Annals of Oncology Advance Access published online on April 28, 2005
Annals of Oncology, doi:10.1093/annonc/mdi218
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1 Pacific Coast Hematology Oncology Medical Group, Fountain Valley, CA, USA;
* To whom correspondence should be addressed. Background: This randomized, open-label study evaluated the efficacy, safety and pharmacokinetics of darbepoetin alfa administered intravenously (i.v.) or subcutaneously (s.c.) in chemotherapy-induced anemia. Patients and methods: Patients received darbepoetin alfa i.v. (n=59) or s.c. (n=59) at a dose of 4.5 µg/kg once weekly for 6 weeks (correction phase) followed by 4.5 µg/kg once every 3 weeks for the remainder of the 18-week treatment period (maintenance phase). Results: During the correction phase, the mean [95% confidence interval (CI)] change in hemoglobin (intention-to-treat) was 1.1 (0.6-1.5) g/dl in the i.v. group and 1.3 (0.9-1.7) g/dl in the s.c. group; using available data, the mean change was 1.4 (1-1.9) g/dl and 1.6 (1.2-2) g/dl, respectively. The percentage (95% CI) of patients maintaining hemoglobin (i.e. average decrease Conclusions: Darbepoetin alfa can be administered i.v. or s.c. at equal doses for the treatment of anemia in this setting.
Received August 11, 2004
Revised December 1, 2004
Accepted February 8, 2005
Original article
A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia
2 Virginia Oncology Associates, Newport News, VA, USA;
3 Hematology-Oncology Associates of Jacksonville, Jacksonville, FL, USA;
4 Oncology Consultants, Houston, TX, USA;
5 Hematology Oncology Associates, Lake Worth, FL, USA;
6 Amgen Inc., Thousand Oaks, CA, USA
G. Justice, E-mail: glen4jane{at}aol.com
Abstract 
0.5 g/dl) during the maintenance phase was similar between the i.v. (82%; 95% CI 66% to 92%) and s.c. (80%; 95% CI 66% to 90%) groups. Thirty-five per cent (95% CI 20% to 50%) of patients in the i.v. group and 32% of patients in the s.c. group (95% CI 18% to 45%) received red blood cell transfusions during week 5 to the end of the treatment period. Darbepoetin alfa was well tolerated in both groups. No significant difference (P=0.36) in weekly darbepoetin alfa serum concentrations was observed between groups.
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