Final results from the prospective phase III WSG-ARA trial: impact of adjuvant darbepoetin alfa on event-free survival in early breast cancer

Background: WSG-ARA plus trial evaluated the effect of adjuvant darbepoetin alfa (DA) on outcome in node positive primary breast cancer (BC). Patients and methods: One thousand two hundred thirty-four patients were randomized to chemotherapy either with DA (DA+; n = 615) or without DA (DA-; n = 619). DA (500\textgreekmg q3w) was started at hemoglobin (Hb) levels \15g/dl were reported in 0.8\% of cycles. QoL parameters did not significantly differ between arms. At 39 months, DA had no significant impact on EFS (DA+: 89.3\%, DA-: 87.5\%; Plog-rank = 0.55) or OS (DA+: 95.5\%, DA-: 95.4\%; Plog-rank = 0.77). Conclusions: DA treatment did not impact EFS or OS in routine adjuvant BC treatment. \copyright The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.