Cardiothoracic surgery department, People's Hospital of Deyang City, Deyang City, China.
Cardiothoracic surgery department, People's Hospital of Deyang City, Deyang City, China;, Email:
Pharmazie. 2021 May 1;76(5):215-219. doi: 10.1691/ph.2021.1336.
Atezolizumab, an immunoglobulin G1 monoclonal antibody against PD-L1, is accepted to treat advanced non-small-cell lung cancer (NSCLC). Our systematic review aims to evaluate survival efficacy of atezolizumab, overall and in subgroups defined by PD-L1 expression. Search the trials on efficacy of atezolizumab in advanced NSCLC based on online electronic databases from their dates of inception up to June 2019, including PubMed, Embase and Cochrane library databases. After rigorous reviewing of quality, the data of the PFS and OS were measured as outcomes. Six trials including seven researches were included. Overall, 4722 subjects involving 2488 patients received atezolizumab and 2234 patients received investigator's choice chemotherapy were retrieved. For the intention-to-treat (ITT) population, the pooled ORs for overall survival (OS) was 0.81 (95 % confidence interval [CI] 0.75-0.87; P<0.00001) and progression-free survival benefit (PFS) was 0.65 (95 % CI 0.59-0.73; P<0.00001), respectively. For the subgroups PD-L1 expression (negative and high), there were benefits both observed in the PFS and OS in two sub-groups with atezolizumab (P 0.05). However, in the low expression of PD-L1 group, the subjects who received atezolizumab achieved PFS (OR 0.70; 95% CI: 0.58-0.84, P=0.0002) advantage but OS advantage (OR 0.91; 95% CI: 0.62-1.33, P=0.62). In low expression of PD-L1 subgroups, a benefit was observed for PFS but OS. However, the status of PD-L1 expression cannot be recommend as prognostic biomarker to support the decision who will benefit from atezolizumab.
阿特珠单抗是一种针对 PD-L1 的免疫球蛋白 G1 单克隆抗体,已被批准用于治疗晚期非小细胞肺癌(NSCLC)。本系统评价旨在评估阿特珠单抗的总体生存疗效和根据 PD-L1 表达情况进行的亚组疗效。检索了截至 2019 年 6 月,基于在线电子数据库的阿特珠单抗治疗晚期 NSCLC 疗效的临床试验,包括 PubMed、Embase 和 Cochrane 图书馆数据库。经过严格的质量审查,将 PFS 和 OS 的数据作为结果进行测量。纳入了 6 项试验,共 7 项研究。共有 4722 例患者(2488 例接受阿特珠单抗治疗,2234 例接受研究者选择的化疗)。对于意向治疗(ITT)人群,总生存期(OS)的汇总 OR 为 0.81(95%置信区间 [CI]:0.75-0.87;P<0.00001),无进展生存期(PFS)获益的 OR 为 0.65(95%CI:0.59-0.73;P<0.00001)。对于 PD-L1 表达(阴性和高)亚组,在两个亚组中,阿特珠单抗治疗均观察到 PFS 和 OS 获益(P<0.05)。然而,在 PD-L1 低表达组中,接受阿特珠单抗治疗的患者在 PFS 方面获益(OR 0.70;95%CI:0.58-0.84,P=0.0002),但在 OS 方面没有获益(OR 0.91;95%CI:0.62-1.33,P=0.62)。在 PD-L1 低表达亚组中,PFS 获益,而 OS 获益。然而,PD-L1 表达状态不能作为预测生物标志物推荐,以支持谁将从阿特珠单抗治疗中获益的决策。