دورية أكاديمية
Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial
| العنوان: | Trifluridine/tipiracil+bevacizumab (BEV) vs. fluoropyrimidine-irinotecan+BEV as second-line therapy for metastatic colorectal cancer: a randomised noninferiority trial |
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| المؤلفون: | 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, Shirao, Kuniaki, Takenaka, Naruhito, Ozawa, Daisuke, Yoshino, Takayuki |
| المساهمون: | Taiho Pharmaceutical |
| المصدر: | British Journal of Cancer ; volume 128, issue 10, page 1897-1905 ; ISSN 0007-0920 1532-1827 |
| بيانات النشر: | Springer Science and Business Media LLC |
| سنة النشر: | 2023 |
| مصطلحات موضوعية: | Cancer Research, Oncology |
| الوصف: | 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/m 2 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; P noninferiority = 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. |
| نوع الوثيقة: | article in journal/newspaper |
| اللغة: | English |
| DOI: | 10.1038/s41416-023-02212-2 |
| الإتاحة: | https://doi.org/10.1038/s41416-023-02212-2Test https://www.nature.com/articles/s41416-023-02212-2.pdfTest https://www.nature.com/articles/s41416-023-02212-2Test |
| حقوق: | https://creativecommons.org/licenses/by/4.0Test ; https://creativecommons.org/licenses/by/4.0Test |
| رقم الانضمام: | edsbas.54E931D8 |
| قاعدة البيانات: | BASE |
| DOI: | 10.1038/s41416-023-02212-2 |
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