■新辅助免疫疗法已在各种癌症类型中显示出有益的结果;然而,目前缺乏肝细胞癌(HCC)新辅助免疫治疗的标准化方案。本系统综述和荟萃分析旨在探讨新辅助免疫治疗在HCC中的疗效和安全性的可靠性。
■在PubMed(MEDLINE)进行了系统搜索,EMBASE,WebofScience,Cochrane图书馆,和会议程序,以确定涉及可切除的HCC和新辅助免疫疗法的临床试验。采用单臂荟萃分析计算比值比和95%置信区间(CI)。异质性分析,数据质量评估,进行了基于免疫治疗药物类型和联合治疗的亚组分析.该荟萃分析在PROSPERO中注册(标识符CRD42023474276)。
■这项荟萃分析包括来自11项研究的255名患者。在可切除的HCC患者中,新辅助免疫治疗的总体主要病理应答(MPR)率为0.47(95%CI0.31-0.70),病理完全缓解(pCR)率为0.22(95%CI0.14-0.36).总客观缓解率(ORR)为0.37(95%CI0.20-0.69),3-4级治疗相关不良事件(TRAE)发生率为0.35(95%CI0.24-0.51)。此外,联合手术切除率为3.08(95%CI1.66-5.72)。亚组分析显示不同单药免疫疗法的疗效和安全性无显著差异;双ICIs(免疫检查点抑制剂)联合治疗的疗效优于靶向联合免疫治疗和单药治疗,而在安全性方面则相反。
■新辅助免疫疗法在可切除的HCC的治疗中呈现有益的结果。然而,大规模,未来有必要进行高质量的实验,以提供可靠的数据支持。
Neoadjuvant immunotherapy has demonstrated beneficial outcomes in various cancer types; however, standardized protocols for neoadjuvant immunotherapy in hepatocellular carcinoma (HCC) are currently lacking. This systematic review and meta-analysis aims to investigate the reliability of neoadjuvant immunotherapy\'s efficacy and safety in the context of HCC.
A systematic search was conducted across PubMed (MEDLINE), EMBASE, the Web of Science, the Cochrane Library, and conference proceedings to identify clinical trials involving
resectable HCC and neoadjuvant immunotherapy. Single-arm meta-analyses were employed to compute odds ratios and 95% confidence intervals (CIs). Heterogeneity analysis, data quality assessment, and subgroup analyses based on the type of immunotherapy drugs and combination therapies were performed. This meta-analysis is registered in PROSPERO (identifier CRD42023474276).
This meta-analysis included 255 patients from 11 studies. Among
resectable HCC patients, neoadjuvant immunotherapy exhibited an overall major pathological response (MPR) rate of 0.47 (95% CI 0.31-0.70) and a pathological complete response (pCR) rate of 0.22 (95% CI 0.14-0.36). The overall objective response rate (ORR) was 0.37 (95% CI 0.20-0.69), with a grade 3-4 treatment-related adverse event (TRAE) incidence rate of 0.35 (95% CI 0.24-0.51). Furthermore, the combined surgical resection rate was 3.08 (95% CI 1.66-5.72). Subgroup analysis shows no significant differences in the efficacy and safety of different single-agent immunotherapies; the efficacy of dual ICIs (Immune Checkpoint Inhibitors) combination therapy is superior to targeted combined immunotherapy and monotherapy, while the reverse is observed in terms of safety.
Neoadjuvant immunotherapy presents beneficial outcomes in the treatment of
resectable HCC. However, large-scale, high-quality experiments are warranted in the future to provide robust data support.