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Initiation of epoetin-α therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy
An open-label, multicenter study with randomized and nonrandomized treatment arms
Article first published online: 23 JAN 2009
Copyright © 2009 American Cancer Society
Volume 115, Issue 5, pages 1121–1131, 1 March 2009
How to Cite
Glaspy, J. A., Charu, V., Luo, D., Moyo, V., Kamin, M. and Wilhelm, F. E. (2009), Initiation of epoetin-α therapy at a starting dose of 120,000 units once every 3 weeks in patients with cancer receiving chemotherapy. Cancer, 115: 1121–1131. doi: 10.1002/cncr.24127
- Issue published online: 18 FEB 2009
- Article first published online: 23 JAN 2009
- Manuscript Accepted: 30 SEP 2008
- Manuscript Revised: 9 SEP 2008
- Manuscript Received: 15 JUL 2008
- Centocor Ortho Biotech Services, LLC. Grant Number: PR04-27-018
- drug administration schedule;
- antineoplastic agents;
- blood transfusion
Epoetin-α initiated once weekly, followed by once-every-3-weeks maintenance, was effective and well tolerated for chemotherapy-induced anemia. This study evaluated a starting dose of epoetin-α 120,000U once every 3 weeks for chemotherapy-induced anemia using early and late initiation regimens.
Patients with baseline hemoglobin 11.0-12.0 g/dL were randomly assigned to early intervention with immediate epoetin-α (n = 68) or to standard intervention with epoetin-α when hemoglobin decreased to <11 g/dL (n = 68). A third group of patients with baseline hemoglobin <11 g/dL (n = 50) were enrolled but not randomized; epoetin-α was initiated immediately. The primary endpoint was mean proportion of hemoglobin values within the target range (11.0-13.0 g/dL) among randomized patients.
The mean proportion of hemoglobin values in range through week 16 was 60% in each randomized group. Mean hemoglobin by week showed similar increases over the study. Blood transfusions were administered in 9%, 8%, and 24% of patients in the early, standard, and nonrandomized groups. Mean epoetin-α doses were similar between treatment groups. Dose reductions and withholds were more common in the early intervention group. Adverse events (eg, diarrhea, fatigue, nausea) were consistent with the safety profile for epoetin-α . Clinically relevant thrombotic vascular events (regardless of relationship to study treatment) were reported for 9%, 12%, and 12% of patients in the early, standard, and nonrandomized groups.
Early and standard intervention with epoetin-α, administered once every 3 weeks, increased and maintained hemoglobin levels within 11.0-13.0 g/dL in patients with chemotherapy-induced anemia. Cancer 2009. © 2009 American Cancer Society.