233 A phase IV study of epoetin alfa examining clinical outcomes in anaemic cancer patients receiving chemotherapy

Abstract

This Phase IV study, involving over 570 U.S. community-based oncology practices, aimed to measure clinically relevant outcomes in 2,030 Epoetin alfa-treated anemic patients (pts) with solid or hematological tumors, who were receiving chemotherapy. Patients received Epoetin alfa 150 IU/kg 3 times weekly for up to 4 months. If necessary, this dose could be increased to 300 IU/kg 3 times weekly after 8 weeks of therapy. Quality of life (QOL), mean change in hemoglobin (Hb) level and avoidance of transfusion were assessed. One thousand, four hundred and ninety-eight pts had both baseline and end values. The mean changes in energy level, activity level, and overall QOL from baseline were increased significantly (+38%, +32%, +24%, respectively; <i>P</i><0.001). These improvements correlated directly with a significant increase in Hb level from baseline (+1.7 g/dl; <i>P</i><0.001, r=0.254). In the month before therapy, 22% of pts were transfused. During months 2, 3 and 4, the percentage steadily decreased (15%, 11%, 10%; <i>P</i><0.001 compared to baseline). Fifty-nine percent of pts were transfusion-independent after month 1. Forty-one percent of pts discontinued therapy–22% because of illness, adverse effects, or death (none drug related), 19% because of disease progression, discontinued chemotherapy, or personal reasons. In conclusion, the Epoetin alfa-treated anaemia cancer pts assessed experienced significantly improved QOL. Transfusion requirements were significantly reduced, and Hb levels increased significantly. Epoetin alfa was well tolerated.