Department of Oncology, The First Affiliated Hospital of Nanchang University, Nanchang City, China.
Anticancer Drugs. 2020 Jul;31(6):637-645. doi: 10.1097/CAD.0000000000000921.
This study is a meta-analysis assessing the safety and efficacy of programmed cell death-1/cell death-ligand 1 (PD-1/PD-L1) inhibitors in order to improve their efficacy in advanced non-small-cell lung cancer. We retrieved studies of anti-PD-1/PD-L1 therapies for non-small-cell lung cancer from electronic databases; 17 clinical trials were analyzed. The pooled hazard ratios for overall and progression-free survival (PFS), and the odds ratios (ORs) for the objective response rate (ORR) and adverse effects were calculated using Review Manager 5.3. The pooled hazard ratios for overall and PFS were 0.69 and 0.74, respectively, and the pooled OR for the ORR was 1.78, implying a significant improvement in overall survival (OS), PFS, and ORR with administration of PD-1/PD-L1 inhibitors. In subgroup analysis, the ORs of the ORR were 2.48 in PD-L1 positive versus negative tumors, and 0.99 for a high dose of PD-1/PD-L1 inhibitors versus a low dose. The ORs for the occurrence of any treatment-related adverse effects and grades 3-5 treatment-related adverse effects were 0.33 and 0.30, respectively, suggesting a good safety profile. PD-1/PD-L1 immunotherapy has superior outcomes in terms of the ORR, OS, and PFS with tolerable adverse effects when compared with chemotherapy.
本研究是一项荟萃分析，旨在评估程序性细胞死亡蛋白 1/细胞死亡配体 1（PD-1/PD-L1）抑制剂的安全性和有效性，以提高其在晚期非小细胞肺癌中的疗效。我们从电子数据库中检索了抗 PD-1/PD-L1 治疗非小细胞肺癌的研究，共分析了 17 项临床试验。使用 Review Manager 5.3 计算总生存期和无进展生存期（PFS）的合并风险比（HR）、客观缓解率（ORR）和不良反应的比值比（OR）。总生存期和 PFS 的合并 HR 分别为 0.69 和 0.74，ORR 的合并 OR 为 1.78，这表明 PD-1/PD-L1 抑制剂的给药可显著改善总生存期（OS）、PFS 和 ORR。亚组分析显示，PD-L1 阳性肿瘤与阴性肿瘤的 ORR 分别为 2.48 和 0.99，高剂量 PD-1/PD-L1 抑制剂与低剂量的 ORR 分别为 2.48 和 0.99。任何治疗相关不良反应和 3-5 级治疗相关不良反应的发生率的 OR 分别为 0.33 和 0.30，这表明其具有良好的安全性。与化疗相比，PD-1/PD-L1 免疫疗法在 ORR、OS 和 PFS 方面具有更好的疗效，且不良反应可耐受。
