User login
Investigators recommend expanding testing for Lynch syndrome
Strict adherence to pathology guidelines for interpreting immumohistochemical (IHC) staining in endometrial cancer samples may miss the opportunity to identify patients with Lynch syndrome, investigators cautioned.
Current College of American Pathologists recommendations say that any partial, indeterminate, or “heterogeneous” IHC staining for DNA mismatch repair proteins (MMRP) should be considered as intact expression staining.
However, a retrospective review of patients with endometrial cancer showed that 3 of 13 patients with Lynch syndrome had a small proportion of staining and would have been considered at low risk for Lynch syndrome if the reporting rules were followed to the letter, according to Courtney J. Riedinger, MD, and colleagues from the University of Tennessee Medical Center in Knoxville.
“IHC staining for mismatch repair proteins is a way to screen for who should get genetic testing [for Lynch syndrome],” Dr. Riedinger said in an interview. “The pathology guidelines say that any expression is intact staining, but we found some tumor specimens that have about only 20% staining, and we found that 3 of 27 patients with a range of 20%-60% expression had Lynch syndrome.”
The findings suggest that genetic testing for Lynch syndrome should be considered in patients with heterogeneous staining for MMRP, Dr. Riedinger and colleagues wrote in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled due to the COVID-19 pandemic.A recent systematic review estimated the prevalence of Lynch syndrome in women with endometrial cancer to be 3%. The authors of the review recommended universal screening for Lynch syndrome in women with endometrial cancer (Genet Med. 2019 Oct;21[10]:2167-2180).
As Dr. Riedinger and colleagues noted, screening for Lynch syndrome can be performed clinically with microsatellite instability testing or IHC staining for MMRP.
To determine the frequency of Lynch syndrome in women with endometrial cancer whose samples exhibited heterogeneous staining for MMRP, the investigators conducted a retrospective review.
They identified 455 women who underwent hysterectomy for endometrial cancer during 2012-2017. Of this group, samples from 315 patients had no MMRP loss, 92 had complete loss, and 48 had heterogeneous MMRP staining. Of the latter group, 21 samples were reported as intact, and 27 were reported as heterogeneous.
A total of 13 patients were identified as having Lynch syndrome, including 3 of the 27 patients with reported heterogeneous staining and 10 with reported complete loss of MMRP.
The investigators found the frequency of Lynch syndrome among patients with reported heterogeneous staining was not significantly different than that for patients with complete MMRP loss. In addition, there were no significant differences between samples with heterogeneous or complete loss of staining by type of MMRP.
“Our data suggest genetic testing for Lynch syndrome in patients with heterogeneous IHC staining for MMRP should be considered. Current reporting guidelines regarding MMRP expression in endometrial cancer patients need to be reevaluated,” Dr. Riedinger and colleagues concluded.
Dr. Riedinger reported no conflicts of interest. The study was internally funded.
SOURCE: Riedinger CJ et al. SGO 2020, Abstract 104.
Strict adherence to pathology guidelines for interpreting immumohistochemical (IHC) staining in endometrial cancer samples may miss the opportunity to identify patients with Lynch syndrome, investigators cautioned.
Current College of American Pathologists recommendations say that any partial, indeterminate, or “heterogeneous” IHC staining for DNA mismatch repair proteins (MMRP) should be considered as intact expression staining.
However, a retrospective review of patients with endometrial cancer showed that 3 of 13 patients with Lynch syndrome had a small proportion of staining and would have been considered at low risk for Lynch syndrome if the reporting rules were followed to the letter, according to Courtney J. Riedinger, MD, and colleagues from the University of Tennessee Medical Center in Knoxville.
“IHC staining for mismatch repair proteins is a way to screen for who should get genetic testing [for Lynch syndrome],” Dr. Riedinger said in an interview. “The pathology guidelines say that any expression is intact staining, but we found some tumor specimens that have about only 20% staining, and we found that 3 of 27 patients with a range of 20%-60% expression had Lynch syndrome.”
The findings suggest that genetic testing for Lynch syndrome should be considered in patients with heterogeneous staining for MMRP, Dr. Riedinger and colleagues wrote in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled due to the COVID-19 pandemic.A recent systematic review estimated the prevalence of Lynch syndrome in women with endometrial cancer to be 3%. The authors of the review recommended universal screening for Lynch syndrome in women with endometrial cancer (Genet Med. 2019 Oct;21[10]:2167-2180).
As Dr. Riedinger and colleagues noted, screening for Lynch syndrome can be performed clinically with microsatellite instability testing or IHC staining for MMRP.
To determine the frequency of Lynch syndrome in women with endometrial cancer whose samples exhibited heterogeneous staining for MMRP, the investigators conducted a retrospective review.
They identified 455 women who underwent hysterectomy for endometrial cancer during 2012-2017. Of this group, samples from 315 patients had no MMRP loss, 92 had complete loss, and 48 had heterogeneous MMRP staining. Of the latter group, 21 samples were reported as intact, and 27 were reported as heterogeneous.
A total of 13 patients were identified as having Lynch syndrome, including 3 of the 27 patients with reported heterogeneous staining and 10 with reported complete loss of MMRP.
The investigators found the frequency of Lynch syndrome among patients with reported heterogeneous staining was not significantly different than that for patients with complete MMRP loss. In addition, there were no significant differences between samples with heterogeneous or complete loss of staining by type of MMRP.
“Our data suggest genetic testing for Lynch syndrome in patients with heterogeneous IHC staining for MMRP should be considered. Current reporting guidelines regarding MMRP expression in endometrial cancer patients need to be reevaluated,” Dr. Riedinger and colleagues concluded.
Dr. Riedinger reported no conflicts of interest. The study was internally funded.
SOURCE: Riedinger CJ et al. SGO 2020, Abstract 104.
Strict adherence to pathology guidelines for interpreting immumohistochemical (IHC) staining in endometrial cancer samples may miss the opportunity to identify patients with Lynch syndrome, investigators cautioned.
Current College of American Pathologists recommendations say that any partial, indeterminate, or “heterogeneous” IHC staining for DNA mismatch repair proteins (MMRP) should be considered as intact expression staining.
However, a retrospective review of patients with endometrial cancer showed that 3 of 13 patients with Lynch syndrome had a small proportion of staining and would have been considered at low risk for Lynch syndrome if the reporting rules were followed to the letter, according to Courtney J. Riedinger, MD, and colleagues from the University of Tennessee Medical Center in Knoxville.
“IHC staining for mismatch repair proteins is a way to screen for who should get genetic testing [for Lynch syndrome],” Dr. Riedinger said in an interview. “The pathology guidelines say that any expression is intact staining, but we found some tumor specimens that have about only 20% staining, and we found that 3 of 27 patients with a range of 20%-60% expression had Lynch syndrome.”
The findings suggest that genetic testing for Lynch syndrome should be considered in patients with heterogeneous staining for MMRP, Dr. Riedinger and colleagues wrote in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled due to the COVID-19 pandemic.A recent systematic review estimated the prevalence of Lynch syndrome in women with endometrial cancer to be 3%. The authors of the review recommended universal screening for Lynch syndrome in women with endometrial cancer (Genet Med. 2019 Oct;21[10]:2167-2180).
As Dr. Riedinger and colleagues noted, screening for Lynch syndrome can be performed clinically with microsatellite instability testing or IHC staining for MMRP.
To determine the frequency of Lynch syndrome in women with endometrial cancer whose samples exhibited heterogeneous staining for MMRP, the investigators conducted a retrospective review.
They identified 455 women who underwent hysterectomy for endometrial cancer during 2012-2017. Of this group, samples from 315 patients had no MMRP loss, 92 had complete loss, and 48 had heterogeneous MMRP staining. Of the latter group, 21 samples were reported as intact, and 27 were reported as heterogeneous.
A total of 13 patients were identified as having Lynch syndrome, including 3 of the 27 patients with reported heterogeneous staining and 10 with reported complete loss of MMRP.
The investigators found the frequency of Lynch syndrome among patients with reported heterogeneous staining was not significantly different than that for patients with complete MMRP loss. In addition, there were no significant differences between samples with heterogeneous or complete loss of staining by type of MMRP.
“Our data suggest genetic testing for Lynch syndrome in patients with heterogeneous IHC staining for MMRP should be considered. Current reporting guidelines regarding MMRP expression in endometrial cancer patients need to be reevaluated,” Dr. Riedinger and colleagues concluded.
Dr. Riedinger reported no conflicts of interest. The study was internally funded.
SOURCE: Riedinger CJ et al. SGO 2020, Abstract 104.
FROM SGO 2020
Conducting cancer trials amid the COVID-19 pandemic
More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.
The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.
The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.
The impact of COVID-19 on cancer research
Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.
Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.
New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.
Standards that have changed and those that have not
Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.
Among other topics, guidance documents have addressed:
- How COVID-19-related protocol deviations will be judged at monitoring visits and audits
- Missed office visits and endpoint evaluations
- Providing investigational oral medications to patients via mail and potential issues of medication unavailability
- Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
- Potential delays in submitting protocol amendments for institutional review board (IRB) review
- Recommendations for patients confirmed or suspected of having a coronavirus infection.
Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.
Dr. Oyer urged programs to:
- Maintain good clinical practice standards
- Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
- Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.
New questions and considerations
In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.
He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.
To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.
In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
Looking to the future
For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.
When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.
Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.
He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.
The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.
The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.
The impact of COVID-19 on cancer research
Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.
Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.
New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.
Standards that have changed and those that have not
Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.
Among other topics, guidance documents have addressed:
- How COVID-19-related protocol deviations will be judged at monitoring visits and audits
- Missed office visits and endpoint evaluations
- Providing investigational oral medications to patients via mail and potential issues of medication unavailability
- Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
- Potential delays in submitting protocol amendments for institutional review board (IRB) review
- Recommendations for patients confirmed or suspected of having a coronavirus infection.
Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.
Dr. Oyer urged programs to:
- Maintain good clinical practice standards
- Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
- Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.
New questions and considerations
In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.
He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.
To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.
In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
Looking to the future
For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.
When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.
Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.
He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
More than three-quarters of cancer clinical research programs have experienced operational changes during the COVID-19 pandemic, according to a survey conducted by the Association of Community Cancer Centers (ACCC) during a recent webinar.
The webinar included insights into how some cancer research programs have adapted to the pandemic, a review of guidance for conducting cancer trials during this time, and a discussion of how the cancer research landscape may be affected by COVID-19 going forward.
The webinar was led by Randall A. Oyer, MD, president of the ACCC and medical director of the oncology program at Penn Medicine Lancaster General Health in Pennsylvania.
The impact of COVID-19 on cancer research
Dr. Oyer observed that planning and implementation for COVID-19–related illness at U.S. health care institutions has had a predictable effect of limiting patient access and staff availability for nonessential services.
Coronavirus-related exposure and/or illness has relegated cancer research to a lower-level priority. As a result, ACCC institutions have made adjustments in their cancer research programs, including moving clinical research coordinators off-campus and deploying them in clinical areas.
New clinical trials have not been opened. In some cases, new accruals have been halted, particularly for registry, prevention, and symptom control trials.
Standards that have changed and those that have not
Guidance documents for conducting clinical trials during the pandemic have been developed by the Food and Drug Administration, the National Cancer Institute’s Cancer Therapy Evaluation Program and Central Institutional Review Board, and the National Institutes of Health’s Office of Extramural Research. Industry sponsors and parent institutions of research programs have also disseminated guidance.
Among other topics, guidance documents have addressed:
- How COVID-19-related protocol deviations will be judged at monitoring visits and audits
- Missed office visits and endpoint evaluations
- Providing investigational oral medications to patients via mail and potential issues of medication unavailability
- Processes for patients to have interim visits with providers at external institutions, including providers who may not be personally engaged in or credentialed for the research trial
- Potential delays in submitting protocol amendments for institutional review board (IRB) review
- Recommendations for patients confirmed or suspected of having a coronavirus infection.
Dr. Oyer emphasized that patient safety must remain the highest priority for patient management, on or off study. He advised continuing investigational therapy when potential benefit from treatment is anticipated and identifying alternative methods to face-to-face visits for monitoring and access to treatment.
Dr. Oyer urged programs to:
- Maintain good clinical practice standards
- Consult with sponsors and IRBs when questions arise but implement changes that affect patient safety prior to IRB review if necessary
- Document all deviations and COVID-19 related adaptations in a log or spreadsheet in anticipation of future questions from sponsors, monitors, and other entities.
New questions and considerations
In the short-term, Dr. Oyer predicts fewer available trials and a decreased rate of accrual to existing studies. This may result in delays in trial completion and the possibility of redesign for some trials.
He predicts the emergence of COVID-19-focused research questions, including those assessing the course of coronavirus infection in various malignant settings and the impact of cancer-directed treatments and supportive care interventions (e.g., treatment for graft-versus-host disease) on response to COVID-19.
To facilitate developing a clinically and research-relevant database, Dr. Oyer stressed the importance of documentation in the research record, reporting infections as serious adverse events. Documentation should specify whether the infection was confirmed or suspected coronavirus or related to another organism.
In general, when coronavirus infection is strongly suspected, Dr. Oyer said investigational treatments should be interrupted, but study-specific criteria will be forthcoming on that issue.
Looking to the future
For patients with advanced cancers, clinical trials provide an important option for hope and clinical benefit. Disrupting the conduct of clinical trials could endanger the lives of participants and delay the emergence of promising treatments and diagnostic tests.
When the coronavirus pandemic recedes, advancing knowledge and treatments for cancer will demand renewed commitment across the oncology care community.
Going forward, Dr. Oyer advised that clinical research staff protect their own health and the safety of trial participants. He encouraged programs to work with sponsors and IRBs to solve logistical problems and clarify individual issues.
He was optimistic that resumption of more normal conduct of studies will enable the successful completion of ongoing trials, enhanced by the creative solutions that were devised during the crisis and by additional prospective, clinically annotated, carefully recorded data from academic and community research sites.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
Weight loss intervention fails in endometrial cancer survivors
Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m2 who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).
The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”
Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.
The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Retrospective results
At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).
“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.
At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:
- 49.2% and 47%, respectively, gained weight.
- 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
- 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
- 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
- 23.1% and 17.9%, respectively, lost 5% or more of weight.
Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m2 vs. 41.7 kg/m2), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
How can oncologists help patients lose weight?
“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.
However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.
“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”
It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.
“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”
One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.
This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.
“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.
Dr. Zamorano reported having no disclosures. The research was funded by Washington University.
SOURCE: Zamorano A et al. SGO 2020, Abstract 20.
Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m2 who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).
The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”
Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.
The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Retrospective results
At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).
“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.
At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:
- 49.2% and 47%, respectively, gained weight.
- 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
- 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
- 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
- 23.1% and 17.9%, respectively, lost 5% or more of weight.
Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m2 vs. 41.7 kg/m2), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
How can oncologists help patients lose weight?
“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.
However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.
“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”
It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.
“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”
One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.
This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.
“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.
Dr. Zamorano reported having no disclosures. The research was funded by Washington University.
SOURCE: Zamorano A et al. SGO 2020, Abstract 20.
Of 358 endometrial cancer survivors with a body mass index of at least 30 kg/m2 who were approached for participation in the randomized ScaleDown trial, 80 participated and 278 declined. The results of that study, which compared a “high-tech” weight loss intervention to “enhanced usual care,” were reported last year (Gynecol Oncol. 2019 Jun;154[1]:20).
The goal of the ScaleDown trial was to identify a “better mechanism of weight loss encouragement for our patients,” said Abigail Zamorano, MD, of Washington University, St. Louis. “Unfortunately, we found that there was no difference in those two groups. It was rather disappointing.”
Dr. Zamorano and colleagues hypothesized that although the women who participated in the study failed to lose weight, perhaps they gained less weight than women who did not participate. Therefore, the researchers performed a retrospective study comparing the two groups.
The researchers reported results from this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Retrospective results
At both 6 months and 12 months of follow-up, there were no significant differences between the ScaleDown participants and nonparticipants with respect to BMI change from baseline (P = .77 and P = .76, respectively).
“In essence, we unfortunately found no difference in BMI change in these two groups either,” Dr. Zamorano said.
At 12 months, rates of weight loss and weight gain were similar in ScaleDown participants and nonparticipants:
- 49.2% and 47%, respectively, gained weight.
- 13.9% and 23.2%, respectively, lost 0% to 2.5% of weight.
- 10.8% and 7.1%, respectively, lost 2.5% to 4% of weight.
- 3.1% and 4.8%, respectively, lost 4% to 5% of weight.
- 23.1% and 17.9%, respectively, lost 5% or more of weight.
Compared with participants, the nonparticipants were significantly more likely to be white and were older (63.4 years vs. 59.3 years), on more medications (median of 7 vs. 4), had a lower median BMI (39.1 kg/m2 vs. 41.7 kg/m2), were more likely to have recurrent cancer (15.2% vs. 5.1%), and were less likely to have had genetic counseling (10.8% vs. 20%). There were no differences between the groups in cancer histology, stage, or receipt of initial chemotherapy or radiation therapy.
How can oncologists help patients lose weight?
“Overall, I would say that the findings for the primary endpoint were not particularly encouraging,” Dr. Zamorano said.
However, she said an important message emerged from some of the survey results: Patients were very frustrated with their weight loss journey. Many said that, despite having a desire to lose weight, they didn’t know how, and nothing seemed to work. This suggests that, with the right strategies, oncologists are in a position to help, Dr. Zamorano said.
“As their oncologists who see them really regularly for years and years, even after they’ve completed their primary cancer therapy ... we have a unique relationship with them,” she explained. “We have this very unique role that we can play, so we should think a little outside the box about how else we can help our patients potentially lose weight.”
It’s important to try because thousands of women are diagnosed with endometrial cancer in the United States each year, and although many will be “successfully treated from a cancer perspective because they are diagnosed at early stages,” they also can have significant comorbidities – most often obesity, Dr. Zamorano said.
“And in conjunction with that ... diabetes and cardiovascular disease,” she added. “That means they have very high risk of long-term complications of obesity, and even though we are addressing their cancer, we weren’t addressing those other complications.”
One potential solution is bariatric surgery. Weight loss surgery has been shown to improve health care outcomes and reduce mortality rates and costs, yet 89% of ScaleDown participants said they had never considered it, and 67% said they would decline a referral.
This suggests that, despite the available evidence of benefit in patients who are candidates, there is a knowledge gap in awareness of the effectiveness and safety of bariatric surgery in this population, Dr. Zamorano said.
“Given the obesity-related health problems that this population has, we should really address weight as part of the essential cancer management strategy rather than as an afterthought,” she said, adding that it should be incorporated at the start and should potentially include a referral to surgical weight loss.
Dr. Zamorano reported having no disclosures. The research was funded by Washington University.
SOURCE: Zamorano A et al. SGO 2020, Abstract 20.
FROM SGO 2020
‘Brutal’ plan to restrict palliative radiation during pandemic
A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.
“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.
Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.
The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.
Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.
“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”
The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”
“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”
In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”
According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”
“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.
“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.
“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”
The document also recommends shorter courses of RT when radiation is deemed appropriate.
“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”
“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.
Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”
Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.
Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”
“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.
Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.
“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.
“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
This article first appeared on Medscape.com.
A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.
“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.
Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.
The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.
Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.
“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”
The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”
“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”
In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”
According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”
“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.
“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.
“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”
The document also recommends shorter courses of RT when radiation is deemed appropriate.
“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”
“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.
Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”
Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.
Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”
“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.
Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.
“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.
“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
This article first appeared on Medscape.com.
A major comprehensive cancer center at the epicenter of the New York City COVID-19 storm is preparing to scale back palliative radiation therapy (RT), anticipating a focus on only oncologic emergencies.
“We’re not there yet, but we’re anticipating when the time comes in the next few weeks that we will have a system in place so we are able to handle it,” Jonathan Yang, MD, PhD, of Memorial Sloan Kettering Cancer Center (MSKCC) in New York City, told Medscape Medical News.
Yang and an expert panel of colleagues reviewed high-impact evidence, prior systematic reviews, and national guidelines to compile a set of recommendations for triage and shortened palliative rRT at their center, should the need arise.
The recommendations on palliative radiotherapy for oncologic emergencies in the setting of COVID-19 appear in a preprint version in Advances in Radiation Oncology, released by the American Society of Radiation Oncology.
Yang says the recommendations are a careful balance between the risk of COVID-19 exposure of staff and patients with the potential morbidity of delaying treatment.
“Everyone is conscious of decisions about whether patients need treatment now or can wait,” he told Medscape Medical News. “It’s a juggling act every single day, but by having this guideline in place, when we face the situation where we do have to make decisions, is helpful.”
The document aims to enable swift decisions based on best practice, including a three-tiered system prioritizing only “clinically urgent cases, in which delaying treatment would result in compromised outcomes or serious morbidity.”
“It’s brutal, that’s the only word for it. Not that I disagree with it,” commented Padraig Warde, MB BCh, professor, Department of Radiation Oncology, University of Toronto, and radiation oncologist, Princess Margaret Cancer Centre, Toronto, Ontario, Canada.
Like many places, Toronto is not yet experiencing the COVID-19 burden of New York City, but Warde says the MSKCC guideline is useful for everyone. “Other centers should review it and see how they could deal with resource limitations,” he said. “It’s sobering and sad, but if you don’t have the staff to treat all patients, which particular patients do you choose to treat?”
In a nutshell, the MSKCC recommendations defines Tier 1 patients as having oncologic emergencies that require palliative RT, including “cord compression, symptomatic brain metastases requiring whole-brain radiotherapy, life-threatening tumor bleeding, and malignant airway obstruction.”
According to the decision-making guideline, patients in Tiers 2 and 3 would have their palliative RT delayed. This would include Tier 2 patients whose needs are not classified as emergencies, but who have either symptomatic disease for which RT is usually the standard of care or asymptomatic disease for which RT is recommended “to prevent imminent functional deficits.” Tier 3 would be symptomatic or asymptomatic patients for whom RT is “one of the effective treatment options.”
“Rationing is always very difficult because as physicians you always want to do everything you can for your patients but we really have to strike the balance on when to do what, said Yang. The plan that he authored anticipates both reduced availability of radiation therapists as well as aggressive attempts to limit patients’ infection exposure.
“If a patient’s radiation is being considered for delay due to COVID-19, other means are utilized to achieve the goal of palliation in the interim, and in addition to the tier system, this decision is also made on a case-by-case basis with departmental discussion on the risks and benefits,” he explained.
“There are layers of checks and balances for these decisions...Obviously for oncologic emergencies, radiation will be implemented. However for less urgent situations, bringing them into the hospital when there are other ways to achieve the same goal, potential risk of exposure to COVID-19 is higher than the benefit we would be able to provide.”
The document also recommends shorter courses of RT when radiation is deemed appropriate.
“We have good evidence showing shorter courses of radiation can effectively treat the goal of palliation compared to longer courses of radiation,” he explained. “Going through this pandemic actually forces radiation oncologists in the United States to put that evidence into practice. It’s not suboptimal care in the sense that we are achieving the same goal — palliation. This paper is to remind people there are equally effective courses of palliation we can be using.”
“[There’s] nothing like a crisis to get people to do the right thing,” commented Louis Potters, MD, professor and chair of radiation medicine at the Feinstein Institutes, the research arm of Northwell Health, New York’s largest healthcare provider.
Northwell Health has been at the epicenter of the New York outbreak of COVID-19. Potters writes on an ASTRO blog that, as of March 26, Northwell Health “has diagnosed 4399 positive COVID-19 patients, which is about 20% of New York state and 1.2% of all cases in the world. All cancer surgery was discontinued as of March 20 and all of our 23 hospitals are seeing COVID-19 admissions, and ICU care became the primary focus of the entire system. As of today, we have reserved one floor in two hospitals for non-COVID care such as trauma. That’s it.”
Before the crisis, radiation medicine at Northwell consisted of eight separate locations treating on average 280 EBRT cases a day, not including SBRT/SRS and brachytherapy cases. “That of course was 3 weeks ago,” he notes.
Commenting on the recommendations from the MSKCC group, Potters told Medscape Medical News that the primary goal “was to document what are acceptable alternatives for accelerated care.”
“Ironically, these guidelines represent best practices with evidence that — in a non–COVID-19 world — make sense for the majority of patients requiring palliative radiotherapy,” he said.
Potters said there has been hesitance to transition to shorter radiation treatments for several reasons.
“Historically, palliative radiotherapy has been delivered over 2 to 4 weeks with good results. And, as is typical in medicine, the transition to shorter course care is slowed by financial incentives to protract care,” he explained.
“In a value-based future where payment is based on outcomes, this transition to shorter care will evolve very quickly. But given the current COVID-19 crisis, and the risk to patients and staff, the incentive for shorter treatment courses has been thrust upon us and the MSKCC outline helps to define how to do this safely and with evidence-based expected efficacy.”
This article first appeared on Medscape.com.
Water-only fasting may reduce chemo modifications, hospital admissions
Patients with gynecologic malignancies who consumed only water for 24 hours before and 24 hours after each chemotherapy cycle had fewer dose delays and reductions compared with patients who didn’t fast, results of a small study showed.
The study included 23 women with ovarian, uterine, or cervical cancer, most of whom received platinum-based chemotherapy and taxanes. Fewer treatment modifications were required among the 11 patients randomized to a 24-hour water-only fast before and after each chemotherapy cycle than among the 12 patients randomized to standard care. Furthermore, there were no hospital admissions in the fasting group and two admissions in the control group, according to study author Courtney J. Riedinger, MD, of the University of Tennessee Medical Center in Knoxville.
She and her colleagues detailed the rationale and results of this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. Data have been updated from the abstract.
Rationale
“There’s a lot of new research and interest about nonpharmacologic interventions and lifestyle modifications to help patients cope with chemotherapy and even help with treatment, potentially,” Dr. Riedinger said in an interview.
“We decided to test water-only fasting because there’s not much data about the cell-fitness effects of fasting” on chemotherapy outcomes, she said.
Pre-chemotherapy fasting is based on the concept of differential stress resistance intended to protect normal cells but not cancer cells from the effects of chemotherapy. Fasting decreases levels of insulin-like growth factor 1, which leads healthy cells to enter a protective state by decreasing cell growth and proliferation. Cancer cells, in contrast, cannot enter the protective state, and are therefore more vulnerable than healthy, quiescent cells when exposed to drugs that target the cell cycle, Dr. Riedinger and colleagues noted.
The team cited two studies suggesting a benefit from fasting prior to chemotherapy. In the first study, mice that underwent 48-60 hours of short-term fasting were significantly less likely to die after exposure to a high dose of etoposide, compared with mice that did not fast before exposure (PNAS; 105[24]: 8215-822).
The second study showed that breast and ovarian cancer patients had improved quality of life scores and decreased fatigue when they fasted for 36 hours before and 24 hours after a chemotherapy cycle (BMC Cancer;18: article 476).
Study details
Dr. Riedinger and colleagues conducted a nonblinded, randomized trial of fasting in women, aged 34-73 years, who had gynecologic malignancies treated with a planned six cycles of chemotherapy. The patients were instructed to maintain a water-only fast for 24 hours before and 24 hours after each cycle. Controls did not fast.
Patient functional status and quality of life were investigated with the National Comprehensive Cancer Network–Functional Assessment of Cancer Therapy Ovarian Symptom Index (NCCN-FACT FOSI-18). Questionnaires were completed at each chemotherapy visit, and the records were reviewed to evaluate compliance, changes in treatment plan, and hospitalizations.
In all, 92% of chemotherapy cycles were completed with fasting as directed.
There were no significant differences in any of the study measures between patients who fasted and those who did not. However, this study was not powered to detect a difference, according to Dr. Riedinger.
Still, there were trends suggesting a benefit to fasting. Fasting patients had a higher mean change in NCCN-FACT FOSI-18 score compared with controls – increases of 5.11 and .22, respectively.
Five patients in the fasting group required changes to their treatment regimen, compared with eight patients in the control group. In addition, there were no hospital admissions in the fasting group and two admissions in the control group.
Patients tolerated the fast well without significant weight loss, and there were no grade 3 or 4 toxicities among patients who fasted.
The investigators are planning a larger study to further evaluate the effect of fasting on quality of life scores and treatment, and to evaluate the effects of fasting on hematologic toxicities. Future studies will focus on the optimal duration of fasting and the use of fasting-mimicking diets to allow for longer fasting periods, Dr. Riedinger said.
The study was internally funded. The authors reported no conflicts of interest.
SOURCE: Riedinger CJ et al. SGO 2020. Abstract 22.
Patients with gynecologic malignancies who consumed only water for 24 hours before and 24 hours after each chemotherapy cycle had fewer dose delays and reductions compared with patients who didn’t fast, results of a small study showed.
The study included 23 women with ovarian, uterine, or cervical cancer, most of whom received platinum-based chemotherapy and taxanes. Fewer treatment modifications were required among the 11 patients randomized to a 24-hour water-only fast before and after each chemotherapy cycle than among the 12 patients randomized to standard care. Furthermore, there were no hospital admissions in the fasting group and two admissions in the control group, according to study author Courtney J. Riedinger, MD, of the University of Tennessee Medical Center in Knoxville.
She and her colleagues detailed the rationale and results of this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. Data have been updated from the abstract.
Rationale
“There’s a lot of new research and interest about nonpharmacologic interventions and lifestyle modifications to help patients cope with chemotherapy and even help with treatment, potentially,” Dr. Riedinger said in an interview.
“We decided to test water-only fasting because there’s not much data about the cell-fitness effects of fasting” on chemotherapy outcomes, she said.
Pre-chemotherapy fasting is based on the concept of differential stress resistance intended to protect normal cells but not cancer cells from the effects of chemotherapy. Fasting decreases levels of insulin-like growth factor 1, which leads healthy cells to enter a protective state by decreasing cell growth and proliferation. Cancer cells, in contrast, cannot enter the protective state, and are therefore more vulnerable than healthy, quiescent cells when exposed to drugs that target the cell cycle, Dr. Riedinger and colleagues noted.
The team cited two studies suggesting a benefit from fasting prior to chemotherapy. In the first study, mice that underwent 48-60 hours of short-term fasting were significantly less likely to die after exposure to a high dose of etoposide, compared with mice that did not fast before exposure (PNAS; 105[24]: 8215-822).
The second study showed that breast and ovarian cancer patients had improved quality of life scores and decreased fatigue when they fasted for 36 hours before and 24 hours after a chemotherapy cycle (BMC Cancer;18: article 476).
Study details
Dr. Riedinger and colleagues conducted a nonblinded, randomized trial of fasting in women, aged 34-73 years, who had gynecologic malignancies treated with a planned six cycles of chemotherapy. The patients were instructed to maintain a water-only fast for 24 hours before and 24 hours after each cycle. Controls did not fast.
Patient functional status and quality of life were investigated with the National Comprehensive Cancer Network–Functional Assessment of Cancer Therapy Ovarian Symptom Index (NCCN-FACT FOSI-18). Questionnaires were completed at each chemotherapy visit, and the records were reviewed to evaluate compliance, changes in treatment plan, and hospitalizations.
In all, 92% of chemotherapy cycles were completed with fasting as directed.
There were no significant differences in any of the study measures between patients who fasted and those who did not. However, this study was not powered to detect a difference, according to Dr. Riedinger.
Still, there were trends suggesting a benefit to fasting. Fasting patients had a higher mean change in NCCN-FACT FOSI-18 score compared with controls – increases of 5.11 and .22, respectively.
Five patients in the fasting group required changes to their treatment regimen, compared with eight patients in the control group. In addition, there were no hospital admissions in the fasting group and two admissions in the control group.
Patients tolerated the fast well without significant weight loss, and there were no grade 3 or 4 toxicities among patients who fasted.
The investigators are planning a larger study to further evaluate the effect of fasting on quality of life scores and treatment, and to evaluate the effects of fasting on hematologic toxicities. Future studies will focus on the optimal duration of fasting and the use of fasting-mimicking diets to allow for longer fasting periods, Dr. Riedinger said.
The study was internally funded. The authors reported no conflicts of interest.
SOURCE: Riedinger CJ et al. SGO 2020. Abstract 22.
Patients with gynecologic malignancies who consumed only water for 24 hours before and 24 hours after each chemotherapy cycle had fewer dose delays and reductions compared with patients who didn’t fast, results of a small study showed.
The study included 23 women with ovarian, uterine, or cervical cancer, most of whom received platinum-based chemotherapy and taxanes. Fewer treatment modifications were required among the 11 patients randomized to a 24-hour water-only fast before and after each chemotherapy cycle than among the 12 patients randomized to standard care. Furthermore, there were no hospital admissions in the fasting group and two admissions in the control group, according to study author Courtney J. Riedinger, MD, of the University of Tennessee Medical Center in Knoxville.
She and her colleagues detailed the rationale and results of this study in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic. Data have been updated from the abstract.
Rationale
“There’s a lot of new research and interest about nonpharmacologic interventions and lifestyle modifications to help patients cope with chemotherapy and even help with treatment, potentially,” Dr. Riedinger said in an interview.
“We decided to test water-only fasting because there’s not much data about the cell-fitness effects of fasting” on chemotherapy outcomes, she said.
Pre-chemotherapy fasting is based on the concept of differential stress resistance intended to protect normal cells but not cancer cells from the effects of chemotherapy. Fasting decreases levels of insulin-like growth factor 1, which leads healthy cells to enter a protective state by decreasing cell growth and proliferation. Cancer cells, in contrast, cannot enter the protective state, and are therefore more vulnerable than healthy, quiescent cells when exposed to drugs that target the cell cycle, Dr. Riedinger and colleagues noted.
The team cited two studies suggesting a benefit from fasting prior to chemotherapy. In the first study, mice that underwent 48-60 hours of short-term fasting were significantly less likely to die after exposure to a high dose of etoposide, compared with mice that did not fast before exposure (PNAS; 105[24]: 8215-822).
The second study showed that breast and ovarian cancer patients had improved quality of life scores and decreased fatigue when they fasted for 36 hours before and 24 hours after a chemotherapy cycle (BMC Cancer;18: article 476).
Study details
Dr. Riedinger and colleagues conducted a nonblinded, randomized trial of fasting in women, aged 34-73 years, who had gynecologic malignancies treated with a planned six cycles of chemotherapy. The patients were instructed to maintain a water-only fast for 24 hours before and 24 hours after each cycle. Controls did not fast.
Patient functional status and quality of life were investigated with the National Comprehensive Cancer Network–Functional Assessment of Cancer Therapy Ovarian Symptom Index (NCCN-FACT FOSI-18). Questionnaires were completed at each chemotherapy visit, and the records were reviewed to evaluate compliance, changes in treatment plan, and hospitalizations.
In all, 92% of chemotherapy cycles were completed with fasting as directed.
There were no significant differences in any of the study measures between patients who fasted and those who did not. However, this study was not powered to detect a difference, according to Dr. Riedinger.
Still, there were trends suggesting a benefit to fasting. Fasting patients had a higher mean change in NCCN-FACT FOSI-18 score compared with controls – increases of 5.11 and .22, respectively.
Five patients in the fasting group required changes to their treatment regimen, compared with eight patients in the control group. In addition, there were no hospital admissions in the fasting group and two admissions in the control group.
Patients tolerated the fast well without significant weight loss, and there were no grade 3 or 4 toxicities among patients who fasted.
The investigators are planning a larger study to further evaluate the effect of fasting on quality of life scores and treatment, and to evaluate the effects of fasting on hematologic toxicities. Future studies will focus on the optimal duration of fasting and the use of fasting-mimicking diets to allow for longer fasting periods, Dr. Riedinger said.
The study was internally funded. The authors reported no conflicts of interest.
SOURCE: Riedinger CJ et al. SGO 2020. Abstract 22.
FROM SGO 2020
Promising efficacy with adavosertib in uterine serous carcinoma
The experimental agent adavosertib showed hints of efficacy against recurrent uterine serous carcinoma in early data from a phase 2 trial.
The overall response rate among 21 patients with advanced uterine serous carcinoma treated with adavosertib monotherapy was 30%, and an additional patient had an unconfirmed response at the time of data cutoff, reported Joyce F. Liu, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
“These results were noteworthy for the preliminary response rate of 30% that was observed in the first cohort of patients on this study, especially as, on average, patients on this study had received three prior treatments for their cancer. For us, this was an exciting signal of activity, especially for a targeted therapy used by itself in this type of cancer,” Dr. Liu said in an interview.
Preliminary results of the phase 2 trial were published in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Adavosertib is a small molecule that inhibits the Wee1 kinase, a “gatekeeper” of the G2-M cell cycle checkpoint that is highly expressed and active in several types of cancer.
“Molecular characterization of these cancers has demonstrated that they have frequent p53 mutations as well as significant alterations in oncogenes,” Dr. Liu said. “These characteristics mean that these are cancers that may both have significant dysregulation of their cell cycle combined with high levels of replication stress. We hypothesized that these cancers could therefore be particularly vulnerable to further dysregulation of the cell cycle, which can be mediated by a drug such as adavosertib, which interrupts regulation of the G2-M cell cycle checkpoint by inhibiting the protein Wee1.”
Study details
The study enrolled women with recurrent uterine serous carcinoma. Patients were eligible if any disease component was considered to be serous, except for carcinosarcomas. The patients had a minimum of one prior platinum-based chemotherapy regimen (median 3, range 1-7), with no upper limit on prior lines of therapy required for eligibility.
Patients with microsatellite high/deficient mismatch repair disease had to have received prior therapy with programmed death-1/ligand-1 inhibitor, or to have been deemed ineligible for immunotherapy with a checkpoint inhibitor.
The patients received adavosertib at 300 mg daily on days 1 through 5 and days 8 through 12 of each 21-day cycle.
The trial would be considered successful if at least of 4 of 35 patients planned for accrual had a confirmed response or if 8 patients were progression free at 6 months. The coprimary endpoints are overall response rate of 20% or more, or a progression-free survival rate at 6 months of 30% or more.
Results and next steps
As of Aug. 20, 2019, the investigators had enrolled 27 patients, of whom 21 were evaluable for response.
The overall response rate was 30%, consisting of six confirmed partial responses. One additional patient had an unconfirmed response. Eleven of the 21 patients had stable disease, and 3 had disease progression.
Eleven patients remained on treatment with adavosertib at the time of data cutoff. Progression-free survival data were not mature.
The most frequent adverse events included anemia and diarrhea in 67% of patients each, nausea in 58%, and fatigue in 50%.
Frequent grade 3 or higher adverse effects included anemia, neutropenia, and syncope, all occurring in 21% of patients.
Dr. Liu said the investigators plan to present updated data from the study at a future meeting.
“We are planning additional cohorts in this study that will allow us to more deeply investigate why certain uterine serous cancer patients had very good responses to adavosertib and to identify potential biomarkers of response,” she said.
“Additionally, we plan to investigate whether adavosertib has similar activity in another type of uterine cancer, uterine carcinosarcoma, that shares many similar molecular characteristics with uterine serous carcinoma, including p53 mutations and oncogenic alterations, that might make it similarly vulnerable to targeting Wee1,” she said.
Dr. Liu disclosed ties with AstraZeneca, which supported the trial, as well as Merck and other companies.
SOURCE: Liu JF et al. SGO 2020, Abstract 7.
The experimental agent adavosertib showed hints of efficacy against recurrent uterine serous carcinoma in early data from a phase 2 trial.
The overall response rate among 21 patients with advanced uterine serous carcinoma treated with adavosertib monotherapy was 30%, and an additional patient had an unconfirmed response at the time of data cutoff, reported Joyce F. Liu, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
“These results were noteworthy for the preliminary response rate of 30% that was observed in the first cohort of patients on this study, especially as, on average, patients on this study had received three prior treatments for their cancer. For us, this was an exciting signal of activity, especially for a targeted therapy used by itself in this type of cancer,” Dr. Liu said in an interview.
Preliminary results of the phase 2 trial were published in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Adavosertib is a small molecule that inhibits the Wee1 kinase, a “gatekeeper” of the G2-M cell cycle checkpoint that is highly expressed and active in several types of cancer.
“Molecular characterization of these cancers has demonstrated that they have frequent p53 mutations as well as significant alterations in oncogenes,” Dr. Liu said. “These characteristics mean that these are cancers that may both have significant dysregulation of their cell cycle combined with high levels of replication stress. We hypothesized that these cancers could therefore be particularly vulnerable to further dysregulation of the cell cycle, which can be mediated by a drug such as adavosertib, which interrupts regulation of the G2-M cell cycle checkpoint by inhibiting the protein Wee1.”
Study details
The study enrolled women with recurrent uterine serous carcinoma. Patients were eligible if any disease component was considered to be serous, except for carcinosarcomas. The patients had a minimum of one prior platinum-based chemotherapy regimen (median 3, range 1-7), with no upper limit on prior lines of therapy required for eligibility.
Patients with microsatellite high/deficient mismatch repair disease had to have received prior therapy with programmed death-1/ligand-1 inhibitor, or to have been deemed ineligible for immunotherapy with a checkpoint inhibitor.
The patients received adavosertib at 300 mg daily on days 1 through 5 and days 8 through 12 of each 21-day cycle.
The trial would be considered successful if at least of 4 of 35 patients planned for accrual had a confirmed response or if 8 patients were progression free at 6 months. The coprimary endpoints are overall response rate of 20% or more, or a progression-free survival rate at 6 months of 30% or more.
Results and next steps
As of Aug. 20, 2019, the investigators had enrolled 27 patients, of whom 21 were evaluable for response.
The overall response rate was 30%, consisting of six confirmed partial responses. One additional patient had an unconfirmed response. Eleven of the 21 patients had stable disease, and 3 had disease progression.
Eleven patients remained on treatment with adavosertib at the time of data cutoff. Progression-free survival data were not mature.
The most frequent adverse events included anemia and diarrhea in 67% of patients each, nausea in 58%, and fatigue in 50%.
Frequent grade 3 or higher adverse effects included anemia, neutropenia, and syncope, all occurring in 21% of patients.
Dr. Liu said the investigators plan to present updated data from the study at a future meeting.
“We are planning additional cohorts in this study that will allow us to more deeply investigate why certain uterine serous cancer patients had very good responses to adavosertib and to identify potential biomarkers of response,” she said.
“Additionally, we plan to investigate whether adavosertib has similar activity in another type of uterine cancer, uterine carcinosarcoma, that shares many similar molecular characteristics with uterine serous carcinoma, including p53 mutations and oncogenic alterations, that might make it similarly vulnerable to targeting Wee1,” she said.
Dr. Liu disclosed ties with AstraZeneca, which supported the trial, as well as Merck and other companies.
SOURCE: Liu JF et al. SGO 2020, Abstract 7.
The experimental agent adavosertib showed hints of efficacy against recurrent uterine serous carcinoma in early data from a phase 2 trial.
The overall response rate among 21 patients with advanced uterine serous carcinoma treated with adavosertib monotherapy was 30%, and an additional patient had an unconfirmed response at the time of data cutoff, reported Joyce F. Liu, MD, of the Dana-Farber Cancer Institute in Boston, and colleagues.
“These results were noteworthy for the preliminary response rate of 30% that was observed in the first cohort of patients on this study, especially as, on average, patients on this study had received three prior treatments for their cancer. For us, this was an exciting signal of activity, especially for a targeted therapy used by itself in this type of cancer,” Dr. Liu said in an interview.
Preliminary results of the phase 2 trial were published in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
Adavosertib is a small molecule that inhibits the Wee1 kinase, a “gatekeeper” of the G2-M cell cycle checkpoint that is highly expressed and active in several types of cancer.
“Molecular characterization of these cancers has demonstrated that they have frequent p53 mutations as well as significant alterations in oncogenes,” Dr. Liu said. “These characteristics mean that these are cancers that may both have significant dysregulation of their cell cycle combined with high levels of replication stress. We hypothesized that these cancers could therefore be particularly vulnerable to further dysregulation of the cell cycle, which can be mediated by a drug such as adavosertib, which interrupts regulation of the G2-M cell cycle checkpoint by inhibiting the protein Wee1.”
Study details
The study enrolled women with recurrent uterine serous carcinoma. Patients were eligible if any disease component was considered to be serous, except for carcinosarcomas. The patients had a minimum of one prior platinum-based chemotherapy regimen (median 3, range 1-7), with no upper limit on prior lines of therapy required for eligibility.
Patients with microsatellite high/deficient mismatch repair disease had to have received prior therapy with programmed death-1/ligand-1 inhibitor, or to have been deemed ineligible for immunotherapy with a checkpoint inhibitor.
The patients received adavosertib at 300 mg daily on days 1 through 5 and days 8 through 12 of each 21-day cycle.
The trial would be considered successful if at least of 4 of 35 patients planned for accrual had a confirmed response or if 8 patients were progression free at 6 months. The coprimary endpoints are overall response rate of 20% or more, or a progression-free survival rate at 6 months of 30% or more.
Results and next steps
As of Aug. 20, 2019, the investigators had enrolled 27 patients, of whom 21 were evaluable for response.
The overall response rate was 30%, consisting of six confirmed partial responses. One additional patient had an unconfirmed response. Eleven of the 21 patients had stable disease, and 3 had disease progression.
Eleven patients remained on treatment with adavosertib at the time of data cutoff. Progression-free survival data were not mature.
The most frequent adverse events included anemia and diarrhea in 67% of patients each, nausea in 58%, and fatigue in 50%.
Frequent grade 3 or higher adverse effects included anemia, neutropenia, and syncope, all occurring in 21% of patients.
Dr. Liu said the investigators plan to present updated data from the study at a future meeting.
“We are planning additional cohorts in this study that will allow us to more deeply investigate why certain uterine serous cancer patients had very good responses to adavosertib and to identify potential biomarkers of response,” she said.
“Additionally, we plan to investigate whether adavosertib has similar activity in another type of uterine cancer, uterine carcinosarcoma, that shares many similar molecular characteristics with uterine serous carcinoma, including p53 mutations and oncogenic alterations, that might make it similarly vulnerable to targeting Wee1,” she said.
Dr. Liu disclosed ties with AstraZeneca, which supported the trial, as well as Merck and other companies.
SOURCE: Liu JF et al. SGO 2020, Abstract 7.
FROM SGO 2020
Advice from the front lines: How cancer centers can cope with COVID-19
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
according to the medical director of a cancer care alliance in the first U.S. epicenter of the coronavirus outbreak.
Jennie R. Crews, MD, the medical director of the Seattle Cancer Care Alliance (SCCA), discussed the SCCA experience and offered advice for other cancer centers in a webinar hosted by the Association of Community Cancer Centers.
Dr. Crews highlighted the SCCA’s use of algorithms to predict which patients can be managed via telehealth and which require face-to-face visits, human resource issues that arose at SCCA, screening and testing procedures, and the importance of communication with patients, caregivers, and staff.
Communication
Dr. Crews stressed the value of clear, regular, and internally consistent staff communication in a variety of formats. SCCA sends daily email blasts to their personnel regarding policies and procedures, which are archived on the SCCA intranet site.
SCCA also holds weekly town hall meetings at which leaders respond to staff questions regarding practical matters they have encountered and future plans. Providers’ up-to-the-minute familiarity with policies and procedures enables all team members to uniformly and clearly communicate to patients and caregivers.
Dr. Crews emphasized the value of consistency and “over-communication” in projecting confidence and preparedness to patients and caregivers during an unsettling time. SCCA has developed fact sheets, posted current information on the SCCA website, and provided education during doorway screenings.
Screening and testing
All SCCA staff members are screened daily at the practice entrance so they have personal experience with the process utilized for patients. Because symptoms associated with coronavirus infection may overlap with cancer treatment–related complaints, SCCA clinicians have expanded the typical coronavirus screening questionnaire for patients on cancer treatment.
Patients with ambiguous symptoms are masked, taken to a physically separate area of the SCCA clinics, and screened further by an advanced practice provider. The patients are then triaged to either the clinic for treatment or to the emergency department for further triage and care.
Although testing processes and procedures have been modified, Dr. Crews advised codifying those policies and procedures, including notification of results and follow-up for both patients and staff. Dr. Crews also stressed the importance of clearly articulated return-to-work policies for staff who have potential exposure and/or positive test results.
At the University of Washington’s virology laboratory, they have a test turnaround time of less than 12 hours.
Planning ahead
Dr. Crews highlighted the importance of community-based surge planning, utilizing predictive models to assess inpatient capacity requirements and potential repurposing of providers.
The SCCA is prepared to close selected community sites and shift personnel to other locations if personnel needs cannot be met because of illness or quarantine. Contingency plans include specialized pharmacy services for patients requiring chemotherapy.
The SCCA has not yet experienced shortages of personal protective equipment (PPE). However, Dr. Crews said staff require detailed education regarding the use of PPE in order to safeguard the supply while providing maximal staff protection.
Helping the helpers
During the pandemic, SCCA has dealt with a variety of challenging human resource issues, including:
- Extending sick time beyond what was previously “stored” in staff members’ earned time off.
- Childcare during an extended hiatus in school and daycare schedules.
- Programs to maintain and/or restore employee wellness (including staff-centered support services, spiritual care, mindfulness exercises, and town halls).
Dr. Crews also discussed recruitment of community resources to provide meals for staff from local restaurants with restricted hours and transportation resources for staff and patients, as visitors are restricted (currently one per patient).
Managing care
Dr. Crews noted that the University of Washington had a foundational structure for a telehealth program prior to the pandemic. Their telehealth committee enabled SCCA to scale up the service quickly with their academic partners, including training modules for and certification of providers, outfitting off-site personnel with dedicated lines and hardware, and provision of personal Zoom accounts.
SCCA also devised algorithms for determining when face-to-face visits, remote management, or deferred visits are appropriate in various scenarios. The algorithms were developed by disease-specialized teams.
As a general rule, routine chemotherapy and radiation are administered on schedule. On-treatment and follow-up office visits are conducted via telehealth if possible. In some cases, initiation of chemotherapy and radiation has been delayed, and screening services have been suspended.
In response to questions about palliative care during the pandemic, Dr. Crews said SCCA has encouraged their patients to complete, review, or update their advance directives. The SCCA has not had the need to resuscitate a coronavirus-infected outpatient but has instituted policies for utilizing full PPE on any patient requiring resuscitation.
In her closing remarks, Dr. Crews stressed that the response to COVID-19 in Washington state has required an intense collaboration among colleagues, the community, and government leaders, as the actions required extended far beyond medical decision makers alone.
Dr. Lyss was a community-based medical oncologist and clinical researcher for more than 35 years before his recent retirement. His clinical and research interests were focused on breast and lung cancers as well as expanding clinical trial access to medically underserved populations. He is based in St. Louis. He has no conflicts of interest.
20% with cancer on checkpoint inhibitors get thyroid dysfunction
new research suggests.
Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.
In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.
Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.
Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.
“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.
However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”
Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”
“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”
‘A much higher percentage than we were expecting’
Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.
Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.
A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.
“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.
In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.
Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”
Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.
“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.
Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
Differences by cancer type, not checkpoint inhibitor type
And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”
“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”
The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.
The reason for this is not clear, said Dr. Quandt in an interview.
One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.
“That’s definitely one of the questions we’re looking at,” she said.
Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.
In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.
Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.
Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.
“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.
However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”
Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”
“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”
‘A much higher percentage than we were expecting’
Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.
Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.
A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.
“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.
In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.
Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”
Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.
“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.
Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
Differences by cancer type, not checkpoint inhibitor type
And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”
“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”
The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.
The reason for this is not clear, said Dr. Quandt in an interview.
One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.
“That’s definitely one of the questions we’re looking at,” she said.
Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
new research suggests.
Immune checkpoint inhibitors have revolutionized the treatment of many different types of cancers, but can also trigger a variety of immune-related adverse effects. As these drugs become more widely used, rates of these events appear to be more common in the real-world compared with clinical trial settings.
In their new study, Zoe Quandt, MD, of the University of California, San Francisco (UCSF), and colleagues specifically looked at thyroid dysfunction in their own institution’s EHR data and found more than double the rate of hypothyroidism and more than triple the rate of hyperthyroidism, compared with rates in published trials.
Moreover, in contrast to previous studies that have found differences in thyroid dysfunction by checkpoint inhibitor type, Dr. Quandt and colleagues instead found significant differences by cancer type.
Dr. Quandt presented the findings during a virtual press briefing held March 31originally scheduled for ENDO 2020.
“Thyroid dysfunction following checkpoint inhibitor therapy appears to be much more common than was previously reported in clinical trials, and this is one of the first studies to show differences by cancer type rather than by checkpoint inhibitor type,” Dr. Quandt said during the presentation.
However, she also cautioned that there’s “a lot more research to be done to validate case definitions and validate these findings.”
Asked to comment, endocrinologist David C. Lieb, MD, associate professor of medicine at Eastern Virginia Medical School in Norfolk, said in an interview, “These drugs are becoming so much more commonly used, so it’s not surprising that we’re seeing more endocrine complications, especially thyroid disease.”
“Endocrinologists need to work closely with oncologists to make sure patients are being screened and followed appropriately.”
‘A much higher percentage than we were expecting’
Dr. Quandt’s study included 1,146 individuals treated with checkpoint inhibitors at UCSF during 2012-2018 who did not have thyroid cancer or preexisting thyroid dysfunction.
Pembrolizumab (Keytruda) was the most common treatment (45%), followed by nivolumab (Opdivo) (20%). Less than 10% of patients received atezolizumab (Tecentriq), durvalumab (Imfizi), ipilimumab (Yervoy) monotherapy, combined ipilimumab/nivolumab, or other combinations of checkpoint inhibitors.
A total of 19.1% developed thyroid disease, with 13.4% having hypothyroidism and 9.5% hyperthyroidism. These figures far exceed those found in a recent meta-analysis of 38 randomized clinical trials of checkpoint inhibitors that included 7551 patients.
“Using this approach, we found a much higher percentage of patients who developed thyroid dysfunction than we were expecting,” Dr. Quandt said.
In both cases, the two categories – hypothyroidism and hyperthyroidism – aren’t mutually exclusive as hypothyroidism can arise de novo or subsequent to hyperthyroidism.
Dr Lieb commented, “It would be interesting to see what the causes of hyperthyroidism are – thyroiditis or Graves disease.”
Dr. Quandt mentioned a possible reason for the large difference between clinical trial and real-world data.
“Once we’re actually using these drugs outside of clinical trials, some of the restrictions about using them in people with other autoimmune diseases have been lifted, so my guess is that as we give them to a broader population we’re seeing more of these [adverse effects],” she suggested.
Also, “In the initial trials, people weren’t quite as aware of the possibilities of these side effects, so now we’re doing many more labs. Patients get thyroid function tests with every infusion, so I think we’re probably catching more patients who develop disease.”
Differences by cancer type, not checkpoint inhibitor type
And in a new twist, Dr. Quandt found that, in contrast to the differences seen by checkpoint inhibitor type in randomized trials, “surprisingly, we found that this difference did not reach statistical significance.”
“Instead, we saw that cancer type was associated with development of thyroid dysfunction, even after taking checkpoint inhibitor type into account.”
The percentages of patients who developed thyroid dysfunction ranged from 9.7% of those with glioblastoma to 40.0% of those with renal cell carcinoma.
The reason for this is not clear, said Dr. Quandt in an interview.
One possibility relates to other treatments patients with cancer also receive. In renal cell carcinoma, for example, patients also are treated with tyrosine kinase inhibitors, which can also cause thyroid dysfunction, so they may be more susceptible. Or there may be shared antigens activating the immune system.
“That’s definitely one of the questions we’re looking at,” she said.
Dr. Quandt and Dr. Lieb have reported no relevant financial relationships.
A version of this article originally appeared on Medscape.com.
No staff COVID-19 diagnoses after plan at Chinese cancer center
Short-term results
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Short-term results
Short-term results
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
No staff members or patients were diagnosed with COVID-19 after “strict protective measures” for screening and managing patients were implemented at the National Cancer Center/Cancer Hospital, Chinese Academy of Sciences, in Beijing, according to a report published online April 1 in JAMA Oncology.
However, the time period for the analysis, which included nearly 3000 patients, was short — only about 3 weeks (February 12 to March 3). Also, Beijing is more than 1100 kilometers from Wuhan, the center of the Chinese outbreak of COVID-19.
The Beijing cancer hospital implemented a multipronged safety plan in February in order to “avoid COVID-19 related nosocomial cross-infection between patients and medical staff,” explain the authors, led by medical oncologist Zhijie Wang, MD.
Notably, “all of the measures taken in China are actively being implemented and used in major oncology centers in the United States,” Robert Carlson, MD, chief executive officer, National Comprehensive Cancer Network (NCCN), told Medscape Medical News.
John Greene, MD, section chief, Infectious Disease and Tropical Medicine, Moffitt Cancer Center, Tampa, Florida, pointed out that the Chinese safety plan, which is full of “good measures,” is being largely used at his center. However, he observed that one tool — doing a temperature check at the hospital front door — is not well supported by most of the literature. “It gives good optics and looks like you are doing the most you possibly can, but scientifically it may not be as effective [as other screening measures],” he said.
The Chinese plan consists of four broad elements
First, the above-mentioned on-site temperature tests are performed at the entrances of the hospital, outpatient clinic, and wards. Contact and travel histories related to the Wuhan epidemic area are also established and recorded.
Second, an outpatient appointment scheduling system allows both online scheduling and on-site registration. Online consultation channels are open daily, featuring instruction on medication taking and cancer-related symptom management. These “substantially reduced the flow of people in the hospital,” write the authors. On-site patients must wear a mask and have their own disinfectant.
Third, for patients with cancer preparing to be admitted to hospital, symptoms associated with COVID-19, such as fever and cough, are recorded. Mandatory blood tests and CT scans of the lungs are performed. COVID-19 virus nucleic acid tests are performed for patients with suspected pneumonia on imaging.
Fourth, some anticancer drugs conventionally administered by infusion have been changed to oral administration, such as etoposide and vinorelbine. For adjuvant or maintenance chemotherapy, the infusion intervals were appropriately prolonged depending on patients’ conditions.
Eight out of 2,900 patients had imaging suspicious for infection
The Chinese authors report that a total of 2,944 patients with cancer were seen for clinic consultation and treatment in the wards (2795 outpatients and 149 inpatients).
Patients with cancer are believed to have a higher probability of severe illness and increased mortality compared with the healthy population once infected with COVID-19, point out the authors.
Under the new “strict screening strategy,” 27 patients showed radiologic manifestations of inflammatory changes or multiple-site exudative pneumonia in the lungs, including eight suspected of having COVID-19 infection. “Fortunately, negative results from nucleic acid testing ultimately excluded COVID-19 infection in all these patients,” the authors report.
However, two of these patients “presented with recovered pneumonia after symptomatic treatment.” Commenting on this finding, Moffitt’s Greene said that may mean these two patients were tested and found to be positive but were early in the infection and not yet shedding the virus, or they were infected after the initial negative result.
Greene said his center has implemented some measures not mentioned in the Chinese plan. For example, the Florida center no longer allows inpatient visitation. Also, one third of staff now work from home, resulting in less social interaction. Social distancing in meetings, the cafeteria, and hallways is being observed “aggressively,” and most meetings are now on Zoom, he said.
Moffitt has not been hard hit with COVID-19 and is at level one preparedness, the lowest rung. The center has performed 60 tests to date, with only one positive for the virus (< 2%), Greene told Medscape Medical News.
Currently, in the larger Tampa Bay community setting, about 12% of tests are positive.
The low percentage found among the Moffitt patients “tells you that a lot of cancer patients have fever and respiratory symptoms due to other viruses and, more importantly, other reasons, whether it’s their immunotherapy or chemotherapy or their cancer,” said Greene.
NCCN’s Carlson said the publication of the Chinese data was a good sign in terms of international science.
“This is a strong example of how the global oncology community rapidly shares information and experience whenever it makes a difference in patient care,” he commented.
The authors, as well as Carlson and Greene, have reported no relevant financial relationships.
This article first appeared on Medscape.com.
Younger gynecologic cancer patients at risk for early bone loss
Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.
This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.
Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.
Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.
“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.
Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.
“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
Patient analysis
To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.
The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.
Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.
The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m2. Each patient had at least a baseline scan and one additional CT scan during follow-up.
The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
Results and next steps
The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.
The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (P < .01).
“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”
This study was internally funded. Dr. Sobecki reported no conflicts of interest.
SOURCE: Sobecki J et al. SGO 2020, Abstract 130.
Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.
This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.
Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.
Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.
“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.
Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.
“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
Patient analysis
To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.
The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.
Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.
The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m2. Each patient had at least a baseline scan and one additional CT scan during follow-up.
The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
Results and next steps
The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.
The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (P < .01).
“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”
This study was internally funded. Dr. Sobecki reported no conflicts of interest.
SOURCE: Sobecki J et al. SGO 2020, Abstract 130.
Younger women treated for uterine or ovarian cancer are at increased risk for decreased bone mineral density and osteoporosis, especially in the first year after diagnosis, and they should be screened for bone changes, investigators advise.
This recommendation is based on results from a retrospective study of women, age 65 years and younger, all of whom underwent oophorectomy and most of whom received chemotherapy. Half of the women who had normal bone mineral density (BMD) at baseline were at risk for osteopenia or osteoporosis 5 years after diagnosis.
Rates of patients at risk for osteoporosis roughly doubled each year for the first 3 years of follow-up, reported study author Janelle Sobecki, MD, of the University of Wisconsin–Madison, and colleagues.
Their research is detailed in an abstract that had been slated for presentation at the Society of Gynecologic Oncology’s Annual Meeting on Women’s Cancer. The meeting was canceled because of the COVID-19 pandemic.
“Clinicians should follow current National Comprehensive Cancer Network guidelines regarding bone mineral density screening in women under 65 years old with cancer who have undergone therapy affecting their ovarian function [ovarian removal and/or antiestrogen therapies],” Dr. Sobecki said in an interview.
“Our findings indicate women with gynecologic cancer undergoing ovarian removal and chemotherapy may warrant sooner bone density evaluation, as early as 1 year following treatment. Bone loss screening in this population is feasible using opportunistic CT imaging,” she added.
Current guidelines recommending routine BMD evaluation every 2 years in women who received treatments impairing ovarian function are based largely on data in breast cancer patients, but there is a paucity of data on women who undergo oophorectomy and cancer therapies, both of which are known risk factors for bone loss, Dr. Sobecki noted.
“Bone loss is an important issue for women’s cancer survivorship, particularly for women who we expect to have long survival,” she said. “Identifying bone loss early is important for long-term bone health and prevention of osteoporosis in cancer survivors.”
Patient analysis
To get a better picture of long-term BMD changes and osteoporosis risk in younger patients, Dr. Sobecki and colleagues conducted a retrospective cohort study of women with uterine or ovarian cancers who underwent oophorectomy from 2010 to 2015.
The investigators calculated CT-based L1 trabecular attenuation BMD measurements (Hounsfield units, HU) on CT scans performed at baseline and at 1 year, 3 years, 5 years, and beyond 5 years after cancer diagnosis.
Osteoporosis risk was defined based on HU. Less than 100 HU was deemed “concerning” for osteoporosis, 100-150 HU was suggestive of osteopenia, and more than 150 HU indicated normal BMD.
The investigators reviewed scans for 185 patients with a median age of 55 years and a mean body mass index of 32 kg/m2. Each patient had at least a baseline scan and one additional CT scan during follow-up.
The majority of patients (78.1%) had ovarian cancer, 78.1% underwent chemotherapy, and 17.1% were treated with external beam radiation. As of 2019, 118 patients (63.6%) were still alive.
Results and next steps
The investigators found that BMD decreased from a mean of 179.4 HU at baseline to 146.5 HU at 1 year, a significant decline (P < .001), and to 123.63 HU beyond 5 years (P < .001). As noted before, half of the patients with normal BMD at baseline were at risk for osteopenia or osteoporosis at 5 years.
The proportion of patients at risk for osteoporosis at baseline was 4.3%, compared with 7.4% at 1 year, 15.7% at 3 years, 18% at 5 years, and 23.3% beyond 5 years. BMD at baseline was a significant predictor for bone loss at all time points. In multivariate analysis, chemotherapy predicted bone loss at 1 year (P = .03), and current smoking predicted BMD decrease at 5 years (P < .01).
“We plan to further investigate the role of chemotherapy in bone loss in gynecologic cancer patients, including chemotherapy dose-related bone loss,” Dr. Sobecki said. “We also plan to investigate bone loss in older women [over the age of 65] undergoing treatment for gynecologic cancer as they may be at greater risk than their baseline age-related risk.”
This study was internally funded. Dr. Sobecki reported no conflicts of interest.
SOURCE: Sobecki J et al. SGO 2020, Abstract 130.
FROM SGO 2020