信迪利单抗联合化疗治疗Ⅲ~Ⅳ期胃/胃食管结合部腺癌的疗效与安全性  

Efficacy and safety of sintilimab combined with chemotherapy in the treatment of stage Ⅲ to Ⅳ gastric/gastroesophageal junction adenocarcinoma

作　　者：胡雪阳[1] 李烦繁[2] 吴红阳[1] 戴映[1] 赵陈琛[1] 黄玮[1] 张从军[1] HU Xueyang;LI Fanfan;WU Hongyang;DAI Ying;ZHAO Chenchen;HUANG Wei;ZHANG Congjun(Department of Medical Oncology,the First Affiliated Hospital of Anhui Medical University,Hefei 230031,China;Oncology Center,the Second Affiliated Hospital of Anhui Medical University,Hefei 230031,China)

机构地区：[1]安徽医科大学第一附属医院肿瘤内科,合肥230031 [2]安徽医科大学第二附属医院肿瘤中心,合肥230031

出　　处：《临床药物治疗杂志》2024年第7期29-34,共6页Clinical Medication Journal

基　　金：国家自然科学基金(81402427);安徽省重点研究与开发计划(2022e07020038);安徽省自然科学基金(2008085QH424)。

摘　　要：目的探讨信迪利单抗联合化疗一线治疗Ⅲ~Ⅳ期胃/胃食管结合部腺癌的疗效和安全性。方法选取2020年7月至2023年12月安徽医科大学第一附属医院收治的Ⅲ~Ⅳ期胃/胃食管结合部腺癌患者,采用倾向性评分匹配(PSM)分析将接受信迪利单抗联合化疗者纳入治疗组,仅接受化疗者纳入对照组。比较两组治疗的有效性、总生存期(OS)和无进展生存期(PFS),以及安全性和耐受性。结果共纳入83例患者,中位随访时间为16.9个月,治疗组患者30例,对照组患者53例,PSM后两组均为30例。PSM后,治疗组PR比例高于对照组,临床疗效优于对照组,且ORR高于对照组,差异均有统计学意义(P<0.05)。治疗组中位PFS为8.5个月(95%CI:7.0~10.3),中位OS为16.5个月(95%CI:12.8~19.6);对照组中位PFS为6.5个月(95%CI:4.2~7.1),中位OS为13.8个月(95%CI:10.5~16.9),治疗组中位PFS和中位OS均长于对照组,差异有统计学意义(P<0.05)。两组治疗相关不良事件总发生率与3级以上不良事件发生率比较,差异均无统计学意义(P>0.05)。结论信迪利单抗联合化疗一线治疗提高了Ⅲ~Ⅳ期胃/胃食管结合部腺癌患者的PFS和OS,且具有良好的耐受性。Objective To investigate the efficacy and safety of sintilimab in combination with chemotherapy for the firstline treatment of stage Ⅲ to Ⅳ gastric/gastroesophageal junction adenocarcinoma.Methods Patients with stage Ⅲ to Ⅳ gastric/gastroesophageal junction adenocarcinoma admitted to the First Affiliated Hospital of Anhui Medical University from July 2020 to December 2023 were selected,and propensity score matching(PSM)analysis was used to include those who received sintilimab in combination with chemotherapy into the treatment group and those who received only chemotherapy into the control group.Treatment efficacy,overall survival(OS),and progression-free survival(PFS),as well as safety and tolerability were compared between the two groups.Results A total of 83 patients were included,with a median follow-up time of 16.9 months.30 patients were included in the treatment group and 53 in the control group,and 30 patients in both groups after PSM.After PSM,the PR ratio of the treatment group was higher than that of the control group,the clinical efficacy was better than that of the control group,and the ORR was higher than that of the control group with statistically significant differences(P<0.05).The median PFS and OS were 8.5(95%CI:7.0 to 10.3)months and 16.5(95%CI:12.8 to 19.6)months in the treatment group.The median PFS of the control group was 6.5(95%CI:4.2 to 7.1)months,and the median OS was 13.8(95%CI:10.5 to 16.9)months.The median PFS and median OS were longer in the treatment group than those in the control group,and the differences were statistically significant(P<0.05).For the total incidence of treatment-related adverse events and the incidence of grade 3 or higher adverse events,the differences between the two groups were not statistically significant(P>0.05).Conclusion First-line treatment with sintilimab combined with chemotherapy can improve PFS and OS in patients with stageⅢtoⅣgastric/gastroesophageal junction adenocarcinoma and it is well tolerated.

关 键 词：信迪利单抗 晚期胃癌 胃食管结合部腺癌 倾向性评分匹配分析 有效性 安全性 

分 类 号：R979.1[医药卫生—药品] R735.2[医药卫生—药学]