免疫检查点抑制剂治疗肝细胞癌患者生存的潜在预测因素：一项荟萃分析。
Potential predictors for survival in hepatocellular carcinoma patients treated with immune checkpoint inhibitors: A meta-analysis.
机构信息
Department of Oncology, The Fifth Hospital of WuHan, WuHan, Hubei 430000, China.
Department of Oncology, RenMin Hospital of WuHan University, WuHan, Hubei 430000, China.
出版信息
Int Immunopharmacol. 2021 Nov;100:108135. doi: 10.1016/j.intimp.2021.108135. Epub 2021 Sep 13.
BACKGROUND
Immune checkpoint inhibitors (ICI) are increasingly used in hepatocellular carcinoma (HCC) trials. However, the correlations between early endpoints, such as progression free survival (PFS), objective response rate (ORR), and disease control rate (DCR), and overall survival (OS) are unclear. In this study, the correlations between OS and other early endpoints were evaluated in HCC patients who received ICI.
METHODS
Pubmed and Embase were searched to October 2020. Clinical studies evaluating efficacy and outcomes of HCC patients treated with ICI were included. ORR, DCR, PFS and OS were extracted from individual studies. The Spearman's rank correlation coefficient and linear regression model were used to assess the correlation.
RESULTS
74 studies involving 9001 HCC cases were included. For HCC patients treated with ICI, the pooled ORR and DCR were 16% (95% CI: 14-18%) and 52% (95% CI: 47-57%), and the median PFS and OS were 3.75 (95% CI: 2.88-4.90) months, and 13.20 (95% CI: 11.88-14.82) months, retrospectively. The correlation between ORR, DCR, PFS and OS were 0.35 (R = 0.21, p < 0.05), 0.43 (R = 0.18, p < 0.05), and 0.50 (R = 0.33, p < 0.05), respectively. Further, the association between PFS and OS of the combination strategy showed a better correlation (rs = 0.79, R = 0.75, p < 0.05).
CONCLUSION
These results suggest that PFS could be potential surrogates for OS, especially PFS for patients who treated with ICI combination regimen.
背景
免疫检查点抑制剂（ICI）在肝细胞癌（HCC）试验中越来越多地被使用。然而，早期终点（如无进展生存期（PFS）、客观缓解率（ORR）和疾病控制率（DCR））与总生存期（OS）之间的相关性尚不清楚。在这项研究中，评估了接受 ICI 治疗的 HCC 患者中 OS 与其他早期终点之间的相关性。
方法
检索了 Pubmed 和 Embase 数据库，检索时间截至 2020 年 10 月。纳入了评估 HCC 患者接受 ICI 治疗的疗效和结局的临床研究。从各个研究中提取 ORR、DCR、PFS 和 OS。采用 Spearman 秩相关系数和线性回归模型评估相关性。
结果
纳入了 74 项研究，共涉及 9001 例 HCC 病例。接受 ICI 治疗的 HCC 患者的汇总 ORR 和 DCR 分别为 16%（95%CI：14-18%）和 52%（95%CI：47-57%），中位 PFS 和 OS 分别为 3.75 个月（95%CI：2.88-4.90 个月）和 13.20 个月（95%CI：11.88-14.82 个月）。ORR、DCR、PFS 和 OS 之间的相关性分别为 0.35（R=0.21，p<0.05）、0.43（R=0.18，p<0.05）和 0.50（R=0.33，p<0.05）。此外，联合治疗策略的 PFS 和 OS 之间的相关性更好（rs=0.79，R=0.75，p<0.05）。
结论
这些结果表明 PFS 可能是 OS 的潜在替代指标，特别是对于接受 ICI 联合治疗方案的患者。
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