Introduction

There have been significant developments in colorectal cancer (CRC) research over the last few years, with the introduction of new agents that have been prolonged median overall survival of metastatic colorectal cancer (mCRC). These therapies have improved patient outcomes; however, despite significant progress in strategies for cancer treatment, their use is limited by development of resistant mechanism. Almost 30% of patients with refractory mCRC will remain good candidates for further treatment. Regorafenib and TAS-102 are novel antitumor agents for patients with refractory mCRC. However, it is unclear which patients may derive a survival benefit from these drugs in real-life clinical practice.

Methods

We performed a retrospective analysis evaluating safety and efficacy of TAS-102 and regorafenib in a cohort of refractory mCRC patients, in 3 different centers between January 1 2018 and May 31 2020, with the aim of assessing the optimal sequence treatment for these 2 drugs.

Results

One hundred and forty mCRC patients were included in the analysis. Of these patients, 64 received regorafenib and 76 received TAS-102 as first treatment. After progression, in the regorafenib 24 (37%) patients switched to secondary treatment with TAS-102, instead, in the TAS-102 group, among 76 patients, 29 (45%) patients switched to secondary treatment with regorafenib. Disease control was achieved in 8 (12.5%) of 64 patients in the regorafenib group and 17 (22.4%) of 76 patients in the TAS-102 group. In terms of efficacy, the PFS and OS were similar in both treatment groups for primary and secondary treatments. AEs reported in this analysis were mostly consistent with the known safety profiles of regorafenib and TAS-102 in previous clinical trials.

Conclusion

The present study is the first one to compare the activity of the two agents in a large cohort of chemo-refractory mCRC patients providing more details about the best sequence, to be incorporated in clinical practice.

中文翻译：

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Regorafenib 与 TAS-102 在化疗难治性转移性结直肠癌 (mCRC) 患者中的疗效和安全性的回顾性研究：多机构真实生活临床数据

介绍

在过去几年中，结直肠癌 (CRC) 研究取得了重大进展，新药物的引入延长了转移性结直肠癌 (mCRC) 的中位总生存期。这些疗法改善了患者的预后；然而，尽管癌症治疗策略取得了重大进展，但它们的使用受到耐药机制的发展的限制。几乎 30% 的难治性 mCRC 患者仍将是进一步治疗的良好候选者。Regorafenib 和 TAS-102 是用于难治性 mCRC 患者的新型抗肿瘤药物。然而，目前尚不清楚哪些患者可以在现实生活中的临床实践中从这些药物中获得生存益处。

方法

我们在 2018 年 1 月 1 日至 2020 年 5 月 31 日期间在 3 个不同的中心进行了一项回顾性分析，评估 TAS-102 和 regorafenib 在难治性 mCRC 患者队列中的安全性和有效性，目的是评估这两种药物的最佳顺序治疗。

结果

分析中包括 140 名 mCRC 患者。在这些患者中，64 名接受瑞戈非尼治疗，76 名接受 TAS-102 作为首次治疗。进展后，在瑞格非尼组中，24 名（37%）患者转为使用 TAS-102 进行二级治疗，而在 TAS-102 组中，76 名患者中，29 名（45%）名患者转为使用瑞格非尼进行二级治疗。瑞戈非尼组 64 名患者中的 8 名（12.5%）和 TAS-102 组 76 名患者中的 17 名（22.4%）实现了疾病控制。在疗效方面，两个治疗组的初级和次级治疗的 PFS 和 OS 相似。该分析中报告的 AE 大多与先前临床试验中已知的瑞戈非尼和 TAS-102 的安全性概况一致。

结论

本研究是第一个比较这两种药物在一大群化疗难治性 mCRC 患者中的活性的研究，提供了有关最佳序列的更多详细信息，以纳入临床实践。