Final hematologic results: Epoetin alfa (EPO) 40,000 U QW vs darbepoetin alfa (DARB) 200 μg Q2W in anemic cancer patients (pts) receiving chemotherapy (CT)

Abstract

8030 Background: We report final results of a trial comparing hematologic outcomes, QOL, & safety for EPO & DARB using dosing regimens commonly prescribed in anemic pts with cancer receiving CT. Methods: Randomized, open-label trial enrolled pts ≥18 y with solid tumors, baseline (BL) hemoglobin (Hb) ≤11 g/dL, scheduled for ≥12 weeks (wks) of CT. Pts were stratified by +/− platinum CT, then randomized to EPO 40,000 U SC QW or DARB 200 μg SC Q2W for 12–16 wks; dose adjustments per NCCN guidelines. 150 pts per arm ensured 90% power to detect ≥20% difference in primary endpoint, Hb response rate (HRR; proportion of pts with Hb increase ≥1 g/dL within first 4 wks). Interim analysis of primary endpoint was planned after first 300 pts completed 4 wks. If HRR was statistically greater (P<.0125, 1-sided) for EPO compared with DARB, the null hypothesis would be refuted & enrollment would be terminated. Results: 358 pts were randomized to EPO (178) or DARB (180). Primary endpoint achieved based on interim analysis o...