ASCO aims to ‘smooth transition’ to post-COVID-19 cancer care
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The COVID-19 pandemic has challenged the field of oncology in countless ways.
As the medical profession redoubles its efforts to control the spread of the novel coronavirus, oncologists must find adaptive ways to continue to provide quality care to their patients, according to participants in a webcast conducted by ASCO and its affiliate organization, the Association for Clinical Oncology.
“People with cancer are being hit especially hard by the COVID-19 pandemic, and the pandemic is making incredible demands on the cancer care system — with sometimes tragic results for patients and their families,” ASCO President Howard A. “Skip” Burris, III, MD, FACP, FASCO, chief medical officer and president of clinical operations for Sarah Cannon Research Institute, said during the webcast.
Burris and other participants in the webcast — titled “COVID-19 and Cancer: Addressing a Healthcare System in Crisis” — discussed the importance of trying to overcome unprecedented challenges to delivering oncology care, including delays in screening, surgery and chemotherapy radiation; current or potential shortages of medicines, ventilators and personal protective equipment; the rapid shift to virtual health care; and the possible ramifications of halting clinical trials.
Clinical trial interruptions
Burris discussed the potentially harmful implications of cancer clinical trial interruptions.
He cited results of an ASCO survey, posted online prior to publication in JCO Oncology Practice, regarding the impact of COVID-19 on clinical trials.
“Only a few weeks into the pandemic, 60% of research programs reported halted screening or enrollment for at least some of their trials,” he said. “They reported a range of challenges — in particular, the patients’ lack of ability or willingness to come in for evaluations.”
Burris said he has seen substantial clinical trial slowdowns at his institution due to COVID-19.
“Trial interruptions are devastating news for thousands of patients; in many cases, clinical trials are the best or the only appropriate option of care,” Burris said during the webcast. “At my own institution, we have tried to stay safe while staying the course, yet we are still seeing approximately one-third of our clinical trial portfolio on hold as a result of COVID-19.”
It is unclear exactly how many cancer clinical trials have been interrupted during the COVID-19 pandemic, according to Richard L. Schilsky, MD, FACP, FSCT, FASCO, chief medical officer and executive vice president of ASCO.
“We don’t have a specific number of clinical trials that we know have been delayed or suspended,” he said. “We know that at least three major pharmaceutical companies have already announced publicly that they are pausing enrollment on all of their clinical trials for at least 2 to 3 months.”
Enrollment on NCI-sponsored trials has declined by about 40%, Schilsky added.
“There’s no doubt that clinical trials are being put on hold,” he said. “Patients are reluctant to enroll on clinical trials because it requires more visits to the health care system and, of course, many physician practices and hospitals that have been dedicated to offering clinical trials to patients have chosen to delay or suspend enrollment in part because they have to redirect staff away from supporting research programs to supporting critically ill patients with COVID-19 and cancer. It’s going to take a while for all of this to recover, but we certainly are optimistic that clinical trials will remain a key element of cancer care going forward.”
Allocating scarce resources
As the pandemic continues to exhaust medical equipment, treatments and hospital space, clinicians may be faced with difficult decisions about how to allocate limited resources, according to Jonathan Marron, MD, MPH, clinical ethicist at Boston Children’s Hospital, pediatric oncologist at Dana Farber Cancer Institute and chair-elect of ASCO’s Ethics Committee.
Marron served as lead author on a set of ASCO recommendations designed to support the oncology community as it confronts ethical issues around health care resource allocation. The guidelines have been posted online ahead of publication in Journal of Clinical Oncology.
“One of the challenges caused by COVID-19 is the prospect of our medical needs outpacing our medical resources,” Marron said in the webcast. “Hospitals, clinics and clinicians are being stretched more thinly than ever before.”
Marron discussed the possibility that demand for medical resources, especially critical care resources such as ventilators and beds in intensive care units, will be greater than the supply.
“This will force clinicians to make incredibly difficult — if not absolutely impossible — decisions,” Marron said. “As a result of this, our aim was to provide guidance on these nearly impossible decisions. We hope to ensure that medical resources are allocated through a thoughtful process.”
The recommendations focus on developing consistent policies before allocation becomes necessary, maximizing overall health benefits, and separating resource allocation from bedside decision-making, Marron said.
“Oncologists are experts at providing the highest quality care to the patient in front of them,” he said, “but the COVID-19 pandemic may require allocation decisions that may not always align with what’s best for that patient in front of them.”
ASCO guidelines are designed to ensure oncologists are fully engaged in the process of allocation by providing information about their patients, Marron said. He added, however, that oncologists should not be the ones ultimately making these decisions for their patients.
“In short, these recommendations encourage the development and implementation of fair and equitable policies at the institutional level while simultaneously outlining the role the oncologist can and should play,” Marron said. “Even when impossible decisions have to be made because multiple patients might stand to benefit from scarce resources, a cancer diagnosis alone should not keep a patient from having a fair chance to access potentially lifesaving resources. We hope to assure patients with cancer that decisions about medical resource allocation will be well-informed, evidence-based and carried out with compassion, as was the case before the pandemic and will be again once the pandemic is over.”
Lessons from Washington state
Although the COVID-19 pandemic eventually will end, lessons learned in the oncology community will be lasting.
Gary H. Lyman, MD, MPH, FRCP, FASCO — senior lead of health care quality and policy at Hutchinson Institute for Cancer Outcomes Research at Fred Hutchinson Cancer Research Center in Seattle — discussed the response in Washington state, one of the earliest epicenters of the pandemic.
Lyman emphasized the need to anticipate and plan for a long-term impact on cancer care, to expand COVID-19 testing as much as possible, to prepare for second and third waves of infections, and to share data that will benefit future treatment of COVID-19.
“I am particularly concerned about rural, remote areas in the country, and even in our state, that do not have many ICU beds and may not have ventilators,” he said. “We need to be sure they are getting resources to manage a rapid spike in COVID-19 infections. We are also working to collect and share data as rapidly as possible regarding the impact of COVID-19 on [patients with cancer].”
Lyman said shared data may lay the groundwork for future clinical trials of antiviral treatments, as well as vaccines against the virus.
‘Bold policy actions’
Burris discussed the ways in which the delivery of cancer care has been changed indelibly.
“[Although] the worst of COVID-19 might soon be behind us, the impact of the pandemic is clearly going to be with us for a long while,” he said. “Now is the time to plan collectively for a smooth transition to post-crisis cancer care. To do that, bold policy actions will be essential.”
The Association for Clinical Oncology announced an advocacy agenda for Congress and the Trump administration that outlines eight policy changes deemed essential to sustain high-quality cancer care during the pandemic and also plan for the future.
The recommendations include permanently expanded support for telehealth, additional and immediate financial support for oncology practices, additional relief from sequester, the passage of “oral parity” legislation, prevention of additional drug shortages, suspended reporting of financial risk requirements for Medicare’s oncology care model , and adaptation of clinical trials.
Burris also discussed the formation of multidisciplinary workgroups devoted to transitioning cancer care to its future beyond COVID-19. Workgroup 1, which will focus on cancer care delivery, will evaluate lasting changes in practice and research. Workgroup 2 will focus on cancer research processes, and will recommend updated approaches to strengthen cancer care and research. These workgroups will consist of a diverse group of ASCO volunteers, including patients and patient advocates, surgeons, medical and radiation oncologists, nurses, nurse practitioners and physicians’ assistants, and supportive care specialists.
Burris said the volunteer workgroups are expected to deliver recommendations as early as the fall, Burris said. – by Jennifer Byrne
References:
Marron JM, et al. Ethics and resource scarcity: ASCO recommendations for the oncology community during the COVID19 pandemic. Available at: www.asco.org/sites/new-www.asco.org/files/content-files/advocacy-and-policy/documents/JCO.20.00960.pdf?cid=DM4876&bid=41686163.
Waterhouse D, et al. Early impact of COVID-19 on the conduct of oncology clinical trials and long-term opportunities for transformation: Findings from an American Society of Clinical Oncology Survey. Available at: www.asco.org/sites/new-www.asco.org/files/content-files/blog-release/pdf/2020-asco-covid19-clinical-trial-site-survey-manuscript.pdf?cid=DM4954&bid=42598701.