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Type: Journal article
Title: Randomized trial of TAS-102 for refractory metastatic colorectal cancer
Author: Mayer, R.
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.
Zaniboni, A.
Hochster, H.
Cleary, J.
Prenen, H.
Benedetti, F.
et al.
Citation: New England Journal of Medicine, 2015; 372(20):1909-1919
Publisher: Massachusetts Medical Society
Issue Date: 2015
ISSN: 0028-4793
Statement of
Robert J. Mayer, Eric Van Cutsem, Alfredo Falcone, Takayuki Yoshino, Rocio Garcia-Carbonero ... Marc Peeters ... et al.
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% confidence interval [CI], 0.58 to 0.81; P<0.001). 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<0.001). 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 number, NCT01607957.).
Keywords: RECOURSE Study Group
Rights: © 2015, Massachusetts Medical Society.
DOI: 10.1056/NEJMoa1414325
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