BACKGROUND A previous phase I/II C-TASK FORCE study of trifluridine/tipiracil plus bevacizumab for patients with heavily pretreated metastatic colorectal cancer (mCRC) showed promising activity with an acceptable toxicity profile. This retrospective study aimed to investigate the safety and efficacy of trifluridine/tipiracil plus bevacizumab compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC in clinical settings. METHODS Records of patients with mCRC refractory to standard therapies who initiated trifluridine/tipiracil plus bevacizumab from January 2016 to March 2018 or trifluridine/tipiracil monotherapy from June 2014 to December 2015 were retrospectively reviewed at our institution. RESULTS Totally, 60 patients received trifluridine/tipiracil plus bevacizumab and 66 received trifluridine/tipiracil monotherapy. All patients had previously received standard chemotherapy. Median progression-free survival (PFS) was 3.7 months [95% confidence interval (CI), 2.3-5.1] in the trifluridine/tipiracil plus bevacizumab group and 2.2 months (95% CI, 1.8-2.6) in the trifluridine/tipiracil monotherapy group [hazards ratio (HR) 0.69; 95% CI 0.48-0.99]. PFS rate at 16 weeks was 46.6% for the trifluridine/tipiracil plus bevacizumab group and 33.9% for the trifluridine/tipiracil monotherapy group. Although a relatively higher incidence of grade ≥ 3 neutropenia was observed in the trifluridine/tipiracil plus bevacizumab group than that in the other group (50.0% vs. 40.9%, p = 0.371), the incidence of febrile neutropenia was not high (3.3% vs. 7.8%, p = 0.444). CONCLUSIONS In real-world settings, trifluridine/tipiracil plus bevacizumab prolonged PFS and helped achieve higher 16-week PFS rate compared with trifluridine/tipiracil monotherapy in patients with heavily pretreated mCRC with manageable toxicities. TRIAL REGISTRATION Retrospectively registered.

中文翻译：

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回顾性队列研究了三氟吡啶/替普拉西酯（TAS-102）加上贝伐单抗与三氟吡啶/替普拉西单药治疗转移性结直肠癌的关系。

背景技术先前对三氟吡啶/替普拉西酯联合贝伐单抗进行I / II C-TASK FORCE研究的患者，对转移性结直肠癌（mCRC）进行了高度预处理，该研究显示出令人鼓舞的活性，并且具有可接受的毒性。这项回顾性研究旨在研究在临床环境中经过大量预处理的mCRC患者中，三氟哌啶/替普拉西酯联合贝伐单抗与三氟哌啶/替普拉西单药相比的安全性和有效性。方法回顾性分析我院2016年1月至2018年3月开始使用三氟哌啶/替普拉西酯联合贝伐单抗或2014年6月至2015年12月使用三氟哌啶/替普拉西单药治疗的标准疗法难治性mCRC患者的病历。结果总的来说，60例患者接受了三氟吡啶/替普拉西酯联合贝伐单抗治疗，而66例患者接受了三氟吡啶/替普拉西单药治疗。所有患者以前都接受过标准化疗。三氟哌啶/替普拉西酯+贝伐单抗组的中位无进展生存期（PFS）为3.7个月[95％置信区间（CI），2.3-5.1]，三氟哌啶/替普拉西单药治疗的中位无进展生存期为2.2个月（95％CI，1.8-2.6）组[危险比（HR）0.69；95％CI 0.48-0.99]。三氟吡啶/替普拉西酯+贝伐单抗组在16周时的PFS率为46.6％，三氟吡啶/替普拉西酯单药治疗组为33.9％。尽管在三氟吡啶/替普拉西酯+贝伐单抗组中发现≥3级中性粒细胞减少症的发生率高于其他组（50.0％对40.9％，p = 0.371），但发热性中性粒细胞减少症的发生率并不高（3.3％） vs. 7.8％，p = 0.444）。结论在经过严格治疗的mCRC患者中，三氟哌啶/替普拉西酯联合贝伐单抗与三氟哌啶/替比拉西单药治疗相比，可延长PFS并有助于实现更高的16周PFS率。试用注册追溯注册。