瑞戈非尼单药或联合PD-1抑制剂治疗MSS/pMMR型转移性结直肠癌的疗效和安全性对比

Efficacy and safety of regorafenib monotherapy versus regorafenib plus PD-1 inhibitors in the treatment of MSS/pMMR metastatic colorectal cancer

目的:探讨瑞戈非尼联合PD-1抑制剂三线及以上治疗微卫星稳定/无错配修复缺陷型(MSS/pMMR型)转移性结直肠癌的疗效和安全性。方法:收集2018年4月至2022年11月在郑州大学第一附属医院肿瘤内科就诊并接受瑞戈非尼治疗(n=52,单药组)或瑞戈非尼联合PD-1抑制剂治疗(n=64,联合组)的MSS/pMMR型转移性结直肠癌患者的资料,比较2组疗效及不良反应。结果:单药组的客观缓解率和疾病控制率分别为3.8%和69.2%,无疾病进展期和总生存期(T_(75),T_(25))分别为3.9(2.1,6.3)个月和16.7(9.1,36.6)个月,联合组以上指标分别为4.7%和70.3%,3.0(1.9,7.0)个月和14.6(6.2,26.7)个月,2组间以上指标差异均无统计学意义(P>0.05)。联合组甲状腺功能减退和心肌酶增高的发生率(15.6%和21.9%)均高于单药组(0.0%和5.8%,P<0.05)。结论:瑞戈非尼联合PD-1抑制剂三线及以上治疗MSS/pMMR型转移性结直肠癌的效果与瑞戈非尼单药治疗效果类似,且增加了部分不良反应。

Aim:To investigate the efficacy and safety of regorafenib alone or in combination with PD-1 inhibitors in the at least third-line treatment of microsatellite stable/proficient mismatch repair(MSS/pMMR)metastatic colorectal cancer.Methods:Clinical data of patients with MSS/pMMR metastatic colorectal cancer who received regorafenib(n=52,the monotherapy group)or regorafenib plus PD-1 inhibitors(n=64,the combined group)as the third-line treatment or beyond in the First Affiliated Hospital of Zhengzhou University from April 2018 to November 2022.Clinical efficacy and adverse reactions between the 2 groups were compared.Results:In the monotherapy group,the objective response rate and disease control rate were 3.8%and 69.2%,the median progression-free survival(T_(75),T_(25))and the median overall survival(T_(75),T_(25))were 3.9(2.1,6.3)and 16.7(9.1,36.6)months,respectively,the above indexes in the combined group were 4.7%,70.3%,3.0(1.9,7.0)months and 14.6(6.2,26.7)months,respectively,and there were no statistical differences between the 2 groups(P>0.05).The incidences of hypothyroidism and increased myocardial enzymes(15.6%,21.9%)in the combined group were significantly higher than those of the monotherapy group(0.0%,5.8%,P<0.05).Conclusion:Regorafenib plus PD-1 inhibitors are not superior to regorafenib monotherapy in the at least third-line treatment of MSS/pMMR metastatic colorectal cancer,and increase some adverse reactions.