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.

IF 4 2区 医学 Q2 ONCOLOGY
Translational lung cancer research Pub Date : 2025-05-30 Epub Date: 2025-05-27 DOI:10.21037/tlcr-2025-271
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
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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.

派姆单抗联合化疗与贝伐单抗联合/不联合化疗治疗不可切除、局部晚期或转移性非小细胞肺癌的疗效比较:一项强调pd - l1阴性人群的中国多中心现实世界分析
背景:目前有限的证据表明,pembrolizumab联合化疗可能对treatment-naïve转移性非小细胞肺癌(NSCLC)和程序性细胞死亡配体1 (PD-L1)阴性表达的患者有效,但实际数据相对较少。这项回顾性队列研究分析了这些患者接受或不接受派姆单抗化疗的疗效、不良事件和预后因素。方法:本回顾性研究分析了PD-L1表达阴性且接受一线派姆单抗加化疗(pembrolizumab组)或铂基双化疗(贝伐单抗组)或不加贝伐单抗(Chemo组)的不可切除、局部晚期或转移性非小细胞肺癌患者的数据。比较两组的疗效、结局和安全性。结果:纳入246例患者(Pembro组,n=114;化疗组,n=132)。中位随访期为28.3个月。与Chemo组相比,Pembro组显著延长了无进展生存期(PFS)[9.5个月,95%可信区间(CI): 7.5-11.5 vs. 7.2个月,95% CI: 5.7-8.7;风险比(HR) =0.64, 95% CI: 0.46 ~ 0.87;P = 0.004)。鳞状细胞肺癌(SCC)患者表现出显著的PFS获益(13.8个月,95% CI: 3.2-24.1 vs. 4.8个月,95% CI: 3.4-6.2;pv: 8.0个月,95% CI: 6.0-10.0;P = 0.56)。总生存期(OS)有利于Pembro组(21.2个月,95% CI: 16.0-26.4 vs. 20.1个月,95% CI: 15.5-24.7;Hr =0.71, 95% ci: 0.50-1.00;P = 0.052)。与化疗组的14.2个月(HR =0.42, 95% CI: 0.22-0.78)相比,Pembro组的SCC患者表现出显著的生存获益,中位OS未达到(95% CI: 6.3-22.1);P = 0.007)。pembroo组≥3级非免疫相关不良事件(non-irAEs)发生率(46.8%)高于Chemo组(33.1%,P=0.03)。此外,45例(39.5%)患者经历了63次irae,未观察到5级或新的irae。结论:Pembrolizumab联合化疗可以延长pd - l1阴性晚期NSCLC患者的生存期,特别是那些有鳞状组织的患者。
本文章由计算机程序翻译,如有差异,请以英文原文为准。
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来源期刊
CiteScore
7.20
自引率
2.50%
发文量
137
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.
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