An Extended Dosing Regimen of Epoetin Alfa 60,000 Units Every 2 Weeks in Anemic Patients with Cancer Receiving Chemotherapy

PurposeThis open-label study evaluated the safety and efficacy of epoetin alfa 60,000 U once weekly Initialsly followed by 60,000 U every 2 weeks in anemic patients with cancer receiving chemotherapy.Patients and MethodsPatients receiving weekly or every- 4-weeks chemotherapy regimens for nonmyeloid malignancy and with hemoglobin (Hb) level ≤ 11 g/dL were enrolled. They received epoetin alfa 60,000 U weekly during the Initials dosing phase (IDP) to a target Hb level of 12 g/dL. Patients who did not exhibit target Hb level within 12 weeks were withdrawn. Patients who had a hemogloblin level of 12 g/dL during the IDP entered the extended dosing phase (EDP), where epoetin alfa 60,000 U was administered every 2 weeks. Total maximum study duration was 24 weeks.ResultsA total of 129 patients (mean baseline Hb level, 10 g/dL) were enrolled and received ≥ 1 dose of epoetin alfa. Sixty-eight percent of patients had hematopoietic response (Hb increase ≥ 2 g/dL from baseline or Hb level ≥ 12 g/dL during the IDP; primary endpoint). Eighty-four patients entered the EDP; 74 of 84 patients (88%) maintained average Hb level between 11 g/dL and 13 g/dL up to time of withdrawal or study completion. Adverse events were consistent with the underlying disease process and chemotherapy treatment. Six patients (4.7%) in the IDP and 8 patients (9.5%) in the EDP experienced clinically relevant thrombotic vascular events.ConclusionIn this study, approximately 90% of patients receiving an extended dosing regimen of epoetin alfa 60,000 U every 2 weeks were able to maintain Hb level between 11 g/dL and 13 g/dL.