An open-label pilot study to evaluate a flexible dosing regimen of epoetin alfa for the treatment of chemotherapy-induced anemia: 60,000 units weekly followed by 60,000 units every 2 weeks.
OBJECTIVE
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]).


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 Patients who did not exhibit this increase in the IDP were withdrawn.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.


CONCLUSIONS
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.
Reddy
Prabhakara K
PK
St. Joseph's Mercy Cancer Center, Hot Springs, AR.
Williams
Denise
D
Wilhelm
Francois E
FE