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)
Language English Country England, Great Britain Media print-electronic
Document type Clinical Trial, Phase III, Comparative Study, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't
PubMed
34091420
DOI
10.1016/j.ejca.2021.04.028
PII: S0959-8049(21)00274-4
Knihovny.cz E-resources
- Keywords
- BRAF(V600E−K) mutant Melanoma, BRAF/MEK inhibitors Combination, Encorafenib plus binimetinib, Health-related quality of life, Hospitalisation rate,
- MeSH
- Benzimidazoles administration & dosage adverse effects MeSH
- Progression-Free Survival MeSH
- Adult MeSH
- Carbamates administration & dosage adverse effects MeSH
- Quality of Life * MeSH
- Middle Aged MeSH
- Humans MeSH
- Melanoma drug therapy genetics mortality psychology MeSH
- Young Adult MeSH
- Mutation MeSH
- Skin Neoplasms drug therapy genetics mortality psychology MeSH
- Antineoplastic Combined Chemotherapy Protocols administration & dosage adverse effects MeSH
- Proto-Oncogene Proteins B-raf genetics MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Sulfonamides administration & dosage adverse effects MeSH
- Vemurafenib administration & dosage adverse effects MeSH
- Check Tag
- Adult MeSH
- Middle Aged MeSH
- Humans MeSH
- Young Adult MeSH
- Male MeSH
- Aged, 80 and over MeSH
- Aged MeSH
- Female MeSH
- Publication type
- Journal Article MeSH
- Clinical Trial, Phase III MeSH
- Multicenter Study MeSH
- Research Support, Non-U.S. Gov't MeSH
- Randomized Controlled Trial MeSH
- Comparative Study MeSH
- Names of Substances
- Benzimidazoles MeSH
- binimetinib MeSH Browser
- BRAF protein, human MeSH Browser
- encorafenib MeSH Browser
- Carbamates MeSH
- Proto-Oncogene Proteins B-raf MeSH
- Sulfonamides MeSH
- Vemurafenib MeSH
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.
At Time of Research Pfizer Inc Boulder CO USA
Department of Dermatologic Oncology National Cancer Center Hospital Tokyo Japan
Department of Medical Oncology Isala Oncological Center Zwolle Netherlands
Eberhard Karls University Tuebingen Germany
Hannover Medical School Hannover Germany
Hospital Clinic of Barcelona Barcelona Spain
Institute Gustave Roussy Villejuif France
Istituto Nazionale Tumori IRCCS Fondazione Pascale Napoli Italy
Massachusetts General Hospital Boston MA USA
National and Kapodistrian University of Athens Laikon Hospital Athens Greece
National Institute of Oncology Budapest Hungary
Oncology Institute of Veneto IRCCS Padua Italy
Pierre Fabre Medicament Boulogne Billancourt France
Unit of Medical Oncology University of Perugia Perugia Italy
University Hospital Centre Bordeaux Hôpital Saint André Bordeaux France
University Hospital Essen Essen Germany; German Cancer Consortium Heidelberg Germany
University Hospital Prague and Charles University 1st Medical Faculty Prague Czech Republic
University Hospital Zürich Skin Cancer Center Zürich Switzerland
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