Background: Regorafenib (R) and Trifluridine/Tipiracil ± bevacizumab (T) are approved for treating refractory metastatic colorectal cancer (mCRC) but their optimal sequence is unclear. This study describes the characteristics/clinical outcomes of patients with mCRC in U.S. clinical practice treated sequentially with R-T or T-R.Methods: A retrospective cohort study of 818 patients treated with R-T or T-R between January 2015 and November 2022 was conducted using an electronic health record-derived database. The primary objective was to describe the demographic/clinical characteristics and biomarker status of patients treated with R-T or T-R, stratified by treatment line/age. Secondary objectives were to evaluate/estimate the frequency of neutropenia and myelosuppression-related treatments, the number/type of subsequent therapies, time to treatment discontinuation (TTD), and overall survival (OS).Results: Baseline characteristics were similar among patients who received R-T (n = 393) or T-R (n = 425). Lower rates of moderate/severe neutropenia (26%/12% vs. 32%/16%) and granulocyte colony-stimulating factor/erythropoietin use (22% vs. 24%) were observed with R-T versus T-R. The median TTD was 8.7 months and 8.5 months with R-T versus 8.1 months and 7.9 months with T-R as third- and fourth-line treatment, respectively. The median OS was 13.1 months and 11.6 months with R-T versus 11.5 months and 10.3 months with T-R as third- and fourth-line treatment, respectively.Conclusions: This study did not show a statistically significant difference in OS with R-T versus T-R. Although limited by its retrospective nature, the study suggested R-T may be preferable to T-R given the observed reduction in neutropenia/myelosuppression-related treatments.
背景：瑞戈非尼（R）与曲氟尿苷/替匹嘧啶±贝伐珠单抗（T）已获批用于治疗难治性转移性结直肠癌（mCRC），但两者的最佳序贯顺序尚不明确。本研究旨在描述美国临床实践中接受R-T或T-R序贯治疗的mCRC患者的特征及临床结局。 方法：基于电子健康记录数据库，对2015年1月至2022年11月期间接受R-T或T-R治疗的818例患者开展回顾性队列研究。主要目的是按治疗线数和年龄分层，描述接受R-T或T-R治疗患者的人口学/临床特征及生物标志物状态。次要目标包括评估/估计中性粒细胞减少症及骨髓抑制相关治疗的发生频率、后续治疗的数量/类型、治疗终止时间（TTD）以及总生存期（OS）。 结果：接受R-T（n=393）或T-R（n=425）治疗患者的基线特征相似。与T-R相比，R-T方案的中度/重度中性粒细胞减少发生率较低（26%/12% vs. 32%/16%），粒细胞集落刺激因子/促红细胞生成素使用率更低（22% vs. 24%）。作为三线及四线治疗时，R-T方案的中位TTD分别为8.7个月和8.5个月，而T-R方案分别为8.1个月和7.9个月；R-T方案的中位OS分别为13.1个月和11.6个月，T-R方案分别为11.5个月和10.3个月。 结论：本研究未显示R-T与T-R方案在OS方面存在统计学显著差异。尽管受回顾性研究性质所限，但基于观察到的中性粒细胞减少/骨髓抑制相关治疗的减少，提示R-T方案可能优于T-R方案。
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