Introduction

Compared with the best supportive care, a survival benefit of using regorafenib and trifluridine/tipiracil (TFTD) in patients with colorectal cancer has been shown in previous randomized controlled trials (RCTs). However, there is no RCT or large-scale observational study directly comparing regorafenib and TFTD.

Patients and Methods

We used a nationwide claims database in Japan and compared the effectiveness of regorafenib and TFTD for metastatic colorectal cancer during 2013 to 2018. The patients were divided into 4 groups (regorafenib monotherapy, regorafenib/TFTD: regorafenib followed by TFTD, TFTD monotherapy, and TFTD/regorafenib: TFTD followed by regorafenib). Overall survival (OS) and adverse events were compared between the groups. In a subgroup analysis, we also compared treatment effectiveness between the group in which regorafenib was administered first and the group in which TFTD was administered first.

Results

We identified 7279 patients (regorafenib: 1501, regorafenib/TFTD: 973, TFTD: 3777, and TFTD/regorafenib: 1028). The corresponding median OS was 6.4, 16.4, 10.2, and 16.9 months, respectively. A log-rank test showed significant intergroup differences (P < .001). In the subgroup analysis, the group in which TFTD was administered first showed significantly longer OS. The incidences of most adverse events were the lowest in the TFTD group. The TFTD group showed longer OS than the regorafenib group, and sequential drug use resulted in the most prolonged OS.

Conclusion

Our findings indicate that it might be better to prescribe TFTD first. Furthermore, owing to the longer OS than monotherapy, sequential administration of regorafenib and TFTD ought to be considered.

中文翻译：

---

Regorafenib 与 Trifluridine/Tipiracil 在不可切除的结直肠癌中的有效性和安全性：一项回顾性队列研究。

介绍

与最佳支持治疗相比，之前的随机对照试验 (RCT) 已经显示，在结直肠癌患者中使用瑞戈非尼和曲氟尿苷/替吡嘧啶 (TFTD) 的生存获益。然而，没有直接比较瑞戈非尼和TFTD的随机对照试验或大规模观察性研究。

患者和方法

我们使用日本全国性的理赔数据库，比较了 2013 年至 2018 年期间瑞戈非尼和 TFTD 治疗转移性结直肠癌的有效性。 将患者分为 4 组（瑞戈非尼单药治疗、瑞戈非尼/TFTD：瑞戈非尼后继 TTD、TFTD 单药治疗和 TTFTD /regorafenib：TFTD，然后是瑞戈非尼）。比较各组的总生存期（OS）和不良事件。在亚组分析中，我们还比较了首先使用瑞戈非尼的组和首先使用 TFTD 的组之间的治疗效果。

结果

我们确定了 7279 名患者（瑞戈非尼：1501、瑞戈非尼/TFTD：973、TFTD：3777 和 TFTD/瑞戈非尼：1028）。相应的中位 OS 分别为 6.4、16.4、10.2 和 16.9 个月。对数秩检验显示显着的组间差异 ( P  < .001)。在亚组分析中，首先施用 TFTD 的组显示出明显更长的 OS。大多数不良事件的发生率在TFTD组中最低。与瑞戈非尼组相比，TFTD 组显示出更长的 OS，并且序贯药物使用导致了最长的 OS。

结论

我们的研究结果表明，最好先开 TFTD。此外，由于 OS 比单药治疗更长，应考虑顺序给药瑞戈非尼和 TTFT。