Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial
Year: 2023
Type: article
Study designs: Randomized Controlled Trial, Clinical Trial
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.
Source: British Journal of Cancer
Authors: Yasutoshi Kuboki, Tetsuji Terazawa, Toshiki Masuishi, Masato Nakamura, Jun Watanabe, Hitoshi Ojima, Akitaka Makiyama, Masahito Kotaka, Hiroki Hara, Yoshinori Kagawa, Naotoshi Sugimoto, Hisato Kawakami, Atsuo Takashima, Takeshi Kajiwara, Eiji Oki, Yu Sunakawa, Soichiro Ishihara, Hiroya Taniguchi, Takako Eguchi Nakajima, Satoshi Morita, Kuniaki Shirao, Naruhito Takenaka, Daisuke Ozawa, Takayuki Yoshino
Institutions: National Cancer Centre Japan, National Cancer Center Hospital East, Osaka Medical and Pharmaceutical University, Aichi Cancer Center, Aichi Cancer Center Hospital, Aizawa Hospital, Yokohama City University Medical Center, Gunma Prefectural Cancer Center, Gifu University Hospital, Kyushu Hospital, Sano Hospital, Saitama Cancer Center, Osaka Prefectural Medical Center, Kansai Rosai Hospital, Osaka International Cancer Institute, Kindai University Hospital, National Cancer Center Hospital, Shikoku Cancer Center, Kyushu University, St. Marianna University School of Medicine, The University of Tokyo, Kyoto University, Oita University, Taiho Pharmaceutical (Japan)
Language: English
Subfield: Oncology
Field: Medicine
Domain: Health Sciences
Open Access status: hybrid
Estimated APC paid: $4,690
OpenAlex ID: W4323075868