Hematopoietic Response to Extended Dosing of Epoetin alfa 60,000 U Every 2 Weeks in Anemic Cancer Patients Not Receiving Therapy: Final Results.

Epoetin alfa administered weekly raises hemoglobin (Hb) in anemic cancer patients not receiving therapy. For optimal management of this group of patients more information is needed about extended dosing intervals. The objective of this open-label, single arm, multicenter study was to evaluate the hematopoietic response (HR) when anemic cancer patients not receiving chemotherapy (CT) or radiotherapy (RT) were treated with 60,000 U of epoetin alfa every two weeks (Q2W). Patients with non-myeloid malignancy, no CT within 8 weeks or RT within 4 weeks prior to study entry, and baseline Hb ≤ 11 g/dL were enrolled. Epoetin alfa was administered at 60,000 U SC Q2W for 12 weeks. If Hb increased < 1 g/dL after 4 weeks, epoetin alfa was increased to 80,000 U SC Q2W. Epoetin alfa was held for Hb > 13 g/dL. Patients were to receive iron supplementation daily at physician’s discretion. The primary efficacy endpoint was the proportion of patients achieving HR (defined as a ≥ 2 g/dL increase in Hb from baseline and/or Hb ≥ 12 g/dL during the treatment period, independent of transfusion within 28 days). Fifty-seven patients were enrolled and 56 met the criteria for efficacy analyses (received ≥ 1 dose of epoetin alfa and had ≥ 1 post-baseline Hb or transfusion evaluation). Mean age was 71.7 ± 9.3 years, 35.7% of patients were male, and mean baseline Hb was 10.2 ± 0.7 g/dL. HR was achieved in 43/56 (76.8%) patients. Mean change in Hb from baseline was 1.5 ± 0.8 g/dL (n=51) after 4 weeks, and 1.8 ± 1.0 g/dL (n=49) after 8 weeks on study. Nine (15.8%) patients had a dose increase and 22 (38.6%) had a dose held. Three (5.4%) patients received RBC transfusion and 37 (64.9%) received iron supplementation. The most common adverse events were peripheral edema, dizziness, nausea, and asthenia. Two (3.5%) patients experienced a clinically relevant thrombovascular event (TVE). No deaths were reported. This study suggests that cancer patients with anemia not receiving CT or RT can be treated effectively and safely with 60,000 U epoetin alfa every two weeks.