TY  - JOUR
AU  - Dreno, B
AU  - Ascierto, PA
AU  - Atkinson, V
AU  - Liszkay, G
AU  - Maio, M
AU  - Mandala, M
AU  - Demidov, L
AU  - Stroyakovskiy, D
AU  - Thomas, L
AU  - de la Cruz-Merino, L
AU  - Dutriaux, C
AU  - Garbe, C
AU  - Bartley, K
AU  - Karagiannis, T
AU  - Chang, I
AU  - Rooney, I
AU  - Koralek, DO
AU  - Larkin, J
AU  - McArthur, GA
AU  - Ribas, A
Y2  - 2020/12/18
Y1  - 2018/03/20
SN  - 0007-0920
UR  - http://hdl.handle.net/11343/256024
AB  - 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.
LA  - English
PB  - NATURE PUBLISHING GROUP
T1  - Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAF(V600) mutation-positive melanoma
DO  - 10.1038/bjc.2017.488
IS  - British Journal of Cancer
VL  - 118
IS  - 6
SP  - 777-784
L1  - /bitstream/handle/11343/256024/PMC5877437.pdf?sequence=1&isAllowed=y
ER  -