{"status":"ok","message-type":"work","message-version":"1.0.0","message":{"indexed":{"date-parts":[[2026,6,3]],"date-time":"2026-06-03T13:43:20Z","timestamp":1780494200718,"version":"3.54.1"},"reference-count":18,"publisher":"Springer Science and Business Media LLC","issue":"2","license":[{"start":{"date-parts":[[2016,7,21]],"date-time":"2016-07-21T00:00:00Z","timestamp":1469059200000},"content-version":"tdm","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"},{"start":{"date-parts":[[2016,7,21]],"date-time":"2016-07-21T00:00:00Z","timestamp":1469059200000},"content-version":"vor","delay-in-days":0,"URL":"https:\/\/creativecommons.org\/licenses\/by\/4.0\/"}],"funder":[{"name":"Taiho Oncology Inc."}],"content-domain":{"domain":["link.springer.com"],"crossmark-restriction":false},"short-container-title":["Clin Transl Oncol"],"published-print":{"date-parts":[[2017,2]]},"abstract":"<jats:title>Abstract<\/jats:title>\n          <jats:sec>\n            <jats:title>Purpose<\/jats:title>\n            <jats:p>TAS-102 is a combination of the thymidine-based nucleoside analog trifluridine and the thymidine phosphorylase inhibitor tipiracil. Efficacy and safety of TAS-102 in patients with metastatic colorectal cancer (mCRC) refractory or intolerant to standard therapies were evaluated in the phase 3 RECOURSE trial. Results of RECOURSE demonstrated significant improvement in overall survival (OS) and progression-free survival (PFS) with TAS-102 versus placebo [hazard ratio (HR)\u00a0=\u00a00.68 and 0.48 for OS and PFS, respectively; both <jats:italic>P<\/jats:italic>\u00a0&lt;\u00a00.001]. The current analysis evaluates efficacy and safety of TAS-102 in the RECOURSE Spanish subgroup.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Methods<\/jats:title>\n            <jats:p>Primary and key secondary endpoints were evaluated in a post hoc analysis of the RECOURSE Spanish subgroup, using univariate and multivariate analyses. Safety and tolerability were reported with descriptive statistics.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Results<\/jats:title>\n            <jats:p>The RECOURSE Spanish subgroup included 112 patients (mean age 61\u00a0years, 62\u00a0% male). Median OS was 6.8\u00a0months in the TAS-102 group (<jats:italic>n<\/jats:italic>\u00a0=\u00a080) versus 4.6\u00a0months in the placebo group (<jats:italic>n<\/jats:italic>\u00a0=\u00a032) [HR\u00a0=\u00a00.47; 95\u00a0% confidence interval (CI): 0.28\u20130.78; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.0032). Median PFS was 2.0\u00a0months in the TAS-102 group and 1.7\u00a0months in the placebo group (HR\u00a0=\u00a00.47; 95\u00a0% CI: 0.30\u20130.74; <jats:italic>P<\/jats:italic>\u00a0=\u00a00.001). Eighty (100\u00a0%) TAS-102 versus 31 (96.9\u00a0%) placebo patients had adverse events (AEs). The most common drug-related \u2265Grade 3 AE was neutropenia (40\u00a0% TAS-102 versus 0\u00a0% placebo). There was 1 (1.3\u00a0%) case of febrile neutropenia in the TAS-102 group versus none in the placebo group.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>Conclusions<\/jats:title>\n            <jats:p>In the RECOURSE Spanish subgroup, TAS-102 was associated with significantly improved OS and PFS versus placebo, consistent with the overall RECOURSE population. No new safety signals were identified.<\/jats:p>\n          <\/jats:sec>\n          <jats:sec>\n            <jats:title>ClinicalTrials.gov study number<\/jats:title>\n            <jats:p>NCT01607957<\/jats:p>\n          <\/jats:sec>","DOI":"10.1007\/s12094-016-1528-7","type":"journal-article","created":{"date-parts":[[2016,7,21]],"date-time":"2016-07-21T08:50:40Z","timestamp":1469091040000},"page":"227-235","update-policy":"https:\/\/doi.org\/10.1007\/springer_crossmark_policy","source":"Crossref","is-referenced-by-count":26,"title":["Efficacy of trifluridine and tipiracil (TAS-102) versus placebo, with supportive care, in a randomized, controlled trial of patients with metastatic colorectal cancer from Spain: results of a subgroup analysis of the phase 3 RECOURSE trial"],"prefix":"10.1007","volume":"19","author":[{"given":"F.","family":"Longo-Mu\u00f1oz","sequence":"first","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"G.","family":"Argiles","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"J.","family":"Tabernero","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Cervantes","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Gravalos","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"C.","family":"Pericay","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"S.","family":"Gil-Calle","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"H.","family":"Mizuguchi","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"A.","family":"Carrato-Mena","sequence":"additional","affiliation":[],"role":[{"vocabulary":"crossref","role":"author"}]},{"given":"M. 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Author B reports providing scientific advice to Bayer. Author C reports consulting\/advisory fees from Amgen, Boehringer Ingelheim, Celgene, Chugai, Imclone Systems Inc., Eli Lilly and Company, Merck & Co., Merck Serono, Millennium, Novartis, F. Hoffmann-La Roche Ltd., Sanofi, Symphogen, and Taiho Oncology Inc. All other authors declare that they have no conflicts of interest.","order":2,"name":"Ethics","group":{"name":"EthicsHeading","label":"Conflict of interest"}},{"value":"Informed consent was obtained from all individual participants included in the study.","order":3,"name":"Ethics","group":{"name":"EthicsHeading","label":"Informed consent"}},{"value":"All procedures performed in studies involving human participants were in accordance with the ethical standards of the institutional and\/or national research committee and with the 1964 Helsinki declaration and its later amendments or comparable ethical standards.","order":4,"name":"Ethics","group":{"name":"EthicsHeading","label":"Research involving human participants"}}]}}