An extended dosing regimen of epoetin alfa 60,000 units every 2 weeks in anemic patients with cancer receiving chemotherapy.
OBJECTIVE
This 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.


METHODS
Patients 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 Patients who did not exhibit target Hb level within 12 weeks were withdrawn.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.


RESULTS
A 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.


CONCLUSIONS
In 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.
Gregory
Stephanie A
SA
Division of Hematology and Oncology, Rush University Medical Center, Chicago, IL.
Xie
John
J
Szczudlo
Tomek
T
Williams
Denise
D
Woodman
Richard C
RC
Wilhelm
Francois E
FE