基于真实世界分析信迪利单抗联合化学治疗方案治疗晚期胃癌的临床疗效及安全性

Clinical Efficacy and Safety of Combination Chemotherapy Regimen with Sintilimab in the Treatment of Advanced Gastric Cancer Based on Real-World Analysis

目的探讨真实世界信迪利单抗联合化学治疗(简称化疗)方案治疗晚期胃癌的临床疗效及安全性,以及预后影响因素。方法回顾性分析医院2019年6月至2022年5月接受信迪利单抗联合化疗治疗的晚期胃癌患者的临床资料,采用Kaplan-Meier法和Log-rank检验进行生存分析,COX回归模型分析无进展生存期(PFS)的影响因素,并统计不良反应发生情况。结果82例患者的中位PFS为5.5个月,一线联合治疗中位PFS为7.27个月,显著优于二线联合治疗的5.37个月和后线联合治疗的3.00个月(P<0.001)。一线联合治疗的客观缓解率为23.08%,显著高于二线联合治疗的6.90%和后线联合治疗的0(P<0.05)。多因素分析结果显示,腹膜转移和治疗线数是影响PFS的独立因素。最常见的3-4级不良反应为白细胞减少(10.98%)、血小板减少(6.10%)和恶心呕吐(6.10%),与免疫相关的3-4级不良反应主要有甲状腺功能异常(2.44%)和免疫性肺炎(3.66%)。结论信迪利单抗联合化疗方案可延长晚期胃癌患者的生存期,且不良反应可耐受。

Objective To investigate the efficacy and safety of the combination chemotherapy regimen with sintilimab in the treatment of advanced gastric cancer in the real world,and to investigate the prognostic factors.Methods The clinical data of patients with advanced gastric cancer treated with combination chemotherapy regimen with sintilimab in the hospital from June 2019 to May 2022 were retrospectively analyzed.The Kaplan-Meier method and Log-rank test was used for survival analysis,the COX proportional hazards regression model was used for the influencing factors of progression-free survival(PFS),and the incidence of adverse reactions was counted.Results The median PFS of 82 patients was 5.5 months,while the median PFS of first-line combination therapy was 7.27 months,which was significantly better than the 5.37 months of second-line combination therapy and the 3.00 months of later-line combination therapy(P<0.001).The objective response rate(ORR)of first-line combination therapy was 23.08%,which was significantly higher than 6.90%of second-line combination therapy and 0 of the later-line combination therapy(P<0.05).The results of multivariate analysis showed that peritoneal metastasis and the treatment lines were independent factors affecting PFS.The most common grade 3-4 adverse reactions were leukopenia(10.98%)and thrombocytopenia(6.10%),while the immune-related grade 3-4 adverse reactions were mainly thyroid dysfunction(2.44%)and immune-related pneumonia(3.66%).Conclusion The combination chemotherapy regimen with sintilimab can prolong the survival period of patients with advanced gastric cancer,with tolerable adverse reactions.