Quality of life in patients with BRAF-mutant melanoma receiving the combination encorafenib plus binimetinib: Results from a multicentre, open-label, randomised, phase III study (COLUMBUS)

Helen Gogas, Reinhard Dummer, Paolo A. Ascierto, Ana Arance, Mario Mandalà, Gabriella Liszkay, Claus Garbe, Dirk Schadendorf, Ivana Krajsová, Ralf Gutzmer, Vanna Chiarion Sileni, Caroline Dutriaux, Naoya Yamazaki, Carmen Loquai, Paola Queirolo, Groot Jan de Willem, Abir Tadmouri Sellier, Jeanne Suissa, Juliette Murris, Ashwin GollerkeriCaroline Robert, Keith T. Flaherty

Research output: Contribution to journalArticlepeer-review

Abstract

Background: In COLUMBUS, treatment with encorafenib plus binimetinib in patients with advanced BRAF-mutant melanoma showed improved progression-free and overall survival with favourable tolerability compared to vemurafenib treatment. Here, results on health-related quality of life (HRQoL) are presented. Methods: COLUMBUS was a two-part, open-label, randomised, phase III study in patients with BRAF-mutant melanoma. In PART-I, 577 patients were randomised (1:1:1) to encorafenib plus binimetinib, encorafenib or vemurafenib. The primary objective was to assess progression-free survival. As a secondary objective, HRQoL was assessed by the EQ-5D, the EORTC QLQ-C30 and the FACT-M questionnaires. Furthermore, time to definitive 10% deterioration was estimated with a Kaplan–Meier analysis and differences in mean scores between groups were calculated with a mixed-effect model for repeated measures. Hospitalisation rate and the impact of hospitalisation on HRQoL were also assessed. Results: Patients receiving the combination treatment showed improvement of their FACT-M and EORTC QLQ-C30 global health status scores, compared to those receiving vemurafenib (post-baseline score differences: 3.03 [p < 0.0001] for FACT M and 5.28 [p = 0.0042] for EORTC QLQ-C30), indicative of a meaningful change in patient's status. Furthermore, a delay in the deterioration of QoL was observed in non-hospitalised patients compared to hospitalised patients (hazard ratio [95% CI]: 1.16 [0.80; 1.68] for EORTC QLQ-C30 and 1.27 [0.81; 1.99] for FACT-M) and a risk reduction of 10% deterioration, favoured the combination in both groups. Conclusion: The improved efficacy of encorafenib plus binimetinib compared to vemurafenib, translates into a positive impact on the perceived health status as assessed by the HRQoL questionnaires. The study is registered with ClinicalTrials.gov, number NCT01909453 and EudraCT number 2013-001176-38.

Original languageEnglish
Pages (from-to)116-128
Number of pages13
JournalEuropean Journal of Cancer
Volume152
DOIs
Publication statusPublished - Jul 2021

Keywords

  • BRAF/MEK inhibitors Combination
  • BRAF mutant Melanoma
  • Encorafenib plus binimetinib
  • Health-related quality of life
  • Hospitalisation rate

ASJC Scopus subject areas

  • Oncology
  • Cancer Research

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