Annals of Oncology Advance Access originally published online on April 28, 2005
Annals of Oncology 2005 16(7):1192-1198; doi:10.1093/annonc/mdi218
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
© 2005 European Society for Medical Oncology
A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa for the treatment of chemotherapy-induced anemia
1 Pacific Coast Hematology Oncology Medical Group, Fountain Valley, CA; 2 Virginia Oncology Associates, Newport News, VA; 3 Hematology-Oncology Associates of Jacksonville, Jacksonville, FL; 4 Oncology Consultants, Houston, TX; 5 Hematology Oncology Associates, Lake Worth, FL; 6 Amgen Inc., Thousand Oaks, CA, USA
* Correspondence to: Dr G. Justice, Pacific Coast Hematology Oncology Medical Group, 11190 Warner Avenue, Suite 300, Fountain Valley, CA 92708, USA. Tel: +1-714-751-2600; Fax: +1-714-751-4501; Email: glen4jane{at}aol.com
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 
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.
Conclusions: Darbepoetin alfa can be administered i.v. or s.c. at equal doses for the treatment of anemia in this setting.
Key words: anemia, darbepoetin alfa, drug administration schedule, erythropoietin, hemoglobin
CiteULike 
Connotea 
Del.icio.us What's this?
This article has been cited by other articles:
|
|
 |
|
  G Mustacchi, R Ceccherini, C Dellach, S Foladore, S Milani, M Leita, and M Sisto An induction dose of epoetin {alpha} of 40 000 IU daily for three consecutive days increases and maintains hemoglobin levels in anemic cancer patients undergoing chemotherapy Ann. Onc., November 1, 2006; 17(11): 1705 - 1708. [Abstract] [Full Text] [PDF]
|
|
|
|
 |
|
 R. Boccia, I. A. Malik, V. Raja, S. Kahanic, R. Liu, T. Lillie, D. Tomita, B. Clowney, and P. Silberstein Darbepoetin alfa administered every three weeks is effective for the treatment of chemotherapy-induced anemia. Oncologist, April 1, 2006; 11(4): 409 - 417. [Abstract] [Full Text] [PDF]
|
|