A controlled, randomized, open-label study to evaluate the effect of every-2-week darbepoetin alfa for anemia of cancer

Abstract

8084 Background: Patients (pts) with cancer who are not receiving chemotherapy (ctx) or radiotherapy (rtx) often develop anemia. A previous randomized, controlled trial evaluating the effect of recombinant human erythropoietin therapy vs placebo on transfusion (tfn) incidence in this pt population failed to show a significant reduction in tfn requirements in treated pts, relative to control (Abels, 1991). This multicenter, randomized, controlled, 25-week (wk) study is closed to enrollment (n = 298) and was designed to assess the effect of darbepoetin alfa (DA; Aranesp®) in pts with anemia of cancer (AOC) with respect to hospitalization, incidence of tfn, and pt-reported outcomes. Methods: Eligible pts (anemia [hemoglobin (Hb) ≤ 11 g/dL]) due to cancer or prior ctx and/or rtx; had no ctx or rtx within 4 wks before screening or during the study) were randomized 4:1 to DA 3.0 mcg/kg every 2 weeks [Q2W] for 21 wks (DA arm) or 12 wks of observation followed by 9 wks of DA 3.0 mcg/kg Q2W (control arm). Data were analyzed using an intent-to-treat approach. Results are provided for all pts and stratified by baseline (BL) Hb category. Results: Data through the comparative phase (first 12 wks) were analyzed for the first 170 pts (135 DA, 35 control) enrolled. BL Hb was 10.2 (SD: 0.9) in the DA arm and 10.3 (0.9) in the control arm. Efficacy results (with 95% CL) are shown below. The safety profile was as expected for this population. Conclusions: These results show that AOC pts treated with darbepoetin alfa Q2W (vs no treatment) had marked improvements in Hb corresponding to clinically meaningful improvements in fatigue and a substantial reduction in tfn requirements. Importantly, the stratified analysis suggests that pts with AOC experience important clinical benefits, regardless of BL Hb category; however, earlier intervention (Hb >10 to <11g/dL) may optimize anemia management for this pt population. Author Disclosure Employment or Leadership Consultant or Advisory Stock Ownership Honoraria Research Funding Expert Testimony Other Remuneration Amgen Amgen Amgen Amgen Amgen