publication date: Mar. 13, 2020

Pandemic: Bracing for coronavirus surge

By Alexandria Carolan and Matthew Ong

The COVID-19 pandemic will affect every aspect of cancer care and cancer research.

  • Cancer centers in the United States are racing to protect patients most vulnerable to the expected surge—elderly cancer patients and those with suppressed immune systems.

  • Many worry that the pandemic will confound clinical trials, too, potentially affecting drug approvals for years to come.

  • In preparation, centers are instituting travel bans and work from home policies, and professional societies are rescheduling or cancelling annual meetings. The 2020 annual meeting of the American Association for Cancer Research was postponed, and the American Society of Clinical Oncology is weighing a digital annual meeting instead. The Cancer Letter’s running list of cancelled meetings appears here.

  

To gauge the impact of COVID-19 on oncology, The Cancer Letter spoke with leaders at Seattle Cancer Care Alliance/Fred Hutchinson Cancer Research Center, MD Anderson Cancer Center, University of California, Los Angeles, Robert H. Lurie Comprehensive Cancer Center of Northwestern University, the University of Kansas Cancer Center, and Sidney Kimmel Cancer Center at Thomas Jefferson University.

Their responses appear here.

In Washington state, hit hardest—with 420 cases and 31 deaths at this writing—the Seattle Cancer Care Alliance and Fred Hutch faced the landfall of the pandemic.

“Seattle Cancer Care Alliance has had to make the very difficult decision to reschedule non-essential patient visits for the time being out of concern for our patients’ health—and to make sure that we are well-positioned to care for our patients in active treatment and prepare as the number of COVID-19 cases in our area continues to grow,” said Steve Pergam, medical director of Infection Prevention at Seattle Cancer Care Alliance and clinical and infectious disease researcher at Fred Hutch.

NCI Director Ned Sharpless said the institute is developing strategies for minimizing disruption to clinical trials as well as preparing contingency plans for safeguarding its workforce.

“We believe we will be able to do the things that we really need to do, like support clinical trials externally or provide grants to extramural awardees, or even keep intramural activities going, to the extent possible,” Sharpless said in a March 12 meeting of the NCI Clinical Trials Advisory Committee. “I want to assure you that we are prepared. And we have given thought to how to deal with the impact of the coronavirus epidemic on clinical trials.

“We’ve been discussing how clinical trials, in particular, could be affected by, say, decreased ability of patients to get to treatment or infusion centers in the community, for example.”

Based on previous, more limited, emergency situations, NCI anticipates that there will be “disruptions in the continuity of care for patients currently enrolled on clinical trials as well as decreased accrual to trials as health care providers try to ensure appropriate care for their patients,”  Margaret Mooney, acting associate director of the Cancer Therapy Evaluation Program, chief of the Clinical Investigations Branch in CTEP in NCI’s Division of Cancer Treatment and Diagnosis, said to The Cancer Letter.

“This is a far more challenging situation in that it spans the entire country, older adults and those with serious underlying medical conditions are at higher risk of getting sick from the illness, and we do not know how COVID-19 outbreak will evolve or the extent of the stress it will be put on the health care system and the families, caregivers, and communities that support cancer patients,” Mooney said.

FDA has postponed all foreign inspections not determined to be critical, a move that could potentially delay drug approvals and other regulatory functions.

The novel coronavirus will be deadly for many cancer patients. Patients with blood malignancies are at particularly high risk.

“Many of our therapies compromise the immune system, and particularly in the blood cancers—where it’s the immune system itself and parts of it that are cancerous,” said Joseph McGuirk, professor of medicine, Schutte-Speas Professor of Hematology-Oncology, director of the Division of Hematologic Malignancies and Cellular Therapeutics, and medical director of the Blood and Marrow Transplant Program at The University of Kansas Cancer Center.

“We suppress the immune system on purpose, and that sets our patients up for risk for infections—including [COVID19],” McGuirk said during a Facebook Live event on the subject March 11.

Older patients, bone marrow transplant recipients, and solid tumor patients who actively or have recently received chemotherapy should adhere to the same guidelines provided by CDC for the general public—avoid touching areas of the face, practice social distancing, washing hands thoroughly and often, avoiding coming into contact with high-touch public surfaces, said Dana Hawkinson, medical director for infection prevention and control, The University of Kansas Health System, and an assistant professor specializing in infectious diseases at University of Kansas Medical Center.

Canceling follow-up appointments isn’t on the table yet, Hawkinson said. “Individually, I would say, continue to be vigilant, talk with your provider, get good guidance. And by all means, if it’s safe and you’ve talked with your provider, please come in to your clinic visit—because missing a clinic visit could be even worse.”

The transcript of McGuirk’s conversation with Hawkinson and KU Cancer Center Director Roy Jensen appears here.

A guest editorial by Karen Knudsen, executive vice president of Oncology Services at Jefferson Health, enterprise director at Sidney Kimmel Cancer Center at Jefferson, Thomas Jefferson University, and chair & Hilary Koprowski Endowed Professor in the Department of Cancer Biology, and Jensen appears here. Jensen is president of the Association of American Cancer Institutes and Knudsen is president-elect.

“Given the specialized needs of cancer patients, it is imperative to consider how we as the major cancer centers may address and communicate how the impact of COVID-19 may impact the timing and delivery of cancer care, and to communicate this information to cancer patients,” Knudsen and Jensen wrote.

Today, Italy has the greatest number of COVID-19 cases outside China, and if the situation in Italy’s cancer centers today is indicative of what’s about to happen in the U.S., extreme concern would be justified. In Italy, more than 10,000 people have tested positive for COVID-19 and more than 1,000 have died. The country is on a travel lockdown.

“What are we doing in Italy in order to reduce the risk of our patients? We stopped follow-up visits,” said Giuseppe Curigliano, associate professor of Medical Oncology at University of Milano and the head of the Division of Early Drug Development at European Institute of Oncology, Italy, who is based in the Lombardy region—the epicenter of the outbreak. “Any patients that were supposed to visit our comprehensive cancer center for follow up, we decided to stop the visits. We decided to give priority to patients with active disease over patients who are treated in the curative setting.”

Italy has  4.1 MDs per 1,000 people, and 2.4 hospital beds per 1,000 people. By comparison, the U.S. has about half that—2.6 MDs per 1,000 people, and 2.9 beds per 1,000 people, according to data from The World Bank.

“The more you’re high at risk, like our cancer patients, the more probability you have of dying. There is a high fatality rate in cancer patients,” Curigliano said.

Faculty and staff at the European Institute of Oncology in Milan check in with patients one day before their scheduled visit. Do they have a cough, fever, or a runny nose?

“They can come directly to the hospital only if they have no symptoms related to coronavirus,” Curigliano said. “Once they arrive in the hospital, there is a checkpoint, external to the hospital, where temperature is measured and an exam is done. If everything is OK, they come directly into the hospital.”

In China, Curigliano estimated that 5% of patients who tested positive for COVID-19 have cancer—data that’s not yet available in Italy.

“It’s like being in a war or under a terrorist attack, when usually 15% of people go in intensive care. This is exactly the atmosphere that we are living in,” Curigliano said. “It’s a complete lockdown. Universities are closed, schools are closed, any other activity that is not a hospital, a food market, or a pharmacy is closed.”

Curigliano’s conversation with The Cancer Letter  appears here.

At least 33 states and the District of Columbia have declared a state of emergency at this writing. Nearly 1,800 people in the U.S. have tested positive for coronavirus, and 41 have died.

Aggressive respiratory viruses are always a danger to cancer patients, KU’s McGuirk said. “It’s always critically important that we know about that, and we can guide our patients in terms of coming in, taking special precautions,” he said. “For example, and coming to clinic to minimize exposure to others—regardless of what type of virus it is—and then isolating those patients as soon as they come in so that we can investigate what’s going on with them.”

AACI is launching a platform for its members to share coronavirus experiences and best practices, Knudsen and Jensen wrote.

“As cancer center leaders, we are responsible for delivering accurate information to our faculty and staff, and to our patients,” they wrote.

 

NCI: The list of items is enormous

NCI has set up a task force to prepare contingency plans for the institute. Also, the NCI Clinical Trials Advisory Committee is expected to issue a guidance for adapting clinical trials to the outbreak to ensure that NCI’s networks can be flexible enough to cope with issues of patient access, while minimizing protocol deviations that could present problems during the auditing phase of the trials.

“Our goal is to help physician and healthcare providers address some of the current challenges in providing care to patients enrolled on NCTN and NCORP clinical trials,” CTEP’s Mooney said. “We are looking at changes we can make in our usual procedures such as allowing sites to ship oral investigational agents to patients directly, instead of requiring patients to come to the site given travel restrictions during this period, extending use of local healthcare providers for routine study follow-up visits, and if needed and feasible, helping transfer patient care to other participating sites in the NCTN/NCORP network.

“We will continue to monitor closely the trials being conducted across the network with the NCTN Groups and NCORP Research Bases and their investigators to see if there are additional accommodations that can be made to help maintain continuity of care for patients on clinical trials as much as possible in this challenging situation.

“The recommendations provided by the CDC and other public health experts to mitigate risks to people at high risk are the best guide currently on how to protect patients.  As more information becomes available on mitigation strategies from physicians directly caring for cancer patients, that information will be able to be shared broadly in the oncology community.”

Following are remarks from NCI Director Ned Sharpless, addressing CTAC members at a meeting March 12:

I would say a word about the ongoing impact of the coronavirus planning on the National Cancer Institute. As you can imagine, NCI is a large federal agency with lots of employees and contractors and a really important mission. The continuance of operations towards that mission is of utmost priority to the NCI and the American public. So, we’ve done a lot of planning around how we can continue to carry out our mission should this epidemic continue.

We believe we will be able to do the things that we really need to do, like support clinical trials externally or provide grants to extramural awardees, or even keep intramural activities going, to the extent possible. I want to assure you that we are prepared. And we have given thought to how to deal with the impact of the coronavirus epidemic on clinical trials.

The operational challenges provided by COVID-19 are significant, and, working closely with the NIH, we have instituted a number of measures to try and get a handle on this proactively. The NCI has set up a task force that meets daily to discuss topics like our teleworking policy, school closings, as well as what will happen to the intramural program in terms of feeding cells and animal care, should there be limited access to campus.

First, as for contingency planning, one of the things we talked about, is that we have a large workforce and a number of contractors whose safety and ability to work are our utmost priorities. I think one of the areas where I’m more optimistic is in our ability to issue grants, even under fairly difficult circumstances, so I expect that we will be able to continue operations of disbursing funds to extramural grantees, even should the situation at NIH become significantly worse than it is today.

Right now, we’re limiting meetings and limiting travel, limiting group sizes. Work is, to date, not dramatically affected, although we are considering contingencies where necessary.

Second, we are also very much interested in what cancer patients should do who are undergoing therapy at this time. This is the reason for planning discussions with ASCO and other similar organizations about how we can provide useful advice during this time,  in this fast-moving situation where data are somewhat unclear as to how to handle this situation, as a clinical matter, for the benefit of patients.

And lastly, we’ve been discussing how clinical trials, in particular, could be affected by, say, decreased ability of patients to get to treatment or infusion centers in the community, for example.

So, the list of items that we have to think about and plan for is enormous. As you can imagine, patient safety is our top priority. The ability to do clinical trials in a way that decreases patients’ need to travel as well as their exposure, and allows for good clinical trials practice, is what we’re working on

 

 

Meeting cancellations, travel restrictions

Dozens of organizations in oncology have postponed or canceled annual meetings to prevent spread of the virus, and a Biogen conference in Boston Feb. 29 has proven to cause upwards of 70 cases of coronavirus in the U.S.

Whether meetings in oncology will take place is mostly no longer a question. They will likely not happen as scheduled (The Cancer Letter, March 4, 2019).

The American Association for Cancer Research postponed its annual meeting April 24-29 until later this year, and the American Society of Clinical Oncology has said it’s considering a digital format for its May annual meeting.

“If the meeting is moved to a digital format, ASCO will be able to offer a rich program online, with tools that allow attendees to connect and participate,” ASCO said in a statement. “A final decision on the meeting format will be made by the end of April if not sooner to allow participants adequate time to adjust their plans.”

The Cancer Letter is tracking canceled meetings in oncology, travel advisories, and confirmed cases in the U.S., here.

Numerous cancer centers in the U.S. have instituted work from home policies and travel restrictions.

Cary Gross, professor of medicine and of epidemiology, founder and director of Cancer Outcomes Public Policy and Effectiveness Research Center at Yale School of Medicine; and director of Adult Primary Care Center, Quality Improvement; chair and director of the  National Clinician Scholars Program, began a crowdsourcing document of institutions with travel restrictions.

 

Testing still inadequate

The mortality rate for COVID-19, at about 2% to 4%, is much higher compared with the seasonal flu, which generally has below a .1% mortality rate, according to the World Health Organization. The basic reproduction number (R0) for the novel coronavirus is also nearly double that of the flu.

On March 11, the WHO declared COVID-19 a pandemic. On the same day, President Donald Trump instituted a travel ban for Europe (excluding the United Kingdom). However, his tweets about the virus have understated the threat.

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On March 12, Vice President Mike Pence—responding to a loss of 11 years of stock gains stemming from investors bailing due to the rapid uptick in U.S. cases and lack of an early national containment and response plan—is now saying there has been “irresponsible rhetoric” from those who have downplayed the seriousness of coronavirus.

Trump and Pence have reportedly been exposed to the virus but refused testing.

“Both the President and Vice President had almost no interactions with the individual who tested positive and do not require being tested at this time,” the White House said in a statement March 12.

Testing for the virus in the U.S. has been slower than in other countries. CDC has tested 3,791 specimens, and public health laboratories have tested 7,288 specimens as of March 11, according to CDC.

“The system is not really geared to what we need right now, what you are asking for. That is a failing,” Anthony Fauci, director of the National Institute of Allergy and Infectious Diseases, told the House Oversight and Reform Committee March 11 at a hearing on the nation’s preparedness for the outbreak. “The idea of anybody getting it easily the way people in other countries are doing it, we’re not set up for that. Do I think we should be? Yes. But we’re not.”

Former FDA Commissioner Scott Gottlieb surmised that there are two paths the U.S. can follow to mitigate COVID-19: That of South Korea, which has been largely successful in containing the virus and has tested more than 100,000 specimens, and that of Italy—which has upwards of 10,000 cases that grow by the day.

“We probably lost chance to have an outcome like South Korea,” Gottlieb wrote in a tweet March 12.

CDC can produce between 300 and 350 tests a day, CDC director Robert Redfield said at the hearing. Private labs LabCorp and Quest have the capacity to test at a large scale—more so than public labs, Redfield and Fauci said.

Some have called for academic health centers to take the lead. Cleveland Clinic has developed its own test that gives results within eight hours, rather than the 2-3 days it can take for other tests to show a result, according to reports.

Health care workers at M Health Fairview, of Minnesota Medical Center, MN, have begun offering curbside COVID-19 testing outside their facilities, according to reports.

“It starts with aggressive screening to get people diagnosed,” Gottlieb wrote. “While testing capacity expands, it’s not evenly distributed to places most needed, we’re far behind current caseloads. Too many people still can’t get screened. So, we can’t identify clusters and isolate disease.”

 

This story is part of The Cancer Letter’s ongoing coverage of COVID-19’s impact on oncology. A full list of our coverage, as well as the latest meeting cancellations, is available here.

Copyright (c) 2020 The Cancer Letter Inc.