Background:Regorafenib (R) and trifluridine/tipiracil (T) are approved treatments for metastatic colorectal cancer (mCRC) in refractory cases. However, the optimal sequencing of these agents is unknown. The ReTrITA study planned to assess the real-world efficacy of R and T, administered either sequentially or as monotherapy, in a large Italian multicentre population.Methods:This retrospective observational analysis comprised 1156 mCRC patients treated between 2012 and 2023 at 17 Italian cancer centres. Patients were divided into four groups: sequential T/R (n= 261), sequential R/T (n= 155), R monotherapy (n= 313), and T monotherapy (n= 427). The primary objectives were overall survival (OS) and progression-free survival (PFS), with secondary goals being disease control rate, objective response rate, and treatment-related toxicity.Results:The monotherapy cohorts showed no significant difference in OS (R: 5.0 months; T: 5.9 months;p= 0.8371) or PFS (R: 3.2 months; T: 3.3 months;p= 0.6531). Compared to T/R, the sequential R/T group had significantly better outcomes: median OS was 16.6 vs. 12.6 months (HR = 0.67;p= 0.0004), and median PFS was 11.5 vs. 8.5 months (HR = 0.60;p< 0.0001). The survival advantage of R/T was consistent across clinical subgroups. The toxicity profiles were comparable with known safety data, with a lower prevalence of neutropenia reported in the R/T sequence.Conclusions:ReTrITA confirms the efficacy of R and T as monotherapies and provides compelling real-world evidence that the R/T sequence improves survival in refractory mCRC. These findings support a regorafenib-first approach in patients who are eligible, and they emphasise the need for future research into combination strategies and comparisons with newer drugs such as fruquintinib.
背景：瑞戈非尼（R）与曲氟尿苷/替匹嘧啶（T）是经批准用于难治性转移性结直肠癌（mCRC）的治疗方案。然而，这两种药物的最佳用药顺序尚未明确。ReTrITA研究旨在通过意大利多中心大样本队列，评估R与T序贯治疗或单药治疗在真实世界中的疗效。 方法：本回顾性观察性分析纳入2012年至2023年间在意大利17家肿瘤中心接受治疗的1156例mCRC患者。患者被分为四组：T/R序贯组（n=261）、R/T序贯组（n=155）、R单药组（n=313）及T单药组（n=427）。主要研究终点为总生存期（OS）和无进展生存期（PFS），次要终点包括疾病控制率、客观缓解率及治疗相关毒性。 结果：单药治疗组在OS（R组：5.0个月；T组：5.9个月；p=0.8371）和PFS（R组：3.2个月；T组：3.3个月；p=0.6531）方面均无显著差异。与T/R序贯治疗相比，R/T序贯治疗组显示出更优的生存结局：中位OS为16.6个月 vs 12.6个月（HR=0.67；p=0.0004），中位PFS为11.5个月 vs 8.5个月（HR=0.60；p<0.0001）。R/T序贯治疗的生存优势在各临床亚组中保持一致。毒性特征与已知安全性数据相符，其中R/T序贯组的中性粒细胞减少症发生率较低。 结论：ReTrITA研究证实了R与T单药治疗的疗效，并提供了强有力的真实世界证据，表明R/T序贯治疗可改善难治性mCRC患者的生存。这些发现支持对符合条件的患者采取瑞戈非尼优先的治疗策略，同时强调未来需进一步研究联合治疗方案以及与呋喹替尼等新型药物的疗效对比。
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