| Autor: |
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 |
| Zdroj: |
British Journal of Cancer; May2023, Vol. 128 Issue 10, p1897-1905, 9p |
| Abstrakt: |
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. [ABSTRACT FROM AUTHOR] |
| Databáze: |
Complementary Index |
| Externí odkaz: |
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