背景:免疫检查点抑制剂(ICIs)正在成为不可切除的肝细胞癌(uHCC)患者的新治疗方法。然而,与标准靶向治疗方案相比,其疗效结果不一致.
目的:我们的目的是对现有研究进行荟萃分析,以揭示两种治疗系统的疗效和安全性的差异。
方法:在PubMed,WebofScience,Cochrane图书馆,Embase从成立到6月30日,2022年。总生存期(OS)数据,无进展生存期(PFS),客观反应率(ORR),疾病控制率(DCR),将治疗相关不良事件(TrAE)的发生率及其95%置信区间(CI)汇总并通过Stata12.0软件进行分析.
结果:共纳入10项高质量对照临床研究,其中5,539例uHCC患者。OS和PFS的风险比(HR)分别为0.80(95%CI,0.74-0.86)和0.72(95%CI,0.58-0.89),分别。此外,ORR和DCR的比值比(OR)分别为3.39(95%CI,2.75-4.17)和1.20(95%CI,0.84-1.73),分别。ICIs单一疗法的ORR,ICIs+抗血管内皮生长因子(VEGF)和ICIs+ICIs为16%(95%CI,0.13-0.18),17%(95%CI,0.10-0.27),和20%(95%CI,0.16-0.24),分别。对于所有纳入的研究,总体TrAE的OR为0.51(95%CI,0.22-1.18),≥3级TrAE为0.78(95%CI,0.53-1.14)。
结论:ICIs在uHCC患者的生存期和ORR方面比靶向药物更有效,同时保持稳定的安全性。
BACKGROUND: Immune Checkpoint Inhibitors (ICIs) are becoming a new treatment approach for patients with unresectable hepatocellular carcinoma (uHCC). However, the results regarding its efficacy compared with the standard regimen of targeted therapy are not consistent.
OBJECTIVE: Our aim was to conduct a meta-analysis of existing studies to reveal the differences in the efficacy and safety of the two systems of treatment.
METHODS: The related studies were searched in PubMed, Web of Science, the Cochrane Library, and Embase from inception to June 30th, 2022. Data on overall survival (OS), progression-free survival (PFS), objective response rate (ORR), disease control rate (DCR), and rate of treatment- related adverse events (TrAEs) with their 95% confidence intervals (CI) were pooled and analyzed by Stata 12.0 software.
RESULTS: A total of ten high-quality controlled clinical studies with 5,539 patients with uHCC were included. The hazard ratio (HR) of the OS and PFS were 0.80 (95% CI, 0.74-0.86) and 0.72 (95% CI, 0.58-0.89), respectively. In addition, the odds ratio (OR) of the ORR and DCR were 3.39 (95% CI, 2.75-4.17) and 1.20 (95% CI, 0.84-1.73), respectively. The ORR of ICIs monotherapy, ICIs plus anti-vascular endothelial growth factor (VEGF) and ICIs plus ICIs were 16% (95% CI, 0.13-0.18), 17% (95% CI, 0.10-0.27), and 20% (95% CI, 0.16-0.24), respectively. For all included studies, the OR of the overall TrAEs was 0.51(95% CI, 0.22-1.18), and grade ≥ 3 TrAEs was 0.78 (95% CI, 0.53-1.14).
CONCLUSIONS: ICIs were more effective than targeted drugs concerning survival periods and ORR in patients with uHCC while maintaining a stable safety profile.