Journal
BRITISH JOURNAL OF CANCER
Volume 118, Issue 6, Pages 777-784Publisher
NATURE PUBLISHING GROUP
DOI: 10.1038/bjc.2017.488
Keywords
vemurafenib; cobimetinib; MEK inhibitor; BRAF inhibitor; HRQOL; EORTC QLQ-C30; metastatic melanoma
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Funding
- F. Hoffmann-La Roche Ltd.
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Background: In the coBRIM study, cobimetinib plus vemurafenib (C+V) significantly improved survival outcomes vs placebo and vemurafenib (P+V) in patients with advanced/metastatic BRAF(V600)-mutated melanoma. An analysis of health-related quality of life (HRQOL) from coBRIM is reported. Methods: Patients completing the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire Core 30 (QLQ-C30) at baseline and >= 1 time point thereafter constituted the analysis population. Change from baseline >= 10 points was considered clinically meaningful. Results: Mean baseline scores for all QLQ-C30 domains were similar between arms. Most on-treatment scores for QLQ-C30 domains were also comparable between arms. A transient deterioration in role function in cycle 1 day 15 (C1D15; -14.7 points) in the P+V arm and improvement in insomnia in the C+V arm at C2D15 (-12.4 points) was observed. Among patients who experienced a >= 10-point change from baseline (responders), between-group differences were greatest for insomnia (16%), social functioning (10%), fatigue (9%) and pain (7%), all favouring C+V. Diarrhoea, photosensitivity reaction, pyrexia, and rash did not meaningfully affect global health status (GHS). Serous retinopathy was associated with a transient decrease in GHS at C1D15 assessment. Conclusions: In patients with advanced/metastatic BRAFV600-mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.
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