Phase III trial (EORTC 18071 / CA184-029) of post-operative adjuvant ipilimumab compared to placebo in patients with resected stage III cutaneous melanoma: Health Related Quality of Life (HRQoL) results

摘要

INTRODUCTIONHRQoL was a secondary endpoint in the EORTC 18071 phase 3 trial in stage III melanoma patients comparing adjuvant Ipilimumab at 10 mg/kg (Ipi, N=475) versus placebo (Pbo, N=476). The primary endpoint was recurrence-free survival [HR (95% CI) = 0.75 (0.64–0.90); P=0.0013]. Toxicity of Ipi consisted mainly of skin, gastrointestinal, endocrine and hepatic immune-related adverse events. Adjuvant treatment with Ipi was approved in October 2014 by the FDA based on the results of this trial.