Weighing the Hazards of Erythropoiesis Stimulation in Patients with Cancer

Abstract

On May 10, 2007, the Food and Drug Administration (FDA) convened a meeting of its Oncology Drug Advisory Committee to discuss concerns about risks associated with the erythropoiesis-stimulating agents (ESAs) used to treat anemia caused by chemotherapy. The principal ESAs under scrutiny were epoetin alfa (Procrit, Eprex, and Epogen) and darbepoetin alfa (Aranesp), and the risks — actual or potential — were thromboembolic disease, promotion of tumor growth, and decreased survival. The actual risk of thromboembolic events was shown in two phase 3 clinical trials, reported in the Journal in 2006, that unequivocally showed an increased risk of death or cardiovascular or thromboembolic events among patients with chronic renal failure who were treated with ESAs to drive hemoglobin levels into the normal range (13.5 g per deciliter or higher), as compared with those treated to achieve levels in a subnormal range (10.5 to 11.5 g per deciliter).