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

Abstract

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 (500μg q3w) was started at hemoglobin (Hb) levels <13.0g/dl (<12g/dl after DA label amendment) and stopped at Hb levels ≥14.0g/dl (12g/dl after label amendment). Primary efficacy end point was event-free survival (EFS); secondary end points were toxicity, quality of life (QoL) and overall survival (OS). Results: Venous thrombosis (DA+: 3.0%, DA-: 1.0%; P = 0.013) was significantly higher for DA+, but not pulmonary embolism (0.3% in both arms). Median Hb levels were stable in DA+ (12.6g/dl) and decreased in DA- (11.7g/dl). 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. © The Author 2013. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.