarters of oncology pharmacists at 68 organizations surveyed from 2019 to 2020 said shortages prompted treatment delays, reduced doses, or alternative regimens. But the current shortages are having a much wider impact.

The National Comprehensive Cancer Network recently reported that 93% of 27 member institutions surveyed in late May are short on carboplatin, and 70% have reported a shortage of cisplatin. Plus, 20% of 19 centers said they weren’t able to continue carboplatin regimens for all patients. 

The drugs are mainstays of multiple types of treatment for a long list of cancer types including lung, breast, gynecologic, and many others.

Several scenarios are possible when the drugs are in short supply, said Dr. Yardley, who noted that the shortage is more severe than any she’s seen in her medical career of more than 3 decades. Patients may need to be switched to regimens with more side effects, even when they’re in the middle of a treatment, she said. Or patients might have to go longer between treatments.

In some cases, Dr. Yardley said, the shortage is forcing patients to go without an important component of a larger combination therapy regimen. “The Keynote 522 neoadjuvant regimen for triple-negative breast cancer has carboplatin given with Taxol [paclitaxel] and Keytruda [pembrolizumab]. We are just deleting the carboplatin.”

She added that carboplatin is part of the following so-called TCHP regimen for HER2+ early-stage breast cancer: Taxotere (docetaxel), carboplatin, Herceptin (trastuzumab), and Perjeta (pertuzumab).

“You can delete [carboplatin] or consider substituting cyclophosphamide for carboplatin,” she said. But she cautioned the Keynote 522 and TCHP regimens haven’t been tested without carboplatin in curative-intent trials.

At Duke University in Durham, N.C., doses of carboplatin for many patients are being lowered by a third to the level that’s commonly used for older and frail patients, said oncologist Arif Kamal, MD, MBA, MHS, who works at the academic center and is the chief patient officer at the American Cancer Society.

“We don’t know if [the lower doses will negatively affect cancer patients’ outcomes]. What’s amazing is how many patients [are understanding about having to take smaller amounts of the chemotherapy],” he said.

Medical organizations are offering guidance. The Society of Gynecologic Oncology, for example, in late April recommended that oncologists increase intervals between chemotherapy treatments when appropriate, round down vial sizes to ensure “efficient use,” and eliminate or minimize use of cisplatin and carboplatin in certain platinum-resistant cancers.

In early June, ASCO published guidance regarding alternatives to cisplatin, carboplatin, and 5-fluorouracil, which is also in short supply, in gastrointestinal cancer. As the guidance notes, some alternatives are more untested or more toxic than ideal treatments.

In addition, ASCO has a webpage devoted to news and resources about shortages of cancer drugs. It offers drug availability updatesgeneral guidance, and breast cancer guidance. ASCO also offers ethical guidance about handling drug shortages.

Patients in clinical trials and those who hope to join them are especially vulnerable to the drug shortage, oncologists interviewed for this story said. Cisplatin and carboplatin are the backbones of many clinical trials, Dr. Yardley said. “When you can’t supply a drug in one of the [trial] arms, that puts the whole trial on pause.”

Even clinics that have managed to find adequate supplies of the drugs are planning for when they run out.

“Our institution and other institutions are trying to come up with a rationing protocol, deciding which patients are going to get access, and which ones have reasonable alternatives,” radiation oncologist Corey Speers MD, PhD, of University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, said in an interview. “In some settings, there really isn’t an effective alternative. Or the alternatives are tens of thousands of dollars more expensive.”

Oncologists also noted that cisplatin and carboplatin aren’t the only cancer drugs in short supply.

“Methotrexate is critically low, and 5FU [fluorouracil] is critically low,” Dr. Yardley said, referring to drugs that each treat several types of cancer. According to the May NCNN survey, 67% of respondents reported low supplies of methotrexate, and 26% said they were low on 5FU.

“Viscous lidocaine is a component of many supportive care mouth rinses for the stomatitis caused by our drugs but is not available at all,” Dr. Yardley said. 

She added that there are also low supplies of fludarabine, which is used to treat chronic lymphocytic lymphom; clofarabine, which is used to treat acute lymphoblastic leukemia; and rasburicase, which is used to treat high levels of uric acid in patients on chemotherapy.

Dr. Speers said his institution is facing a shortage of capecitabine, which is used to treat several types of cancer.

“Numerous trials have demonstrated the improved, safety, efficacy, and convenience of oral capecitabine. With the shortage we’re having to use infusional 5FU, which not only is less convenient but also ends up being more costly and requires infusion room space or continuous infusion pumps. This impacts our ability to treat cancer patients,” he said. “Our capacity is becoming more limited to accommodate these added patients, and we have to use infusional formulations of a drug that previously was readily available via an oral formulation. Patients and caregivers now have to come to the cancer center for appointments and infusions that previously weren’t needed as they could take an oral pill.”

Dr. Speers added that his institution is rationing methotrexate. “We are now prioritizing patients being treated with curative intent and adjusting protocols to use the lowest allowable doses to conserve supply,” he said.

The roots of the platinum chemotherapy drug shortage link back to the India-based Intas Pharmaceuticals company, a major manufacturer of cisplatin and carboplatin. According to Kellyann Zuzulo, spokeperson for Accord Healthcare, an Instas U.S. subsidiary, a facility inspection in December 2022 prompted a decision to temporarily stop making the drugs. The inspection identified multiple problems.

“Intas and Accord are working with the FDA on a plan to return to manufacturing,” Ms. Zuzulo said in an interview. “This will allow for continued production of products that will be prioritized based on medical necessity. A date has not yet been confirmed in which the facility will return to manufacturing for cisplatin, carboplatin or any other products.”

Ms. Zuzulo said the company is not a health care provider and cannot offer advice to patients about alternatives.

Other companies that make cisplatin and carboplatin have also reported shortages. In interviews, representatives for Fresenius Kabi and Pfizer said the companies have limited supplies because of increased demand – not because of manufacturing problems.

On June 12, the American Society of Health-System Pharmacists (ASHP) reported that carboplatin remains in short supply, with all five companies that sell the drug listed as having limited or back-ordered supplies. Cisplatin is also in short supply, the organization reported in a June 9 update, although some is available.

In a June 12 update on methotrexate, ASHP said manufacturing delays at Accord have caused a shortage, and other companies are running low due to increased demand.

As for the future, Congress and the Biden administration, according to a report by Bloomberg, are trying to figure out what to do regarding shortages of cheap generic drugs such as cisplatin and carboplatin. The FDA is exploring a partnership with a Chinese drugmaker to make cisplatin, NBC News reported.

However, fixes will be challenging, according to former FDA commissioner and Pfizer board member, Scott Gottlieb, MD.

“This generic business, particularly for these complex drugs, these complex formulations, is not a healthy business right now. Yet it’s a vital business from a public standpoint,” he told CBS News.

In an interview, Dr. Kamal said that there is even talk about boosting the prices of cheap generic drugs “to ensure that there’s enough incentive for multiple manufacturers to be involved.”

Dr. Kamal said he is crossing his fingers that cutting chemotherapy doses at his clinic doesn’t result in worse outcomes for his patients.

“Right now, I think dropping someone by 25% or 30% is okay. And for some patients, particularly in a curative setting, we try to keep them at as much as 100% as possible. But there’s just a lot of unknowns,” he said.

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– Oncologist Denise Yardley, MD, isn’t used to expressing uncertainty when she tells patients about what’s in store for them in terms of drug treatment. But things are dramatically different now amid a severe national shortage of carboplatin and cisplatin, two common and crucial cancer drugs.

“There’s a regimen I’m thinking about,” Dr. Yardley told a new patient recently, “but we’ll have to wait until you finish your staging evaluation to see whether I can deliver this. Another regimen that’s a little more toxic is my second choice.” And, she added, the alternative chemotherapy treatment – anthracycline instead of carboplatin – requires a longer treatment period.

This ambiguity is hardly ideal, said Dr. Yardley, of Tennessee Oncology and Sarah Cannon Research Institute in Nashville. “It’s another factor in being overwhelmed in a first-time visit and wanting to know the details about what your treatment is going to look like. You’re not walking out knowing exactly what you’re going to take or the exact timing so you can start mapping out your calendar and work schedule.”

This kind of scenario is becoming all too familiar this spring, according to oncologists who gathered at the annual meeting of the American Society of Clinical Oncology (ASCO). In interviews, these physicians said the limited supply of multiple cancer drugs – including the chemotherapies carboplatin and cisplatin – is having an unprecedented negative effect since their use is so widespread in cancer care.

“Every patient could get impacted. That’s why we need to address this sooner rather than later,” said oncologist Aditya Baria, MBBS, MPH, director of the Breast Cancer Research Program at Massachusetts General Hospital, Boston.

Shortages of cancer drugs are not unusual. Three-quarters of oncology pharmacists at 68 organizations surveyed from 2019 to 2020 said shortages prompted treatment delays, reduced doses, or alternative regimens. But the current shortages are having a much wider impact.

The National Comprehensive Cancer Network recently reported that 93% of 27 member institutions surveyed in late May are short on carboplatin, and 70% have reported a shortage of cisplatin. Plus, 20% of 19 centers said they weren’t able to continue carboplatin regimens for all patients. 

The drugs are mainstays of multiple types of treatment for a long list of cancer types including lung, breast, gynecologic, and many others.

Several scenarios are possible when the drugs are in short supply, said Dr. Yardley, who noted that the shortage is more severe than any she’s seen in her medical career of more than 3 decades. Patients may need to be switched to regimens with more side effects, even when they’re in the middle of a treatment, she said. Or patients might have to go longer between treatments.

In some cases, Dr. Yardley said, the shortage is forcing patients to go without an important component of a larger combination therapy regimen. “The Keynote 522 neoadjuvant regimen for triple-negative breast cancer has carboplatin given with Taxol [paclitaxel] and Keytruda [pembrolizumab]. We are just deleting the carboplatin.”

She added that carboplatin is part of the following so-called TCHP regimen for HER2+ early-stage breast cancer: Taxotere (docetaxel), carboplatin, Herceptin (trastuzumab), and Perjeta (pertuzumab).

“You can delete [carboplatin] or consider substituting cyclophosphamide for carboplatin,” she said. But she cautioned the Keynote 522 and TCHP regimens haven’t been tested without carboplatin in curative-intent trials.

At Duke University in Durham, N.C., doses of carboplatin for many patients are being lowered by a third to the level that’s commonly used for older and frail patients, said oncologist Arif Kamal, MD, MBA, MHS, who works at the academic center and is the chief patient officer at the American Cancer Society.

“We don’t know if [the lower doses will negatively affect cancer patients’ outcomes]. What’s amazing is how many patients [are understanding about having to take smaller amounts of the chemotherapy],” he said.

Medical organizations are offering guidance. The Society of Gynecologic Oncology, for example, in late April recommended that oncologists increase intervals between chemotherapy treatments when appropriate, round down vial sizes to ensure “efficient use,” and eliminate or minimize use of cisplatin and carboplatin in certain platinum-resistant cancers.

In early June, ASCO published guidance regarding alternatives to cisplatin, carboplatin, and 5-fluorouracil, which is also in short supply, in gastrointestinal cancer. As the guidance notes, some alternatives are more untested or more toxic than ideal treatments.

In addition, ASCO has a webpage devoted to news and resources about shortages of cancer drugs. It offers drug availability updatesgeneral guidance, and breast cancer guidance. ASCO also offers ethical guidance about handling drug shortages.

Patients in clinical trials and those who hope to join them are especially vulnerable to the drug shortage, oncologists interviewed for this story said. Cisplatin and carboplatin are the backbones of many clinical trials, Dr. Yardley said. “When you can’t supply a drug in one of the [trial] arms, that puts the whole trial on pause.”

Even clinics that have managed to find adequate supplies of the drugs are planning for when they run out.

“Our institution and other institutions are trying to come up with a rationing protocol, deciding which patients are going to get access, and which ones have reasonable alternatives,” radiation oncologist Corey Speers MD, PhD, of University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, said in an interview. “In some settings, there really isn’t an effective alternative. Or the alternatives are tens of thousands of dollars more expensive.”

Oncologists also noted that cisplatin and carboplatin aren’t the only cancer drugs in short supply.

“Methotrexate is critically low, and 5FU [fluorouracil] is critically low,” Dr. Yardley said, referring to drugs that each treat several types of cancer. According to the May NCNN survey, 67% of respondents reported low supplies of methotrexate, and 26% said they were low on 5FU.

“Viscous lidocaine is a component of many supportive care mouth rinses for the stomatitis caused by our drugs but is not available at all,” Dr. Yardley said. 

She added that there are also low supplies of fludarabine, which is used to treat chronic lymphocytic lymphom; clofarabine, which is used to treat acute lymphoblastic leukemia; and rasburicase, which is used to treat high levels of uric acid in patients on chemotherapy.

Dr. Speers said his institution is facing a shortage of capecitabine, which is used to treat several types of cancer.

“Numerous trials have demonstrated the improved, safety, efficacy, and convenience of oral capecitabine. With the shortage we’re having to use infusional 5FU, which not only is less convenient but also ends up being more costly and requires infusion room space or continuous infusion pumps. This impacts our ability to treat cancer patients,” he said. “Our capacity is becoming more limited to accommodate these added patients, and we have to use infusional formulations of a drug that previously was readily available via an oral formulation. Patients and caregivers now have to come to the cancer center for appointments and infusions that previously weren’t needed as they could take an oral pill.”

Dr. Speers added that his institution is rationing methotrexate. “We are now prioritizing patients being treated with curative intent and adjusting protocols to use the lowest allowable doses to conserve supply,” he said.

The roots of the platinum chemotherapy drug shortage link back to the India-based Intas Pharmaceuticals company, a major manufacturer of cisplatin and carboplatin. According to Kellyann Zuzulo, spokeperson for Accord Healthcare, an Instas U.S. subsidiary, a facility inspection in December 2022 prompted a decision to temporarily stop making the drugs. The inspection identified multiple problems.

“Intas and Accord are working with the FDA on a plan to return to manufacturing,” Ms. Zuzulo said in an interview. “This will allow for continued production of products that will be prioritized based on medical necessity. A date has not yet been confirmed in which the facility will return to manufacturing for cisplatin, carboplatin or any other products.”

Ms. Zuzulo said the company is not a health care provider and cannot offer advice to patients about alternatives.

Other companies that make cisplatin and carboplatin have also reported shortages. In interviews, representatives for Fresenius Kabi and Pfizer said the companies have limited supplies because of increased demand – not because of manufacturing problems.

On June 12, the American Society of Health-System Pharmacists (ASHP) reported that carboplatin remains in short supply, with all five companies that sell the drug listed as having limited or back-ordered supplies. Cisplatin is also in short supply, the organization reported in a June 9 update, although some is available.

In a June 12 update on methotrexate, ASHP said manufacturing delays at Accord have caused a shortage, and other companies are running low due to increased demand.

As for the future, Congress and the Biden administration, according to a report by Bloomberg, are trying to figure out what to do regarding shortages of cheap generic drugs such as cisplatin and carboplatin. The FDA is exploring a partnership with a Chinese drugmaker to make cisplatin, NBC News reported.

However, fixes will be challenging, according to former FDA commissioner and Pfizer board member, Scott Gottlieb, MD.

“This generic business, particularly for these complex drugs, these complex formulations, is not a healthy business right now. Yet it’s a vital business from a public standpoint,” he told CBS News.

In an interview, Dr. Kamal said that there is even talk about boosting the prices of cheap generic drugs “to ensure that there’s enough incentive for multiple manufacturers to be involved.”

Dr. Kamal said he is crossing his fingers that cutting chemotherapy doses at his clinic doesn’t result in worse outcomes for his patients.

“Right now, I think dropping someone by 25% or 30% is okay. And for some patients, particularly in a curative setting, we try to keep them at as much as 100% as possible. But there’s just a lot of unknowns,” he said.

– Oncologist Denise Yardley, MD, isn’t used to expressing uncertainty when she tells patients about what’s in store for them in terms of drug treatment. But things are dramatically different now amid a severe national shortage of carboplatin and cisplatin, two common and crucial cancer drugs.

“There’s a regimen I’m thinking about,” Dr. Yardley told a new patient recently, “but we’ll have to wait until you finish your staging evaluation to see whether I can deliver this. Another regimen that’s a little more toxic is my second choice.” And, she added, the alternative chemotherapy treatment – anthracycline instead of carboplatin – requires a longer treatment period.

This ambiguity is hardly ideal, said Dr. Yardley, of Tennessee Oncology and Sarah Cannon Research Institute in Nashville. “It’s another factor in being overwhelmed in a first-time visit and wanting to know the details about what your treatment is going to look like. You’re not walking out knowing exactly what you’re going to take or the exact timing so you can start mapping out your calendar and work schedule.”

This kind of scenario is becoming all too familiar this spring, according to oncologists who gathered at the annual meeting of the American Society of Clinical Oncology (ASCO). In interviews, these physicians said the limited supply of multiple cancer drugs – including the chemotherapies carboplatin and cisplatin – is having an unprecedented negative effect since their use is so widespread in cancer care.

“Every patient could get impacted. That’s why we need to address this sooner rather than later,” said oncologist Aditya Baria, MBBS, MPH, director of the Breast Cancer Research Program at Massachusetts General Hospital, Boston.

Shortages of cancer drugs are not unusual. Three-quarters of oncology pharmacists at 68 organizations surveyed from 2019 to 2020 said shortages prompted treatment delays, reduced doses, or alternative regimens. But the current shortages are having a much wider impact.

The National Comprehensive Cancer Network recently reported that 93% of 27 member institutions surveyed in late May are short on carboplatin, and 70% have reported a shortage of cisplatin. Plus, 20% of 19 centers said they weren’t able to continue carboplatin regimens for all patients. 

The drugs are mainstays of multiple types of treatment for a long list of cancer types including lung, breast, gynecologic, and many others.

Several scenarios are possible when the drugs are in short supply, said Dr. Yardley, who noted that the shortage is more severe than any she’s seen in her medical career of more than 3 decades. Patients may need to be switched to regimens with more side effects, even when they’re in the middle of a treatment, she said. Or patients might have to go longer between treatments.

In some cases, Dr. Yardley said, the shortage is forcing patients to go without an important component of a larger combination therapy regimen. “The Keynote 522 neoadjuvant regimen for triple-negative breast cancer has carboplatin given with Taxol [paclitaxel] and Keytruda [pembrolizumab]. We are just deleting the carboplatin.”

She added that carboplatin is part of the following so-called TCHP regimen for HER2+ early-stage breast cancer: Taxotere (docetaxel), carboplatin, Herceptin (trastuzumab), and Perjeta (pertuzumab).

“You can delete [carboplatin] or consider substituting cyclophosphamide for carboplatin,” she said. But she cautioned the Keynote 522 and TCHP regimens haven’t been tested without carboplatin in curative-intent trials.

At Duke University in Durham, N.C., doses of carboplatin for many patients are being lowered by a third to the level that’s commonly used for older and frail patients, said oncologist Arif Kamal, MD, MBA, MHS, who works at the academic center and is the chief patient officer at the American Cancer Society.

“We don’t know if [the lower doses will negatively affect cancer patients’ outcomes]. What’s amazing is how many patients [are understanding about having to take smaller amounts of the chemotherapy],” he said.

Medical organizations are offering guidance. The Society of Gynecologic Oncology, for example, in late April recommended that oncologists increase intervals between chemotherapy treatments when appropriate, round down vial sizes to ensure “efficient use,” and eliminate or minimize use of cisplatin and carboplatin in certain platinum-resistant cancers.

In early June, ASCO published guidance regarding alternatives to cisplatin, carboplatin, and 5-fluorouracil, which is also in short supply, in gastrointestinal cancer. As the guidance notes, some alternatives are more untested or more toxic than ideal treatments.

In addition, ASCO has a webpage devoted to news and resources about shortages of cancer drugs. It offers drug availability updatesgeneral guidance, and breast cancer guidance. ASCO also offers ethical guidance about handling drug shortages.

Patients in clinical trials and those who hope to join them are especially vulnerable to the drug shortage, oncologists interviewed for this story said. Cisplatin and carboplatin are the backbones of many clinical trials, Dr. Yardley said. “When you can’t supply a drug in one of the [trial] arms, that puts the whole trial on pause.”

Even clinics that have managed to find adequate supplies of the drugs are planning for when they run out.

“Our institution and other institutions are trying to come up with a rationing protocol, deciding which patients are going to get access, and which ones have reasonable alternatives,” radiation oncologist Corey Speers MD, PhD, of University Hospitals Seidman Cancer Center and Case Western Reserve University, Cleveland, said in an interview. “In some settings, there really isn’t an effective alternative. Or the alternatives are tens of thousands of dollars more expensive.”

Oncologists also noted that cisplatin and carboplatin aren’t the only cancer drugs in short supply.

“Methotrexate is critically low, and 5FU [fluorouracil] is critically low,” Dr. Yardley said, referring to drugs that each treat several types of cancer. According to the May NCNN survey, 67% of respondents reported low supplies of methotrexate, and 26% said they were low on 5FU.

“Viscous lidocaine is a component of many supportive care mouth rinses for the stomatitis caused by our drugs but is not available at all,” Dr. Yardley said. 

She added that there are also low supplies of fludarabine, which is used to treat chronic lymphocytic lymphom; clofarabine, which is used to treat acute lymphoblastic leukemia; and rasburicase, which is used to treat high levels of uric acid in patients on chemotherapy.

Dr. Speers said his institution is facing a shortage of capecitabine, which is used to treat several types of cancer.

“Numerous trials have demonstrated the improved, safety, efficacy, and convenience of oral capecitabine. With the shortage we’re having to use infusional 5FU, which not only is less convenient but also ends up being more costly and requires infusion room space or continuous infusion pumps. This impacts our ability to treat cancer patients,” he said. “Our capacity is becoming more limited to accommodate these added patients, and we have to use infusional formulations of a drug that previously was readily available via an oral formulation. Patients and caregivers now have to come to the cancer center for appointments and infusions that previously weren’t needed as they could take an oral pill.”

Dr. Speers added that his institution is rationing methotrexate. “We are now prioritizing patients being treated with curative intent and adjusting protocols to use the lowest allowable doses to conserve supply,” he said.

The roots of the platinum chemotherapy drug shortage link back to the India-based Intas Pharmaceuticals company, a major manufacturer of cisplatin and carboplatin. According to Kellyann Zuzulo, spokeperson for Accord Healthcare, an Instas U.S. subsidiary, a facility inspection in December 2022 prompted a decision to temporarily stop making the drugs. The inspection identified multiple problems.

“Intas and Accord are working with the FDA on a plan to return to manufacturing,” Ms. Zuzulo said in an interview. “This will allow for continued production of products that will be prioritized based on medical necessity. A date has not yet been confirmed in which the facility will return to manufacturing for cisplatin, carboplatin or any other products.”

Ms. Zuzulo said the company is not a health care provider and cannot offer advice to patients about alternatives.

Other companies that make cisplatin and carboplatin have also reported shortages. In interviews, representatives for Fresenius Kabi and Pfizer said the companies have limited supplies because of increased demand – not because of manufacturing problems.

On June 12, the American Society of Health-System Pharmacists (ASHP) reported that carboplatin remains in short supply, with all five companies that sell the drug listed as having limited or back-ordered supplies. Cisplatin is also in short supply, the organization reported in a June 9 update, although some is available.

In a June 12 update on methotrexate, ASHP said manufacturing delays at Accord have caused a shortage, and other companies are running low due to increased demand.

As for the future, Congress and the Biden administration, according to a report by Bloomberg, are trying to figure out what to do regarding shortages of cheap generic drugs such as cisplatin and carboplatin. The FDA is exploring a partnership with a Chinese drugmaker to make cisplatin, NBC News reported.

However, fixes will be challenging, according to former FDA commissioner and Pfizer board member, Scott Gottlieb, MD.

“This generic business, particularly for these complex drugs, these complex formulations, is not a healthy business right now. Yet it’s a vital business from a public standpoint,” he told CBS News.

In an interview, Dr. Kamal said that there is even talk about boosting the prices of cheap generic drugs “to ensure that there’s enough incentive for multiple manufacturers to be involved.”

Dr. Kamal said he is crossing his fingers that cutting chemotherapy doses at his clinic doesn’t result in worse outcomes for his patients.

“Right now, I think dropping someone by 25% or 30% is okay. And for some patients, particularly in a curative setting, we try to keep them at as much as 100% as possible. But there’s just a lot of unknowns,” he said.

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ACS officer provides ASCO highlights: Targeting hidden cancer, AI in oncology

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– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

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– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

– For the chief patient officer of the American Cancer Society, this year’s annual meeting of the American Society of Clinical Oncology was a gem. And it didn’t just sparkle because of the sequined Taylor Swift fans clogging the nearby streets during the meeting.

Arif Kamal, MD, MBA, MHS, who is also an oncologist at Duke University, Durham, N.C., said he was impressed by a pair of landmark studies released at the meeting that show hidden cancer can be targeted with “really remarkable outcomes.” He also highlighted sessions that examined the role of artificial intelligence (AI) in oncology, during an interview.

Below are lightly edited excerpts from a conversation with Dr. Kamal:



Question: What are some of most groundbreaking studies released at ASCO?

Answer: One is an interim analysis of the NATALEE trial, which involved patients with early-stage hormone receptor-positive, HER2-negative (HR+/HER2–) breast tumors. This phase 3 randomized trial compared maintenance therapy with the cyclin-dependent kinase 4/6 (CDK4/6) inhibitor ribociclib (Kisqali) plus endocrine therapy with an aromatase inhibitor to endocrine therapy alone in patients with node-positive or node-negative and stage II or III HR+/HER– breast cancer.

For a long time, the standard care in these patients has been to use endocrine therapy alone. This is the first big trial to show that upstream usage of additional therapy in early stages is also beneficial for disease-free survival. The 3-year invasive disease-free survival rate was 90.4% in the rebociclib-endocrine therapy group vs. 87.1% for patients who received only endocrine therapy (P = .0014).



Q: How do these findings add to current knowledge?

A: Typically, we let people get metastatic disease before we use CDK4/6 inhibitors. These findings show that systemic treatment beyond endocrine therapy will be helpful in cases where you’ve got smaller disease that has not spread yet.

Even in patients with node-negative breast cancer, micrometastatic disease is clearly there, because the medication killed the negative lymph nodes.



Q: What else struck you as especially important research?

A: The NATALEE findings match what we saw in another study – the ADAURA trial, which looked at adjuvant osimertinib in non–small-cell lung cancer patients with EGFR-mutated, stage IB to IIIA disease – cancer that has not spread to the lymph nodes.

This is another example where you have a treatment being used in earlier-stage disease that’s showing really remarkable outcomes. The study found that 5-year overall survival was 88% in an osimertinib group vs. 78% in a placebo group (P < .001). This is a disease where, in stage IB, we wouldn’t even necessarily give these patients treatment at all, other than surgical resection of the tumor and maybe give them a little bit of chemotherapy.

Even in these smaller, early tumors, osimertinib makes a difference.



Q: As a whole, what are these studies telling us about cancer cells that can’t be easily detected?

A: To find a disease-free survival benefit with adding ribociclib in a stage II, stage III setting, particularly in node-negative disease, is remarkable because it says that the cells in hiding are bad actors, and they are going to cause trouble. The study shows that medications can find these cells and reverse that risk of bad outcomes.

If you think about the paradigm of cancer, that’s pretty remarkable because the ADAURA trial does the same thing: You do surgery for [early-stage] lung cancers that have not spread to the lymph nodes and you figure, “Well, I’ve got it all, right? The margins are real big, healthy, clean.” And yet, people still have recurrences, and you ask the same question: “Can any medicine find those few cells, the hundreds of cells that are still left somewhere in hiding?” And the answer is again, yes. It’s changing the paradigm of our understanding of minimal residual disease.

That’s why there’s so much interest in liquid biopsies. Let’s say that after treatment we don’t see any cancer radiologically, but there’s a signal from a liquid biopsy [detecting residual cancer]. These two trials demonstrate that there’s something we can do about it.



Q: There were quite a few studies about artificial intelligence released at ASCO. Where do we stand on that front?

A: We’re just at the beginning of people thinking about the use of generative AI for clinical decision support, clinical trial matching, and pathology review. But AI, at least for now, still has the issue of making up things that aren’t true. That’s not something patients are going to be okay with.



Q: How can AI be helpful to medical providers considering its limitations?

A: AI is going to be very good at the data-to-information transition. You’ll start seeing people use AI to start clinical notes for them and to match patients to the best clinical trials for them. But fundamentally, the clinician’s role will continue to be to check facts and offer wisdom.



Q: Will AI threaten the careers of oncologists?

A: The body of knowledge about oncology is growing exponentially, and no one can actually keep up. There’s so much data that’s out there that needs to be turned into usable information amid a shortage of oncologists. At the same time, the prevalence of cancer is going up, even though mortality is going down.

Synthesis of data is what oncologists are waiting for from AI. They’ll welcome it as opposed to being worried. That’s the sentiment I heard from my colleagues.

Dr. Kamal has no disclosures.

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‘New standard of care’ for capecitabine hand-foot syndrome

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The common side effect of hand-foot syndrome seen in patients taking capecitabine can be prevented with a cheap and safe topical gel containing 1% diclofenac, researchers reported in a study that has been hailed by experts as “practice changing.”

Hand-foot syndrome causes painful, bleeding blisters and ulcers on the palms and soles. It often leads to dose reductions and sometimes even discontinuations, both of which limit the effectiveness of capecitabine, a standard oral chemotherapy drug widely used for colorectal and breast  cancers.

In a new study presented at the annual meeting of the American Society of Clinical Oncology, Indian researchers reported that a cheap, safe, and widely available over-the-counter nonsteroidal anti-inflammatory gel containing 1% diclofenac reduced the incidence of hand-foot syndrome by 75% among patients with cancer being treated with capecitabine.

Up until now, the oral anti-inflammatory celecoxib (Celebrex) was the only agent proven to prevent the problem, but it’s rarely used because of the risk for strokes, gastric bleeding, and other issues, none of which are a concern with topical diclofenac, which osteoarthritis patients have used safely for years.

The Indian trial, dubbed D-Torch, establishes “1% topical diclofenac gel as the new standard of care to prevent capecitabine-associated hand-foot syndrome,” said investigator and study presenter Atul Batra, MD, a medical oncologist at the All India Institute of Medical Sciences, New Delhi.

Dr. Batra told ASCO Daily News that there is no need for a second trial. “We don’t feel there’s a need to replicate these results” in a larger study “because this was adequately powered, and the results speak for themselves. There’s no confusion about these results. Diclofenac is clearly effective.”

Dr. Batra also commented that his clinic now uses topical diclofenac routinely during capecitabine treatment and that he hopes oncology practices elsewhere will do the same.   

Diclofenac gel is sold under the brand name Voltaren and is also available as a generic; in the United States, a 150-gram tube costs about $18 at Walmart.
 

‘The most practice-changing study’ at ASCO 2023

Audience members at ASCO’s annual meeting immediately saw the importance of the study.

Tarah Ballinger, MD, a breast cancer specialist at Indiana University, Indianapolis, said on Twitter that “this might be the most practice changing study I heard at ASCO23.” Topical diclofenac is “widely available, affordable, [and] addresses [a] major” quality of life issue.



The study discussant at the meeting, gastrointestinal cancer specialist Pallavi Kumar, MD, of the University of Pennsylvania, Philadelphia, concurred: “For me as a GI oncologist, topical diclofenac for prevention of HFS for patients on capecitabine is practice changing,” she said.

The takeaway is “that topical diclofenac significantly reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine.” The results are “very impressive,” Dr. Kumar said.

Study details

The idea for the new study came after Batra and colleagues realized that celecoxib, a COX-2 enzyme inhibitor, helps prevent capecitabine hand-foot syndrome (HFS) by blocking a key process that leads to it, the up-regulation of COX-2 and subsequent release of proinflammatory prostaglandins.

They turned to diclofenac gel hoping to get the same effect but more safely; diclofenac is also a COX-2 blocker, and its topical formulation has a strong safety record. 

To test the approach, the team randomly assigned 130 patients to topical diclofenac and 133 to placebo – the gel vehicle without the medication – while they were being treated with capecitabine for 12 weeks; 56% were being treated for breast cancer and the rest for gastrointestinal cancers.

Subjects rubbed one fingertip’s worth of gel – about half a gram – on each palm and the back of each hand twice a day. The dose was about 4 grams/day, which is well below maximal dosages for osteoarthritis (up to 32 g/day over all affected joints). Adherence to treatment was about 95% in both arms.

By the end of 12 weeks, the incidence of grade 2 or higher HFS was 3.8% in the diclofenac arm (5 patients) versus 15% (n = 20) with placebo (P = .003), a 75% risk reduction.

The incidence of any grade HFS was 6.1% in the treatment group versus 18.1% with placebo (P = .003).

Hand-foot syndrome led to dose reductions of capecitabine in 13.5% of placebo but only 3.8% of those in the diclofenac group (P = .002). 

The findings held regardless of whether patients were being treated for breast or GI cancer or if they were men or women. 

Other capecitabine-induced adverse events, including diarrhea, mucositis, and myelosuppression, were not significantly different between the groups.

The treatment arms were well balanced, with a median age of 47 years in both groups and women making up about 70% of each. About 40% of subjects in each group were on capecitabine monotherapy with the rest on combination treatments. The mean dose of capecitabine was just over 1,880 mg/m2 in both groups.

At the meeting, Dr. Batra was asked if topical diclofenac would also work for another common problem in oncology: hand-food syndrome occurring as a side-effect with VEGF–tyrosine kinase inhibitors. He didn’t think so because it probably has a different cause than capecitabine HFS, one not strongly related to COX-2 up-regulation.

The study was partly funded by the Indian Supportive Care of Cancer Association. The investigators reported no relevant financial relationships.

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

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The common side effect of hand-foot syndrome seen in patients taking capecitabine can be prevented with a cheap and safe topical gel containing 1% diclofenac, researchers reported in a study that has been hailed by experts as “practice changing.”

Hand-foot syndrome causes painful, bleeding blisters and ulcers on the palms and soles. It often leads to dose reductions and sometimes even discontinuations, both of which limit the effectiveness of capecitabine, a standard oral chemotherapy drug widely used for colorectal and breast  cancers.

In a new study presented at the annual meeting of the American Society of Clinical Oncology, Indian researchers reported that a cheap, safe, and widely available over-the-counter nonsteroidal anti-inflammatory gel containing 1% diclofenac reduced the incidence of hand-foot syndrome by 75% among patients with cancer being treated with capecitabine.

Up until now, the oral anti-inflammatory celecoxib (Celebrex) was the only agent proven to prevent the problem, but it’s rarely used because of the risk for strokes, gastric bleeding, and other issues, none of which are a concern with topical diclofenac, which osteoarthritis patients have used safely for years.

The Indian trial, dubbed D-Torch, establishes “1% topical diclofenac gel as the new standard of care to prevent capecitabine-associated hand-foot syndrome,” said investigator and study presenter Atul Batra, MD, a medical oncologist at the All India Institute of Medical Sciences, New Delhi.

Dr. Batra told ASCO Daily News that there is no need for a second trial. “We don’t feel there’s a need to replicate these results” in a larger study “because this was adequately powered, and the results speak for themselves. There’s no confusion about these results. Diclofenac is clearly effective.”

Dr. Batra also commented that his clinic now uses topical diclofenac routinely during capecitabine treatment and that he hopes oncology practices elsewhere will do the same.   

Diclofenac gel is sold under the brand name Voltaren and is also available as a generic; in the United States, a 150-gram tube costs about $18 at Walmart.
 

‘The most practice-changing study’ at ASCO 2023

Audience members at ASCO’s annual meeting immediately saw the importance of the study.

Tarah Ballinger, MD, a breast cancer specialist at Indiana University, Indianapolis, said on Twitter that “this might be the most practice changing study I heard at ASCO23.” Topical diclofenac is “widely available, affordable, [and] addresses [a] major” quality of life issue.



The study discussant at the meeting, gastrointestinal cancer specialist Pallavi Kumar, MD, of the University of Pennsylvania, Philadelphia, concurred: “For me as a GI oncologist, topical diclofenac for prevention of HFS for patients on capecitabine is practice changing,” she said.

The takeaway is “that topical diclofenac significantly reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine.” The results are “very impressive,” Dr. Kumar said.

Study details

The idea for the new study came after Batra and colleagues realized that celecoxib, a COX-2 enzyme inhibitor, helps prevent capecitabine hand-foot syndrome (HFS) by blocking a key process that leads to it, the up-regulation of COX-2 and subsequent release of proinflammatory prostaglandins.

They turned to diclofenac gel hoping to get the same effect but more safely; diclofenac is also a COX-2 blocker, and its topical formulation has a strong safety record. 

To test the approach, the team randomly assigned 130 patients to topical diclofenac and 133 to placebo – the gel vehicle without the medication – while they were being treated with capecitabine for 12 weeks; 56% were being treated for breast cancer and the rest for gastrointestinal cancers.

Subjects rubbed one fingertip’s worth of gel – about half a gram – on each palm and the back of each hand twice a day. The dose was about 4 grams/day, which is well below maximal dosages for osteoarthritis (up to 32 g/day over all affected joints). Adherence to treatment was about 95% in both arms.

By the end of 12 weeks, the incidence of grade 2 or higher HFS was 3.8% in the diclofenac arm (5 patients) versus 15% (n = 20) with placebo (P = .003), a 75% risk reduction.

The incidence of any grade HFS was 6.1% in the treatment group versus 18.1% with placebo (P = .003).

Hand-foot syndrome led to dose reductions of capecitabine in 13.5% of placebo but only 3.8% of those in the diclofenac group (P = .002). 

The findings held regardless of whether patients were being treated for breast or GI cancer or if they were men or women. 

Other capecitabine-induced adverse events, including diarrhea, mucositis, and myelosuppression, were not significantly different between the groups.

The treatment arms were well balanced, with a median age of 47 years in both groups and women making up about 70% of each. About 40% of subjects in each group were on capecitabine monotherapy with the rest on combination treatments. The mean dose of capecitabine was just over 1,880 mg/m2 in both groups.

At the meeting, Dr. Batra was asked if topical diclofenac would also work for another common problem in oncology: hand-food syndrome occurring as a side-effect with VEGF–tyrosine kinase inhibitors. He didn’t think so because it probably has a different cause than capecitabine HFS, one not strongly related to COX-2 up-regulation.

The study was partly funded by the Indian Supportive Care of Cancer Association. The investigators reported no relevant financial relationships.

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

The common side effect of hand-foot syndrome seen in patients taking capecitabine can be prevented with a cheap and safe topical gel containing 1% diclofenac, researchers reported in a study that has been hailed by experts as “practice changing.”

Hand-foot syndrome causes painful, bleeding blisters and ulcers on the palms and soles. It often leads to dose reductions and sometimes even discontinuations, both of which limit the effectiveness of capecitabine, a standard oral chemotherapy drug widely used for colorectal and breast  cancers.

In a new study presented at the annual meeting of the American Society of Clinical Oncology, Indian researchers reported that a cheap, safe, and widely available over-the-counter nonsteroidal anti-inflammatory gel containing 1% diclofenac reduced the incidence of hand-foot syndrome by 75% among patients with cancer being treated with capecitabine.

Up until now, the oral anti-inflammatory celecoxib (Celebrex) was the only agent proven to prevent the problem, but it’s rarely used because of the risk for strokes, gastric bleeding, and other issues, none of which are a concern with topical diclofenac, which osteoarthritis patients have used safely for years.

The Indian trial, dubbed D-Torch, establishes “1% topical diclofenac gel as the new standard of care to prevent capecitabine-associated hand-foot syndrome,” said investigator and study presenter Atul Batra, MD, a medical oncologist at the All India Institute of Medical Sciences, New Delhi.

Dr. Batra told ASCO Daily News that there is no need for a second trial. “We don’t feel there’s a need to replicate these results” in a larger study “because this was adequately powered, and the results speak for themselves. There’s no confusion about these results. Diclofenac is clearly effective.”

Dr. Batra also commented that his clinic now uses topical diclofenac routinely during capecitabine treatment and that he hopes oncology practices elsewhere will do the same.   

Diclofenac gel is sold under the brand name Voltaren and is also available as a generic; in the United States, a 150-gram tube costs about $18 at Walmart.
 

‘The most practice-changing study’ at ASCO 2023

Audience members at ASCO’s annual meeting immediately saw the importance of the study.

Tarah Ballinger, MD, a breast cancer specialist at Indiana University, Indianapolis, said on Twitter that “this might be the most practice changing study I heard at ASCO23.” Topical diclofenac is “widely available, affordable, [and] addresses [a] major” quality of life issue.



The study discussant at the meeting, gastrointestinal cancer specialist Pallavi Kumar, MD, of the University of Pennsylvania, Philadelphia, concurred: “For me as a GI oncologist, topical diclofenac for prevention of HFS for patients on capecitabine is practice changing,” she said.

The takeaway is “that topical diclofenac significantly reduces the incidence of grade 2 or higher HFS in patients receiving capecitabine.” The results are “very impressive,” Dr. Kumar said.

Study details

The idea for the new study came after Batra and colleagues realized that celecoxib, a COX-2 enzyme inhibitor, helps prevent capecitabine hand-foot syndrome (HFS) by blocking a key process that leads to it, the up-regulation of COX-2 and subsequent release of proinflammatory prostaglandins.

They turned to diclofenac gel hoping to get the same effect but more safely; diclofenac is also a COX-2 blocker, and its topical formulation has a strong safety record. 

To test the approach, the team randomly assigned 130 patients to topical diclofenac and 133 to placebo – the gel vehicle without the medication – while they were being treated with capecitabine for 12 weeks; 56% were being treated for breast cancer and the rest for gastrointestinal cancers.

Subjects rubbed one fingertip’s worth of gel – about half a gram – on each palm and the back of each hand twice a day. The dose was about 4 grams/day, which is well below maximal dosages for osteoarthritis (up to 32 g/day over all affected joints). Adherence to treatment was about 95% in both arms.

By the end of 12 weeks, the incidence of grade 2 or higher HFS was 3.8% in the diclofenac arm (5 patients) versus 15% (n = 20) with placebo (P = .003), a 75% risk reduction.

The incidence of any grade HFS was 6.1% in the treatment group versus 18.1% with placebo (P = .003).

Hand-foot syndrome led to dose reductions of capecitabine in 13.5% of placebo but only 3.8% of those in the diclofenac group (P = .002). 

The findings held regardless of whether patients were being treated for breast or GI cancer or if they were men or women. 

Other capecitabine-induced adverse events, including diarrhea, mucositis, and myelosuppression, were not significantly different between the groups.

The treatment arms were well balanced, with a median age of 47 years in both groups and women making up about 70% of each. About 40% of subjects in each group were on capecitabine monotherapy with the rest on combination treatments. The mean dose of capecitabine was just over 1,880 mg/m2 in both groups.

At the meeting, Dr. Batra was asked if topical diclofenac would also work for another common problem in oncology: hand-food syndrome occurring as a side-effect with VEGF–tyrosine kinase inhibitors. He didn’t think so because it probably has a different cause than capecitabine HFS, one not strongly related to COX-2 up-regulation.

The study was partly funded by the Indian Supportive Care of Cancer Association. The investigators reported no relevant financial relationships.

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

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It’s okay to say ‘no’: Setting boundaries in oncology

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Oncologists need to learn how to set boundaries in their professional lives and how to address their fear of saying “no” to sometimes illusory career opportunities in order to protect their well-being and reduce their risk of burnout.

This was the message from speakers at a special session on “Setting Boundaries” during the annual meeting of the American Society of Clinical Oncology (ASCO).

Monica Sheila Chatwal, MD, a medical oncologist at Moffitt Cancer Center and Research Institute, Tampa, Fla., suggested that, like a painting in a museum, physicians should have “some level of guardrail” to protect their knowledge and expertise, and also their ability to be able to continue to care for patients.

Having set boundaries “provides more emotional and cognitive flexibility, and less uncertainty, in the relationships that we have with our colleagues, with our patients, with everyone around us,” she argued.

“More importantly, boundaries acknowledge that, as humans, we are multifaceted, multidimensional people,” and that “we have lives outside of medicine, much as we may or may not want to admit that.

“It’s great to be devoted to what we do, but there are so many other aspects of ourselves that make us who we are, and that is wonderful,” she said.
 

A calling, not a job

However, the idea of demarcating one’s professional and personal life can go against the still-persistent idea that being a doctor is a calling rather than a job.

“I don’t think it matters whether you call it a job or a calling,” commented another speaker at the session, Jonathan M. Marron, MD, MPH, Dana-Farber/Boston Children’s Cancer.

But even if it is a calling, which implies that “you are supposed to devote all of yourself to the work and not to anything else,” there is still a need for setting boundaries, he argued. Saying “no” and allowing “yourself to be yourself” are important measures, Dr. Marron emphasized, as taking time out can make you a better clinician.

Crucial to that is being able to communicate with colleagues and share a degree of “vulnerability,” added Dr. Chatwal. “Showing that you’re vulnerable not only to your trainees, but also to your staff and to your patients really normalizes everything.”

“I have nurses who are feeling like they have to work 24/7 and manage their inbox to answer all of their messages, because they feel like they have to keep up.

“But it’s nice for me to be able to model that and say: ‘Listen, I want you to know it’s not urgent, please take 24 hours and we’ll come back to it.’ ”
 

Communicating with patients

Dr. Chatwal noted that, while there are clear boundaries related to sexual or physical relationships between doctors and patients and around not treating family members or friends, the boundaries pertaining to communication, and “how frequently [patients] have access to us ... are not so clearly defined.”

The advent of telemedicine has added to that, she believes, as it offers a “patient portal that can allow access 24/7.”

“Does that mean we as physicians or providers also give that level of access? Are we supposed to check messages at all periods of time?”

“More and more people are becoming more cognizant of this,” she commented, noting that the issue has taken on greater import with the rise of social media and the “ability for our patients to request us as friends.”

She pointed out that former president of the American College of Physicians Wayne J. Riley, MD, MPH, MBA, suggested doctors should maintain an air of detachment with their patients, as “it allows us to protect ourselves and continue to provide that great level of care.”

On the other hand, she noted that there has been a sea change in how patients see doctors. Whereas in the past, medicine “was very paternalistic” with doctors seen as the “be all and end all,” now patients tend to be more knowledgeable and Dr. Google “makes them much more engaged in their care.”

But this can also cause problems when patients become “demanding for certain treatments,” she said.
 

 

 

Limits to ethical care?

Dr. Marron posed the question: “Is there a limit to my ethical obligations to ethical care?”

He described a hypothetical scenario where a patient has found their doctor’s email address online and they now sends “frequent emails, despite very clear instructions to use the on-call paging system for something that’s urgent, and the electronic health record messaging system otherwise.”

This patient’s behavior is “causing a huge amount of stress” for the doctor, and this is affecting their care of other patients, as well as their academic work and home life.

Dr. Marron asked the audience: Would it be ethically acceptable to stop seeing such a patient?

Taking a quick straw poll of the audience, Dr. Marron noted that there were “not a lot of hands” raised in favor.

He suggested this is because the notion of nonabandonment comes into play, in which there is an obligation to not let patients go without providing adequate time for them to find an alternative clinician.

In this scenario, for example, the doctor could find “several local oncologists who are willing to accept the patient,” as well as talk the situation through with a trusted colleagues, and only then “compassionately but resolutely” tell the patient that they will be transferred.

Dr. Marron acknowledged that this may seem at odds with the theme of this year’s ASCO annual meeting, which emphasizes “partnering with patients.” But he argued that “it doesn’t have to be.”

When thoughtfully done, setting boundaries “can ethically allow us to give more to, and partner more with, our patients, while supporting our well-being, sense of purpose, and job satisfaction,” he argued.
 

Goldilocks situation

Speaking more broadly, Dr. Marron said that boundaries might be considered on a spectrum.

Too few boundaries can lead to conflicts of interest, loss of balance in the patient-physician relationship, and overengagement, while too many boundaries may result in insufficient connection with patients, thus reducing the “human element” and increasing a sense of disengagement.

Either way, “we run the risk of having decreased satisfaction what with what we’re doing, and decreasing the quality of patient care.”

“It’s a little bit of a Goldilocks situation: You want to find just the right balance, somewhere in the middle,” he said.

In the past, issues around having too few boundaries related to conflicts of interest. This reduced trust in the medical profession, he commented, which may have affected patient outcomes, and certainly increased the risk of reduced well-being and burnout.

“Today, we probably still lie on the end of the spectrum with too few boundaries,” Dr. Marron said, “but in a very different way, as we worry about limited work-life balance, and always being connected.”

“I don’t think there’s anybody in the room who doesn’t have some kind of electronic device, either in their hand or not too far from their hand,” he continued.

Moreover, “the patients that we’re taking care of have a greater amount of complexity than they’ve ever had before ... [with] greater numbers of needs than ever before,” and as a result, they require “a greater amount of our time as clinicians.”

Just as with the lack of boundaries in the past, this “runs the risk of us having decreased well-being and an increased risk of burnout,” he suggested.
 

 

 

Wearing several hats

The third speaker, Arif Kamal, MD, MBA, MHS, associate professor of medicine and population health, Duke University, Durham, N.C., and chief patient officer at the American Cancer Society, said that every oncologist wears several “hats” in addition to being a clinician.

These may include, in his case, being “a father, a husband, and a brother, and a soccer coach, and a lot of different things.”

Dr. Kamal underlined that recognizing these various roles is “really important,” especially when it comes to the “moment of comparison with others,” as there is a temptation to see one’s own complexity but not that of a colleague.

“The question is: What are all the other competing priorities that a person faces?”

For example, a person’s tally of publications is “just one of many metrics” when it comes to measuring the “success of a career, and, frankly, I’m not sure that’s one of the good ones,” Dr. Kamal said.

He recalled how a mentor of his when he was at the Mayo Clinic had a “remarkable dip” in the number of publications at a certain point in his career, and he explained to Dr. Kamal that this was the time “when my kids needed me the most.”

“That was really important,” Dr. Kamal said, “because it taught me a lesson about having mentors in your life that are not only focused on your career and academic success, but also those who are very interested in the other hats that you wear.”
 

Fear of saying no

One way of setting boundaries is saying no to certain requests, Dr. Kamal commented.

He gave an example from his own life – when he was at a soccer game and received  a call on his cell from a patient who has seen test results before he has had a chance to review them.

Dr. Kamal also painted a hypothetical scenario, where a doctor on junior faculty, staffing a GI oncology clinic 4 days a week, is also volunteering to collect and organize new cases for the tumor board, and is writing several letters of intent for pharmaceutical trials. They are saying “yes” to 90% of the requests for their time, he said, and the result is they go home “most days feeling like their tank is on empty.”

“Then this person gets asked by the division chief to serve on the hospital’s pain committee,” he said, “regardless of the fact that this is not necessarily in their clinical or research interests.”

“So this is really a bit of an [out of] left field request, and how does this person address this?”

Dr. Kamal said that a useful concept to consider is something commonly ascribed to teenagers, that of the fear of missing out, or FOMO.

The problem is that, “due to this concept of FOMO, when opportunities come your way, saying ‘no’ to them gives rise to the question: What if the opportunity never comes back?”

But Dr. Kamal also reminded the audience that “without being able to say no to things ... your capacity will go down.”

“That’s really important to recognize, because for a long time, healing professions have been thought of as [having] people that can continue to expand and expand and expand, without calling out this concept of inflation.”

This is really about “being true to yourself,” and acknowledging that “no one is going to set boundaries for you.”

“That was a tough lesson I learned in my career,” Dr. Kamal commented, and when he looked for guidance, he found that “everyone is struggling with this.”

Setting boundaries, he emphasized, requires “a certain amount of looking inward ... and it requires some bravery.”

“You just have to ask yourself: Is the only reason you’re going to do something because of FOMO?” Dr. Kamal commented. “Maybe that’s okay, but you have to acknowledge that’s the case.”

Dr. Chatwal reported a relationship with Merck. Dr. Marron reported relationships with Genzyme, Partner Therapeutics, ROM Technologies, Arnett, Draper, & Hagood, and Trentalange & Kelley. Dr. Kamal reported relationships with Acclivity Health, Prepped Health, Private Diagnostic Clinic, AstraZeneca, Care4ward, Compassus, HERON, Janssen Oncology, Medtronic, New Century Health, UnitedHealth Group, and Janssen Oncology.

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

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Oncologists need to learn how to set boundaries in their professional lives and how to address their fear of saying “no” to sometimes illusory career opportunities in order to protect their well-being and reduce their risk of burnout.

This was the message from speakers at a special session on “Setting Boundaries” during the annual meeting of the American Society of Clinical Oncology (ASCO).

Monica Sheila Chatwal, MD, a medical oncologist at Moffitt Cancer Center and Research Institute, Tampa, Fla., suggested that, like a painting in a museum, physicians should have “some level of guardrail” to protect their knowledge and expertise, and also their ability to be able to continue to care for patients.

Having set boundaries “provides more emotional and cognitive flexibility, and less uncertainty, in the relationships that we have with our colleagues, with our patients, with everyone around us,” she argued.

“More importantly, boundaries acknowledge that, as humans, we are multifaceted, multidimensional people,” and that “we have lives outside of medicine, much as we may or may not want to admit that.

“It’s great to be devoted to what we do, but there are so many other aspects of ourselves that make us who we are, and that is wonderful,” she said.
 

A calling, not a job

However, the idea of demarcating one’s professional and personal life can go against the still-persistent idea that being a doctor is a calling rather than a job.

“I don’t think it matters whether you call it a job or a calling,” commented another speaker at the session, Jonathan M. Marron, MD, MPH, Dana-Farber/Boston Children’s Cancer.

But even if it is a calling, which implies that “you are supposed to devote all of yourself to the work and not to anything else,” there is still a need for setting boundaries, he argued. Saying “no” and allowing “yourself to be yourself” are important measures, Dr. Marron emphasized, as taking time out can make you a better clinician.

Crucial to that is being able to communicate with colleagues and share a degree of “vulnerability,” added Dr. Chatwal. “Showing that you’re vulnerable not only to your trainees, but also to your staff and to your patients really normalizes everything.”

“I have nurses who are feeling like they have to work 24/7 and manage their inbox to answer all of their messages, because they feel like they have to keep up.

“But it’s nice for me to be able to model that and say: ‘Listen, I want you to know it’s not urgent, please take 24 hours and we’ll come back to it.’ ”
 

Communicating with patients

Dr. Chatwal noted that, while there are clear boundaries related to sexual or physical relationships between doctors and patients and around not treating family members or friends, the boundaries pertaining to communication, and “how frequently [patients] have access to us ... are not so clearly defined.”

The advent of telemedicine has added to that, she believes, as it offers a “patient portal that can allow access 24/7.”

“Does that mean we as physicians or providers also give that level of access? Are we supposed to check messages at all periods of time?”

“More and more people are becoming more cognizant of this,” she commented, noting that the issue has taken on greater import with the rise of social media and the “ability for our patients to request us as friends.”

She pointed out that former president of the American College of Physicians Wayne J. Riley, MD, MPH, MBA, suggested doctors should maintain an air of detachment with their patients, as “it allows us to protect ourselves and continue to provide that great level of care.”

On the other hand, she noted that there has been a sea change in how patients see doctors. Whereas in the past, medicine “was very paternalistic” with doctors seen as the “be all and end all,” now patients tend to be more knowledgeable and Dr. Google “makes them much more engaged in their care.”

But this can also cause problems when patients become “demanding for certain treatments,” she said.
 

 

 

Limits to ethical care?

Dr. Marron posed the question: “Is there a limit to my ethical obligations to ethical care?”

He described a hypothetical scenario where a patient has found their doctor’s email address online and they now sends “frequent emails, despite very clear instructions to use the on-call paging system for something that’s urgent, and the electronic health record messaging system otherwise.”

This patient’s behavior is “causing a huge amount of stress” for the doctor, and this is affecting their care of other patients, as well as their academic work and home life.

Dr. Marron asked the audience: Would it be ethically acceptable to stop seeing such a patient?

Taking a quick straw poll of the audience, Dr. Marron noted that there were “not a lot of hands” raised in favor.

He suggested this is because the notion of nonabandonment comes into play, in which there is an obligation to not let patients go without providing adequate time for them to find an alternative clinician.

In this scenario, for example, the doctor could find “several local oncologists who are willing to accept the patient,” as well as talk the situation through with a trusted colleagues, and only then “compassionately but resolutely” tell the patient that they will be transferred.

Dr. Marron acknowledged that this may seem at odds with the theme of this year’s ASCO annual meeting, which emphasizes “partnering with patients.” But he argued that “it doesn’t have to be.”

When thoughtfully done, setting boundaries “can ethically allow us to give more to, and partner more with, our patients, while supporting our well-being, sense of purpose, and job satisfaction,” he argued.
 

Goldilocks situation

Speaking more broadly, Dr. Marron said that boundaries might be considered on a spectrum.

Too few boundaries can lead to conflicts of interest, loss of balance in the patient-physician relationship, and overengagement, while too many boundaries may result in insufficient connection with patients, thus reducing the “human element” and increasing a sense of disengagement.

Either way, “we run the risk of having decreased satisfaction what with what we’re doing, and decreasing the quality of patient care.”

“It’s a little bit of a Goldilocks situation: You want to find just the right balance, somewhere in the middle,” he said.

In the past, issues around having too few boundaries related to conflicts of interest. This reduced trust in the medical profession, he commented, which may have affected patient outcomes, and certainly increased the risk of reduced well-being and burnout.

“Today, we probably still lie on the end of the spectrum with too few boundaries,” Dr. Marron said, “but in a very different way, as we worry about limited work-life balance, and always being connected.”

“I don’t think there’s anybody in the room who doesn’t have some kind of electronic device, either in their hand or not too far from their hand,” he continued.

Moreover, “the patients that we’re taking care of have a greater amount of complexity than they’ve ever had before ... [with] greater numbers of needs than ever before,” and as a result, they require “a greater amount of our time as clinicians.”

Just as with the lack of boundaries in the past, this “runs the risk of us having decreased well-being and an increased risk of burnout,” he suggested.
 

 

 

Wearing several hats

The third speaker, Arif Kamal, MD, MBA, MHS, associate professor of medicine and population health, Duke University, Durham, N.C., and chief patient officer at the American Cancer Society, said that every oncologist wears several “hats” in addition to being a clinician.

These may include, in his case, being “a father, a husband, and a brother, and a soccer coach, and a lot of different things.”

Dr. Kamal underlined that recognizing these various roles is “really important,” especially when it comes to the “moment of comparison with others,” as there is a temptation to see one’s own complexity but not that of a colleague.

“The question is: What are all the other competing priorities that a person faces?”

For example, a person’s tally of publications is “just one of many metrics” when it comes to measuring the “success of a career, and, frankly, I’m not sure that’s one of the good ones,” Dr. Kamal said.

He recalled how a mentor of his when he was at the Mayo Clinic had a “remarkable dip” in the number of publications at a certain point in his career, and he explained to Dr. Kamal that this was the time “when my kids needed me the most.”

“That was really important,” Dr. Kamal said, “because it taught me a lesson about having mentors in your life that are not only focused on your career and academic success, but also those who are very interested in the other hats that you wear.”
 

Fear of saying no

One way of setting boundaries is saying no to certain requests, Dr. Kamal commented.

He gave an example from his own life – when he was at a soccer game and received  a call on his cell from a patient who has seen test results before he has had a chance to review them.

Dr. Kamal also painted a hypothetical scenario, where a doctor on junior faculty, staffing a GI oncology clinic 4 days a week, is also volunteering to collect and organize new cases for the tumor board, and is writing several letters of intent for pharmaceutical trials. They are saying “yes” to 90% of the requests for their time, he said, and the result is they go home “most days feeling like their tank is on empty.”

“Then this person gets asked by the division chief to serve on the hospital’s pain committee,” he said, “regardless of the fact that this is not necessarily in their clinical or research interests.”

“So this is really a bit of an [out of] left field request, and how does this person address this?”

Dr. Kamal said that a useful concept to consider is something commonly ascribed to teenagers, that of the fear of missing out, or FOMO.

The problem is that, “due to this concept of FOMO, when opportunities come your way, saying ‘no’ to them gives rise to the question: What if the opportunity never comes back?”

But Dr. Kamal also reminded the audience that “without being able to say no to things ... your capacity will go down.”

“That’s really important to recognize, because for a long time, healing professions have been thought of as [having] people that can continue to expand and expand and expand, without calling out this concept of inflation.”

This is really about “being true to yourself,” and acknowledging that “no one is going to set boundaries for you.”

“That was a tough lesson I learned in my career,” Dr. Kamal commented, and when he looked for guidance, he found that “everyone is struggling with this.”

Setting boundaries, he emphasized, requires “a certain amount of looking inward ... and it requires some bravery.”

“You just have to ask yourself: Is the only reason you’re going to do something because of FOMO?” Dr. Kamal commented. “Maybe that’s okay, but you have to acknowledge that’s the case.”

Dr. Chatwal reported a relationship with Merck. Dr. Marron reported relationships with Genzyme, Partner Therapeutics, ROM Technologies, Arnett, Draper, & Hagood, and Trentalange & Kelley. Dr. Kamal reported relationships with Acclivity Health, Prepped Health, Private Diagnostic Clinic, AstraZeneca, Care4ward, Compassus, HERON, Janssen Oncology, Medtronic, New Century Health, UnitedHealth Group, and Janssen Oncology.

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

Oncologists need to learn how to set boundaries in their professional lives and how to address their fear of saying “no” to sometimes illusory career opportunities in order to protect their well-being and reduce their risk of burnout.

This was the message from speakers at a special session on “Setting Boundaries” during the annual meeting of the American Society of Clinical Oncology (ASCO).

Monica Sheila Chatwal, MD, a medical oncologist at Moffitt Cancer Center and Research Institute, Tampa, Fla., suggested that, like a painting in a museum, physicians should have “some level of guardrail” to protect their knowledge and expertise, and also their ability to be able to continue to care for patients.

Having set boundaries “provides more emotional and cognitive flexibility, and less uncertainty, in the relationships that we have with our colleagues, with our patients, with everyone around us,” she argued.

“More importantly, boundaries acknowledge that, as humans, we are multifaceted, multidimensional people,” and that “we have lives outside of medicine, much as we may or may not want to admit that.

“It’s great to be devoted to what we do, but there are so many other aspects of ourselves that make us who we are, and that is wonderful,” she said.
 

A calling, not a job

However, the idea of demarcating one’s professional and personal life can go against the still-persistent idea that being a doctor is a calling rather than a job.

“I don’t think it matters whether you call it a job or a calling,” commented another speaker at the session, Jonathan M. Marron, MD, MPH, Dana-Farber/Boston Children’s Cancer.

But even if it is a calling, which implies that “you are supposed to devote all of yourself to the work and not to anything else,” there is still a need for setting boundaries, he argued. Saying “no” and allowing “yourself to be yourself” are important measures, Dr. Marron emphasized, as taking time out can make you a better clinician.

Crucial to that is being able to communicate with colleagues and share a degree of “vulnerability,” added Dr. Chatwal. “Showing that you’re vulnerable not only to your trainees, but also to your staff and to your patients really normalizes everything.”

“I have nurses who are feeling like they have to work 24/7 and manage their inbox to answer all of their messages, because they feel like they have to keep up.

“But it’s nice for me to be able to model that and say: ‘Listen, I want you to know it’s not urgent, please take 24 hours and we’ll come back to it.’ ”
 

Communicating with patients

Dr. Chatwal noted that, while there are clear boundaries related to sexual or physical relationships between doctors and patients and around not treating family members or friends, the boundaries pertaining to communication, and “how frequently [patients] have access to us ... are not so clearly defined.”

The advent of telemedicine has added to that, she believes, as it offers a “patient portal that can allow access 24/7.”

“Does that mean we as physicians or providers also give that level of access? Are we supposed to check messages at all periods of time?”

“More and more people are becoming more cognizant of this,” she commented, noting that the issue has taken on greater import with the rise of social media and the “ability for our patients to request us as friends.”

She pointed out that former president of the American College of Physicians Wayne J. Riley, MD, MPH, MBA, suggested doctors should maintain an air of detachment with their patients, as “it allows us to protect ourselves and continue to provide that great level of care.”

On the other hand, she noted that there has been a sea change in how patients see doctors. Whereas in the past, medicine “was very paternalistic” with doctors seen as the “be all and end all,” now patients tend to be more knowledgeable and Dr. Google “makes them much more engaged in their care.”

But this can also cause problems when patients become “demanding for certain treatments,” she said.
 

 

 

Limits to ethical care?

Dr. Marron posed the question: “Is there a limit to my ethical obligations to ethical care?”

He described a hypothetical scenario where a patient has found their doctor’s email address online and they now sends “frequent emails, despite very clear instructions to use the on-call paging system for something that’s urgent, and the electronic health record messaging system otherwise.”

This patient’s behavior is “causing a huge amount of stress” for the doctor, and this is affecting their care of other patients, as well as their academic work and home life.

Dr. Marron asked the audience: Would it be ethically acceptable to stop seeing such a patient?

Taking a quick straw poll of the audience, Dr. Marron noted that there were “not a lot of hands” raised in favor.

He suggested this is because the notion of nonabandonment comes into play, in which there is an obligation to not let patients go without providing adequate time for them to find an alternative clinician.

In this scenario, for example, the doctor could find “several local oncologists who are willing to accept the patient,” as well as talk the situation through with a trusted colleagues, and only then “compassionately but resolutely” tell the patient that they will be transferred.

Dr. Marron acknowledged that this may seem at odds with the theme of this year’s ASCO annual meeting, which emphasizes “partnering with patients.” But he argued that “it doesn’t have to be.”

When thoughtfully done, setting boundaries “can ethically allow us to give more to, and partner more with, our patients, while supporting our well-being, sense of purpose, and job satisfaction,” he argued.
 

Goldilocks situation

Speaking more broadly, Dr. Marron said that boundaries might be considered on a spectrum.

Too few boundaries can lead to conflicts of interest, loss of balance in the patient-physician relationship, and overengagement, while too many boundaries may result in insufficient connection with patients, thus reducing the “human element” and increasing a sense of disengagement.

Either way, “we run the risk of having decreased satisfaction what with what we’re doing, and decreasing the quality of patient care.”

“It’s a little bit of a Goldilocks situation: You want to find just the right balance, somewhere in the middle,” he said.

In the past, issues around having too few boundaries related to conflicts of interest. This reduced trust in the medical profession, he commented, which may have affected patient outcomes, and certainly increased the risk of reduced well-being and burnout.

“Today, we probably still lie on the end of the spectrum with too few boundaries,” Dr. Marron said, “but in a very different way, as we worry about limited work-life balance, and always being connected.”

“I don’t think there’s anybody in the room who doesn’t have some kind of electronic device, either in their hand or not too far from their hand,” he continued.

Moreover, “the patients that we’re taking care of have a greater amount of complexity than they’ve ever had before ... [with] greater numbers of needs than ever before,” and as a result, they require “a greater amount of our time as clinicians.”

Just as with the lack of boundaries in the past, this “runs the risk of us having decreased well-being and an increased risk of burnout,” he suggested.
 

 

 

Wearing several hats

The third speaker, Arif Kamal, MD, MBA, MHS, associate professor of medicine and population health, Duke University, Durham, N.C., and chief patient officer at the American Cancer Society, said that every oncologist wears several “hats” in addition to being a clinician.

These may include, in his case, being “a father, a husband, and a brother, and a soccer coach, and a lot of different things.”

Dr. Kamal underlined that recognizing these various roles is “really important,” especially when it comes to the “moment of comparison with others,” as there is a temptation to see one’s own complexity but not that of a colleague.

“The question is: What are all the other competing priorities that a person faces?”

For example, a person’s tally of publications is “just one of many metrics” when it comes to measuring the “success of a career, and, frankly, I’m not sure that’s one of the good ones,” Dr. Kamal said.

He recalled how a mentor of his when he was at the Mayo Clinic had a “remarkable dip” in the number of publications at a certain point in his career, and he explained to Dr. Kamal that this was the time “when my kids needed me the most.”

“That was really important,” Dr. Kamal said, “because it taught me a lesson about having mentors in your life that are not only focused on your career and academic success, but also those who are very interested in the other hats that you wear.”
 

Fear of saying no

One way of setting boundaries is saying no to certain requests, Dr. Kamal commented.

He gave an example from his own life – when he was at a soccer game and received  a call on his cell from a patient who has seen test results before he has had a chance to review them.

Dr. Kamal also painted a hypothetical scenario, where a doctor on junior faculty, staffing a GI oncology clinic 4 days a week, is also volunteering to collect and organize new cases for the tumor board, and is writing several letters of intent for pharmaceutical trials. They are saying “yes” to 90% of the requests for their time, he said, and the result is they go home “most days feeling like their tank is on empty.”

“Then this person gets asked by the division chief to serve on the hospital’s pain committee,” he said, “regardless of the fact that this is not necessarily in their clinical or research interests.”

“So this is really a bit of an [out of] left field request, and how does this person address this?”

Dr. Kamal said that a useful concept to consider is something commonly ascribed to teenagers, that of the fear of missing out, or FOMO.

The problem is that, “due to this concept of FOMO, when opportunities come your way, saying ‘no’ to them gives rise to the question: What if the opportunity never comes back?”

But Dr. Kamal also reminded the audience that “without being able to say no to things ... your capacity will go down.”

“That’s really important to recognize, because for a long time, healing professions have been thought of as [having] people that can continue to expand and expand and expand, without calling out this concept of inflation.”

This is really about “being true to yourself,” and acknowledging that “no one is going to set boundaries for you.”

“That was a tough lesson I learned in my career,” Dr. Kamal commented, and when he looked for guidance, he found that “everyone is struggling with this.”

Setting boundaries, he emphasized, requires “a certain amount of looking inward ... and it requires some bravery.”

“You just have to ask yourself: Is the only reason you’re going to do something because of FOMO?” Dr. Kamal commented. “Maybe that’s okay, but you have to acknowledge that’s the case.”

Dr. Chatwal reported a relationship with Merck. Dr. Marron reported relationships with Genzyme, Partner Therapeutics, ROM Technologies, Arnett, Draper, & Hagood, and Trentalange & Kelley. Dr. Kamal reported relationships with Acclivity Health, Prepped Health, Private Diagnostic Clinic, AstraZeneca, Care4ward, Compassus, HERON, Janssen Oncology, Medtronic, New Century Health, UnitedHealth Group, and Janssen Oncology.

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

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