With increasing numbers of individuals getting vaccinated against COVID-19 and deaths from the disease declining in the United States, people are optimistic the pandemic that disrupted their lives since March 2020 is coming to an end. In recent months, news reports have pointed to signs that the nation’s economy is bouncing back. The stock market is surging, many restaurants are opening their doors for inside dining for the first time in more than a year, and air travel is returning to pre-pandemic levels.
Whatever the long-term effect the pandemic will have on American life, it is already clear that a legacy of the crisis will be a rethinking of how health care is delivered and clinical research is conducted and a greater awareness of inequities in the delivery of care. Oncology is among the medical disciplines for which this evolution already is well along. Providers of cancer care hurriedly devised strategies to manage patients for whom treatment delays and interruptions could result in cancer progression and death, and, like health care providers in other specialties, had to do this while keeping patients safe from COVID-19.
“The biggest lesson we learned is that we can respond and pivot quickly when faced with a new challenge,” said Crystal S. Denlinger, MD, Chief Scientific Officer for the National Comprehensive Cancer Network® (NCCN®), an alliance of 31 cancer centers in the United States. “The pandemic hit and all of a sudden [and] very quickly, we had to work together to come up with alternative models of care and research, figure out how to risk stratify our patient population, and determine how to deliver care all in the setting of a novel and fairly unknown clinical environment, with an unknown threat [from] this new virus.”
During the first month or so of the pandemic, many states issued mandates for medical practices and hospitals to stop providing all but the most essential health care services. Throughout much of the United States, routine screenings and testing and diagnostic evaluations came to a halt or nearly so. Patient caseloads across medical specialties plunged. Telehealth quickly became the norm for non-urgent consults. When the mandates lifted, caseloads rebounded as medical practices stepped up operations, albeit with safeguards to protect patients and staff from infection. Even after practices resumed providing routine care, however, many patients hesitated to make doctor visits.
By May 2020, Dr Denlinger said, NCCN member institutions were “back up and running” and continuing to provide cancer care with little disruption for patients on active therapy. “Our member institutions pivoted to telehealth very quickly,” she said. “Clinicians worked together to figure out clinical pathways to minimize risk and maximize benefit. The oncology community figured out that we could deliver care multiple different ways.”
Instead of having a one-size-fits-all paradigm, Dr Denlinger said, providers across NCCN member institutions focused on individual patients and their specific cancer in the context of the pandemic to “come up with what we thought was the best treatment plan for them that was going to minimize risk. And while we’ve always done personalized care, I think we even took that to the next level by thinking not just about the patient and their cancer, but in the context of the larger public health emergency.”
The pandemic underscored for Dr Denlinger that “cancer patients really prioritize their cancer care.” Many stopped seeing family and friends and making visits to their primary care doctor, but they made sure to keep appointments with their oncologist, she said.
COVID-19 also highlighted disparities in the delivery of care. “The pandemic laid bare a lot of inequities across multiple different sectors,” Dr Denlinger said, adding that the issues that surfaced were “more than just the traditional disparities that we have previously seen.”
For example, she found that many older patients were more likely than their younger counterparts to have trouble using telehealth technology and patients in rural areas frequently lacked internet access to support video encounters. In addition, patients postponed non-urgent oncology visits because they were furloughed from their jobs and could not afford insurance copays, she noted.
Racial disparities in prostate cancer treatment during the pandemic emerged in a study comparing radical prostatectomy (RP) rates in March-May 2020—during the initial phase of the pandemic—and March-May 2019. Early in the pandemic, “routine oncologic care was deferred to encourage stewardship of resources and prioritize safety,” a team led by Adrien N. Bernstein, MD, of Fox Chase Cancer Center in Philadelphia, Pennsylvania, noted in a poster presentation at the 2021 annual meeting of the American Society of Clinical Oncology.
Dr Bernstein and his colleagues studied a retrospective cohort of 647 patients: 269 during March-May 2020 and 378 during March-May 2019. Black men were less likely than White men to undergo RP for nonmetastatic prostate cancer during the initial pandemic period (1.3% vs 25.9%) despite having similar COVID-19 risk factors and biopsy Gleason grade groups, the investigators reported. By comparison, RP rates during the same period in 2019 did not differ significantly (17.7% vs 19.1%). During the initial pandemic period, Black patients had 94% decreased odds of RP compared with White patients after adjusting for covariates.
“Public health efforts are needed to fully recognize the unintended consequence of diversion of cancer resources to the pandemic in order to develop balanced mitigation strategies as viral rates continue to fluctuate,” the researchers concluded.
Tele-Oncology Myths Dispelled
“There have been many lessons learned by all as a result of the pandemic,” Philippe Spiess, MD, Medical Director of Virtual Health, and Cristina Naso, Virtual Health Director, at Moffitt Cancer Center in Tampa, Florida, said in a joint email comment. “One of the most surprising things was the discovery of how many myths we had clung to regarding tele-oncology.”
For example, providers at Moffitt believed patients must be younger to adopt the technology and that only patients who lived far away from the cancer center would be interested in this service, they noted.
“All of these preconceived notions were upended with the rapid expansion of virtual care and specifically tele-oncology in the early days of the COVID-19 pandemic in March and April of 2020,” they said. “We have since learned quite convincingly that patients value their time, freedom, and choice for care delivery ultimately personalizing the care we deliver to patients and their families. Patients continue to request telemedicine appointments from their providers regardless of age, distance or diagnosis. The experience has taught us that patients should be the drivers of their care journey.”
While in-person care can never, and should never, be replaced, they noted, “telemedicine can supplement the care journey to minimize disruption to patients’ lives. Providing the choice for a telemedicine visit honors the patient’s ability to choose and that is something that should be encouraged and advocated for when clinically appropriate of course.”
Adapting Treatments to the Crisis
As a result of the pandemic, physicians tried therapeutic approaches that differed from the norm, in part with help from the Food and Drug Administration (FDA). The agency loosened dosing requirements for immunotherapies, said Dr Denlinger, who specializes in the treatment of gastrointestinal (GI) cancers and was a clinical investigator at Fox Chase early in the pandemic. For example, instead of dosing pembrolizumab every 3 weeks and nivolumab every 2 weeks, physicians could now dose these medications every 6 weeks and every 4 weeks, respectively. “So for patients who were on these immunotherapy drugs, they were switched from an every 2- to 3-week schedule to an every 4- to 6-week schedule so that they didn’t have to come in as frequently for their immunotherapy infusion,” Dr Denlinger said.
Many therapies for GI cancers involve a combination of pharmacologic therapies and surgery, she noted. Chemotherapy and radiation therapy might be delivered after surgery or surgery might be sandwiched between them. At Fox Chase, this approach changed during the pandemic.
“We moved all of the therapy that would have been done after surgical resection to the neoadjuvant setting, so patients got a total neoadjuvant approach for rectal cancer and pancreas cancer,” Dr Denlinger related. “The data has been evolving to that model but we probably moved a little faster than the data has moved because of the fact that we couldn’t bring people in necessarily for a surgical resection, but we could bring them in for chemotherapy.”
Another strategy put into place was switching from infusion to oral therapies when appropriate. For example, patients on a 5-fluorouracil infusion regimen who came to a center for treatment every 2 weeks were switched to capecitabine, an oral form of the drug when possible.
The pandemic also forced researchers to examine what really is necessary in clinical trial protocols, Dr Denlinger said. For example, many studies require research-only visits in which participants come to a study center for an adverse effect assessment, blood work, or physical examination. Now investigators are questioning whether this is necessary for every protocol, she said. The experience during the pandemic suggests that many such visits can be eliminated without jeopardizing the integrity of the trial.
Although some institutions completely discontinued enrollment in clinical trials during the initial phase of the pandemic, she and her colleagues at Fox Chase, like many other large tertiary care centers, took a more measured approached. For instance, they continued pragmatic trials likely to provide a strong benefit to patients, such as those in which patients in both study arms experience a therapeutic benefit rather than one arm receiving a placebo.
She credits the National Cancer Institute and FDA for issuing guidance early in the pandemic that allowed relaxation of some regulations on protocol adherence. This gave investigators flexibility in obtaining necessary data without compromising patient safety. They used telehealth when possible and did remote data monitoring. In some cases, instead of having patients come to Fox Chase for scheduled blood work, researchers had them go to CLIA-certified commercial laboratories in their community for their blood draws. The laboratories would then report results to the investigators. Occasionally, investigators enlisted the help of local oncology providers to whom patients were already known. These providers would have trial participants make a local clinic visit to perform necessary assessments.
A survey of clinical trial programs in the United States launched in March 2020 by the American Society of Clinical Oncology led investigators to conclude that the impact of the pandemic on clinical trials could lead to changes in how they are conducted after the crisis ends.
“One of the early lessons has been that it is possible to conduct more streamlined or pragmatic trials,” David M. Waterhouse, MD, MPH, of Oncology Hematology Care in Cincinnati, Ohio, and collaborators wrote in a paper published in JCO Oncology Practice. “Many trials currently include tests, procedures, and strict data collection requirements and windows for assessment that are intended to maximize knowledge gained but may prove burdensome to both patients and trial programs.”
The pandemic exposed shortcomings in the nation’s health care system and nudged medical providers and researchers to reconsider how they care for patients and conduct clinical trials. When the crisis recedes, the innovations it sparked may be among its legacies.