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)

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 of first 305 pts (EPO 151, DARB 154) demonstrating HRR was significantly higher for EPO (47%) vs DARB (33%) (P=.0078, 1-sided). Analyses of secondary endpoints were performed on 352 (EPO 175, DARB 177) pts with ≥1 post-BL Hb or transfusion (TFN). Mean BL Hb was 10.2 g/dL (EPO) & 10.1 g/dL (DARB). Mean Hb change, median time to 1-g/dL rise, & % of pts with ≥2-g/dL rise are reported below using last value carried forward. Incidence of RBC TFN from wk 5 to end of study was 11% (EPO) & 16% (DARB) (P=.2078). Preliminary (exploratory) analysis of QOL suggested change scores were similar between groups. Clinically relevant thrombovascular events occurred in 11% of EPO & 9% of DARB pts. 13% of EPO & 16% of DARB pts died on study. Conclusions: This comparative trial in pts with CT-induced anemia demonstrated that Hb response rates were higher & time to 1-g/dL Hb rise was shorter in pts treated with EPO 40,000 U QW compared with DARB 200 μg Q2W. Author Disclosure Employment or Leadership Consultant or Advisory Role Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Ortho-Biotech/ Johnson & Johnson Johnson & Johnson Pharmaceutical Services Amgen, Johnson & Johnson Pharmaceutical Services, Ortho-Biotech/ Johnson & Johnson Johnson & Johnson Pharmaceutical Services, Ortho-Biotech Johnson & Johnson Pharmaceutical Services Ortho-Biotech/ Johnson & Johnson