机构地区:[1]川北医学院附属医院肿瘤科,四川南充637000 [2]川北医学院医学影像学院,四川南充637000
出 处:《川北医学院学报》2025年第2期200-205,共6页Journal of North Sichuan Medical College
基 金:四川省卫生和计划生育委员会项目(19PJ037);医学影像四川省重点实验室开放课题项目(MIKLSP202107);川北医学院附属医院科研项目(2022ZD004)。
摘 要:目的:探索经PD-1/PD-L1抑制剂治疗的进展期胃癌患者的免疫相关不良反应(irAEs)的特征及影响因素;分析与预后相关的临床特征。方法:回顾性分析60例进展期胃癌患者的临床资料,根据有无irAEs发生,分为irAEs组(n=32)和非irAEs组(n=28)。通过常见不良事件评价标准(CTCAE 5.0)评估免疫治疗相关不良反应;通过实体瘤疗效评价标准(RECIST 1.1)评估近期疗效;用总生存期(OS)、无进展生存期(PFS)评估远期疗效。分析影响irAEs发生的相关因素;评估临床特征对预后的影响;分析影响患者预后的临床特征。结果:irAEs组患者Ki-67指数高于非irAEs组,胃蛋白酶原Ⅱ低于非irAEs组(P<0.05)。多因素Logistic回归分析显示,Ki-67指数是irAEs发生的危险因素(P<0.05)。两组患者治疗效果无统计学差异(P>0.05)。预后分析显示:TNM分期Ⅲ患者OS、PFS均高于Ⅳ期患者(P<0.05);HER-2为阳性患者中位PFS高于阴性表达患者(P<0.05)。进一步Cox比例风险分析发现,TNM分期、HER-2的表达情况是影响患者PFS的独立危险因素(P<0.05)。结论:PD-1/PD-L1抑制剂治疗进展期胃癌的irAEs发生率较高,但大多数为低级别irAEs,安全性较高,Ki-67指数是irAEs发生的独立危险因素,TNM分期Ⅲ期患者较Ⅳ期患者的OS及PFS更长,HER-2表达阳性患者PFS更长。Objective:To explore the characteristics and influencing factors of immune-related adverse events(irAEs)in advanced gastric cancer patients treated with PD-1/PD-L1 inhibitors,analyse clinical features associated with prognosis.Methods:A retrospective analysis was conducted on the clinical data of 60 patients with advanced gastric cancer.Based on the occurrence of irAEs,the patients were divided into an irAEs group(n=32)and a non-irAEs group(n=28).Immune-related adverse reactions were assessed using the Common Terminology Criteria for Adverse Events(CTCAE 5.0).Short-term efficacy was evaluated using the Response Evaluation Criteria in Solid Tumors(RECIST 1.1).Long-term efficacy was assessed using overall survival(OS)and progression-free survival(PFS).A multivariate Logistic regression model was employed to analyze the factors influencing the occurrence of irAEs.The Kaplan-Meier survival curve was used to evaluate the impact of clinical characteristics on prognosis,and the Cox proportional hazards model was used to analyze the clinical characteristics affecting patient prognosis.Results:The Ki-67 index in the irAEs group was higher than that in the non irAEs group,and the pepsinogenⅡlevel was lower than that in the non irAEs group(P<0.05).Multivariate Logistic regression analysis showed that the Ki-67 index was a risk factor for the occurrence of irAEs(P<0.05).There was no statistically significant difference in treatment efficacy between the two groups of patients(P>0.05).Prognostic analysis showed that OS and PFS in TNM stageⅢpatients were higher than those in stage IV patients(P<0.05),the median PFS of HER-2 positive patients was higher than that of negative expression patients(P<0.05).Cox regression analysis indicated that TNM staging and HER-2 expression were independent risk factors for PFS in patients(P<0.05).Conclusion:The incidence of irAEs in the treatment of advanced gastric cancer with PD-1/PD-L1 inhibitors is relatively high,but most irAEs are low-grade,indicating a high level of safety.The Ki-67 i
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