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- Title
Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial.
- Authors
Kuboki, Yasutoshi; Terazawa, Tetsuji; Masuishi, Toshiki; Nakamura, Masato; Watanabe, Jun; Ojima, Hitoshi; Makiyama, Akitaka; Kotaka, Masahito; Hara, Hiroki; Kagawa, Yoshinori; Sugimoto, Naotoshi; Kawakami, Hisato; Takashima, Atsuo; Kajiwara, Takeshi; Oki, Eiji; Sunakawa, Yu; Ishihara, Soichiro; Taniguchi, Hiroya; Nakajima, Takako Eguchi; Morita, Satoshi
- Abstract
Background: 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). Methods: 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. Results: 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 interval [CI] 0.99–1.93; Pnoninferiority = 0.5920). In patients with a baseline sum of the diameter of target lesions of <60 mm (n = 216, post hoc analyses), the adjusted median OS was similar between groups (FTD/TPI plus bevacizumab vs. control, 21.4 vs. 20.7 months; HR 0.92; 95% CI 0.55–1.55). Grade ≥3 adverse events (FTD/TPI plus bevacizumab vs. control) included neutropenia (65.8% vs. 41.6%) and diarrhoea (1.5% vs. 7.1%). Conclusions: FTD/TPI plus bevacizumab did not demonstrate noninferiority to fluoropyrimidine and irinotecan plus bevacizumab as second-line treatment for mCRC. Clinical trial registration: JapicCTI-173618, jRCTs031180122.
- Publication
British Journal of Cancer, 2023, Vol 128, Issue 10, p1897
- ISSN
0007-0920
- Publication type
Article
- DOI
10.1038/s41416-023-02212-2