Please use this identifier to cite or link to this item:
Title: The subgroups of the phase III RECOURSE trial of trifluridine/tipiracil (TAS-102) versus placebo with best supportive care in patients with metastatic colorectal cancer.
Authors: Van Cutsem, Eric
Mayer, Robert J
Laurent, Stéphanie
Winkler, Robert
Grávalos, Cristina
Benavides, Manuel
Longo-Munoz, Federico
Portales, Fabienne
Ciardiello, Fortunato
Siena, Salvatore
Yamaguchi, Kensei
Muro, Kei
Denda, Tadamichi
Tsuji, Yasushi
Makris, Lukas
Loehrer, Patrick
Lenz, Heinz-Josef
Ohtsu, Atsushi
RECOURSE Study Group
Keywords: Fluoropyrimidine;Metastatic colorectal cancer;Randomised controlled trial;TAS-102;Tipiracil;Trifluridine
metadata.dc.subject.mesh: Adult
Antineoplastic Combined Chemotherapy Protocols
Colorectal Neoplasms
Disease-Free Survival
Double-Blind Method
Drug Combinations
Kaplan-Meier Estimate
Middle Aged
Proportional Hazards Models
Treatment Outcome
Issue Date: 21-Dec-2017
Abstract: In the phase III RECOURSE trial, trifluridine/tipiracil (TAS-102) extended overall survival (OS) and progression-free survival (PFS) with an acceptable toxicity profile in patients with metastatic colorectal cancer refractory or intolerant to standard therapies. The present analysis investigated the efficacy and safety of trifluridine/tipiracil in RECOURSE subgroups. Primary and key secondary end-points were evaluated using a Cox proportional hazards model in prespecified subgroups, including geographical subregion (United States of America [USA], European Union [EU], Japan), age ( Eight-hundred patients were enrolled: USA, n = 99; EU, n = 403; Japan, n = 266. Patients aged ≥65 years and those with mutant KRAS tumours comprised 44% and 51% of all patients in the subregions, respectively. Final OS analysis (including 89% of events, compared with 72% in the initial analysis) confirmed the survival benefit associated with trifluridine/tipiracil, with a hazard ratio (HR) of 0.69 (95% confidence interval [CI] 0.59-0.81; P = 0.0001). Median OS in the three regions was 6.5-7.8 months in the trifluridine/tipiracil arm and 4.3-6.7 months in the placebo arm (USA: HR 0.56; 95% CI 0.34-0.94; P = 0.0277; EU: HR 0.62; 95% CI 0.48-0.80; P = 0.0002; Japan: HR 0.75; 95% CI 0.57-1.00; P = 0.0470). Median PFS was 2.0-2.8 months for trifluridine/tipiracil and 1.7-1.8 months for placebo; HRs favoured trifluridine/tipiracil in all regions. Similar clinical benefits of trifluridine/tipiracil were observed in elderly patients and in those with mutant KRAS tumours. There were no marked differences among subregions in terms of safety and tolerability. Trifluridine/tipiracil was effective in all subgroups, regardless of age, geographical origin or KRAS status. This trial is registered with NCT01607957.
metadata.dc.identifier.doi: 10.1016/j.ejca.2017.10.009
Appears in Collections:Producción 2020

Files in This Item:
File SizeFormat 
PMC7493695.pdf725,38 kBAdobe PDFView/Open

This item is protected by original copyright

This item is licensed under a Creative Commons License Creative Commons