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

Brigitte Dréno, Paolo A. Ascierto, Victoria Atkinson, Gabriella Liszkay, Michele Maio, Mario Mandalà, Lev Demidov, Daniil Stroyakovskiy, Luc Thomas, Luis De La Cruz-Merino, Caroline Dutriaux, Claus Garbe, Karen Bartley, Thomas Karagiannis, Ilsung Chang, Isabelle Rooney, Daniel O. Koralek, James Larkin, Grant A. McArthur, Antoni Ribas

Research output: Contribution to journalArticle

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 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.

Original languageEnglish
Pages (from-to)777-784
Number of pages8
JournalBritish Journal of Cancer
Volume118
Issue number6
DOIs
Publication statusPublished - Mar 20 2018

Keywords

  • BRAF inhibitor
  • Cobimetinib
  • EORTC QLQ-C30
  • HRQOL
  • MEK inhibitor
  • Metastatic melanoma
  • Vemurafenib

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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  • Cite this

    Dréno, B., Ascierto, P. A., 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, D. O., Larkin, J., McArthur, G. A., & Ribas, A. (2018). Health-related quality of life impact of cobimetinib in combination with vemurafenib in patients with advanced or metastatic BRAFV600 mutation-positive melanoma. British Journal of Cancer, 118(6), 777-784. https://doi.org/10.1038/bjc.2017.488