TY - JOUR
T1 - Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma
AU - Dréno, Brigitte
AU - Ascierto, Paolo A.
AU - Atkinson, Victoria
AU - Liszkay, Gabriella
AU - Maio, Michele
AU - Mandalà, Mario
AU - Demidov, Lev
AU - Stroyakovskiy, Daniil
AU - Thomas, Luc
AU - De La Cruz-Merino, Luis
AU - Dutriaux, Caroline
AU - Garbe, Claus
AU - Bartley, Karen
AU - Karagiannis, Thomas
AU - Chang, Ilsung
AU - Rooney, Isabelle
AU - Koralek, Daniel O.
AU - Larkin, James
AU - McArthur, Grant A.
AU - Ribas, Antoni
PY - 2018/3/20
Y1 - 2018/3/20
N2 - 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 X1 time point thereafter constituted the analysis population. Change from baseline X10 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 1day 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 X10-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.
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 X1 time point thereafter constituted the analysis population. Change from baseline X10 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 1day 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 X10-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.
KW - BRAF inhibitor
KW - Cobimetinib
KW - EORTC QLQ-C30
KW - HRQOL
KW - MEK inhibitor
KW - Metastatic melanoma
KW - Vemurafenib
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U2 - 10.1038/bjc.2017.488
DO - 10.1038/bjc.2017.488
M3 - Article
AN - SCOPUS:85044192869
VL - 118
SP - 777
EP - 784
JO - British Journal of Cancer
JF - British Journal of Cancer
SN - 0007-0920
IS - 6
ER -