Randomized trial of TAS-102 for refractory metastatic colorectal cancer

Robert J. Mayer, Eric Van Cutsem, Alfredo Falcone, Takayuki Yoshino, Rocio Garcia-Carbonero, Nobuyuki Mizunuma, Kentaro Yamazaki, Yasuhiro Shimada, Josep Tabernero, Yoshito Komatsu, Alberto Sobrero, Eveline Boucher, Marc Peeters, Ben Tran, Heinz Josef Lenz, Alberto Zaniboni, Howard Hochster, James M. Cleary, Hans Prenen, Fabio BenedettiHirokazu Mizuguchi, Lukas Makris, Masanobu Ito, Atsushi Ohtsu

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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

Original languageEnglish
Pages (from-to)1909-1919
Number of pages11
JournalNew England Journal of Medicine
Issue number20
Publication statusPublished - May 14 2015

ASJC Scopus subject areas

  • Medicine(all)

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    Mayer, R. J., Van Cutsem, E., Falcone, A., Yoshino, T., Garcia-Carbonero, R., Mizunuma, N., Yamazaki, K., Shimada, Y., Tabernero, J., Komatsu, Y., Sobrero, A., Boucher, E., Peeters, M., Tran, B., Lenz, H. J., Zaniboni, A., Hochster, H., Cleary, J. M., Prenen, H., ... Ohtsu, A. (2015). Randomized trial of TAS-102 for refractory metastatic colorectal cancer. New England Journal of Medicine, 372(20), 1909-1919. https://doi.org/10.1056/NEJMoa1414325