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树突状细胞疫苗治疗胶质母细胞瘤:一项更新的 meta 分析和试验序贯分析

英文原题:Dendritic cell vaccine for glioblastoma: an updated meta-analysis and trial sequential analysis.

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Dendritic cell vaccine for glioblastoma: an updated meta-analysis and trial sequential analysis.

PubMed 2024/08/21(内容时间) J Neurooncol Q2 · IF 3.4(JCR 2025)

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研究概要

这项更新的 meta 分析纳入了首个针对胶质母细胞瘤的 DC 疫苗 III 期试验,显示 DC 疫苗与 OS 改善相关。此外,TSA 显示所需样本量已达到,表明结果为真阳性。未来仍需针对新诊断和复发胶质母细胞瘤患者亚组开展研究。

研究思路结论见上方概要

树突状细胞(DC)疫苗是一种新兴的免疫疗法,可能改善胶质母细胞瘤的生存。首个DC疫苗的III期临床试验最近已发表。本meta分析旨在更新并重新评估DC疫苗在胶质母细胞瘤患者中疗效的现有证据。

我们检索了PubMed、Embase和Cochrane Library中关于DC疫苗治疗胶质母细胞瘤的临床试验。使用RoB 2.0和ROBINS-I工具评估研究质量。总生存期(OS)和无进展生存期(PFS)的结果使用风险比(HR)及相应的95%置信区间(CI)进行合并。汇总效应采用随机效应模型评估。进行了试验序贯分析(TSA)。

纳入7项临床试验,共3,619例患者。DC疫苗联合标准治疗与OS显著改善相关(HR = 0.71;95% CI,0.57 - 0.88)和PFS显著改善相关(HR = 0.65;95% CI,0.43 - 0.98)。在新诊断胶质母细胞瘤亚组中,DC疫苗与PFS改善相关(HR = 0.59;95% CI,0.39 - 0.90)。OS的TSA显示,DC疫苗的累积z评分线越过了获益边界并达到了所需样本量。PFS的TSA和新诊断胶质母细胞瘤的亚组分析显示未达到所需样本量。

展开英文摘要原文

Dendritic cell (DC) vaccine is an emerging immunotherapy that could potentially improve glioblastoma survival. The first phase III clinical trial of DC vaccine was recently published. This meta-analysis aims to update and reappraise existing evidence on the efficacy of DC vaccine in patients with glioblastoma.

We searched PubMed, Embase, and Cochrane Library for clinical trials of DC vaccine for glioblastoma. The quality of the studies was assessed using the RoB 2.0 and ROBINS-I tools. The results of overall survival (OS) and progression-free survival (PFS) were pooled using hazard ratios (HRs) with corresponding 95% confidence intervals (CI). Summary effects were evaluated using random effects models. Trial sequential analysis (TSA) was performed.

Seven clinical trials involving 3,619 patients were included. DC vaccine plus standard care was associated with significantly improved OS (HR = 0.71; 95% CI, 0.57 - 0.88) and PFS (HR = 0.65; 95% CI, 0.43 - 0.98). In the subgroup of newly diagnosed glioblastoma, DC vaccine was associated with improved PFS (HR = 0.59; 95% CI, 0.39 - 0.90). TSA of OS showed that the cumulative z-score line for the DC vaccine crossed the benefit boundary and reached the required sample size. TSA of PFS and subgroup analysis of newly diagnosed glioblastoma showed that the required sample size was not reached.

This updated meta-analysis, which included the first phase III trial of a DC vaccine for glioblastoma, demonstrated that the DC vaccine was associated with improved OS. Moreover, TSA showed that the required sample size was reached, indicating a true-positive result. Future studies are required for patient subgroups with newly diagnosed and recurrent glioblastoma.

论文信息

作者
Wong CE、Chang Y、Chen PW、Huang YT、Chang YC、Chiang CH、Wang LC、Lee PH
第一作者单位
Department of Neurosurgery, Department of Surgery, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.Taiwan
通讯作者单位
Department of Neurosurgery, Department of Surgery, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan. nslee1218@gmail.com.Taiwan
文献类型
荟萃分析 · 系统综述
期刊
Journal of neuro-oncology2024 Nov
原文标识
PubMed 39167243 · DOI 10.1007/s11060-024-04798-w