Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma.
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ICR Authors
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
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
Document Type
Journal Article
Date
2018-03-20
Date Accepted
2017-12-15
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.
Citation
British Journal of Cancer, 2018, 118 (6), pp. 777 - 784
Source Title
British Journal of Cancer
Publisher
NATURE PUBLISHING GROUP
ISSN
0007-0920
eISSN
1532-1827
1532-1827
1532-1827