TY - JOUR
TI - 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)
AU - Gogas, Helen
AU - Dummer, Reinhard
AU - Ascierto, Paolo A.
AU - Arance, Ana
AU - and Mandala, Mario
AU - Liszkay, Gabriella
AU - Garbe, Claus and
AU - Schadendorf, Dirk
AU - Krajsova, Ivana
AU - Gutzmer, Ralf
AU - Sileni,
AU - Vanna Chiarion
AU - Dutriaux, Caroline
AU - Yamazaki, Naoya
AU - Loquai,
AU - Carmen
AU - Queirolo, Paola
AU - de Willem, Groot Jan
AU - Sellier, Abir
AU - Tadmouri
AU - Suissa, Jeanne
AU - Murris, Juliette
AU - Gollerkeri, Ashwin
AU - and Robert, Caroline
AU - Flaherty, Keith T.
JO - EUROPEAN JOURNAL OF CANCER
PY - 2021
VL - 152
TODO - null
SP - 116-128
PB - Elsevier Sci Ltd, Exeter, United Kingdom
SN - null
TODO - 10.1016/j.ejca.2021.04.028
TODO - Health-related quality of life; Encorafenib plus binimetinib; BRAF/MEK
inhibitors Combination; BRAF(V600E-K) mutant Melanoma; Hospitalisation
rate
TODO - 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.
ER -