Adjuvant treatment with ipilimumab did not worsen health-related quality of life despite increasing toxicity among patients with high-risk stage III melanoma, according to a study published in The Lancet Oncology.1
The phase 3 EORTC 18071 trial (ClinicalTrials.gov Identifier: NCT00636168), which led to the approval of ipilimumab for this indication, demonstrated that adjuvant ipilimumab after complete resection significantly prolonged recurrence-free survival compared with placebo in patients with stage III melanoma. The drug was, however, associated with increased toxicity, leading to treatment discontinuation for most patients during the induction phase. In this analysis of EORTC 18071, researchers evaluated the impact of ipilimumab on health-related quality of life (HRQoL).
Mean global health scores during (P = .00011) and after induction (P = .00067) were significantly different between ipilimumab-treated patients and those who received placebo, though there were no clinically relevant differences during those periods.
Mean global health scores differed most between the 2 groups at week 7 and week 10, with mean HRQoL scores differing by more than 10 points at week 10 between groups for diarrhea and insomnia. No clinically relevant differences persisted after induction therapy.
Although ipilimumab-related toxicities led to treatment discontinuation in a substantial proportion of patients, treatment with the CTLA-4 inhibitor resulted in little impairment in HRQoL.
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Investigators evaluated HRQoL using the EORTC QLQ-C30 instrument at baseline, weeks 4, 7, 10, and 24, and every 12 weeks thereafter up to 2 years, regardless of whether the patient experienced disease progression.
- Coens C, Suciu S, Chiarion-Sileni V, et al. Health-related quality of life with adjuvant ipilimumab versus placebo after complete resection of high-risk stage III melanoma (EORTC 18071): secondary outcomes of a multinational, randomised, double-blind, phase 3 trial. Lancet Oncol. 2017 Feb 2. doi: 10.1016/S1470-2045(17)30015-3 [Epub ahead of print]