Randomized, Double-Blind, Placebo-Controlled Study of Darbepoetin alfa Every 3 Weeks for the Treatment of Chemotherapy-Induced Anemia.

Background: Darbepoetin alfa (Aranesp®; DA) has been shown to be safe and effective for treating chemotherapy-induced anemia (CIA). The ability to administer darbepoetin alfa every 3 weeks (Q3W) (coincident with chemotherapy) would simplify the treatment of CIA. We report results from the first multicenter, randomized, double-blind, placebo-controlled, phase 3 clinical trial evaluating efficacy and safety of fixed Q3W administration of an erythropoietic agent. Methods: This study enrolled subjects ≥18 years, diagnosed with anemia (hemoglobin [Hb] Results: A total of 386 randomized patients were included in the analysis. Demographic characteristics were similar between the 2 groups. Mean (SD) Hb levels at baseline were 10.03 (0.86) and 10.05 (0.92) g/dL in the placebo and DA groups, respectively. The most common tumor types were breast (23%), colon (11%), nonsmall-cell-lung cancer (10%), and hematologic malignancies (11%; 8% Non-Hodgkin’s Lymphoma). The incidence of RBC transfusions from week 5 to the end of treatment phase (EOTP) (the primary endpoint) was significantly lower for the DA group than for the placebo group ( P P Conclusions: Fixed Q3W administration of DA is well tolerated and effective for the treatment of CIA.