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Use of hydroxychloroquine in cancer patients who are also diagnosed with COVID-19 provided no benefits, and may have worsened outcomes, researchers suggested.

Treatment with the combination of hydroxychloroquine and azithromycin to treat COVID-19 in cancer patients was associated with a 2.89-fold greater risk of 30-day mortality than use of neither drug, reported Jeremy Warner, MD, of Vanderbilt University in Nashville, in a late-breaker abstract at the virtual American Society of Clinical Oncology (ASCO) annual meeting.

The study, which used data from the , included 928 patients from Canada, Spain, and the U.S. Taking hydroxychloroquine alone was also not associated with either benefit or harm, but those outcomes might be influenced by the lack of patients in the study taking the drug as monotherapy, Warner said.

"About 20% of the patients in the study received the combination of hydroxychloroquine and azithromycin, and 10% received hydroxychloroquine alone," he said at an online press conference. "Almost all of the patients received the drugs off-label. Only two of the patients received the drugs as part of a clinical trial."

"There is a lot to learn about the characteristics," Warner said in response to questions. "Patients of all levels of severity of COVID-19 received these drugs, but certainly the patients who were hospitalized were more likely to receive them."

He noted that the criteria for hospitalization vary in different geographic areas, but in general, the likelihood of receiving the drugs depended on whether the patient was hospitalized. Analysis of the data was unable to determine if patients receiving the drug early in the disease course or late in the course fared better or worse, Warner said.

About 10% of the patients who were taking hydroxychloroquine were receiving it at the time they acquired COVID-19 infection, but the vast majority were prescribed hydroxychloroquine while they were being treated for COVID-19, Warner noted.

An exploratory analysis appeared to indicate that an increase in performance status score, receiving any cancer treatment within 2 weeks, and non-Hispanic ethnicity among patients receiving hydroxychloroquine were all associated with increased mortality.

"As we grow our database, we will be able to answer these questions with more detail," Warner said. "Clinical trials are still necessary to determine if there is a benefit or risk with hydroxychloroquine. I will caution that these results are of uncertain validity due to a high risk of residual confounding. For example, patients receiving this combination are more likely to have severe disease and are more likely to be hospitalized."

He said the study is the first from the CCC19 registry, adding that the consortium was organized on March 15 and now includes 104 participating institutions.

Matthew G. Heinz, MD, an internist at Tucson Medical Center in Arizona who was involved in the domestic response to the 2014 Ebola crisis, told 麻豆传媒, "These findings are consistent with multiple recent studies that similarly demonstrate no significant benefit in the treatment of SARS-Cov-2 infection from hydroxychloroquine or chloroquine therapy."

"Most data actually point to significant harm for COVID-19 patients treated with hydroxychloroquine, such as higher mortality and/or serious cardiac side effects," said Heinz, who was not involved in the study. "These new data further support the FDA advisory cautioning against the use of hydroxychloroquine or chloroquine for the treatment or prevention of SARS-CoV-2 infection."

Study Details

About half the patients in the study were male, and the median age of the patients overall was 66. "This is much older than the median age reported for other more general COVID-19 populations, but is consistent with the cancer diagnosis as 30% of these patients were older than 75," Warner said. "Most of the patients were white; 16% were black or African American, and 16% were Hispanic."

He said that the percentage of black and Hispanic populations, based on geographic regions included in the survey, is about double what would be expected based on census representation. About 9% of these patients were on active anti-cancer treatment, defined as either cytotoxic chemotherapy or other therapies such as targeted therapies; 43% had active or measurable cancer.

The most common cancer type was breast cancer, reported by 21% of the cases, followed by prostate cancer, gastrointestinal cancer, lymphoma, and thoracic cancer (including lung cancer). "Most of our patients had performance status 0-1. Half of our patients were never smokers; a third were former smokers, and a small number -- 5% -- were current smokers," Warner said.

The median follow-up was 21 days. At the time of his presentation, 121 patients (13%) had died -- all within 30 days of their COVID-19 diagnosis, which is about twice the 6.5% survival for all such patients across the globe, Warner noted.

Male sex, former smoking, and age over 75 were also associated with greater mortality levels; older age was associated with a 25% mortality rate, and patients with ECOG status of 2 or greater – about 8% of the total group – had a mortality rate of 35%.

Hospitalization was also a marker of increased mortality: About half the patients were hospitalized, and 34% of those individuals died; of the 14% of hospitalized patients who were admitted to the intensive care unit, 38% died.

ASCO President Howard A. Burris III, MD, commented: "The cancer care community urgently needs data on the effects of COVID-19, specifically in patients with cancer. How we improve the care we provide these patients and reduce the number of deaths and severe consequences associated with this disease are among the top questions. The COVID-19 and Cancer Consortium registry is a great example of the community quickly coming together to identify and collect the data we need on a large scale."

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