Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma.

Abstract:

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.

journal_name

Br J Cancer

authors

Dréno B,Ascierto PA,Atkinson V,Liszkay G,Maio M,Mandalà 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 DO,Larkin J,McArthur GA,Ribas A

doi

10.1038/bjc.2017.488

subject

Has Abstract

pub_date

2018-03-20 00:00:00

pages

777-784

issue

6

eissn

0007-0920

issn

1532-1827

pii

bjc2017488

journal_volume

118

pub_type

杂志文章,多中心研究,随机对照试验
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