Researchers from more than 20 U.S. medical centers have reported that erythropoiesis stimulating agents (ESAs) Epogen® (epoetin alfa) and darbebpoetin (Aranesp®) administered to patients with cancer-related anemia is associated with a 57% increase in the incidence of venous-thromboembolism (VTE) and a 10% increase in mortality from all causes. The details of this study were published in the February 27, 2008 issue of the Journal of the American Medical Association.1
Recent concerns have been raised over the possibility that ESAs can increase the relapse rates and increase the incidence of VTE in patients with cancer. The increased incidence of VTE with use of ESAs is fairly well documented, but most studies have shown no impact of ESAs on overall survival.
The current study looked at 51 randomized clinical trials evaluating ESAs versus a placebo in patients with cancer-related anemia (n=2,089) or treatment-related anemia in cancer patients (n=11,522). Survival was evaluated in 13,611 patients in 51 Phase 3 trials. There was a 10% increase in mortality in patients receiving ESAs compared with control patients. The relative risk for mortality in cancer-related anemia was 1.19 versus 1.09 for patients with treatment-related anemia. VET was evaluated in 38 of the 51 trials involving 8,172 patients. Patients receiving ESAs had a 57% increase in VTE compared with placebo recipients.
Comments: These findings raise concern about the safety of ESAs in patients with cancer and the potential of these agents for increasing relapse rates. Physicians should be aware of the new guidelines for the use of ESAs in cancer patients.
Related News:
ASH/ASCO Updates Clinical Practice Guidelines for Epoetin Alfa and Darbepoetin Alfa (11/12/2007)
Amgen Revises Labeling on Erythropoietin-stimulating Agents (11/8/2007)
Epoetin Alfa Has No Effect on Survival or Relapse in Patients with Head and Neck Cancer (11/6/2007)
Aranesp® for Chemotherapy Induced Anemia has no Adverse Effect on Survival or Relapse (9/27/2007)
Reference:
1 Bennett CL, Silver SM, Djulbegovic B, et al. Venous thromboembolism and mortality associated with recombinant erythropoietin and darbepoietin administration for the treatment of cancer-associated anemia. Journal of the American Medical Association. 2008;299:914-924.
© 1998-2007 OncoEd.com All Rights Reserved.
These materials may discuss uses and dosages for therapeutic products that have not been approved by the United States Food and Drug Administration. All readers should verify all information and data before administering any drug, therapy or treatment discussed herein. Neither the editors nor the publisher accepts any responsibility for the accuracy of the information or consequences from the use or misuse of the information contained herein.
Patient Home
