PD-1 / PD-L1抑制剂在晚期肝细胞癌中的临床益处：系统评价和

StephenW

Clinical benefits of PD-1/PD-L1 inhibitors in advanced hepatocellular carcinoma: a systematic review and meta-analysis

    Quan Rao, Min Li, Wei Xu, Kai Pang, XiaoBo Guo, Dong Wang, Jun Liu, Wei Guo & ZhongTao Zhang

Hepatology International volume 14, pages765–775(2020)Cite this article

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Abstract
Background

Significant improvement of objective response rate and overall survival period has been achieved in several types of solid tumors by treatment with PD-1/PD-L1 inhibitors, which shed some light on hepatocellular carcinoma (HCC). Currently, a number of clinical trials concerning the application of checkpoint inhibitors in HCC are ongoing, some of which have shown favorable expectations. Hereby, we conducted a meta-analysis of existing studies to reveal the efficacy and safety of checkpoint inhibitors in advanced HCC.
Methods

Medline, Embase, Cochrane Library, and Web of Science were searched from inception to January 31, 2020. The clinical trials reporting the efficacy of PD-1/PD-L1 inhibitors in advanced HCC patients were eligible. Overall results of complete response (CR), partial response (PR), stable disease (SD), progression of disease (PD), objective response rate (ORR), disease control rate (DCR), overall survival (OS), progression-free survival (PFS) and rate of adverse events (AE) with their 95% confidence intervals (95%CI) were calculated as the primary focus of the meta-analysis. Subgroup analyses were conducted primarily according to the categories of PD-1 inhibitor or PD-L1 inhibitor and combination therapy or monotherapy. In addition, pooled results of PD-1/PD-L1 monoclonal antibodies (mAb) combining with anti-VEGF agents were calculated separately.
Results

A total of 20 studies with 1232 patients were included. The overall CR, PR and SD rate were 0.01 (95% CI 0.01–0.03), 0.17 (95% CI 0.14–0.22) and 0.39 (95% CI 0.34–0.43), respectively. The overall ORR and DCR were 0.20 (95% CI 0.16–0.24) and 0.60 (95% CI 0.54–0.67), respectively. The overall PFS and OS were 3.58 months (95% CI 2.65–4.50) and 12.24 months (95% CI 10.48–14.00), respectively. For patients treated with PD-1/PD-L1 mAb combing with anti-VEGF agent, ORR was 29% (95% CI 0.15–0.43) and DCR was 77% (95% CI 0.70–0.84). For all included studies, the overall rate of AE was 0.63 (95% CI 0.45–0.78) and serious adverse events (SAE) was 0.11 (95% CI 0.06–0.22).
Conclusions

PD-1/PD-L1 inhibitors showed favorable outcomes concerning response rates and survival periods in advanced HCC. Updated results from high-quality clinical trials are expected to validate these findings.

StephenW

PD-1 / PD-L1抑制剂在晚期肝细胞癌中的临床益处：系统评价和荟萃分析

    饶全，李敏，徐伟，庞凯，郭小波，王冬，刘军，郭伟＆张忠道

《国际肝病学》第14卷，765-775页（2020年）

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抽象
背景

通过使用PD-1 / PD-L1抑制剂治疗，在几种类型的实体瘤中，客观缓解率和总生存期得到了显着改善，这为肝细胞癌（HCC）的发展提供了一些启示。当前，许多有关在HCC中使用检查点抑制剂的临床试验正在进行中，其中一些已显示出良好的期望。因此，我们对现有研究进行了荟萃分析，以揭示检查点抑制剂在晚期HCC中的疗效和安全性。
方法

从开始到2020年1月31日，对Medline，Embase，Cochrane图书馆和Web of Science进行了搜索。符合条件的临床试验报道了PD-1 / PD-L1抑制剂在晚期HCC患者中的疗效。完全缓解（CR），部分缓解（PR），稳定疾病（SD），疾病进展（PD），客观缓解率（ORR），疾病控制率（DCR），总体生存率（OS），进展的总体结果-荟萃分析的主要重点是计算其95％置信区间（95％CI）的自由生存期（PFS）和不良事件发生率（AE）。主要根据PD-1抑制剂或PD-L1抑制剂的类别以及联合疗法或单一疗法进行亚组分析。此外，分别计算了PD-1 / PD-L1单克隆抗体（mAb）与抗VEGF试剂组合的合并结果。
结果

共纳入20项研究，涉及1232例患者。总体CR，PR和SD率分别为0.01（95％CI 0.01-0.03），0.17（95％CI 0.14-0.22）和0.39（95％CI 0.34-0.43）。总体ORR和DCR分别为0.20（95％CI 0.16-0.24）和0.60（95％CI 0.54-0.67）。总体PFS和OS分别为3.58个月（95％CI 2.65–4.50）和12.24个月（95％CI 10.48-14.00）。对于使用PD-1 / PD-L1 mAb结合抗VEGF药物治疗的患者，ORR为29％（95％CI 0.15-0.43），DCR为77％（95％CI 0.70-0.84）。对于所有纳入研究，总不良事件发生率为0.63（95％CI 0.45–0.78），严重不良事件（SAE）为0.11（95％CI 0.06–0.22）。
结论

在晚期HCC中，PD-1 / PD-L1抑制剂在缓解率和生存期方面显示出良好的疗效。高质量临床试验的最新结果有望验证这些发现。