作者
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 Gollerkeri, Caroline Robert, Keith T Flaherty
发表日期
2021/7/1
期刊
European Journal of Cancer
卷号
152
页码范围
116-128
出版商
Pergamon
简介
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 …
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H Gogas, R Dummer, PA Ascierto, A Arance… - European Journal of Cancer, 2021