Early Results Suggest That Epoetin Alfa 60,000 U Every 2 Weeks Improves Hemoglobin in Patients with Cancer Not Receiving Chemotherapy or Radiotherapy.

Epoetin alfa has been shown to increase hemoglobin (Hb), decrease transfusion requirements, and improve quality of life (QOL) in patients receiving chemotherapy (CT) and/or radiotherapy (RT). However, the efficacy of epoetin alfa in cancer patients receiving neither CT nor RT is not as well characterized, particularly at doses less frequent than 3 times weekly. The objective of this open-label, nonrandomized, multicenter pilot study was to evaluate epoetin alfa 60,000 U subcutaneously (SC) every 2 weeks (Q2W) in 50 anemic patients with cancer who were not receiving CT or RT. The primary efficacy endpoint is the proportion of patients achieving a hematopoietic response (HR; Hb increase ≥2 g/dL from baseline and/or Hb increase to ≥12 g/dL at any scheduled visit) independent of transfusion within 28 days. Patients with histologically confirmed nonmyeloid malignancy, Hb ≤11 g/dL, and who had not received CT in the previous 8 weeks or RT in the previous 4 weeks were enrolled. Patients were permitted to receive hormonal therapy, androgen deprivation therapy, and/or immunotherapy. Patients were to receive epoetin alfa 60,000 U SC Q2W, with escalation to 80,000 U Q2W after 4 weeks if Hb increased ≤1 g/dL. Dose will be titrated to maintain Hb ≤13 g/dL; all patients were to receive oral ferrous sulfate 325 mg daily. Patients will be treated for up to 12 weeks, with a 4-week follow-up after last dose of study drug. As of July 2004, 18 patients are evaluable for efficacy (modified intent-to-treat, ie, all enrolled patients who received ≥1 dose of study drug and had ≥1 postbaseline Hb or transfusion evaluation) and 18 for safety (all enrolled patients who received ≥1 dose of study drug). Mean age was 74.4 ± 8.7 yrs, mean baseline Hb was 10.0 ± 1.0 g/dL (n=18), and 7/18 were men. Of these patients, 7 completed 4 weeks, 3 completed 8 weeks, and 1 completed 12 weeks on study. The HR of these patients was assessed regardless of how many weeks of study they completed at the time of this interim analysis; HR was 44.4%. Hb increased 1.4 ± 0.7 g/dL (n=11) after 4 weeks and 1.2 ± 1.4 g/dL (n=4) after 8 weeks of treatment. Adverse events were limited to 1 patient, who experienced back pain and epistaxis. No patients died during the study, and no thrombotic vascular events were reported. Early results of this study suggest that epoetin alfa 60,000-80,000 U SC given every other week is well tolerated and appears to effectively increase Hb in anemic cancer patients not receiving CT or RT. The study is currently ongoing.