A randomized, controlled trial comparing darbepoetin alfa correction/maintenance dosing with weekly dosing for treating chemotherapy-induced anemia

Curr Med Res Opin. 2007 Jun;23(6):1387-401. doi: 10.1185/030079907X188053. Epub 2007 May 8.


Objective: To evaluate if a darbepoetin alfa correction/maintenance dosing regimen is non-inferior to a weekly regimen with respect to red blood cell transfusion requirements in patients with chemotherapy-induced anemia (CIA).

Research design and methods: In this randomized, active-controlled, double-blind phase 3 trial, CIA patients were randomized 1:1 to receive darbepoetin alfa in either a correction/maintenance schedule (4.5 microg/kg weekly for 4 weeks followed by 4.5 microg/kg every 3 weeks (Q3W)) or a weekly schedule (2.25 microg/kg weekly). The primary endpoint was the transfusion incidence during weeks 1-16. Non-inferiority was to be concluded if the upper limit of the 95% confidence interval (CI) of the difference in transfusion incidence between treatment groups was below 12.5%. Hematologic responses and safety profiles were also compared.

Results: Transfusion incidence (95% CI) during weeks 1-16 was 37% (32-42) and 38% (32-43) in the weekly and correction/maintenance groups, respectively. The difference (95% CI) in transfusions was 0.4% (-7.0 to 7.8), demonstrating non-inferiority between treatment groups. Similar percentages in both groups achieved and maintained hemoglobin in a target range of 11-13 g/dL and had clinically meaningful FACT-F score improvements. The median (range) time to hemoglobin response was 10 (1-17) weeks and 12 (2-17) weeks in the weekly and correction/maintenance groups, respectively. Both groups had similar safety profiles.

Conclusions: A correction/maintenance schedule with its initial two-fold higher weekly dosing and subsequent Q3W dosing yielded outcomes similar to those observed with a weekly schedule. Although correction/maintenance dosing provided no incremental clinical benefit, Q3W dosing could provide benefits of convenience and facilitate patient compliance.

Publication types

  • Clinical Trial, Phase III
  • Comparative Study
  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adult
  • Aged
  • Aged, 80 and over
  • Algorithms
  • Anemia / chemically induced*
  • Anemia / drug therapy*
  • Anemia / prevention & control
  • Antineoplastic Combined Chemotherapy Protocols / adverse effects*
  • Darbepoetin alfa
  • Dose-Response Relationship, Drug
  • Double-Blind Method
  • Drug Administration Routes
  • Drug Administration Schedule
  • Erythropoietin / administration & dosage
  • Erythropoietin / adverse effects
  • Erythropoietin / analogs & derivatives*
  • Female
  • Hematinics / administration & dosage
  • Hematinics / adverse effects
  • Humans
  • Male
  • Middle Aged
  • Neoplasms / drug therapy
  • Polypharmacy
  • Treatment Outcome


  • Hematinics
  • Erythropoietin
  • Darbepoetin alfa