{"entity":{"id":"paper-mayer-recourse-tas-102-nejm-2015","kind":"paper","name":"Randomized trial of TAS-102 for refractory metastatic colorectal cancer (RECOURSE)","aka":[],"tldr":"An oral chemotherapy that works where fluorouracil no longer does, adding 1.8 months after everything else has failed, and delaying the slide in performance status by nearly two months.","summary":"Mayer, Van Cutsem, Falcone and colleagues randomly assigned 800 patients with refractory colorectal cancer 2:1 to TAS-102, an oral agent combining trifluridine and tipiracil hydrochloride, or placebo in a double-blind trial, with overall survival as the primary end point. Early trials conducted primarily in Japan had suggested activity in this setting.\n\nOne death related to TAS-102 was reported. The time to worsening of ECOG performance status from 0 or 1 to 2 or more was a pre-specified secondary endpoint and favoured treatment.","asOf":"2026-09-24","links":[{"label":"N Engl J Med 2015","url":"https://doi.org/10.1056/NEJMoa1414325"},{"label":"PubMed","url":"https://pubmed.ncbi.nlm.nih.gov/25970050/"}],"tags":["colorectal-evidence"],"related":["paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023","paper-grothey-correct-regorafenib-lancet-2013"],"cancers":["colorectal"],"sections":["chemotherapy"],"technologies":["cytotoxic-chemotherapy"],"targets":[],"drugs":["trifluridine-tipiracil"],"companies":["taiho"],"institutions":[],"pathways":[],"terms":["performance-status"],"trials":[],"people":["eric-van-cutsem","josep-tabernero","yoshino-takayuki","heinz-josef-lenz"],"bottlenecks":["b-toxicity-qol"],"keyPapers":[],"journals":["nejm"],"dependsOn":[],"notes":[],"journal":"New England Journal of Medicine","year":2015,"doi":"10.1056/NEJMoa1414325","pmid":"25970050","authors":"Mayer RJ, Van Cutsem E, Falcone A, et al.","paperType":"rct","findings":["Median overall survival 7.1 months with TAS-102 against 5.3 months with placebo: hazard ratio 0.68 (95 percent CI 0.58 to 0.81, p<0.001).","Neutropenia in 38 percent and leukopenia in 21 percent of those treated; febrile neutropenia in 4 percent.","Median time to worsening performance status 5.7 against 4.0 months (hazard ratio 0.66, 0.56 to 0.78, p<0.001)."],"whatItMeans":"Trifluridine-tipiracil became the other refractory-line standard alongside regorafenib, and the backbone that SUNLIGHT later improved on by adding bevacizumab.","caveats":["Myelosuppression rather than the hand-foot toxicity of regorafenib; the two drugs differ in how they are tolerated rather than in how much they add.","No predictive biomarker.","Funded by the manufacturer."],"changedPractice":true,"participants":800},"route":"/key-papers/paper-mayer-recourse-tas-102-nejm-2015/","neighbours":{"paper":[{"id":"paper-grothey-correct-regorafenib-lancet-2013","kind":"paper","name":"Regorafenib monotherapy for previously treated metastatic colorectal cancer (CORRECT)","route":"/key-papers/paper-grothey-correct-regorafenib-lancet-2013/"},{"id":"paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023","kind":"paper","name":"Trifluridine-tipiracil and bevacizumab in refractory metastatic colorectal cancer (SUNLIGHT)","route":"/key-papers/paper-prager-sunlight-trifluridine-tipiracil-bevacizumab-nejm-2023/"}],"cancer":[{"id":"colorectal","kind":"cancer","name":"Colorectal cancer","route":"/cancers/colorectal/"}],"section":[{"id":"chemotherapy","kind":"section","name":"Chemotherapy","route":"/fronts/chemotherapy/"}],"technology":[{"id":"cytotoxic-chemotherapy","kind":"technology","name":"Cytotoxic chemotherapy","route":"/technologies/cytotoxic-chemotherapy/"}],"drug":[{"id":"trifluridine-tipiracil","kind":"drug","name":"Trifluridine/tipiracil","route":"/drugs/trifluridine-tipiracil/"}],"company":[{"id":"taiho","kind":"company","name":"Taiho Pharmaceutical (Otsuka)","route":"/companies/taiho/"}],"term":[{"id":"performance-status","kind":"term","name":"Performance status (ECOG, Karnofsky)","route":"/terms/performance-status/"}],"person":[{"id":"eric-van-cutsem","kind":"person","name":"Eric Van Cutsem","route":"/people/eric-van-cutsem/"},{"id":"heinz-josef-lenz","kind":"person","name":"Heinz-Josef Lenz","route":"/people/heinz-josef-lenz/"},{"id":"josep-tabernero","kind":"person","name":"Josep Tabernero","route":"/people/josep-tabernero/"},{"id":"yoshino-takayuki","kind":"person","name":"Takayuki Yoshino","route":"/people/yoshino-takayuki/"}],"bottleneck":[{"id":"b-toxicity-qol","kind":"bottleneck","name":"Toxicity and quality of life are undervalued","route":"/bottlenecks/b-toxicity-qol/"}],"journal":[{"id":"nejm","kind":"journal","name":"New England Journal of Medicine","route":"/journals/nejm/"}],"roadmap":[{"id":"colorectal-roadmap","kind":"roadmap","name":"Colorectal cancer roadmap: from the adenoma-carcinoma sequence and the first screening trials to total mesorectal excision, oxaliplatin, RAS testing, immunotherapy for mismatch repair-deficient disease, ctDNA-guided treatment and organ preservation","route":"/roadmaps/colorectal-roadmap/"}]}}