1.大连理工大学附属肿瘤医院/辽宁省肿瘤医院药学部,沈阳 110042
2.沈阳药科大学生命科学与生物制药学院,沈阳 110016
Received:24 September 2025,
Revised:2026-01-27,
Accepted:28 January 2026,
Published:15 February 2026
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柯力援,王艳,王安平,等.ICIs一线治疗晚期胃癌有效性及安全性的网状Meta分析[J].中国药房,2026,37(03):383-388.
KE Liyuan,WANG Yan,WANG Anping,et al.Network meta-analysis of the efficacy and safety of immune checkpoint inhibitors in first-line treatment of advanced gastric cancer[J].ZHONGGUO YAOFANG,2026,37(03):383-388.
柯力援,王艳,王安平,等.ICIs一线治疗晚期胃癌有效性及安全性的网状Meta分析[J].中国药房,2026,37(03):383-388. DOI: 10.6039/j.issn.1001-0408.2026.03.19.
KE Liyuan,WANG Yan,WANG Anping,et al.Network meta-analysis of the efficacy and safety of immune checkpoint inhibitors in first-line treatment of advanced gastric cancer[J].ZHONGGUO YAOFANG,2026,37(03):383-388. DOI: 10.6039/j.issn.1001-0408.2026.03.19.
目的
2
评价免疫检查点抑制剂(ICIs)一线治疗晚期胃癌的有效性及安全性。
方法
2
检索PubMed、Web of Science、Embase、The Cochrane Library、万方数据、中国知网、维普网,收集ICIs一线治疗晚期胃癌的Ⅲ期临床随机对照试验(RCT)及相关肿瘤学术年会的会议摘要,检索时限为建库起至2025年6月1日。筛选文献、提取数据、评价文献质量后,采用R语言软件4.3.2版进行网状Meta分析。
结果
2
共纳入8项研究,共计7 801例患者。网状Meta分析结果显示,在有效性方面,与化疗(Chemo)比较,SHR-1701_Chemo、卡度尼利单抗+化疗(Cadoni_Chemo)、信迪利单抗+化疗、帕博利珠单抗+化疗和替雷利珠单抗+化疗均能显著延长患者的中位总生存期(OS)和中位无进展生存期(PFS)(
P
<0.05);而纳武利尤单抗+化疗仅显著延长了患者的中位PFS(
P
<0.05)。累积排名曲线下面积(SUCRA)结果显示,中位OS排名前2位的干预措施为SHR-1701_Chemo和Cadoni_Chemo;中位PFS排名前2位的干预措施为Cadoni_Chemo和SHR-1701_Chemo。对于程序性死亡受体配体1(PD-L1)综合阳性评分(CPS)≥5分患者,Cadoni_Chemo和SHR-1701_Chemo同样展现出最优的OS和PFS获益(
P
<0.05)。在安全性方面,各干预措施的任意不良事件(AEs)发生率及≥3级AEs发生率比较,差异均无统计学意义(
P
>0.05)。任意AEs发生率SUCRA排名前2位的为SHR-1701_Chemo和Chemo;≥3级AEs发生率SUCRA排名前2位的为Chemo和舒格利单抗+化疗。
结论
2
对于晚期胃癌患者, Cadoni_Chemo和SHR-1701_Chemo展现出最佳的OS和PFS获益,且在PD-L1 CPS≥5分的患者中优势依然明确;在安全性方面,Chemo引起的任意AEs及≥3级AEs的发生风险相对较低。
OBJECTIVE
2
To evaluate the efficacy and safety of immune checkpoint inhibitors (ICIs) as first-line therapy for advanced gastric cancer.
METHODS
2
PubMed, Web of Science, Embase, The Cochrane Library, Wanfang Data, CNKI, and VIP databases were searched to collect phase Ⅲ clinical randomized controlled trials (RCTs) on ICIs as first-line therapy for advanced gastric cancer, as well as abstracts from relevant oncology academic conferences. The search period spanned from database inception to June 1, 2025. After screening literature, extracting data, and assessing quality, a network meta-analysis was performed using R software version 4.3.2.
RESULTS
2
A total of 8 studies involving 7 801 patients were included. Network meta-analysis results showed that, in terms of efficacy, compared with chemotherapy (Chemo), SHR-1701_Chemo, Cadonilimab_Chemo, Sintilimab_Chemo, Pembrolizumab_Chemo, and Tislelizumab_Chemo significantly prolonged median overall survival (OS) and median progression free survival (PFS) in patients (
P
<0.05); whereas Nivolumab_Chemo only significantly improved median PFS (
P
<0.05). Surface under the cumulative ranking curve (SUCRA) results indicated that the top 2 interventions for median OS were SHR-1701_Chemo and Cadonilimab_Chemo; for PFS, the top 2 were Cadonilimab_Chemo and SHR-1701_Chemo. For patients with combined positive score (CPS) ≥5 points for programmed death-ligand 1 (PD-L1), Cadonilimab_Chemo and SHR-1701_Chemo also demonstrated the optimal OS and PFS benefits (
P
<0.05). Regarding safety, there were no statistically significant differences among the interventions in the incidence of any adverse events (AEs) or grade ≥3 AEs (
P
>0.05). T
he SUCRA ranking for the incidence of any AEs showed the top 2 were SHR-1701_Chemo and Chemo; for grade ≥3 AEs, the top 2 were Chemo and Sugemalimab_Chemo.
CONCLUSIONS
2
For patients with advanced gastric cancer, Cadonilimab_Chemo and SHR-1701_Chemo demonstrate the best benefits in terms of OS and PFS, with their advantages remaining clear in patients with PD-L1 CPS≥5 points. In terms of safety, the risk of developing any AEs and grade ≥3 AEs is relatively lowest with Chemo.
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