Real-world evidence of trifluridine/tipiracil plus bevacizumab in metastatic colorectal cancer using an administrative claims database in Japan

• Published in: ESMO open 2023-08, Vol.8 (4), p.101614-101614, Article 101614
• Main Authors: Kagawa, Y., Shinozaki, E., Okude, R., Tone, T., Kunitomi, Y., Nakashima, M.
• Format: Article
• Language: English
• Subjects: FTD/TPI; Original Research; real-world data; regorafenib; TAS-102; trifluridine/tipiracil + bevacizumab
• ISSN: 2059-7029; 2059-7029
• DOI: 10.1016/j.esmoop.2023.101614

Trifluridine/tipiracil (FTD/TPI) and regorafenib (REG) are standard therapies for refractory metastatic colorectal cancer (mCRC). No results of large real-world data directly comparing FTD/TPI + bevacizumab (BEV) with FTD/TPI or REG monotherapy have been reported. We evaluated the efficacy and safety of FTD/TPI + BEV in a real-world setting. This retrospective study used a Japanese claims database provided by Medical Data Vision Co., Ltd. (Tokyo, Japan). Eligible patients were aged 20 years and over with a diagnosis of mCRC, and received their first dose of FTD/TPI or REG from 2014 to 2021. The primary endpoint was overall survival (OS) in a propensity score matching (PSM) population in which PSM was carried out by matching using a 1 : 1 ratio for the FTD/TPI + BEV group and the control group (FTD/TPI or REG) by propensity score. To enhance robustness, sensitivity analyses of OS were carried out using the inverse probability treatment weighted (IPTW) approach and the analysis in the all eligible population. Secondary endpoints included time to treatment discontinuation (TTD), incidence of adverse events, and post-treatment. Eligible population was 2369 for the FTD/TPI + BEV group and 9318 for the control group. The PSM population was 1787 for each group. Median OS (mOS) was longer in the FTD/TPI + BEV group compared to the control group [17.0 versus 11.6 months, hazard ratio (HR) = 0.70, P < 0.001] in the PSM population. Similarly, mOS was longer for the FTD/TPI + BEV group compared to that for the control group in IPTW analyses and in the all eligible population (both HRs = 0.68). Median TTD was 3.3 months for the FTD/TPI + BEV group and 1.8 months for the control group in the PSM population (P < 0.001). Real-world data showed that FTD/TPI + BEV was significantly associated with OS and TTD compared to FTD/TPI or REG. In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC. •The efficacy and safety of FTD/TPI + BEV in mCRC patients were evaluated using Japanese administrative claims database.•The FTD/TPI + BEV group was found to be significantly associated with mOS (17.0 versus 11.6 months).•Median TTD was found to be significantly associated with the FTD/TPI + BEV group (3.3 versus 1.8 months).•The result was a similar trend to that of a prospective randomized phase III trial (SUNLIGHT study).•In clinical practice, FTD/TPI + BEV can be a favorable regimen for refractory mCRC.