新辅助免疫疗法（nIT）是一种适用于晚期可切除非小细胞肺癌（NSCLC）的新兴范式。这项 PRISMA/MOOSE/PICOD 指导下的系统综述和荟萃分析的目的是：（1）评估 nIT 的安全性和疗效，（2）比较新辅助化疗免疫疗法（nCIT）与单独化疗（nCT）的安全性和疗效，（3）探讨 nIT 病理学响应的预测因素及其与结果的关联。符合条件的病例为可切除的 I-III 期 NSCLC 患者，行免疫检查点抑制剂治疗并在手术前进行了其他形式和方式的新辅助和/或辅助治疗。在统计分析方面，根据异质性采用 Mantel-Haenszel 固定效应或随机效应模型。66篇文章符合标准（8篇随机研究、39篇前瞻性非随机研究和19篇回顾性研究）。综合病理学完全缓解（pCR）率为28.1％。预测的≥3评级毒性率为18.0％。与 nCT 相比，nCIT 在 pCR (odds ratio [OR]，7.63；95％置信区间 [CI]，4.49-12.97；p＜.001)、无进展生存期（PFS）(hazard ratio [HR]，0.51；95％CI，0.38-0.67；p＜.001)和总生存期（OS）(HR，0.51；95％CI，0.36-0.74；p＝.0003) 方面取得了更高的治疗率，但产生的毒性率相似 (OR，1.01；95％CI，0.67-1.52；p＝.97)。当剔除所有回顾性出版物时，结果仍然坚固敏感度分析。pCR 与改善 PFS (HR，0.25；0.15-0.43；p＜.001) 和OS (HR，0.26；95％CI，0.10-0.67；p＝.005) 相关。PD-L1表达者（≥1％）更有可能获得 pCR (OR，2.93；95％CI，1.22-7.03；p＝.02)。对于晚期可切除的 NSCLC 患者，新辅助免疫治疗是安全和有效的。nCIT 在没有增加毒副反应的情况下，改善了具有 PD-L1 表达的肿瘤患者的病理学响应率、PFS/OS。这项包括66个研究的荟萃分析表明，对于晚期可切除的非小细胞肺癌，新辅助免疫疗法是安全和有效的，与单独化疗相比，化疗免疫疗法提高了病理学响应率和生存率，特别是对于表达程序性细胞死亡配体-1的肿瘤患者，而不增加毒副反应。

Neoadjuvant immunotherapy (nIT) is a rapidly emerging paradigm for advanced resectable non-small cell lung cancer (NSCLC). The objectives of this PRISMA/MOOSE/PICOD-guided systematic review and meta-analysis were (1) to assess the safety and efficacy of nIT, (2) to compare the safety and efficacy of neoadjuvant chemoimmunotherapy (nCIT) versus chemotherapy alone (nCT), and (3) to explore predictors of pathologic response with nIT and their association with outcomes.Eligibility was resectable stage I-III NSCLC and the receipt of programmed death-1/programmed cell death ligand-1 (PD-L1)/cytotoxic T-lymphocyte-associated antigen-4 inhibitors before resection; other forms and modalities of neoadjuvant and/or adjuvant therapies were allowed. For statistical analysis, the Mantel-Haenszel fixed-effect or random-effect model was used, depending on the heterogeneity (I2 ).Sixty-six articles met the criteria (eight randomized studies, 39 prospective nonrandomized studies, and 19 retrospective studies). The pooled pathologic complete response (pCR) rate was 28.1%. The estimated grade ≥3 toxicity rate was 18.0%. Compared with nCT, nCIT achieved higher rates of pCR (odds ratio [OR], 7.63; 95% confidence interval [CI], 4.49-12.97; p < .001), progression-free survival (PFS) (hazard ratio [HR] 0.51; 95% CI, 0.38-0.67; p < .001), and overall survival (OS) (HR, 0.51; 95% CI, 0.36-0.74; p = .0003) but yielded similar toxicity rates (OR, 1.01; 95% CI, 0.67-1.52; p = .97). The results remained robust on sensitivity analysis when all retrospective publications were removed. pCR was associated with improved PFS (HR, 0.25; 0.15-0.43; p < .001) and OS (HR, 0.26; 95% CI, 0.10-0.67; p = .005). PD-L1 expressors (≥1%) were more likely to achieve a pCR (OR, 2.93; 95% CI, 1.22-7.03; p = .02).In patients with advanced resectable NSCLC, neoadjuvant immunotherapy was safe and efficacious. nCIT improved pathologic response rates and PFS/OS over nCT, particularly in patients who had tumors that expressed PD-L1, without increasing toxicities.This meta-analysis of 66 studies showed that neoadjuvant immunotherapy for advanced resectable non-small cell lung cancer is safe and efficacious. Compared with chemotherapy alone, chemoimmunotherapy improved pathologic response rates and survival, particularly for patients who had tumors that expressed programmed cell death ligand-1, without increasing toxicities.© 2023 American Cancer Society.