{"database":"biostudies-literature","file_versions":[],"scores":null,"additional":{"omics_type":["Unknown"],"volume":["128(10)"],"submitter":["Kuboki Y"],"funding":["Taiho Pharmaceutical"],"pubmed_abstract":["<h4>Background</h4>This open-label, multicentre, phase II/III trial assessed the noninferiority of trifluridine/tipiracil (FTD/TPI) plus bevacizumab vs. fluoropyrimidine and irinotecan plus bevacizumab (control) as second-line treatment for metastatic colorectal cancer (mCRC).<h4>Methods</h4>Patients were randomised (1:1) to receive FTD/TPI (35 mg/m<sup>2</sup> twice daily, days 1-5 and days 8-12, 28-day cycle) plus bevacizumab (5 mg/kg, days 1 and 15) or control. The primary endpoint was overall survival (OS). The noninferiority margin of the hazard ratio (HR) was set to 1.33.<h4>Results</h4>Overall, 397 patients were enrolled. Baseline characteristics were similar between the groups. Median OS was 14.8 vs. 18.1 months (FTD/TPI plus bevacizumab vs. control; HR 1.38; 95% confidence interva"],"journal":["British journal of cancer"],"pagination":["1897-1905"],"full_dataset_link":["https://www.ebi.ac.uk/biostudies/studies/S-EPMC10147634"],"repository":["biostudies-literature"],"pubmed_title":["Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial."],"pmcid":["PMC10147634"],"pubmed_authors":["Kawakami H","Masuishi T","Ojima H","Nakamura M","Takenaka N","Nakajima TE","Takashima A","Morita S","Ozawa D","Kotaka M","Kuboki Y","Watanabe J","Kagawa Y","Sunakawa Y","Taniguchi H","Hara H","Oki E","Makiyama A","Kajiwara T","Terazawa T","Ishihara S","Shirao K","Sugimoto N","Yoshino T"],"additional_accession":[]},"is_claimable":false,"name":"Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial.","description":"<h4>Background</h4>This open-label, multicentre, phase II/III trial assessed the noninferiority of trifluridine/tipiracil (FTD/TPI) plus bevacizumab vs. fluoropyrimidine and irinotecan plus bevacizumab (control) as second-line treatment for metastatic colorectal cancer (mCRC).<h4>Methods</h4>Patients were randomised (1:1) to receive FTD/TPI (35 mg/m<sup>2</sup> twice daily, days 1-5 and days 8-12, 28-day cycle) plus bevacizumab (5 mg/kg, days 1 and 15) or control. The primary endpoint was overall survival (OS). The noninferiority margin of the hazard ratio (HR) was set to 1.33.<h4>Results</h4>Overall, 397 patients were enrolled. Baseline characteristics were similar between the groups. Median OS was 14.8 vs. 18.1 months (FTD/TPI plus bevacizumab vs. control; HR 1.38; 95% confidence interva","dates":{"release":"2023-01-01T00:00:00Z","publication":"2023 May","modification":"2025-04-26T01:28:54.617Z","creation":"2025-02-19T02:55:58.06Z"},"accession":"S-EPMC10147634","cross_references":{"pubmed":["36871043"],"doi":["10.1038/s41416-023-02212-2"]}}