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Title: Erythropoiesis-Stimulating Agents Linked to Increased Risk of Death in Patients With Cancer
URL: http://www.pslgroup.com/dg/21DAEE.htm
Doctor's Guide
February 26, 2008

NEW YORK -- February 26, 2008 -- According to a review of phase 3 trials, erythropoiesis-stimulating agents (ESAs) may be associated with an increased risk of venous thromboembolism (VTE) and death in patients with cancer. These results will appear in the February 27, 2008, edition of the Journal of the American Medical Association.

Erythropoietin and darbepoetin alfa are used to treat anaemia in patients who have cancer. Although some studies suggested that there could be a higher risk of VTE with these medications, it was not known whether there also was an associated risk of death. Therefore, Charles L. Bennett, MD, PhD, Professor, Division of Hematology/Oncology, Northwestern University Feinberg School of Medicine, Chicago, and colleagues reviewed the rate of VTE and death associated with the administration of ESAs for the treatment of anaemia in patients with cancer in phase 3 trials.

To examine survival rate, the researchers identified 13,611 patients in 51 clinical trials. They found that the risk of death was significantly higher in patients with cancer who had also been treated with ESA compared with those in the control group.

In addition, the risk of VTE was analysed in 38 trials that included 8,172 patients. The researchers found a 57 percent increased risk of VTE among patients who were treated with ESA (173 events among 3,562 patients in the control group compared with 334 events among 4,610 patients treated with ESA), which was significant.

"These risks are important given the prevalence of ESA use as a supportive care drug among patients with cancer as well as the dissemination of a series of safety advisories by the [US] Food and Drug Administration and ESA manufacturers," the authors note. "Our findings, in conjunction with basic science reports on erythropoietin and erythropoietin receptors in solid cancers, raise concern about ESA safety for patients with cancer."

Source: Journal of the American Medical Association, February 27, 2008

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