The first large observational study of nearly 1,000 cancer patients who contracted COVID-19 was published today by The Lancet and simultaneously announced at a virtual ASCO 2020, the large annual meeting of the American Society of Clinical Oncology.
The findings, gleaned from over 100 institutions participating in the international COVID-19 & Cancer Consortium, or CCC19, patient registry, underscore how deadly the new coronavirus can be for patients with active cancer and other underlying health conditions.
“If you have active cancer and are older or have multiple comorbid conditions that require therapy, you are likely at much greater risk from complications of COVID-19,” said co-senior author Dr. Gary Lyman of Fred Hutchinson Cancer Research Center.
“That’s one of the major findings and one of the most concerning findings. However, the risk is greatest in those with progressive disease and poor performance status and less when the cancer is stable or responding.”
Launched just two months ago, the CCC19 patient registry uses a REDCap online survey tool to crowdsource data from clinicians on the risk factors, treatments, prognosis and overall outcomes of cancer patients with COVID-19. Patients were followed for 21 days. However, the registry is ongoing and will continue to capture and disseminate information in near-real time to better manage patients dealing with both diseases.
“We’re crowdsourcing because we wanted to get the data urgently, quickly,” said Lyman, who sits on the CCC19 national steering committee. “We’re not trying to replace clinical trials, but to gather as much data as quickly as we can on how common these problems are in this population.”
Lyman said early studies out of China indicated cancer patients might be at greater risk from infection from the new coronavirus. They also appeared to have poorer outcomes. The newly released CCC19 data confirms this.
“Outcomes reported for cancer patients and those with other chronic conditions appear to be worse from COVID-19 than it is for the general population,” he said. “I think that’s clear.”
This first CCC19 study looked at the outcomes for 928 cancer patients who were subsequently diagnosed with COVID-19. Patients with active cancer as well as those in remission with a past history of cancer were included. Their care came from both academic and community sites from across the U.S. (and a few from Canada and Spain).
Half the patients identified as male and half female; half identified as white, 16% as black and 16% as Hispanic (not all patients identify with an ethnic group). The patients had a mix of hematologic and solid tumors, most commonly breast and prostate cancer.
Forty-five percent were considered to be in remission; 43% had active cancer. Of those with active cancer, 74% had stable or responding disease and 26% had progressive disease at the time of their COVID-19 diagnosis. Thirty-nine percent of patients had received anti-cancer therapy, which was defined as cytotoxic chemotherapy or other treatments (except surgery) within four weeks of their COVID-19 diagnosis. Other treatments included targeted agents, endocrine therapy, immunotherapy and radiation therapy.
— Fred Hutch public health researcher and oncologist Dr. Gary Lyman
The COVID-19 & Cancer Consortium, or CCC19, is a collaboration of over 100 cancer centers around the U.S. and the world. Utilizing a REDCap survey tool, the CCC19 registry is rapidly gathering data on cancer patients diagnosed with COVID-19 — demographics, comorbidities, cancer treatment details and COVID-19 therapies — then disseminating their findings.
Fred Hutch’s Dr. Gary Lyman, who sits on the CCC19 national steering committee, said the idea is to “crowdsource information in order to optimally manage patients with both diseases.”
Over the course of the study period, 26% of patients, or 242 individuals, became severely ill or died. Severe illness required hospitalization, intensive care unit admission and/or mechanical ventilation.
Overall, there were 121 deaths within the 30-day study window, yielding a mortality rate of 13%, more than twice the mortality reported by Johns Hopkins University as the global average for COVID-19 deaths in the general population.
“At the time we did the analysis, a lot of these patients were still on ventilators in the ICU and many may not have survived,” Lyman said. “Further follow-up will be reported in the coming months.”
The four most common symptoms for patients with cancer and COVID-19 were fever, cough, fatigue or malaise and shortness of breath. Only 4% of the patient cohort were without symptoms in this early cohort, before routine COVID-19 screening had started.
Patients with COVID-19 and cancer who died were more likely to be older and male. Men were found to experience more serious outcomes from COVID-19, as has been seen in the general COVID-19 patient population. Former and current smokers also died more than those who had never smoked.
Comorbidities — underlying health conditions that require therapy such as diabetes, cardiovascular disease, COPD or kidney disease — hugely influenced outcomes.
“The more comorbidities you have, the greater the risk,” Lyman said. “If you have two or more comorbid conditions, the risk for mortality goes up quite steeply, more than fourfold.”
Lyman said COVID-19 patients with hematologic cancers may be at a greater risk than those with solid tumors, but he said the difference was not statistically significant, at least at this time.
Patients with active cancer, however, were much more at risk than those in remission. According to the study, patients with progressing cancer had a fivefold relative risk of dying within 30 days compared to those in remission.
“It appears that active cancer that is progressing may be an especially poor risk factor for adverse COVID-19 outcomes,” he said. “Clinicians may want to consider earlier end-of-life conversations.”
Researchers also noted a “strong association” between higher mortality rates and treatment with hydroxychloroquine and azithromycin, although they noted the combo treatment was “commonly used in high-risk patients” so they couldn’t determine whether poor outcome was "due to the drug or the higher risk patient population that received the drug combination.”
The World Health Organization just halted a clinical trial investigating the antimalarial drug’s effectiveness in treating COVID-19 due to safety concerns raised by another observational study published last week by The Lancet.
“The results of our study should not be used to make a final judgment about this regimen for COVID-19,” Lyman said of the treatment, which has become a political hot potato. “There are many other clinical factors that doctors use to decide which patient to put on a potential therapy that we couldn’t assess in this model and many we may not even be aware of yet.”
The bottom line: Prospective clinicals trials are still needed to establish the safety and efficacy of treatments for COVID-19, he said.
There are conclusions that can be taken from the study, Lyman stressed.
First, if you’ve been diagnosed with COVID-19 and are on active cancer therapy, you should talk to your oncologist immediately.
“If you have active COVID-19, you should delay treatment for your cancer until you recover,” Lyman said. “It’s highly risky for you.”
Second, cancer patients who need to go in for treatment, despite the pandemic, should carefully balance the risks and benefits, particularly if they suffer from additional comorbidities. Some patients, he said, may be able to change the order of their treatments, using endocrine therapy first for instance, and following up with chemotherapy at a later time.
“Taken together, these results suggest that fit, nonelderly patients with cancer and few comorbidities can proceed with appropriate anticancer treatment,” he said. “Whereas those with poor performance status or cancer that’s progressing need to have thoughtful conversations with their oncology providers about risk versus benefit of treatment.”
For these patients, supportive care is key, he said.
“We are encouraging clinicians to be very aggressive with supportive care and to pay special attention to these patients, especially those with comorbidities and a smoking history,” he said. “If you have COVID-19 and cancer and other medical problems or are older, you will really need careful attention.”
Lyman said clinicians should consider more aggressive supportive care in their patients to avoid infections, severe fatigue and bleeding complications from chemotherapy. This could also help to keep immunocompromised patients away from an overtaxed, and COVID-19 saturated, health care system.
He also pointed to newly issued COVID-19 cancer treatment guidelines from the National Comprehensive Cancer Network. Lyman is a contributing author with NCCN.
“We’re modifying previous guidelines in order to further prevent other infections or bleeding,” Lyman said. “We also need to keep these patients away from the health care institutions where they might get exposed to the infection.”
Lyman, who recently published a piece on personalizing supportive care for cancer patients in the era of COVID-19, said these practices represent a marked, but necessary, change for oncologists.
“We’re usually pretty cautious about using these supportive-care treatments because they’re costly, they have side effects and they’re not always needed,” he said. “But for the time being, we want to pull out all the stops. We’re doing what we can to help patients get through cancer treatment when they need it, and at the same time, minimize their exposure to hospitals and infected patients.”
Lyman and researchers from the other 103 participating institutions within the Covid-19 & Cancer Consortium will continue to follow the patients in the registry — there are more than 2,000 patients now — and publish findings as they emerge.
Our one consolation as the pandemic continues to grow: So does the data and our understanding of this threat.
Diane Mapes is a staff writer at Fred Hutchinson Cancer Research Center. She has written extensively about health issues for NBC News, TODAY, CNN, MSN, Seattle Magazine and other publications. A breast cancer survivor, she blogs at doublewhammied.com and tweets @double_whammied. Email her at firstname.lastname@example.org.
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