新辅助全身治疗在可切除肝细胞癌中的疗效与安全性：一项系统评价与荟萃分析
Efficacy and safety of neoadjuvant systemic therapy in resectable hepatocellular carcinoma: a Systematic Review and meta-analysis.
作者信息
Wu Dongdong, Liu Ning, Dong Hao, Zhou Kan, Du Lei, Li Ying, Chao Yanjun, Ma Fuping
机构信息
Department of Hepatobiliary Surgery, Xianyang Central Hospital, Xianyang, Shaanxi, China.
出版信息
Front Oncol. 2025 May 9;15:1504917. doi: 10.3389/fonc.2025.1504917. eCollection 2025.
BACKGROUND
Neoadjuvant systemic therapy has been shown to benefit patients with solid tumors such as breast cancer and colorectal cancer, but its application in hepatocellular carcinoma (HCC) is still in the exploratory stage, with no established effective regimen. This systematic review and meta-analysis aims to investigate the efficacy and safety of neoadjuvant systemic therapy in patients with resectable HCC.
METHODS
The clinical trials of resectable HCC neoadjuvant systemic therapy in PubMed, Embase and the Cochrane Library were systematically searched. A meta-analysis was performed using STATA/MP18.0 software, and the effect size was calculated using either a fixed effects model or a random effects model, and 95% confidence intervals (CIs) were calculated. Subgroup analysis was performed according to the neoadjuvant systemic therapy regimen.
RESULTS
This meta-analysis included 328 patients from 15 studies. In patients with resectable HCC, the pooled pathologic complete response (pCR) rate was 15% (95%CI: 10%-21%), the major pathologic response (MPR) rate was 28% (95%CI: 21%-35%), the incidence of grade 3-4 treatment-related adverse events (TRAEs) was 11% (95% CI: 4%-20%), the objective response rate (ORR) was 27% (95% CI: 20%-35%), the surgical resection rate was 84% (95%CI: 75%-92%), and the delay rate was 0.00% (95% CI: 0%-4%). The results of subgroup analysis showed that the efficacy of targeted therapy combined with immunotherapy is superior to dual ICI (immune checkpoint inhibitor) combination therapy and ICI monotherapy, while the safety of the ICI monotherapy was the highest, superior to the dual ICIs and the targeted therapy combined with immunotherapy.
CONCLUSION
Neoadjuvant systemic therapy shows preliminarily beneficial outcomes in resectable HCC treatment. However, future large-scale and multicenter randomized controlled trials are needed to confirm this conclusion.
SYSTEMATIC REVIEW REGISTRATION
https://www.crd.york.ac.uk/prospero/, identifier CRD42024562257.
背景
新辅助全身治疗已被证明对乳腺癌和结直肠癌等实体瘤患者有益，但其在肝细胞癌（HCC）中的应用仍处于探索阶段，尚未建立有效的治疗方案。本系统评价和荟萃分析旨在探讨新辅助全身治疗对可切除HCC患者的疗效和安全性。
方法
系统检索了PubMed、Embase和Cochrane图书馆中关于可切除HCC新辅助全身治疗的临床试验。使用STATA/MP18.0软件进行荟萃分析，采用固定效应模型或随机效应模型计算效应量，并计算95%置信区间（CI）。根据新辅助全身治疗方案进行亚组分析。
结果
本荟萃分析纳入了15项研究中的328例患者。在可切除HCC患者中，汇总的病理完全缓解（pCR）率为15%（95%CI：10%-21%），主要病理缓解（MPR）率为28%（95%CI：21%-35%），3-4级治疗相关不良事件（TRAEs）的发生率为11%（95%CI：4%-20%），客观缓解率（ORR）为27%（95%CI：20%-35%），手术切除率为84%（95%CI：75%-92%），延迟率为0.00%（95%CI：0%-4%）。亚组分析结果显示，靶向治疗联合免疫治疗的疗效优于双免疫检查点抑制剂（ICI）联合治疗和ICI单药治疗，而ICI单药治疗的安全性最高，优于双ICI和靶向治疗联合免疫治疗。
结论
新辅助全身治疗在可切除HCC治疗中显示出初步的有益结果。然而，未来需要大规模多中心随机对照试验来证实这一结论。
系统评价注册
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