Results of a randomized study of every three-week dosing (Q3W) of darbepoetin alfa for chemotherapy-induced anemia (CIA)

8064 Background: Darbepoetin alfa (DA, Aranesp®) administered Q3W is effective for the treatment of CIA (Kotasek et al, 2003). NCCN guidelines recommend initiating erythropoietic therapy when hemoglobin (Hb) is < 11 g/dL with a suggested target Hb of 11 to 12 g/dL. This study was designed to evaluate the ability of DA to maintain Hb ≥ 10 g/dL in mildly anemic pts (early intervention) and pts who become moderately to severely anemic before treatment (late intervention). Methods: Pts with baseline Hb ≥ 10.5 and ≤ 12 g/dL were randomized 1:1 to early (DA 300 mcg Q3W) or late intervention (treated if Hb ≤ 10 g/dL with DA 300 mcg Q3W) groups for up to 23 weeks. The primary endpoint was the percentage of pts in each group with a Hb drop below 10 g/dL. Patient-reported outcomes included the FACT-Fatigue subscale. Proportion endpoints were calculated using Kaplan-Meier (KM) methods. Results: The study is fully enrolled with 204 pts. Data through week 17 for 201 evaluable pts (99 early and 102 late) were analyzed....