三氟胞嘧啶/替匹利胺（FTD/TPI）和雷哥替尼（REG）是晚期转移性结直肠癌（mCRC）的标准治疗方案。迄今为止，尚未有大规模实际世界数据直接比较FTD/TPI + 贝伐单抗（BEV）与FTD/TPI或REG单药疗法的结果被报道。我们在实际临床环境中评估了FTD/TPI + BEV的疗效和安全性。本回顾性研究使用了由医疗数据愿景有限公司（日本东京）提供的日本索赔数据库。符合条件的患者年龄在20岁以上，诊断为mCRC，并在2014年至2021年期间接受了首次FTD/TPI或REG剂量。主要终点是应用倾向评分匹配（PSM）人群中的总生存期（OS），其中通过倾向评分进行匹配，1:1比例将FTD/TPI + BEV组和对照组（FTD/TPI或REG）进行配对。为增加鲁棒性，还采用倒数概率治疗加权（IPTW）方法和所有符合条件人群的分析进行OS的敏感性分析。次要终点包括治疗中断时间（TTD）、不良事件发生率和治疗后情况。FTD/TPI + BEV组的符合条件人群为2369人，对照组为9318人。PSM人群各组分别为1787人。FTD/TPI + BEV组在PSM人群中的中位OS（mOS）较对照组更长[17.0个月对11.6个月，风险比（HR）= 0.70，P < 0.001]。同样，在IPTW分析和所有符合条件人群中，FTD/TPI + BEV组的mOS均较对照组更长（两个HR均为0.68）。在PSM人群中，FTD/TPI + BEV组的中位TTD为3.3个月，对照组为1.8个月（P < 0.001）。真实世界数据显示，与FTD/TPI或REG相比，FTD/TPI + BEV明显与OS和TTD相关。在临床实践中，对于难治性mCRC，FTD/TPI + BEV可以是一个有利的治疗方案。© 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.

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.Copyright © 2023 The Authors. Published by Elsevier Ltd.. All rights reserved.