Department of Neurosurgery, Department of Surgery, College of Medicine, National Cheng Kung University Hospital, National Cheng Kung University, Tainan, Taiwan.
Department of Cell Biology and Anatomy, College of Medicine, National Cheng Kung University, Tainan, Taiwan.
J Neurooncol. 2024 Nov;170(2):253-263. doi: 10.1007/s11060-024-04798-w. Epub 2024 Aug 21.
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.
树突状细胞（DC）疫苗是一种新兴的免疫疗法，有可能改善胶质母细胞瘤患者的生存。最近发表了首个 DC 疫苗的 III 期临床试验。本荟萃分析旨在更新和重新评估 DC 疫苗治疗胶质母细胞瘤患者的疗效的现有证据。
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。使用风险比（HR）及其相应的 95%置信区间（CI）汇总总生存期（OS）和无进展生存期（PFS）的结果。使用随机效应模型评估汇总效果。进行了试验序贯分析（TSA）。
纳入了 7 项临床试验，共 3619 名患者。与标准治疗相比，DC 疫苗联合治疗可显著改善 OS（HR=0.71；95%CI，0.57-0.88）和 PFS（HR=0.65；95%CI，0.43-0.98）。在新诊断的胶质母细胞瘤亚组中，DC 疫苗与改善的 PFS 相关（HR=0.59；95%CI，0.39-0.90）。OS 的 TSA 表明，DC 疫苗的累积 z 得分线穿过了获益边界并达到了所需的样本量。PFS 的 TSA 和新诊断的胶质母细胞瘤亚组分析表明，未达到所需的样本量。
这项更新的荟萃分析包括了首个 DC 疫苗治疗胶质母细胞瘤的 III 期临床试验，表明 DC 疫苗与 OS 改善相关。此外，TSA 表明达到了所需的样本量，表明这是一个真正的阳性结果。需要对新诊断和复发性胶质母细胞瘤的患者亚组进行进一步研究。
