PMID- 15860486
OWN - NLM
STAT- MEDLINE
DCOM- 20051004
LR  - 20200203
IS  - 0923-7534 (Print)
IS  - 0923-7534 (Linking)
VI  - 16
IP  - 7
DP  - 2005 Jul
TI  - A randomized, multicenter study of subcutaneous and intravenous darbepoetin alfa 
      for the treatment of chemotherapy-induced anemia.
PG  - 1192-8
AB  - 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 
      mug/kg once weekly for 6 weeks (correction phase) followed by 4.5 mug/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 < 
      or =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.
FAU - Justice, G
AU  - Justice G
AD  - Pacific Coast Hematology Oncology Medical Group, Fountain Valley, CA 92708, USA. 
      glen4jane@aol.com
FAU - Kessler, J F
AU  - Kessler JF
FAU - Jadeja, J
AU  - Jadeja J
FAU - Campos, L
AU  - Campos L
FAU - Weick, J
AU  - Weick J
FAU - Chen, C-F
AU  - Chen CF
FAU - Heatherington, A C
AU  - Heatherington AC
FAU - Amado, R G
AU  - Amado RG
LA  - eng
PT  - Clinical Trial
PT  - Journal Article
PT  - Multicenter Study
PT  - Randomized Controlled Trial
PT  - Research Support, Non-U.S. Gov't
DEP - 20050428
PL  - England
TA  - Ann Oncol
JT  - Annals of oncology : official journal of the European Society for Medical 
      Oncology
JID - 9007735
RN  - 0 (Antineoplastic Agents)
RN  - 0 (Hemoglobins)
RN  - 11096-26-7 (Erythropoietin)
RN  - 15UQ94PT4P (Darbepoetin alfa)
SB  - IM
MH  - Aged
MH  - Anemia/*drug therapy
MH  - Antineoplastic Agents/*adverse effects
MH  - Darbepoetin alfa
MH  - Erythropoietin/administration & dosage/adverse effects/*analogs & 
      derivatives/pharmacokinetics/therapeutic use
MH  - Female
MH  - Hemoglobins/analysis
MH  - Humans
MH  - Infusions, Intravenous
MH  - Injections, Subcutaneous
MH  - Male
MH  - Middle Aged
EDAT- 2005/04/30 09:00
MHDA- 2005/10/05 09:00
CRDT- 2005/04/30 09:00
PHST- 2005/04/30 09:00 [pubmed]
PHST- 2005/10/05 09:00 [medline]
PHST- 2005/04/30 09:00 [entrez]
AID - S0923-7534(19)47683-7 [pii]
AID - 10.1093/annonc/mdi218 [doi]
PST - ppublish
SO  - Ann Oncol. 2005 Jul;16(7):1192-8. doi: 10.1093/annonc/mdi218. Epub 2005 Apr 28.