Please use this identifier to cite or link to this item: http://hdl.handle.net/2440/121267
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dc.contributor.authorMayer, R.en
dc.contributor.authorVan Cutsem, E.en
dc.contributor.authorFalcone, A.en
dc.contributor.authorYoshino, T.en
dc.contributor.authorGarcia-Carbonero, R.en
dc.contributor.authorMizunuma, N.en
dc.contributor.authorYamazaki, K.en
dc.contributor.authorShimada, Y.en
dc.contributor.authorTabernero, J.en
dc.contributor.authorKomatsu, Y.en
dc.contributor.authorSobrero, A.en
dc.contributor.authorBoucher, E.en
dc.contributor.authorPeeters, M.en
dc.contributor.authorTran, B.en
dc.contributor.authorLenz, H.en
dc.contributor.authorZaniboni, A.en
dc.contributor.authorHochster, H.en
dc.contributor.authorCleary, J.en
dc.contributor.authorPrenen, H.en
dc.contributor.authorBenedetti, F.en
dc.contributor.authoret al.en
dc.date.issued2015en
dc.identifier.citationNew England Journal of Medicine, 2015; 372(20):1909-1919en
dc.identifier.issn0028-4793en
dc.identifier.issn1533-4406en
dc.identifier.urihttp://hdl.handle.net/2440/121267-
dc.description.abstractBACKGROUND: 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 ClinicalTrials.gov number, NCT01607957.).en
dc.description.statementofresponsibilityRobert J. Mayer, Eric Van Cutsem, Alfredo Falcone, Takayuki Yoshino, Rocio Garcia-Carbonero ... Marc Peeters ... et al.en
dc.language.isoenen
dc.publisherMassachusetts Medical Societyen
dc.rights© 2015, Massachusetts Medical Society.en
dc.subjectRECOURSE Study Groupen
dc.titleRandomized trial of TAS-102 for refractory metastatic colorectal canceren
dc.typeJournal articleen
dc.identifier.rmid0030130038en
dc.identifier.doi10.1056/NEJMoa1414325en
dc.identifier.pubid489964-
pubs.library.collectionMedicine publicationsen
pubs.library.teamDS10en
pubs.verification-statusVerifieden
pubs.publication-statusPublisheden
dc.identifier.orcidPeeters, M. [0000-0003-4969-2303]en
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