Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAF(V600) mutation-positive melanoma
AuthorDreno, B; Ascierto, PA; Atkinson, V; Liszkay, G; Maio, M; Mandala, M; Demidov, L; Stroyakovskiy, D; Thomas, L; de la Cruz-Merino, L; ...
Source TitleBritish Journal of Cancer
PublisherNATURE PUBLISHING GROUP
University of Melbourne Author/sMcArthur, Grant
AffiliationMelbourne Medical School
Document TypeJournal Article
CitationsDreno, B., Ascierto, P. A., Atkinson, V., Liszkay, G., Maio, M., Mandala, M., Demidov, L., Stroyakovskiy, D., Thomas, L., de la Cruz-Merino, L., Dutriaux, C., Garbe, C., Bartley, K., Karagiannis, T., Chang, I., Rooney, I., Koralek, D. O., Larkin, J., McArthur, G. A. & Ribas, A. (2018). Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAF(V600) mutation-positive melanoma. BRITISH JOURNAL OF CANCER, 118 (6), pp.777-784. https://doi.org/10.1038/bjc.2017.488.
Access StatusOpen Access
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 BRAFV600-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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