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Article Dans Une Revue New England Journal of Medicine Année : 2015

Randomized trial of TAS-102 for refractory metastatic colorectal cancer

Robert J. Mayer
  • Fonction : Auteur
Eric van Cutsem
  • Fonction : Auteur
Takayuki Yoshino
  • Fonction : Auteur
Rocio Garcia-Carbonero
Nobuyuki Mizunuma
  • Fonction : Auteur
Kentaro Yamazaki
  • Fonction : Auteur
Josep Tabernero
  • Fonction : Auteur
Yoshito Komatsu
  • Fonction : Auteur
Alberto Sobrero
  • Fonction : Auteur
Marc Peeters
Ben Tran
  • Fonction : Auteur
Heinz-Josef Lenz
  • Fonction : Auteur
Alberto Zaniboni
  • Fonction : Auteur
Howard Hochster
  • Fonction : Auteur
James M. Cleary
  • Fonction : Auteur
Hans Prenen
  • Fonction : Auteur
Fabio Benedetti
  • Fonction : Auteur
Hirokazu Mizuguchi
  • Fonction : Auteur
Lukas Makris
  • Fonction : Auteur
Masanobu Ito
  • Fonction : Auteur
Atsushi Ohtsu
  • Fonction : Auteur
Recourse Study Group
  • Fonction : Auteur

Résumé

BACKGROUND: Early clinical trials conducted primarily in Japan have shown that TAS-102, an oral agent that combines trifluridine and tipiracil hydrochloride, was effective in the treatment of refractory colorectal cancer. We conducted a phase 3 trial to further assess the efficacy and safety of TAS-102 in a global population of such patients. METHODS: In this double-blind study, we randomly assigned 800 patients, in a 2:1 ratio, to receive TAS-102 or placebo. The primary end point was overall survival. RESULTS: The median overall survival improved from 5.3 months with placebo to 7.1 months with TAS-102, and the hazard ratio for death in the TAS-102 group versus the placebo group was 0.68 (95% confidence interval [CI], 0.58 to 0.81; P\textless0.001). The most frequently observed clinically significant adverse events associated with TAS-102 were neutropenia, which occurred in 38% of those treated, and leukopenia, which occurred in 21%; 4% of the patients who received TAS-102 had febrile neutropenia, and one death related to TAS-102 was reported. The median time to worsening performance status (a change in Eastern Cooperative Oncology Group performance status [on a scale of 0 to 5, with 0 indicating no symptoms and higher numbers indicating increasing degrees of disability] from 0 or 1 to 2 or more) was 5.7 months with TAS-102 versus 4.0 months with placebo (hazard ratio, 0.66; 95% CI, 0.56 to 0.78; P\textless0.001). CONCLUSIONS: In patients with refractory colorectal cancer, TAS-102, as compared with placebo, was associated with a significant improvement in overall survival. (Funded by Taiho Oncology-Taiho Pharmaceutical; RECOURSE ClinicalTrials.gov number, NCT01607957.).

Dates et versions

hal-01152847 , version 1 (18-05-2015)

Identifiants

Citer

Robert J. Mayer, Eric van Cutsem, Alfredo Falcone, Takayuki Yoshino, Rocio Garcia-Carbonero, et al.. Randomized trial of TAS-102 for refractory metastatic colorectal cancer. New England Journal of Medicine, 2015, 372 (20), pp.1909--1919. ⟨10.1056/NEJMoa1414325⟩. ⟨hal-01152847⟩
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