biostudies-literatureUnknown128(10)Kuboki YTaiho Pharmaceutical<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/m² 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 intervaBritish journal of cancer1897-1905https://www.ebi.ac.uk/biostudies/studies/S-EPMC10147634biostudies-literatureTrifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial.PMC10147634Kawakami HMasuishi TOjima HNakamura MTakenaka NNakajima TETakashima AMorita SOzawa DKotaka MKuboki YWatanabe JKagawa YSunakawa YTaniguchi HHara HOki EMakiyama AKajiwara TTerazawa TIshihara SShirao KSugimoto NYoshino TfalseTrifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial.<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/m² 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 interva2023-01-01T00:00:00Z2023 May2025-04-26T01:28:54.617Z2025-02-19T02:55:58.06ZS-EPMC101476343687104310.1038/s41416-023-02212-2