ABSTRACT
PURPOSE: This open-label, single-arm pilot study assessed the safety and efficacy of administering an Initials epoetin alfa dose of 60,000 U subcutaneously once weekly (Initials dosing phase [IDP]) followed by an extended dose regimen of 60,000 U subcutaneously every 2 weeks (extended dosing phase [EDP]). PATIENTS AND METHODS: Patients who had a hematologic response, defined as hemoglobin (Hb) level increase >/= 1 g/dL from week 1 baseline at any time during the 4-week IDP (the primary efficacy endpoint), were eligible to enter the EDP at week 5 and receive every-other-week treatment for up to 12 additional weeks. Patients who did not exhibit this increase in the IDP were withdrawn. RESULTS: Fifty-one patients were enrolled; the mean baseline Hb level was 10.1 g/dL +/- 0.79 g/dL. Thirty-three patients (64.7%) met the primary efficacy endpoint of Hb increase >/= 1 g/dL during the IDP; 29 patients (56.9%) proceeded to the EDP. Mean Hb level at entry to the EDP was 12.4 g/dL +/- 0.99 g/dL. Further Hb increase in the EDP (average Hb level >/= week 5 Hb value) was achieved in 12 of 29 patients (41.4%). Final Hb value for patients in the EDP was 11.7 g/dL +/- 1.28 g/dL. Four patients received a total of 5 red blood cell transfusions during the study. Epoetin alfa was well tolerated and had a safety profile similar to that observed with labeled dosing. Two patients experienced a clinically relevant thrombotic vascular event. CONCLUSION: RESULTS from this pilot study suggest that higher Initials weekly dosing of epoetin alfa followed by extended dosing is safe and effective for treating chemotherapy-induced anemia.