Department of Respiratory and Critical Care Medicine, The First Affiliated Hospital of Anhui Medical University, Hefei 230022, China.
Hefei Prevention and Treatment Center for Occupational Diseases, Hefei 230022, China.
Int Immunopharmacol. 2020 Mar;80:106214. doi: 10.1016/j.intimp.2020.106214. Epub 2020 Jan 23.
Programmed death-ligand-1 (PD-L1) is a well-known predictive biomarker in non-small cell lung cancer (NSCLC) patients, however, its accuracy remains controversial. Here, we investigated the correlation between PD-L1 expression level and efficacy of its inhibitors, and hence assessed the predictive effect of PD-L1 expression.
Studies that evaluated the efficacy of programmed death-1 (PD-1)/ PD-L1 inhibitors in advanced NSCLC patients according to tumor PD-L1 expression levels were searched for on Medline, Cochrane Library, and Embase. The pooled risk ratio (RR) and 95% confidence intervals (95% CIs) were calculated for the objective response rate (ORR) with overall survival (OS) and progression-free survival (PFS) were measured in terms of hazard ratio (HR) and the corresponding 95% CIs.
1432 NSCLC patients from six randomized controlled trials (RCTs) were included and three PD-1/PD-L1 inhibitors (atezolizumab, nivolumab, and pembrolizumab) were used to treat the patients. A significantly higher ORR was observed in the high PD-L1 expression group compared to the low expression group (0.35 [95% CI, 0.30-0.40] vs 0.11 [95% CI, 0.09-0.14]). The results of the subgroup analysis, grouped by the type of drugs and antibodies which assess immune checkpoint inhibitors were identical with the pooled result. However, our study showed that PD-L1 expression was neither prognostic nor predictive of overall survival (OS) or progression-free survival (PFS) in patients treated with PD-1/PD-L1 inhibitors compared to chemotherapy.
PD-L1 can be a predictive biomarker for ORR. Nevertheless, PD-L1 expression is not a good predictive tool for OS and PFS.
程序性死亡配体-1(PD-L1)是一种众所周知的非小细胞肺癌(NSCLC)患者的预测性生物标志物,但其实用性仍存在争议。在这里,我们研究了 PD-L1 表达水平与 PD-1/PD-L1 抑制剂疗效之间的相关性,并评估了 PD-L1 表达的预测效果。
在 Medline、Cochrane Library 和 Embase 上搜索了评估肿瘤 PD-L1 表达水平与 PD-1/PD-L1 抑制剂在晚期 NSCLC 患者中的疗效相关的研究。使用总缓解率(ORR)和无进展生存期(PFS)的风险比(HR)及其相应的 95%置信区间(95%CI)来计算客观缓解率(ORR),并用总体生存期(OS)进行测量。
纳入了六项随机对照试验(RCT)的 1432 例 NSCLC 患者,使用三种 PD-1/PD-L1 抑制剂(阿特珠单抗、纳武单抗和帕博利珠单抗)治疗患者。高 PD-L1 表达组的 ORR 明显高于低表达组(0.35 [95%CI,0.30-0.40] vs 0.11 [95%CI,0.09-0.14])。按药物类型和评估免疫检查点抑制剂的抗体进行亚组分析的结果与汇总结果一致。然而,我们的研究表明,与化疗相比,PD-L1 表达既不能预测 PD-1/PD-L1 抑制剂治疗患者的总生存期(OS)或无进展生存期(PFS),也不能对其进行预后评估。
PD-L1 可作为 ORR 的预测性生物标志物。然而,PD-L1 表达不是 OS 和 PFS 的良好预测工具。