NCI director: COVID-19 having ‘profound’ effects on cancer outcomes, research
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The oncology community has demonstrated a remarkable ability to adapt amid the COVID-19 pandemic but must be prepared for its long-term effects on cancer care, NCI Director Norman E. “Ned” Sharpless, MD, told ASCO Virtual Scientific Program attendees.
“As people who work with cancer day in and day out, we are well-acquainted with both suffering and tragedy, and navigating uncertainty is a specialty of ours,” Sharpless said. “The developments, as bad as they have been, will not rattle us or distract us from our mission.”
Treatment delays and care deferrals have been necessary to preserve hospital and clinical capacity during the pandemic response, but there will be costs for patients with cancer, he added.
“We know delayed diagnoses and delayed therapy lead to worse outcomes,” Sharpless said. “It may mean more cancer suffering and more bad outcomes for patients. What we don’t know yet is the scale of these bad outcomes.”
The impact likely will result in “lost ground, progress undone and reverses in positive trends,” Sharpless said.
Each year, NCI collaborates with CDC, American Cancer Society and the North American Association of Central Cancer Registries to publish the Annual Report to the Nation on the Status of Cancer.
“Thanks to advances in cancer screening, prevention, treatment and survivorship, this report over the last few years has become an annual shot in the arm to the cancer research community — confirmation that we are moving in the right direction, confirmation that things we do to prevent diagnosis and treat cancer are working,” Sharpless said.
However, the COVID-19 pandemic likely will have a negative impact on cancer mortality, which has declined steadily since 1990.
“We expect to see these trends play out over several years,” Sharpless said. “We cannot escape this reality, but we can work together collaboratively, creatively and proactively to expand our definitions of what services are most needed, and devise safe approaches to delivering them to those most in need.”
The pandemic also has had a profound effect on cancer research. Accrual across NCI’s clinical trials network declined by about 50% in March and April, Sharpless said.
“In my conversations with industry leaders, I have heard their accrual numbers are as bad or worse,” he said. “This is not surprising, but it is concerning. Clinical trials are how we make progress for patients with cancer, and these decreases in accrual will translate to reduced new approaches for patients. We certainly hope, as circumstances permit, that institutions and providers will resume accrual to ensure continued research progress as they are able.”
In the wake of the pandemic, NCI has extended application and report deadlines for grantees, increased flexibility for funding carryover, and extended eligibility for early-stage investigators. It has transitioned some research efforts toward COVID-19, evaluating commercially available serology tests on behalf of FDA and working to increase national capacity for high-quality serological testing.
NCI has helped set up trials that hold promise for treating cytokine storm associated with COVID-19. One is evaluating tocilizumab (Actemra, Genentech), and another is evaluating acalabrutinib (Calquence, AstraZeneca) to address the overly exuberant immune responses among patients with COVID-19, Sharpless said.
NCI also launched the COVID-19 in Cancer Patients Study (NCCAPS), a longitudinal natural history study designed to enroll at least 2,000 patients with cancer infected with COVID-19, with an emphasis on minority, underserved and rural recruitment.
The study, to be conducted at more than 1,000 sites across the country, will yield insights into how the disease develops and progresses, Sharpless said.
“This is not a registry. This is an [institutional review board]-approved trial with consent, which has several advantages, including sample collection, very extensive biomarker analysis and the ability to do germline sequencing of patients,” Sharpless said.
The trial is open to patients receiving active cancer treatment — chemotherapy, targeted therapy, immunotherapy and/or radiation — and patients in follow-up care. Blood samples and routine imaging scans will be collected for up to 2 years.
“This study showcases NCI’s ability to adapt our clinical trials research infrastructure during this national emergency,” Sharpless said. “A study this large and complex would typically take more than a year to plan and implement, but NCCAPS went from an idea to launch in 6 weeks. We expect this study will provide a wealth of valuable data to inform future management of [patients with cancer] infected with COVID-19, and it will complement other registry efforts getting underway.” – by Mark Leiser
Reference:
Sharpless NE. S, et al. Ensuring cancer research progress during a global pandemic. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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Sharpless NE. S, et al. Ensuring cancer research progress during a global pandemic. Presented at: ASCO20 Virtual Scientific Program; May 29-31, 2020.
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