ImportanceTo date, no meta-analyses have comprehensively assessed the association of neoadjuvant chemoimmunotherapy with clinical outcomes in non–small cell lung cancer (NSCLC) in randomized and nonrandomized settings. In addition, there exists controversy concerning the efficacy of neoadjuvant chemoimmunotherapy for patients with NSCLC with programmed cell death 1 ligand 1 (PD-L1) levels less than 1%.ObjectiveTo compare neoadjuvant chemoimmunotherapy with chemotherapy by adverse events and surgical, pathological, and efficacy outcomes using recently published randomized clinical trials and nonrandomized trials.Data SourcesMEDLINE and Embase were systematically searched from January 1, 2013, to October 25, 2023, for all clinical trials of neoadjuvant chemoimmunotherapy and chemotherapy that included at least 10 patients.Study SelectionObservational studies and trials reporting the use of neoadjuvant radiotherapy, including chemoradiotherapy, molecular targeted therapy, or immunotherapy monotherapy, were excluded.Main Outcomes and MeasuresSurgical, pathological, and efficacy end points and adverse events were pooled using a random-effects meta-analysis.ResultsAmong 43 eligible trials comprising 5431 patients (4020 males [74.0%]; median age range, 55-70 years), there were 8 randomized clinical trials with 3387 patients. For randomized clinical trials, pooled overall survival (hazard ratio, 0.65; 95% CI, 0.54-0.79; I2 = 0%), event-free survival (hazard ratio, 0.59; 95% CI, 0.52-0.67; I2 = 14.9%), major pathological response (risk ratio, 3.42; 95% CI, 2.83-4.15; I2 = 31.2%), and complete pathological response (risk ratio, 5.52; 95% CI, 4.25-7.15; I2 = 27.4%) favored neoadjuvant chemoimmunotherapy over neoadjuvant chemotherapy. For patients with baseline tumor PD-L1 levels less than 1%, there was a significant benefit in event-free survival for neoadjuvant chemoimmunotherapy compared with chemotherapy (hazard ratio, 0.74; 95% CI, 0.62-0.89; I2 = 0%).Conclusion and RelevanceThis study found that neoadjuvant chemoimmunotherapy was superior to neoadjuvant chemotherapy across surgical, pathological, and efficacy outcomes. These findings suggest that patients with resectable NSCLC with tumor PD-L1 levels less than 1% may have an event-free survival benefit with neoadjuvant chemoimmunotherapy.

中文翻译：

---

非小细胞肺癌的新辅助化学免疫治疗

重要性迄今为止，还没有荟萃分析在随机和非随机环境中全面评估新辅助化学免疫疗法与非小细胞肺癌（NSCLC）临床结果的关联。此外，新辅助化疗免疫治疗对于程序性细胞死亡1配体1（PD-L1）水平低于1%的NSCLC患者的疗效也存在争议。 目的比较新辅助化疗免疫治疗与化疗的不良事件以及手术、病理和疗效。使用最近发表的随机临床试验和非随机试验的结果。数据来源MEDLINE和Embase系统地检索了2013年1月1日至2023年10月25日期间包含至少10名患者的新辅助化学免疫治疗和化疗的所有临床试验。研究选择观察性研究和报告使用新辅助放疗（包括放化疗、分子靶向治疗或免疫治疗单一疗法）的试验被排除在外。主要结果和措施使用随机效应荟萃分析汇总手术、病理、疗效终点和不良事件。结果在 43 项符合条件的研究中试验包含 5431 名患者（4020 名男性 [74.0%]）；中位年龄范围，55-70岁），有8项随机临床试验，涉及3387名患者。对于随机临床试验，汇总总生存率（风险比，0.65；95% CI，0.54-0.79；我2= 0%），无事件生存（风险比，0.59；95% CI，0.52-0.67；我2= 14.9%），主要病理反应（风险比，3.42；95% CI，2.83-4.15；我2= 31.2%），并且完全病理缓解（风险比，5.52；95% CI，4.25-7.15；我2= 27.4%）赞成新辅助化学免疫治疗胜过新辅助化疗。对于基线肿瘤PD-L1水平低于1%的患者，与化疗相比，新辅助化学免疫疗法在无事件生存方面具有显着的益处（风险比，0.74；95% CI，0.62-0.89；我2= 0%）。结论和相关性本研究发现，新辅助化学免疫疗法在手术、病理和疗效结果方面均优于新辅助化疗。这些发现表明，肿瘤 PD-L1 水平低于 1% 的可切除 NSCLC 患者可能通过新辅助化学免疫疗法获得无事件生存获益。