Web of Science: 16 citations, Scopus: 19 citations, Google Scholar: citations,
Proxies of quality of life in metastatic colorectal cancer : analyses in the RECOURSE trial
Van Cutsem, Eric (University Hospitals Leuven (Bèlgica))
Falcone, Alfredo (Azienda Ospedaliero-Universitaria Pisana)
García Carbonero, Rocio (Hospital Universitario 12 de Octubre (Madrid))
Komatsu, Yoshito (Hokkaido University Hospital)
Pastorino, Alessandro (IRCCS AOU San Martino IST)
Peeters, Marc (University Hospital Antwerp (Bèlgica))
Shimada, Yasuhiro (National Cancer Center Hospital)
Yamazaki, Kentaro (Shizuoka Cancer Center)
Yoshino, Takayuki (National Cancer Center Hospital East)
Zaniboni, Alberto (Fondazione Poliambulanza)
Amellal, Nadia (Institut de Recherches Servier)
Kanehisa, Akira (Institut de Recherches Servier)
Winkler, Robert (Taiho Oncology)
Makris, Lukas (Taiho Oncology)
Mayer, Robert J. (Dana-Farber Cancer Institute (Boston, Estats Units d'Amèrica))
Ohtsu, Atsushi (National Cancer Center Hospital East)
Tabernero, Josep (Universitat Autònoma de Barcelona. Departament de Medicina)

Date: 2017
Abstract: In the pivotal phase III, randomised, double-blind, placebo-controlled RECOURSE study, treatment with trifluridine/tipiracil was well tolerated and associated with prolonged progression-free and overall survival in patients with metastatic colorectal cancer (mCRC). There was no formal analysis of quality of life (QoL) in RECOURSE. The aim of the present analysis was to assess proxies of QoL during the RECOURSE treatment period, in terms of adverse events (AEs) likely to affect QoL and Eastern Cooperative Oncology Group performance status (ECOG PS). Enrolled patients had documented, previously treated (≥2 prior chemotherapy lines) mCRC and an ECOG PS of 0 or 1. Patients received best supportive care plus trifluridine/tipiracil 35 mg/m 2 twice daily (n=534) or placebo (n=266) in a 28-day cycle. AEs analysed included nausea, vomiting, diarrhoea, dysgeusia and fatigue/asthenia. ECOG PS was determined at baseline, on day 1 of each treatment cycle, at treatment end and 30 days post-treatment discontinuation. AEs that affect QoL were more frequent in patients treated with trifluridine/tipiracil than placebo. Median treatment duration for patients experiencing at least one of these AEs was longer than that observed for the overall RECOURSE population (trifluridine/tipiracil: 12 vs 7 weeks; placebo: 10 vs 6 weeks). Versus placebo, the duration of most AEs was longer in trifluridine/tipiracil recipients; however, all AEs except nausea and vomiting occupied a lower proportion of the total treatment period. Of the patients who had their PS recorded at discontinuation, PS was maintained in 67% and 63% of trifluridine/tipiracil and placebo recipients, and 84% and 81% of the trifluridine/tipiracil and placebo patients remained at a PS of 0 or 1 at discontinuation. Analysis of ECOG PS and AEs thought to affect QoL in the RECOURSE patient population suggests that trifluridine/tipiracil treatment does not result in a deterioration of patient QoL versus placebo.
Rights: Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, la comunicació pública de l'obra i la creació d'obres derivades, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. Creative Commons
Language: Anglès
Document: Article ; recerca ; Versió publicada
Subject: Advanced colorectal cancer ; Trifluridine/tipiracil ; Quality of life ; Performance status
Published in: ESMO open, Vol. 2 (november 2017) , ISSN 2059-7029

DOI: 10.1136/esmoopen-2017-000261
PMID: 29215098


7 p, 770.6 KB

The record appears in these collections:
Articles > Research articles
Articles > Published articles

 Record created 2018-02-08, last modified 2023-03-20



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