User login
FDA approves glofitamab for DLBCL
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 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 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.”
‘Professional grief’ is a daily reality for oncologists
– 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.
– 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.
– 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.
FROM ASCO 2023
Rehabilitation improves walk test results for post–pulmonary embolism patients with persistent dyspnea
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
In patients with persistent dyspnea following a pulmonary embolism, rehabilitation should be considered as a treatment option, according to findings from a randomized, controlled trial comparing usual care to a twice-weekly, 8-week physical exercise program.
The prevalence of persistent dyspnea, functional limitations, and reduced quality of life (QoL) after pulmonary embolism (PE) ranges from 30% to 50% in published studies. While the underlying mechanisms remain unclear and are likely multifactorial, Øyvind Jervan, MD, and colleagues reported, research suggests that deconditioning and psychological factors contribute substantially to post-PE impairment. Optimal management remains unknown.
The investigators randomized adult patients 1:1 from two hospitals (Osfold Hospital and Akershus University Hospital) with PE identified via computed tomography pulmonary angiography 6-72 months prior to study inclusion to either a supervised outpatient exercise program or usual care. The once- or twice-weekly home-based program was tailored to each participant and included a 90-minute educational session on the cardiopulmonary system, diagnosis and treatment of PE and its possible long-term effects, the benefits of exercise and physical activity, and the management of breathlessness. Also during the intervention period, participants were given a simple home-based exercise program to be performed once or twice weekly. Differences between groups in the Incremental Shuttle Walk Test (ISWT), a standardized walking test that assesses exercise capacity, was the primary endpoint. Secondary endpoints included an endurance walk test (ESWT) and measures of symptoms and QoL.
Among 211 participants (median age 57 years; 56% men), the median time from diagnosis to inclusion was 10.3 months. Median baseline walking distance on the ISWT was 695 m with 21% achieving the 1,020-m maximum distance. At follow-up, a between-group difference of 53.0 m favored the rehabilitation group (89 evaluable subjects; 87 in usual care) (P = .0035). While subgroup analysis revealed a greater difference for those with shorter time from diagnosis (6-12 months vs. 12.1-72 months), the between-group differences were nonsignificant. Also, no ISWT differences between the intervention and control group were found for those with higher pulmonary embolism severity and dyspnea scores. The walk endurance test revealed no between-group differences.
Scores at follow-up on the Pulmonary Embolism-QoL questionnaire favored the rehabilitation group (mean difference –4%; P = .041), but there were no differences in generic QoL, dyspnea scores, or the ESWT.
“The present study adds to the growing evidence of the benefits of rehabilitation after PE,” the researchers stated. Although several recent studies have shown rehabilitation after PE results that were promising, the authors pointed out that most of these studies have been small or have lacked a control group, with great variations between them with respect to time, mode, and duration of intervention. In addition, the current study is the largest one addressing the effect of rehabilitation after PE to demonstrate in subjects with persistent dyspnea a positive effect on exercise capacity and QoL.
The researchers also commented that the small detected mean difference of 53 m in walking distance was lower than has been considered a worthwhile improvement by some, and its clinical relevance can be debated. Other studies, however, have used mean group differences of 40-62 m as clinically meaningful. The authors underscored also that the ISWT data were subject to a considerable ceiling effect which may underestimate the effect size.
Addressing study limitations, the researchers added that: “The rehabilitation program in the present study consisted mainly of exercise training. It is unknown whether the addition of occupational therapy, psychology, or dietary therapy would provide additional benefits for the participants. Most participants had mild symptoms, which may have limited the potential benefits of our rehabilitation program.”
The project was funded by Østfold Hospital Trust. Dr. Jervan reported no relevant conflicts of interest.
FROM THE JOURNAL CHEST
Patients with post-COVID cognitive symptoms may have gliosis
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
In a case-control study of 40 patients who were treated at a tertiary care psychiatric hospital in Canada, the level of translocator protein total distribution volume (TSPO VT), a marker of gliosis, was 9.23 mL/cm3 among patients with COVID-DC and 7.72 mL/cm3 among control persons. Differences were particularly notable in the ventral striatum and dorsal putamen.
“Most theories assume there is inflammation in the brain [with] long COVID,” but that assumption had not been studied, author Jeffrey H. Meyer, MD, PhD, Canada Research Chair in Neurochemistry of Major Depressive Disorder at the University of Toronto, said in an interview. “Such information is pivotal to developing treatments.”
The study was published online in JAMA Psychiatry.
Quantifiable marker
The investigators sought to determine whether levels of TSPO VT, which are quantifiable with PET, are elevated in the dorsal putamen, ventral striatum, prefrontal cortex, anterior cingulate cortex, and hippocampus of patients with COVID-DC, compared with patients without this syndrome. These brain regions were chosen, according to the authors, “because injury in these regions, which can cause gliosis, also induces symptoms of COVID-DC.”
The study was conducted from April 2021 through June 30, 2022. The investigators compared levels of TSPO VT in the selected brain regions of 20 participants with COVID-DC (mean age, 32.7 years; 60% women) with that of 20 control persons (mean age, 33.3 years; 55% women). TSPO VT was measured with fluorine F18–labeled N-(2-(2-fluoroethoxy)benzyl)-N-(4-phenoxypyridin-3-yl)acetamide PET.
The difference in TSPO VT was most noticeable in the ventral striatum (mean difference, 1.97 mL/cm3) and dorsal putamen (mean difference, 1.70 mL/cm3). The study authors suggest that gliosis in these areas may explain some of the persistent symptoms reported in structured clinical interviews and assessed on neuropsychological and psychological testing.
For patients with COVID-DC, motor speed on the finger-tapping test was negatively associated with dorsal putamen TSPO VT (r, −0.53). The 10 participants with COVID-DC whose speed was lowest had higher mean dorsal putamen TSPO VT levels than those of control persons by 2.3 mL/cm3.
The investigators could not assess a possible association between the ventral striatum TSPO VT and anhedonia because all participants had these symptoms. No significant correlations were found between depression and TSPO VT in the prefrontal cortex or anterior cingulate cortex.
The authors acknowledged that the study was cross-sectional, and so the duration of persistently elevated TSPO VT is not yet known. In addition, elevation in TSPO VT is not completely specific to glial cells, and although correlations with finger-tapping test performance reflect associations between brain changes and symptoms, they do not prove cause and effect.
“Presently, clinicians can use treatments for symptoms in other illnesses that are [also] common with long COVID. We need better than this,” said Dr. Meyer. “Clients with long COVID should be able to state their symptoms, and the practitioner should have an evidence-based matching treatment to recommend.”
Research is ongoing. “We are acquiring more information regarding different types of inflammation in the brain, whether there is ongoing injury, and whether treatments that influence inflammation are helpful,” said Dr. Meyer.
Jigsaw puzzle
“While this is an important piece in the jigsaw puzzle of neuroinflammation in chronic neurological disease, it is important to keep in mind that we still lack understanding of the complex picture for several reasons,” Alexander Gerhard, MD, honorary senior lecturer in neuroscience at the University of Manchester, England, wrote in an accompanying editorial.
Among these reasons is that the PET technique used in the study is noisy and not restricted to glial cells, he wrote. TSPO expression is only one part of the brain’s neuroinflammatory response, but PET techniques “do not currently allow us to distinguish between different states of microglial activation.” In addition, “a much more detailed understanding of microglial activation at different time points” is needed before neuroinflammatory changes can be targeted therapeutically, Dr. Gerhard wrote.
In a comment, Vilma Gabbay, MD, professor of psychiatry and neuroscience and director of biomarkers and dimensional psychiatry in the Psychiatry Research Institute at Montefiore Einstein, Albert Einstein College of Medicine, New York, said that “this is an important initial step to better understand the neuropsychiatric consequences of COVID even in only a mild and moderate viral illness.” TSPO imaging through PET scanning has been used as an index for neuroinflammation and gliosis. Researchers have used it to study neurodegenerative diseases, but as the authors noted, the ligand is not specific for gliosis.
“Follow-up large cohort studies including other measures of neuroimaging modalities assessing circuitry and neurochemistry are needed,” she said. “Similarly, studying the blood-brain barrier will also allow us to better understand how the immune reaction in the blood transitions to the brain.”
This field of research is evolving, and clinical trials are ongoing, Dr. Gabbay added. Meanwhile, clinicians should monitor for, assess, and treat neuropsychiatric symptoms and “follow the literature for new research and management recommendations.”
The study was primarily funded by a Canadian Institutes of Health Research Project grant to the authors, with some funding from the Canadian Institute for Military and Veteran Health Research. Dr. Meyer received support from their Canada Research Chair awards and received grants and support from several pharmaceutical companies outside of the submitted work. Dr. Gerhard and Dr. Gabbay disclosed no relevant financial relationships.
A version of this article first appeared on Medscape.com.
FROM JAMA PSYCHIATRY
ASCO 2023: Promising results in breast cancer from NATALEE and PHERGain
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.
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.
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.
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.
Low-carb, plant-rich diets tied to breast cancer survival?
TOPLINE:
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:
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:
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.
Experts share their sun protection tips for children
“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.
“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.
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.
“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.
“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.
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.
“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.
“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.
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.
FROM THE MEDSCAPELIVE! HAWAII DERMATOLOGY SEMINAR
High physical activity reduces visceral fat mass and percentage body fat in PsA
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Key clinical point: The visceral fat mass and percentage body fat were significantly higher in patients with psoriatic arthritis (PsA) compared with control individuals, and moderate-to-high physical activity was associated with reduced visceral fat mass and percentage body fat.
Major finding: PsA was associated with a mean increase in visceral fat mass of 2.0 kg (95% CI 1.2-2.8 kg) and in percentage body fat of 2.7% (95% CI 1.6%-3.8%). Moderate and high vs low physical activity were associated with lower visceral fat mass and percentage body fat in patients with PsA and control individuals (P < .001).
Study details: The data come from a retrospective study including 356 patients with PsA and 47,470 control individuals.
Disclosures: This study was funded by the Faculty of Medicine and Health Sciences at Norwegian University of Science and Technology. M Hoff declared receiving speaker honoraria from AbbVie and Janssen Pharmaceuticals. No other conflicts of interest were declared.
Source: Osman AA et al. High physical activity in persons with psoriatic arthritis is associated with reduced visceral fat mass and percentage body fat: The Trøndelag Health study. Rheumatol Int. 2023 (Jun 5). doi: 10.1007/s00296-023-05348-9
Higher disease burden among women with PsA vs RA
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Key clinical point: Patients with psoriatic arthritis (PsA), particularly women, have higher disease burden from the patient’s perspective than those with rheumatoid arthritis (RA).
Major finding: The mean Visual Analogue Scale scores for pain (34 vs 32; P < .001) and fatigue (35 vs 33; P = .001) were slightly higher in patients with PsA vs RA. Women with PsA vs RA across all age groups had significantly higher scores for pain (<50 years old: 28 vs 18; >70 years old: 48 vs 38) and fatigue (50-59 years old: 41 vs 31; >70 years old: 46 vs 36; all P < .05).
Study details: Findings are from a cross-sectional analysis including patients with PsA (n = 3598) and RA (n = 13,913).
Disclosures: This study was funded by State Research Funding, Kuopio University Hospital Catchment Area, Kuopio, Finland. The authors declared no conflicts of interest.
Source: Weman L et al. Disease burden measured by patient-reported outcomes: Does psoriatic arthritis feel worse than rheumatoid arthritis? A cross-sectional nationwide study. Clin Exp Rheumatol. 2023 (May 15). doi: 10.55563/clinexprheumatol/h9hn90
Patients with PsA, especially women, likely to have abnormal sleep behavior
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912
Key clinical point: Many patients with psoriatic arthritis (PsA) and axial spondyloarthritis (axSpA) have impaired sleep despite treatment, with female patients having worse sleep quality than male patients.
Major finding: Overall, 46.6% of patients in the entire cohort had abnormal sleep behavior, with sleep quality being worse in women vs men (P < .001). Depressive symptoms (P < .001), female sex (P = .014), and Disease Activity Score in 28 joints (P = .003) predicted insomnia in PsA.
Study details: The data come from a retrospective medical chart analysis of 330 patients with spondyloarthritis, including 168 patients with PsA and 162 patients with axSpA.
Disclosures: This study was partly funded by an unrestricted grant from Novartis Pharma GmbH, Germany. Several authors, including the lead author, reported receiving speaker honoraria or research or travel grants or serving on advisory boards for several sources, including Novartis.
Source: Frede N et al. Sleep behaviour differs in women and men with psoriatic arthritis and axial spondyloarthritis with impact on quality of life and depressive symptoms. RMD Open. 2023;9:e002912 (May 19). doi: 10.1136/rmdopen-2022-002912