摘要
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.
Abstract
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.
基金项目
吴阶平基金(320.6750.2020-01-14)
NETL
NSTL
万方数据