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[晚期胃癌免疫治疗再挑战的临床分析]

[Clinical analysis of immunotherapy rechallenge in advanced gastric cancer].

作者信息

Zhang X X, Yang X F, Li S, Wu C, Hou X F

机构信息

Department of Gastroenterology, The Affiliated Cancer Hospital of Zhengzhou University, Cancer Hospital of Henan Province, Zhengzhou 450008, China.

出版信息

Zhonghua Zhong Liu Za Zhi. 2023 Jul 23;45(7):605-612. doi: 10.3760/cma.j.cn112152-20220418-00261.

Abstract

To evaluate the efficacy and influencing factors of programmed death protein 1 (PD-1) monoclonal antibody rechallenge therapy in advanced gastric cancer (GC). The clinical data of patients with advanced GC who were treated with anti-PD-1 rechallenge in Henan Cancer Hospital from January 2020 to December 2021 were collected retrospectively. The progression-free survival (PFS) was defined as the time from the first or second used of anti-PD-1 treatment to the date of disease progression or the last follow-up, named PFS(1) and PFS(2), respectively. Kaplan-Meier method and Log rank test were used for survival analysis, Cox proportional hazard model was used to analyze the influencing factors. A total of 60 patients with anti-PD-1 rechallenge therapy were collected, the median follow-up time was 12.2 months. The median progression-free survival (PFS(2)) of anti-PD-1 rechallenge therapy was 2.9 months, the objective response rate (ORR) was 16.7%, and the disease control rate (DCR) was 55.0%. The median PFS(2) of the first and second anti-PD-1 identical and different rechallenge treatment was 3.5 months and 1.9 months (=0.007) respectively. The median PFS(2) of positive PD-L1 expression in rechallenge therapy was 3.4 months, ORR was 22.7%, and DCR was 63.6%; the median PFS(2) was 4.5 months, ORR was 27.3%, and DCR was 54.5% in patients with median PFS(1)≥6 months. Multivariate analysis showed that peritoneal metastasis was independently associated with anti-PD-1 rechallenge therapy with PFS(2) (=2.327, 95% 1.066-5.082, =0.034). The incidence of adverse reactions in grade 1-2 and grade 3-4 of anti-PD-1 rechallenge therapy was 83.3%, and 35.0%, respectively, and the safety was controllable. Rechallenge therapy with anti-PD-1 is a feasible treatment in advanced GC, but the screening of suitable population for rechallenge therapy still needs prospective data analysis and verification.

摘要

评估程序性死亡蛋白1(PD-1)单克隆抗体再挑战疗法在晚期胃癌(GC)中的疗效及影响因素。回顾性收集2020年1月至2021年12月在河南省肿瘤医院接受抗PD-1再挑战治疗的晚期GC患者的临床资料。无进展生存期(PFS)定义为从首次或第二次使用抗PD-1治疗至疾病进展日期或最后一次随访的时间,分别命名为PFS(1)和PFS(2)。采用Kaplan-Meier法和Log rank检验进行生存分析,采用Cox比例风险模型分析影响因素。共收集60例接受抗PD-1再挑战治疗的患者,中位随访时间为12.2个月。抗PD-1再挑战治疗的中位无进展生存期(PFS(2))为2.9个月,客观缓解率(ORR)为16.7%,疾病控制率(DCR)为55.0%。首次和第二次抗PD-1相同及不同再挑战治疗的中位PFS(2)分别为3.5个月和1.9个月(P=0.007)。再挑战治疗中PD-L1表达阳性患者的中位PFS(2)为3.4个月,ORR为22.7%,DCR为63.6%;PFS(1)≥6个月患者的中位PFS(2)为4.5个月,ORR为27.3%,DCR为54.5%。多因素分析显示,腹膜转移与抗PD-1再挑战治疗的PFS(2)独立相关(P=2.327,95%CI 1.066-5.082,P=0.034)。抗PD-1再挑战治疗1-2级和3-4级不良反应发生率分别为83.3%和35.0%,安全性可控。抗PD-1再挑战治疗在晚期GC中是一种可行的治疗方法,但仍需前瞻性数据分析和验证来筛选合适的再挑战治疗人群。

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