regorafenib-替氟尿苷/替吡嘧啶对比反向序贯方案治疗难治性转移性结直肠癌患者：一项多中心回顾性真实世界研究。

Regorafenib-to-trifluridine/tipiracil Versus the Reverse Sequence for Refractory Metastatic Colorectal Cancer Patients: A Multicenter Retrospective Real-life Experience.

机构信息

Medical Oncology Unit, Belcolle Hospital, ASL Viterbo, Viterbo, Italy;

Medical Oncology Unit, ASL Frosinone, Sora, Italy.

出版信息

Anticancer Res. 2021 May;41(5):2553-2561. doi: 10.21873/anticanres.15033.

DOI:10.21873/anticanres.15033

PMID:33952483

Abstract

BACKGROUND/AIM: Regorafenib (REG) and trifluridine/tipiracil (FTD/TPI) have have been shown to improve overall survival in patients with refractory metastatic colorectal cancer. The aim of our study was to evaluate the efficacy and safety profiles of these agents administered in sequence in real world practice.

PATIENTS AND METHODS

Clinical data of patients treated beyond the 2°line with REG or FTD/TPI between January 2016 and August 2020, were retrospectively collected from eight institutes in the Lazio Region.

RESULTS

We included 49 patients treated with both drug sequences. A total of 28 G3/G4 toxicity events (53.8%) were recorded in the FTD/TPI-to-REG sequence vs. 24 (46.1%) in the reverse sequence. Median overall survival for the patients included in the FTP/TPI-to-REG group was 20 months (95%CI=16.7-23.3) vs. 27 months in the reverse group (95%CI=17.8-36.2). The disease control rate was 45.0% for patients treated with the REG-to-FTD/TPI sequence vs. 24.1% in those treated with the FTD/TPI-to-REG sequence (p=0.18).

CONCLUSION

The sequence REG-to-FTD/TPI and vice versa can extend survival, whereas only REG-to-FTD/TPI stabilizes cancer growth.

摘要

背景/目的：regorafenib（REG）和三氟尿苷/盐酸替匹嘧啶（FTD/TPI）已被证明可改善转移性结直肠癌患者的总生存期。我们研究的目的是评估这两种药物在真实世界实践中序贯给药的疗效和安全性特征。

患者和方法

我们回顾性地收集了 2016 年 1 月至 2020 年 8 月期间，来自拉齐奥地区 8 家机构的接受 REG 或 FTD/TPI 二线以上治疗的患者的临床数据。

结果

我们纳入了 49 例接受这两种药物序贯治疗的患者。在 FTD/TPI-REG 序贯治疗中，共记录了 28 例 G3/G4 毒性事件（53.8%），而在反向序贯中则记录了 24 例（46.1%）。纳入 FTD/TPI-REG 组的患者中位总生存期为 20 个月（95%CI=16.7-23.3），而反向组为 27 个月（95%CI=17.8-36.2）。接受 REG-FTD/TPI 序贯治疗的患者疾病控制率为 45.0%，而接受 FTD/TPI-REG 序贯治疗的患者为 24.1%（p=0.18）。