Comparative effectiveness of pembrolizumab-chemotherapy versus chemotherapy with/without bevacizumab in unresectable, locally advanced or metastatic non-small cell lung cancer: a Chinese multicenter real-world analysis emphasizing PD-L1-negative populations.
Xiaobei Guo, Hui Zhang, Yuequan Shi, Qi He, Anwen Liu, Zhimin Zeng, Jinghui Wang, Song Wei, Tong Zhang, Cuimin Ding, Jian Fang, Xiaoling Chen, Paul Van Schil, Haoran Zhang, Junyi Pang, Minjiang Chen, Jing Zhao, Wei Zhong, Zhen Huo, Yan Xu, Mengzhao Wang
{"title":"Comparative effectiveness of pembrolizumab-chemotherapy versus chemotherapy with/without bevacizumab in unresectable, locally advanced or metastatic non-small cell lung cancer: a Chinese multicenter real-world analysis emphasizing PD-L1-negative populations.","authors":"Xiaobei Guo, Hui Zhang, Yuequan Shi, Qi He, Anwen Liu, Zhimin Zeng, Jinghui Wang, Song Wei, Tong Zhang, Cuimin Ding, Jian Fang, Xiaoling Chen, Paul Van Schil, Haoran Zhang, Junyi Pang, Minjiang Chen, Jing Zhao, Wei Zhong, Zhen Huo, Yan Xu, Mengzhao Wang","doi":"10.21037/tlcr-2025-271","DOIUrl":null,"url":null,"abstract":"<p><strong>Background: </strong>Current limited evidence suggests that the use of pembrolizumab combined with chemotherapy may be effective for treatment-naïve patients with metastatic non-small cell lung cancer (NSCLC) and negative programmed cell death ligand 1 (PD-L1) expression, but real-world data are relatively scarce. This retrospective cohort study analyzed the efficacy, adverse events, and prognostic factors in these patients treated with chemotherapy with or without pembrolizumab.</p><p><strong>Methods: </strong>This retrospective study analyzed the data of patients with unresectable, locally advanced or metastatic NSCLC without sensitive epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or proto-oncogene receptor tyrosine kinase (ROS1) alterations who had negative PD-L1 expression and received first-line pembrolizumab plus chemotherapy (the Pembro group) or platinum-based dual chemotherapy with or without bevacizumab (the Chemo group). The efficacy outcomes and safety profiles of the two groups were compared.</p><p><strong>Results: </strong>The study included 246 patients (Pembro group, n=114; Chemo group, n=132). The median follow-up period was 28.3 months. The Pembro group significantly prolonged progression-free survival (PFS) compared with the Chemo group [9.5 months, 95% confidence interval (CI): 7.5-11.5 <i>vs</i>. 7.2 months, 95% CI: 5.7-8.7; hazard ratio (HR) =0.64, 95% CI: 0.46-0.87; P=0.004]. Squamous cell lung cancer (SCC) patients demonstrated substantial PFS benefit (13.8 months, 95% CI: 3.2-24.1 <i>vs</i>. 4.8 months, 95% CI: 3.4-6.2; P<0.001), while non-SCC patients showed comparable PFS (9.3 months, 95% CI: 7.6-11.0 <i>vs</i>. 8.0 months, 95% CI: 6.0-10.0; P=0.56). Overall survival (OS) favored the Pembro group (21.2 months, 95% CI: 16.0-26.4 <i>vs</i>. 20.1 months, 95% CI: 15.5-24.7; HR =0.71, 95% CI: 0.50-1.00; P=0.052). The SCC patients in the Pembro group demonstrated a significant survival benefit with a median OS that was not reached, compared to 14.2 months (95% CI: 6.3-22.1) in the chemo group (HR =0.42, 95% CI: 0.22-0.78; P=0.007). Grade ≥3 non-immune-related adverse events (non-irAEs) occurred more often in the Pembro group (46.8%) than the Chemo group (33.1%, P=0.03). Moreover, 45 (39.5%) patients experienced 63 irAEs, and no grade 5 or new irAEs were observed.</p><p><strong>Conclusions: </strong>Pembrolizumab combined with chemotherapy may prolong survival in patients with PD-L1-negative advanced NSCLC, particularly those with squamous histology.</p>","PeriodicalId":23271,"journal":{"name":"Translational lung cancer research","volume":"14 5","pages":"1804-1820"},"PeriodicalIF":4.0000,"publicationDate":"2025-05-30","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"https://www.ncbi.nlm.nih.gov/pmc/articles/PMC12170236/pdf/","citationCount":"0","resultStr":null,"platform":"Semanticscholar","paperid":null,"PeriodicalName":"Translational lung cancer research","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.21037/tlcr-2025-271","RegionNum":2,"RegionCategory":"医学","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"2025/5/27 0:00:00","PubModel":"Epub","JCR":"Q2","JCRName":"ONCOLOGY","Score":null,"Total":0}
引用次数: 0
Abstract
Background: Current limited evidence suggests that the use of pembrolizumab combined with chemotherapy may be effective for treatment-naïve patients with metastatic non-small cell lung cancer (NSCLC) and negative programmed cell death ligand 1 (PD-L1) expression, but real-world data are relatively scarce. This retrospective cohort study analyzed the efficacy, adverse events, and prognostic factors in these patients treated with chemotherapy with or without pembrolizumab.
Methods: This retrospective study analyzed the data of patients with unresectable, locally advanced or metastatic NSCLC without sensitive epidermal growth factor receptor (EGFR) or anaplastic lymphoma kinase (ALK) or proto-oncogene receptor tyrosine kinase (ROS1) alterations who had negative PD-L1 expression and received first-line pembrolizumab plus chemotherapy (the Pembro group) or platinum-based dual chemotherapy with or without bevacizumab (the Chemo group). The efficacy outcomes and safety profiles of the two groups were compared.
Results: The study included 246 patients (Pembro group, n=114; Chemo group, n=132). The median follow-up period was 28.3 months. The Pembro group significantly prolonged progression-free survival (PFS) compared with the Chemo group [9.5 months, 95% confidence interval (CI): 7.5-11.5 vs. 7.2 months, 95% CI: 5.7-8.7; hazard ratio (HR) =0.64, 95% CI: 0.46-0.87; P=0.004]. Squamous cell lung cancer (SCC) patients demonstrated substantial PFS benefit (13.8 months, 95% CI: 3.2-24.1 vs. 4.8 months, 95% CI: 3.4-6.2; P<0.001), while non-SCC patients showed comparable PFS (9.3 months, 95% CI: 7.6-11.0 vs. 8.0 months, 95% CI: 6.0-10.0; P=0.56). Overall survival (OS) favored the Pembro group (21.2 months, 95% CI: 16.0-26.4 vs. 20.1 months, 95% CI: 15.5-24.7; HR =0.71, 95% CI: 0.50-1.00; P=0.052). The SCC patients in the Pembro group demonstrated a significant survival benefit with a median OS that was not reached, compared to 14.2 months (95% CI: 6.3-22.1) in the chemo group (HR =0.42, 95% CI: 0.22-0.78; P=0.007). Grade ≥3 non-immune-related adverse events (non-irAEs) occurred more often in the Pembro group (46.8%) than the Chemo group (33.1%, P=0.03). Moreover, 45 (39.5%) patients experienced 63 irAEs, and no grade 5 or new irAEs were observed.
Conclusions: Pembrolizumab combined with chemotherapy may prolong survival in patients with PD-L1-negative advanced NSCLC, particularly those with squamous histology.
期刊介绍:
Translational Lung Cancer Research(TLCR, Transl Lung Cancer Res, Print ISSN 2218-6751; Online ISSN 2226-4477) is an international, peer-reviewed, open-access journal, which was founded in March 2012. TLCR is indexed by PubMed/PubMed Central and the Chemical Abstracts Service (CAS) Databases. It is published quarterly the first year, and published bimonthly since February 2013. It provides practical up-to-date information on prevention, early detection, diagnosis, and treatment of lung cancer. Specific areas of its interest include, but not limited to, multimodality therapy, markers, imaging, tumor biology, pathology, chemoprevention, and technical advances related to lung cancer.