Background:The benefit of adding programmed cell death protein 1 (PD-1)/programmed death-ligand 1 (PD-L1) inhibitors to the treatment of early-stage non-small cell lung cancer (NSCLC), both neoadjuvant therapy (NAT) and adjuvant therapy (AT), is not yet fully elucidated.Methods:We searched PubMed, Embase, and Cochrane databases for randomized controlled trials (RCT) that investigated PD-1/PD-L1 inhibitors plus chemotherapy for resectable stage NSCLC. We computed hazard ratios (HRs) or odds ratios (ORs) for binary endpoints, with 95% confidence intervals (CIs).Results:A total of seven RCTs comprising 3915 patients with resectable stage NSCLC were randomized to chemotherapy with or without PD-1/PD-L1 inhibitors as NAT or AT. As NAT, the PD-1/PD-L1 inhibitors plus chemotherapy group demonstrated significantly improved overall survival (HR 0.66; 95% CI 0.51–0.86) and event-free survival (HR 0.53; 95% CI 0.43–0.67) compared with the chemotherapy alone group. There was a significant increase in favor of the PD-1/PD-L1 inhibitors plus chemotherapy group for major pathological response (OR 6.40; 95% CI 3.86–10.61) and pathological complete response (OR 8.82; 95% CI 4.51–17.26). Meanwhile, as AT, disease-free survival was significant in favor of the PD-1/PD-L1 inhibitors plus chemotherapy group (HR 0.78; 95% CI 0.69–0.90).Conclusions:In this comprehensive systematic review and meta-analysis of RCTs, the incorporation of PD-1/PD-L1 inhibitors alongside chemotherapy offers a promising prospect for reshaping the established treatment paradigms for patients diagnosed with resectable stages of NSCLC. Moreover, our analyses support that neoadjuvant administration with these agents should be encouraged, in light of the fact that it was associated with an increased survival and pathological response, at the expense of a manageable safety profile.
背景：在早期非小细胞肺癌（NSCLC）的治疗中，无论是新辅助治疗（NAT）还是辅助治疗（AT），联合使用程序性细胞死亡蛋白1（PD-1）/程序性死亡配体1（PD-L1）抑制剂的获益尚未完全明确。 方法：我们检索了PubMed、Embase和Cochrane数据库中关于PD-1/PD-L1抑制剂联合化疗治疗可切除期NSCLC的随机对照试验（RCT）。我们计算了二元终点的风险比（HR）或比值比（OR），并给出了95%置信区间（CI）。 结果：共纳入7项RCT，涉及3915例可切除期NSCLC患者，随机分配至化疗联合或不联合PD-1/PD-L1抑制剂作为NAT或AT。作为NAT，与单纯化疗组相比，PD-1/PD-L1抑制剂联合化疗组的总生存期（HR 0.66；95% CI 0.51–0.86）和无事件生存期（HR 0.53；95% CI 0.43–0.67）显著改善。主要病理缓解（OR 6.40；95% CI 3.86–10.61）和病理完全缓解（OR 8.82；95% CI 4.51–17.26）在PD-1/PD-L1抑制剂联合化疗组中显著增加。同时，作为AT，PD-1/PD-L1抑制剂联合化疗组的无病生存期显著优于对照组（HR 0.78；95% CI 0.69–0.90）。 结论：在这项全面的RCT系统综述和荟萃分析中，PD-1/PD-L1抑制剂联合化疗为可切除期NSCLC患者的现有治疗模式提供了重塑的广阔前景。此外，我们的分析支持应鼓励新辅助治疗中使用这些药物，因为其在可管理的安全性前提下，与生存率和病理缓解率的提高相关。
肿瘤(癌症)患者之家