Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAF V600 mutation-positive melanoma.

Autor: Dréno B; Department of Dermato Cancerology, Nantes University, Nantes 44093, France., Ascierto PA; Istituto Nazionale Tumori Fondazione G. Pascale, Naples 80131, Italy., Atkinson V; Princess Alexandra Hospital, Woolloongabba, QLD 4102, Australia., Liszkay G; National Institute of Oncology, Budapest 1122, Hungary., Maio M; Azienda Ospedaliera Universitaria Senese, Siena 53100, Italy., Mandalà M; Department of Oncology and Haematology, Papa Giovanni XXIII Hospital, Bergamo 24127, Italy., Demidov L; N. N. Blokhin Russian Cancer Research Center, Moscow 115478, Russia., Stroyakovskiy D; Moscow City Oncology Hospital 62, Krasnogorsk 14301, Russia., Thomas L; Service de Dermatologie, Centre Hospitalier Lyon Sud, Pierre-Bénite 69495, France., de la Cruz-Merino L; Hospital Universitario Virgen Macarena, Seville 41009, Spain., Dutriaux C; Hôpital Saint André, Bordeaux 33075, France., Garbe C; Department of Dermatology, University of Tübingen, Tübingen 72074, Germany., Bartley K; Genentech, Inc., South San Francisco, CA 94080, USA., Karagiannis T; Genentech, Inc., South San Francisco, CA 94080, USA., Chang I; Genentech, Inc., South San Francisco, CA 94080, USA., Rooney I; Genentech, Inc., South San Francisco, CA 94080, USA., Koralek DO; Genentech, Inc., South San Francisco, CA 94080, USA., Larkin J; The Royal Marsden NHS Foundation Trust, London SW3 6JJ, UK., McArthur GA; Peter MacCallum Cancer Centre, East Melbourne, VIC 3002, Australia.; University of Melbourne, Parkville, VIC 3052, Australia., Ribas A; Jonsson Comprehensive Cancer Center, University of California Los Angeles, Los Angeles, CA 90095, USA.
Jazyk: angličtina
Zdroj: British journal of cancer [Br J Cancer] 2018 Mar 20; Vol. 118 (6), pp. 777-784. Date of Electronic Publication: 2018 Feb 13.
DOI: 10.1038/bjc.2017.488
Abstrakt: 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 BRAF V600 -mutated melanoma, treatment with C+V maintained HRQOL compared with P+V, with superior efficacy.
Databáze: MEDLINE
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