Journal article
Randomized trial of TAS-102 for refractory metastatic colorectal cancer
RJ Mayer, E Van Cutsem, A Falcone, T Yoshino, R Garcia-Carbonero, N Mizunuma, K Yamazaki, Y Shimada, J Tabernero, Y Komatsu, A Sobrero, E Boucher, M Peeters, B Tran, HJ Lenz, A Zaniboni, H Hochster, JM Cleary, H Prenen, F Benedetti Show all
New England Journal of Medicine | Published : 2015
Abstract
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..
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Funding Acknowledgements
Funded by Taiho Oncology-Taiho Pharmaceutical; RECOURSE ClinicalTrials.gov number, NCT01607957.