학술논문
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).
Document Type
Article
Author
Gogas, Helen; Dummer, Reinhard; Ascierto, Paolo A.; Arance, Ana; Mandalà, Mario; Liszkay, Gabriella; Garbe, Claus; Schadendorf, Dirk; Krajsová, Ivana; Gutzmer, Ralf; Sileni, Vanna Chiarion; Dutriaux, Caroline; Yamazaki, Naoya; Loquai, Carmen; Queirolo, Paola; Jan de Willem, Groot; Sellier, Abir Tadmouri; Suissa, Jeanne; Murris, Juliette; Gollerkeri, Ashwin
Source
Subject
*THERAPEUTIC use of antineoplastic agents
*SURVIVAL
*DISEASE progression
*GENETIC mutation
*CONFIDENCE intervals
*MELANOMA
*PROTEIN kinase inhibitors
*METASTASIS
*CANCER patients
*COMPARATIVE studies
*QUALITY of life
*QUESTIONNAIRES
*DESCRIPTIVE statistics
*KAPLAN-Meier estimator
*REPEATED measures design
*HOSPITAL care
*ODDS ratio
*MEDICAL needs assessment
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Language
ISSN
0959-8049
Abstract
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. 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. 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. 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. • Encorafenib + binimetinib improves patient quality of life compared to vemurafenib. •. • Hospitalisation had a negative impact on quality of life. [ABSTRACT FROM AUTHOR]