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中国癌症防治杂志

中国癌症防治杂志 ›› 2022, Vol. 14 ›› Issue (5): 521-528.doi: 10.3969/j.issn.1674?5671.2022.05.08

• 临床研究 • 上一篇    下一篇

Regorafenib联合PD⁃1抑制剂在晚期微卫星稳定型结直肠癌中的疗效和安全性

  

  1. 武汉大学人民医院肿瘤中心
  • 出版日期:2022-10-25 发布日期:2022-11-09
  • 通讯作者: 陈永顺 E-mail：cyszlsk@163.com
  • 基金资助:
    湖北省中央引导地方科技发展专项项目（ZYYD2020000169）

Efficacy and safety of Regorafenib combined with PD⁃1 inhibitors in advanced microsatellite stable colorectal carcinoma

  • Online:2022-10-25 Published:2022-11-09

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摘要： 目的 评估瑞戈非尼（Regorafenib）联合PD-1抑制剂三线及以上治疗晚期微卫星稳定（microsatellite stable，MSS）型结直肠癌（colorectal cancer，CRC）的疗效和安全性。方法 选择2019年1月至2022年3月在武汉大学人民医院肿瘤中心接受Regorafenib联合PD-1抑制剂或Regorafenib单药三线及以上治疗的22例晚期MSS型CRC患者为研究对象，其中联合治疗组10例，Regorafenib单药组12例。比较两组的无疾病进展生存期（progression-free survival，PFS）、总生存期（overall survival，OS）、客观缓解率（objective response rate，ORR）、疾病控制率（disease control rate，DCR）及不良反应发生情况。结果 Kaplan-Meier生存分析显示，联合治疗组和单药组中位OS差异无统计学意义（6.10个月 vs 6.13个月，P=0.827）；但联合治疗组的中位PFS优于单药组（4.00个月 vs 1.63个月，P=0.025）。相比单药组，联合治疗组在DCR（70.0% vs 25.0%，P=0.084）表现出优势，但差异无统计学意义。两组均未出现4级及以上不良反应，联合治疗组和单药组不良反应总发生率（100.0% vs 91.7%）以及≥3级不良反应发生率（30.0% vs 25.0%）比较差异均无统计学意义（均P>0.05）。结论 相比于Regorafenib单药治疗，Regorafenib联合PD-1抑制剂作为晚期MSS型CRC三线及以上治疗方案可能在PFS方面带来获益，值得进一步开展临床试验研究。 

关键词: 结直肠癌, Regorafenib, PD-1抑制剂, 微卫星稳定型, 疗效, 安全性

Abstract: Objective To evaluate the efficacy and safety of Regorafenib combined with PD?1 inhibitors for the third?line or above treatment of advanced microsatellite stable (MSS) colorectal cancer (CRC). Methods A total of 22 patients with advanced MSS CRC, who received Regorafenib combined with PD?1 inhibitors or Regorafenib monotherapy for third?line or above treatment in Renmin Hospital of Wuhan University from January 2019 to March 2022, were selected as the research objects, including 10 patients in the combination therapy group and 12 patients in the Regorafenib monotherapy group. The progression?free survival (PFS), overall survival (OS), objective response rate (ORR), disease control rate (DCR) and incidence of adverse events (AEs) were compared between the two groups. Results Kaplan?Meier survival analysis showed that there was no significant difference in median OS between the combination therapy group and the monotherapy group (6.10 months vs 6.13 months, P=0.827). However, the combination therapy group had better median PFS than the monotherapy group (4.00 months vs 1.63 months, P=0.025), and the DCR in combination therapy group were also better than the monotherapy group, though there was no statistical significance (70.0% vs 25.0%, P=0.084). No grade 4 or higher AEs were observed in either group. The overall incidence of AEs (100.0% vs 91.7%) and the incidence of grade ≥3 AEs (30.0% vs 25.0%) were not statistically different between the combination therapy group and the monotherapy group (all P>0.05). Conclusions  Compared with Regorafenib monotherapy, Regorafenib combined with PD?1 inhibitors as the third?line or above treatment regimen for advanced MSS CRC may bring benefits for PFS, and it is worthy of further clinical trials.

Key words: Colorectal cancer, Regorafenib, PD-1 inhibitors, Microsatellite stable, Efficacy, Safety

中图分类号: 

  • R735.3+5