@article{3029165,
    title = "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)",
    author = "Gogas, Helen and Dummer, Reinhard and Ascierto, Paolo A. and Arance, Ana and and Mandala, Mario and Liszkay, Gabriella and Garbe, Claus and and Schadendorf, Dirk and Krajsova, Ivana and Gutzmer, Ralf and Sileni, and Vanna Chiarion and Dutriaux, Caroline and Yamazaki, Naoya and Loquai, and Carmen and Queirolo, Paola and de Willem, Groot Jan and Sellier, Abir and Tadmouri and Suissa, Jeanne and Murris, Juliette and Gollerkeri, Ashwin and and Robert, Caroline and Flaherty, Keith T.",
    journal = "EUROPEAN JOURNAL OF CANCER",
    year = "2021",
    volume = "152",
    pages = "116-128",
    publisher = "Elsevier Sci Ltd, Exeter, United Kingdom",
    doi = "10.1016/j.ejca.2021.04.028",
    keywords = "Health-related quality of life; Encorafenib plus binimetinib; BRAF/MEK
inhibitors Combination; BRAF(V600E-K) mutant Melanoma; Hospitalisation
rate",
    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. (C)
2021 Elsevier Ltd. All rights reserved."
}