PD-1/PD-L1抑制剂联合抗血管生成药物作为晚期非小细胞肺癌患者第二或后线治疗的益处与风险:前瞻性临床试验的系统综述与单臂荟萃分析。
The benefit and risk of PD-1/PD-L1 inhibitors plus anti-angiogenic agents as second or later-line treatment for patients with advanced non-small-cell lung cancer: a systematic review and single-arm meta-analysis of prospective clinical trials.
发表日期:2023
作者:
Shubin Chen, Wanying Mo, Wei Jiang, Shaozhang Zhou, Haijie Gan, Qitao Yu
来源:
Frontiers in Immunology
摘要:
先前的研究发现,程序性细胞死亡蛋白1(PD-1)/程序性细胞死亡配体蛋白1(PD-L1)抑制剂加上抗血管生成剂具有广泛的抗肿瘤活性。然而,关于PD-1/PD-L1抑制剂加上抗血管生成剂作为晚期非小细胞肺癌患者的二线或更后线治疗的疗效和安全性的研究几乎都是非随机对照试验,且样本量较小,可能导致缺乏有效的指标来评估疗效和安全性。本次荟萃分析旨在评估PD-1/PD-L1抑制剂加上抗血管生成剂作为晚期非小细胞肺癌患者的二线或更后线治疗的疗效和安全性。
采用单臂荟萃分析法,系统检索截至2023年1月13日的PubMed、Web of Science和Embase数据库中的已发表文献。我们使用Cochrane偏倚风险工具和非随机研究方法学指标(MINORS)方法学评估合格临床试验的质量。提取整体反应率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存期(OS)和不良事件(AE)等结果进行进一步分析。采用随机效应模型计算汇总参数。共有19项研究(16项非对照单臂临床试验和3项随机对照试验)纳入本次荟萃分析。在肿瘤反应方面,汇总ORR和DCR分别为22.4%(95% CI,16.6-28.1%)和76.8%(95% CI,72.6-81.1%)。在生存分析方面,汇总PFS和OS分别为5.20(95% CI,4.46-5.93)个月和14.09(95% CI,13.20-14.97)个月。汇总≥3级不良反应(AE)的比率为47.6%(95% CI,33.1-62.0%)。PD-1/PD-L1抑制剂加上抗血管生成剂在晚期非小细胞肺癌患者中作为二线或更后线治疗具有良好的疗效和安全性。
https://www.crd.york.ac.uk/prospero/,识别号CRD42023407559。版权所有 © 2023 Chen,Mo,Jiang,Zhou,Gan和Yu。
Previous studies revealed that Programmed cell death protein 1 (PD-1)/Programmed cell death-Ligand protein 1 (PD-L1) inhibitors plus anti-angiogenic agents had extensive anti-tumor activities. However, almost all studies on the efficacy and safety of PD-1/PD-L1 inhibitors plus anti-angiogenic agents as second or later-line treatment for patients with advanced non-small cell lung cancer are non-randomized controlled trials with small sample sizes, which might lead to a lack of effective metrics to assess the effectiveness and safety of the therapeutic regimen. Here, this meta-analysis aimed to evaluate the efficacy and safety of PD-1/PD-L1 inhibitors plus anti-angiogenic agents as second or later-line treatment for patients with advanced non-small cell lung cancer.A single-arm meta-analysis was performed, and published literature from PubMed, Web of Science and Embase databases as of January 13, 2023, was systematically retrieved. We used the Cochrane risk of bias tool and methodological index for non-randomized studies (MINORS) Methodological items to evaluate the quality of eligible clinical trials. Outcomes including overall response rate (ORR), disease control rate (DCR), progression-free survival (PFS), overall survival (OS), and adverse events (AEs) were extracted for further analysis. The random effect model is used to calculate the pooled parameters.19 studies (16 were non-comparative single-arm clinical trials and 3 were randomized controlled trials) were enrolled in this meta-analysis. In terms of tumor response, the pooled ORR and DCR were 22.4% (95% CI, 16.6-28.1%) and 76.8% (95% CI, 72.6-81.1%), respectively. With regard to survival analysis, the pooled PFS and OS were 5.20 (95% CI, 4.46-5.93) months and 14.09 (95% CI, 13.20-14.97) months, respectively. The pooled grade ≥3 adverse effect (AE) rate was 47.6% (95% CI, 33.1-62.0%).PD-1/PD-L1 inhibitors plus anti-angiogenic agents has promising efficacy and safety as second or later-line treatment in patients with advanced non-small cell lung cancer.https://www.crd.york.ac.uk/prospero/, identifier CRD42023407559.Copyright © 2023 Chen, Mo, Jiang, Zhou, Gan and Yu.