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ASH Registry: Treasure Trove of Data on COVID-19 and Hematologic Malignancies


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The ASH Research Collaborative COVID-19 Registry for Hematology provides up-to-date information on outcomes and the course of illness for a group of patients with hematologic malignancies and COVID-19.1 In general, registry data showed that hematologic malignancies increase the risk of severity of COVID-19 and associated mortality. This registry identified risk factors for more severe COVID-19, such as older age, more advanced disease, pre–COVID-19 prognosis.

“Patients with hematologic malignancies are at increased risk for adverse COVID-19 outcomes and are thus medically vulnerable. The registry data show that risks are greatest in those who are older, have advanced disease [cancer] or a limited prognosis, and forgo intensive care unit (ICU) management; but keep in mind that the risks of COVID-19 are not trivial for others with hematologic malignancies,” said lead author William A. Wood, MD, MPH, Associate Professor at the University of North Carolina’s UNC Lineberger Comprehensive Cancer Center. Dr. Wood presented current registry data at the 2020 American Society of Hematology (ASH) Annual Meeting & Exposition.1


“The registry data show that risks are greatest in those who are older, have advanced disease [cancer] or a limited prognosis.”
— William A. Wood, MD, MPH

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Because of the rapidly evolving landscape during the pandemic, relevant data from clinical trials are difficult to come by. Data from the ASH registry (and others) are helpful in risk stratifying patients, planning for resource allocation, and designing future clinical trials.

“As data accumulate, we will be able to ask and answer other questions about treatments and risk factors,” Dr. Wood added.

As of December 2020, the global COVID-19 pandemic has affected more than 50 million people worldwide and more than 11 million people in the United States. The viral infection is particularly risky for immunocompromised people, such as those with underlying cancers, “especially hematologic malignancies,” Dr. Wood said.

“Patients with hematologic cancer are [already] at risk for greater illness severity and higher mortality due to aging, underlying hematologic disease, and underlying immune dysregulation due to the disease and/or its treatments. The concern is that COVID-19 infection could elevate this script,” Dr. Wood noted.

Background

The first reports from China on COVID-19 suggested that the risk of adverse outcomes was higher in patients with cancer, with mortality approaching 40%. Primary care administrative data also suggested a higher risk of death associated with cancer and COVID-19. This led to the launch of several registries to focus on cancer and COVID-19, among them from the Center for International Blood and Bone Marrow Research, ASCO, and the COVID-19 Consortium.

In this context, the ASH Research Collaborative COVID-19 Registry for Hematology was undertaken to report on patients who tested positive for COVID-19 and had hematologic malignancies and underlying hematologic conditions or post–COVID-19 hematologic complications. Dr. Wood’s presentation at the ASH Annual Meeting focused solely on hematologic malignancies and COVID-19.

Registry Findings

Dr. Wood reported data on 656 patients worldwide, with 396 from North America. All data entered in the registry were submitted by individuals or institutions. The data were de-identified, had a central institutional review board exemption, and were compliant with General Data Protection Regulation.

Overall, 77% were older than age 40, and 60% were male. Among those who reported ethnicity, 43% were White, 27% were Asian, 17% were Latinx, and 13% were Black. More than half of the patients (57%) had comorbidities, with the two most frequently reported being diabetes (30%) and hypertension (50%). Of patients who reported on smoking status, 31% were current or former smokers.

Regarding cancer types, 57% had leukemia, 25% had lymphoma, and 18% had plasma cell neoplasms. Prior to the COVID-19 pandemic, 80% of those entered on the registry had an expected prognosis of more than 12 months.

Common COVID-19–related symptoms were fever, cough, shortness of breath, and fatigue, and this was true in hospitalized patients as well as in those who did not require hospitalization. About 50% of patients received COVID-19–directed therapy, including azithromycin and hydroxychloroquine.

Mild COVID-19 infection (outpatient) were reported in 225 patients, and the vast majority recovered. Among those with moderate COVID-19 infection meriting hospitalization, 196 recovered and 32 died. For severe COVID-19 infection (requiring an ICU stay), 47 recovered and 89 died.

The overall death rate for all patients with hematologic malignancies was 20%, which is much higher than the 2% case fatality rate for the U.S. population, noted Dr. Wood. The mortality rate was higher (33%) in hospitalized patients or those in ICU care.

Factors Associated With COVID-19 Severity

No differences in COVID-19 severity were associated with sex, race, or ethnicity. More than 70% of those with moderate to severe COVID-19 disease had diabetes or hypertension.

The rates of moderate-to-severe COVID-19 among those with leukemia, lymphoma, and plasma cell disorders ranged from 61% to 65%. In the year prior to diagnosis, more than 65% of all patients received cytotoxic chemotherapy, immunotherapy, targeted therapy, and/or other cancer-directed treatment. Moderate-to-severe COVID-19 infection was reported in 69% of those undergoing initial cancer treatment compared with 50% of those in remission and 79% of those with relapsed or refractory cancer.

The mortality rate was 51% among those with a life expectancy of less than 12 months before the COVID-19 pandemic and 13% among those with a life expectancy of more than 12 months prior to the onset of COVID-19.

Mortality also differed across malignancy status, at a rate of 21% for those in initial cancer treatment, 13% for those in remission, and 36% for those with relapsed or refractory hematologic cancer. Overall, 52% of patients with severity data (n = 555) had moderate-to-severe COVID-19, and the severity increased with age.

Among moderate COVID-19 cases, 8 were reported in patients younger than 19; 24 were reported in those between the ages of 19 and 39; 95 were reported in those between the ages of 40 and 69; and 43 were reported among those older than 69. A total of 8 deaths were reported among those between the ages of 40 and 69 with moderate COVID-19, and 14 deaths were reported in those older than 69 with moderate infection.

The rate of severe COVID-19 was very low in patients younger than age 19 and low in those between the ages of 19 and 39. For those between the ages of 40 and 69, 26 recovered, 8 died with palliative care alone, and 37 died with full medical care. For those older than 69 with severe COVID-19, 13 recovered, 17 died with palliative care alone, and 18 died with full medical care.

“An important factor affecting outcome was choice to forgo ICU care, and this choice was strongly associated with age,” Dr. Wood emphasized.

Among those who declined ICU care, the death rate was 73%, whereas it was 13% among those who opted for ICU care.

The decision to forgo ICU care differed according to physician-estimated pre–COVID-19 prognosis. Just 6% of those with a prognosis of more than 12 months prior to the onset of COVID-19 chose to forgo ICU care, compared with 28% of those with a shorter prognosis (ie, < 12 months). Malignancy status also was related to the decision to forgo ICU care, with almost four times as many people with relapsed or refractory cancer declining such care, compared with 6% of those in remission.

Pre–COVID-19 prognosis was also related to the severity of COVID-19. Those with a shorter prognosis were significantly more likely to have moderate-to-severe infection compared with those who had a greater than 12-month prognosis prior to COVID-19 diagnosis (79% vs 58%, respectively).

What Next?

Data collection for the ASH Registry is ongoing, and the registry now supports batch data submission. “We welcome submissions by individuals and institutions and are happy to answer any questions. With more data, the power of the registry to inform decisions will grow. The ASH Research Collaborative Data Hub will also collect COVID-19 data and can be leveraged for surveillance testing and vaccine distribution in vulnerable populations. We encourage data submission and welcome participation from all of you,” Dr. Wood told listeners. “Visit www.ashrc.org to learn about the registry and data hub, to view real-time graphic COVID-19 registry display, and to submit data.” 

DISCLOSURE: Dr. Wood has received research funding from Pfizer; served as a consultant to Teladoc/Best Doctors; and received honoraria from the ASH Research Collaborative.

REFERENCE

1. Wood WA, Neuberg DS, Thompson JC, et al: Outcomes of patients with hematologic malignancies and COVID-19 infection: A report from the ASH Research Collaborative data hub. 2020 ASH Annual Meeting & Exposition. Abstract 215. Presented December 5, 2020.


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