中国循证医学杂志

中国循证医学杂志

抗 PD-1/PD-L1 单抗治疗晚期非小细胞肺癌有效性和安全性的单组率的 Meta 分析

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目的系统评价抗程序性死亡因子 1/程序性死亡因子 1 配体(PD-1/PD-L1)单抗治疗晚期非小细胞肺癌(NSCLC)的有效性和安全性。方法计算机检索 PubMed、EMbase 和 The Cochrane Library,搜集抗 PD-1/PD-L1 单抗治疗晚期 NSCLC 的相关研究,检索时限均从建库至 2017 年 8 月 1 日。由 2 位评价员独立筛选文献、提取资料并评价纳入研究的偏倚风险后,采用 RevMan5.3 软件进行 Meta 分析。结果共纳入 44 个研究。Meta 分析结果显示:抗 PD-1/PD-L1 单抗治疗的客观反映率(ORR)、1 年总生存率(OSR)和 1 年无进展生存率(PFSR)分别为 22%[RD=0.22,95%CI(0.20,0.25),P<0.001],54%[RD=0.54,95%CI(0.46,0.63),P<0.001]和 27%[RD=0.27,95%CI(0.20,0.33),P<0.001]。在安全性方面,抗 PD-1/PD-L1 单抗治疗的不良反应发生率为 61%[RD=0.61,95%CI(0.54,0.68),P<0.001],其中,3~5 级不良反应发生率为 13%[RD=0.13,95%CI(0.10,0.15),P<0.001]。结论抗 PD-1/PD-L1 单抗治疗晚期 NSCLC 具有较好的有效性和安全性。受纳入研究的数量和质量的限制,上述结论尚需开展更多研究予以验证。

ObjectivesTo systematically review the efficacy and safety of anti-PD-1/PD-L1 antibody in the treatment of advanced non-small cell lung cancer (NSCLC).MethodsNon-comparative binary data on anti-PD-1/PD-L1 monoclonal antibodies in the treatment of advanced NSCLC from PubMed, EMbase and The Cochrane Library databases were collected from inception to August 1st 2017. Two reviewers screened literature, extracted data and independently evaluated the risk of bias of included studies, then meta-analysis was conducted by RevMan 5.3 software.ResultsForty-four trials were included. The results of meta-analysis showed that the pooled objective response rate (ORR), overall 1-year survival rate (OSR1 year) and progression-free survival rate at 1 year (PFSR1 year ) of anti-PD-1/PD-1 antibodies were 22% (RD=0.22, 95%CI 0.20 to 0.25, P<0.001), 54% (RD=0.54, 95%CI 0.46 to 0.63,P<0.001) and 27% (RD=0.27, 95%CI 0.20 to 0.33,P<0.001), respectively. The rate of adverse effects (AEs) was 61% (RD=0.61, 95%CI 0.54 to 0.68,P<0.001), and the rate of grade 3 to 5 AEs was 13% (RD=0.13, 95%CI 0.10 to 0.15,P<0.001).ConclusionsAnti- PD-1/PD-1 antibodies show good efficacy and safety in the treatment of advanced NSCLC. Due to limited quality and quantity of included studies, more high-quality studies are needed to verify the above conclusions.

关键词: 非小细胞肺癌; PD-1; PD-L1; 单克隆抗体; Meta 分析; 单组率

Key words: Non-small cell lung cancer; Monoclonal antibodies; PD-1; PD-L1; Monoclonal antibody; Meta-analysis

引用本文: 冯海明, 赵晔, 李敏, 蔺军平, 张建华, 马建兴, 敬涛, 王成, 李斌, 蒋鹏. 抗 PD-1/PD-L1 单抗治疗晚期非小细胞肺癌有效性和安全性的单组率的 Meta 分析. 中国循证医学杂志, 2018, 18(3): 322-333. doi: 10.7507/1672-2531.201705025 复制

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