Randomized, Open-Label Study of Epoetin alfa 40,000 U Once Weekly Versus 80,000 U Every Two Weeks in Anemic Patients with Cancer Receiving Chemotherapy.

Abstract

Epoetin alfa administered three times weekly or once weekly (QW) has been proven and widely accepted in the management of chemotherapy (CT)-induced anemia. Extended dosing intervals less frequent than QW would provide added convenience for patients. An ongoing randomized open-label study was designed to compare the efficacy and safety of a regimen of 80,000 U of epoetin alfa every two weeks (Q2W) to the commonly used regimen of 40,000 U QW. Two hundred and eighty patients with nonmeyloid malignancy, baseline (BL) hemoglobin (Hb) ≤ 11 g/dL, and scheduled to receive CT for a minimum of 12 weeks will be enrolled. Doses will be adjusted to maintain Hb values of approximately 12 g/dL. Endpoints include the comparison of change in mean Hb values at the end of the study (EOS) between the two treatment groups and Hb over time. The first 71 randomized patients (mean age 64 years, 72% women, 31% breast cancer) with at least one post-BL Hb or transfusion were analyzed. Preliminary results (see table) demonstrate similar Hb increases for each group. In the QW group, 50% (10/20) of patients and in the Q2W group 76% (16/21) of patients had ≥ 1 g/dL Hb increase during the first 4 weeks. Five (14%) QW and 7 (20%) Q2W patients had a serious adverse event; no clinically relevant thrombovascular events were reported; 1 patient (QW) died on study. These results suggest that initiating epoetin alfa treatment for CT-induced anemia with 80,000 U every two weeks provides similar efficacy and safety as treatment with 40,000 U weekly.Mean Hb Over TimeEpoetin alfa 40,000 U QWEpoetin alfa 80,000 U Q2WWeeks on StudyMean ± SD (N)Mean ± SD (N)BL9.9 ± 0.9 (36)9.8 ± 0.9 (35)411.0 ± 1.2 (20)11.2 ± 1.2 (21)610.9 ± 1.4 (13)11.0 ± 1.5 (18)810.7 ± 1.3 (7)11.7 ± 1.6 (11)12 (EOS)11.6 ± 1.1 (3)11.1 ± 1.1 (5)