信迪利单抗联合多西他赛二线治疗晚期胃癌的疗效

Clinical study of sindilimab combined with docetaxel for second⁃line treatment of advanced gastric cancer

目的探讨信迪利单抗联合多西他赛二线治疗晚期胃癌的疗效及安全性。方法选取2020年7月-2022年7月一线方案(铂类联合氟尿嘧啶类)治疗失败的晚期胃癌患者23例,给予信迪利单抗联合多西他赛治疗。主要终点为无进展生存期(PFS),次要终点为总生存期(OS)、疾病控制率(DCR)、客观缓解率(ORR)及不良反应。结果23例患者中部分缓解6例,疾病稳定13例,疾病进展4例,ORR为26.1%,DCR为82.6%。中位PFS为4.5个月,中位OS为9.8个月。Cox多因素分析显示,腹膜转移(HR=0.067,95%CI:0.006~0.696,P=0.024)是影响OS的独立危险因素。治疗相关的不良反应多为1~2级,常见不良反应为白细胞减少、中性粒细胞减少、血小板减少、贫血、恶心、呕吐、脱发、外周神经毒性、肝功能异常、甲状腺功能减退。结论信迪利单抗联合多西他赛二线治疗晚期胃癌患者有明显获益,安全性良好。

Objective To investigate the efficacy and safety of sindilimab combined with docetaxel as second⁃line treatment of advanced gastric cancer.Methods From July 2020 to July 2022,23 patients with advanced gastric cancer who failed to first⁃line chemotherapy(platinum combined with fluorouracil)were treated with sindilimab combined with docetaxel.The primary endpoint was progression free survival(PFS),and secondary endpoints were overall survival(OS),disease control rate(DCR),objective response rate(ORR),and adverse reactions.Results A total of 23 patients were evaluated.Among them,6 cases were partial response,13 patients with stable disease,4 patients with progressive disease;the ORR was 26.1%and the DCR was 82.6%.The median PFS was 4.5 months.The median OS was 9.8 months.Cox multivariate analysis showed that peritoneal metastasis(HR=0.067,95%CI:0.006-0.696,P=0.024)was an independent risk factor for OS.The common adverse reactions were leukopenia,neutropenia,thrombocytopenia,anemia,nausea,vomiting,alopecia,peripheral neurotoxicity,abnormal liver function,and hypothyroidism.However most of these adverse events were grade 1 or 2.Conclusion Sindilimab combined with docetaxel for second⁃line treatment of advanced gastric cancer was safe and effective,and it should be worthy of clinical promotion.