Epoetin alfa administered weekly is a proven treatment for chemotherapy (CT)-induced anemia. To increase patient convenience we examined a dosing regimen that would allow patients to receive epoetin alfa 60,000 U Q2W during maintenance therapy. This open-label, multi-center study had two phases: Initiation Phase (IP) of 60,000 U once weekly (QW) to achieve a target hemoglobin (Hb) of 12 g/dL (maximum duration 12 weeks), followed by a Maintenance Phase (MP) of 60,000 U Q2W to maintain Hb between 11.0 and 12.5 g/dL. Only those patients achieving Hb ≥ 12 g/dL in the IP entered the MP. Patients were withdrawn from the MP if Hb decreased to < 11 g/dL. Doses were held for Hb > 13 g/dL and reduced for rate of rise of > 1.3 g/dL/2weeks. Maximum study duration (IP + MP) was 24 weeks. Patients ≥ 18 years of age with non-myeloid malignancy, baseline Hb ≤ 11 g/dL, and CT planned QW or every 4 weeks for at least 16 weeks were enrolled. Endpoints included proportion of patients achieving hematopoietic response in the IP (≥ 2 g/dL Hb increase from baseline or Hb ≥ 12 g/dL) and proportion maintaining mean Hb between 11.0 and 12.5 g/dL in the MP. A total of 129 patients were enrolled and received at least one dose of epoetin alfa; mean age was 62.6 ± 13.0 years, 65.9% were female, mean baseline Hb was 10.0 ± 0.9 g/dL, and 92.2% had solid tumors. During the IP, 84 of 129 (65.1%) patients achieved hematopoietic response (≥ 2 g/dL Hb increase from baseline or Hb ≥ 12 g/dL). The eighty-four patients who achieved Hb ≥ 12 g/dL entered the MP after a median of 4.0 weeks in IP; treatment duration in MP was 13.2 weeks on average. Fifty-one of 84 (60.7%) maintained an average Hb between 11.0 and 12.5 g/dL over the course of the MP. Sixteen (19.0%) patients were withdrawn from the MP because Hb decreased to < 11 g/dL. Of 129 patients dosed in IP, 14 (10.9%) had doses reduced and 8 (6.2%) had doses held; of 84 patients dosed in MP, 47 (36.4%) had doses reduced and 53 (41.1%) had doses held. Sixty-five (50.4%) patients experienced serious adverse events. Fifteen (11.6%) patients experienced clinically relevant thrombotic vascular events. Three and 5 patients discontinued due to adverse events in the IP and MP, respectively. Fifteen (11.6%) patients died during the study or within 30 days after last study dose. Although 60,000 U QW was used during the IP to achieve a HR, 40,000 U QW is the recommended initiation dose of epoetin alfa. This study of patients receiving CT every 1 or 4 weeks, demonstrated that the majority of those who achieved a HR are able to maintain an acceptable Hb level with epoetin alfa 60,000 U every two weeks.

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