PD-(L)1 Inhibitor Monotherapy vs Chemoimmunotherapy for Advanced NSCLC With High PD-L1 Expression: A Systematic Review and Meta-Analysis.

Background

To compare overall survival(OS) and progression-free survival(PFS) associated with PD-(L)1 inhibitor monotherapy vs chemoimmunotherapy in treatment-naive patients with advanced NSCLC and high PD-L1 expression.

本研究旨在比较PD-(L)1抑制剂单药治疗与化疗免疫治疗在未经治疗的晚期非小细胞肺癌（NSCLC）患者中，且这些患者具有高PD-L1表达时，总生存（OS）和无进展生存（PFS）的差异。

data_sources

PubMed, Embase, and major oncology conference proceedings were searched for phase 3 randomized clinical trials (RCTs) published before August 3, 2025.

在PubMed、Embase和主要肿瘤学会议记录中进行了检索，以查找2025年8月3日之前发表的III期随机临床试验(RCTs)。

study_selection

Eligible studies were phase 3 RCTs that enrolled patients with untreated advanced NSCLC, evaluated PD-(L)1 inhibitor monotherapy or chemoimmunotherapy vs chemotherapy alone, and reported outcomes in patients with high PD-L1 expression.

符合条件的研究是III期RCTs，这些研究招募了未接受治疗的晚期非小细胞肺癌(NSCLC)患者，评估了PD-(L)1抑制剂单药治疗或化疗免疫治疗与单独化疗，并报告了高PD-L1表达患者的治疗结果。

data_extraction_and_synthesis

Hazard ratios (HRs) for OS and PFS were extracted from published studies and synthesized using inverse variance methods.

从已发表的研究中提取总生存（OS）和无进展生存（PFS）的风险比（HRs），并使用逆方差方法进行综合分析。

Additional analyses included meta-regression, network meta-analysis, and reconstructed individual patient data from published Kaplan-Meier curves.

额外的分析包括元回归、网络荟萃分析以及从已发表的Kaplan-Meier曲线重建个别患者数据。

main_outcomes_and_measures

Primary outcome was OS; secondary outcome was PFS.

主要结果是总生存期（OS）；次要结果是无进展生存期（PFS）。

Results

Among 24 trials including 5546 patients with PD-L1-high NSCLC, 16 evaluated chemoimmunotherapy and 8 PD-(L)1 inhibitor monotherapy.

在涉及5546名PD-L1高表达非小细胞肺癌患者的24项试验中，有16项评估了化疗免疫治疗，8项评估了PD-(L)1抑制剂单药治疗。

Compared with chemotherapy, survival was improved by both chemoimmunotherapy (OS: HR, 0.63 [95% CI, 0.56-0.72]; P < .001; PFS: HR, 0.44 [95% CI, 0.39-0.49]; P < .001) and PD-(L)1 inhibitor monotherapy (OS: HR, 0.74 [95% CI, 0.69-0.80]; P < .001; PFS: HR, 0.70 [95% CI, 0.65-0.76]; P < .001).

与化疗相比，化疗免疫治疗（总生存：HR，0.63 [95% 置信区间，0.56-0.72]；P < .001；无进展生存期：HR，0.44 [95% 置信区间，0.39-0.49]；P < .001）和PD-(L)1抑制剂单药治疗（总生存：HR，0.74 [95% 置信区间，0.69-0.80]；P < .001；无进展生存期：HR，0.70 [95% 置信区间，0.65-0.76]；P < .001）均提高了生存率。

Tests for subgroup differences suggested improved benefit with chemoimmunotherapy compared to PD-(L)1 inhibitor monotherapy (OS: χ21 = 4.1; P = .04; I2 = 75.8%; PFS: χ21 = 48.1; P < .001; I2 = 97.9%), consistent with meta-regression analyses (OS: HR, 0.85 [95% CI, 0.72-1.00]; P = .048; PFS: HR, 0.61 [95% CI, 0.50-0.75]; P < .001) and network meta-analyses (OS: HR, 0.85 [95% CI, 0.73-0.99]; PFS: HR, 0.61 [95% CI, 0.50-0.75]).

亚组差异检验表明，与PD-(L)1抑制剂单药治疗相比，化疗免疫治疗的益处有所提高（总生存：χ21 = 4.1；P = .04；I2 = 75.8%；无进展生存期：χ21 = 48.1；P < .001；I2 = 97.9%），这与元回归分析（总生存：HR，0.85 [95% 置信区间，0.72-1.00]；P = .048；无进展生存期：HR，0.61 [95% 置信区间，0.50-0.75]；P < .001）和网络荟萃分析（总生存：HR，0.85 [95% 置信区间，0.73-0.99]；无进展生存期：HR，0.61 [95% 置信区间，0.50-0.75]）的结果一致。

In the reconstructed individual patient data analysis, median OS was longer with chemoimmunotherapy (n = 704 patients) compared to PD-(L)1 inhibitor monotherapy (n = 1706 patients) (29.2 months [95% CI, 25.2-35.4] vs 19.8 months [95% CI, 18.3-21.7]; HR, 0.74 [95% CI, 0.66-0.82]; P < .001).

在重建的个体患者数据分析中，化疗免疫治疗组（n = 704名患者）的中位总生存期（OS）比PD-(L)1抑制剂单药治疗组（n = 1706名患者）更长（29.2个月 [95% CI, 25.2-35.4] 对比 19.8个月 [95% CI, 18.3-21.7]；风险比，HR, 0.74 [95% CI, 0.66-0.82]；P < .001）。

Similarly, median PFS was significantly longer with chemoimmunotherapy (n = 701 patients) compared to PD-(L)1 inhibitor monotherapy (n = 1706 patients) (11.3 months [95% CI, 10.3-13.5] vs 6.8 months [95% CI, 6.2-7.1]; HR, 0.67 [95% CI, 0.60-0.75]; P < .001).

同样地，化疗免疫治疗组（n = 701名患者）的中位无进展生存期（PFS）显著长于PD-(L)1抑制剂单药治疗组（n = 1706名患者）（11.3个月 [95% CI, 10.3-13.5] 对比 6.8个月 [95% CI, 6.2-7.1]；风险比，HR, 0.67 [95% CI, 0.60-0.75]；P < .001）。

conclusions_and_relevance

In this meta-analysisof phase 3 RCTs, chemoimmunotherapy was associated with significantly improved OS and PFS compared with PD-(L)1 inhibitor monotherapy in patients with advanced NSCLC and high PD-L1 expression.

在这项针对III期随机对照试验的荟萃分析中，化疗免疫治疗与PD-(L)1抑制剂单药治疗相比，在具有高PD-L1表达的晚期非小细胞肺癌患者中，总生存和无进展生存期有显著改善。

Prospective trials are needed to confirm these findings.

需要前瞻性试验来确认这些发现。