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  

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

作　　者：罗茜茜 陈佳梅 石薇[1] 陈永顺[1] LUO Xixi;CHEN Jiamei;SHI Wei;CHEN Yongshun(Center of Oncology,Renmin Hospital of Wuhan University,Wuhan 430060,China)

机构地区：[1]武汉大学人民医院肿瘤中心,武汉430060

出　　处：《中国癌症防治杂志》2022年第5期521-528,共8页CHINESE JOURNAL OF ONCOLOGY PREVENTION AND TREATMENT

基　　金：湖北省中央引导地方科技发展专项项目(ZYYD2020000169)。

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。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.

关 键 词：结直肠癌 REGORAFENIB PD-1抑制剂 微卫星稳定型 疗效 安全性 

分 类 号：R735.35[医药卫生—肿瘤] R735.37[医药卫生—临床医学]