Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.

Yuequan SHI; Xiaoyan LIU; Anwen LIU; Jian FANG; Qingwei MENG; Cuimin DING; Bin AI; Yangchun GU; Cuiying ZHANG; Chengzhi ZHOU; Yan WANG; Yongjie SHUI; Siyuan YU; Dongming ZHANG; Jia LIU; Haoran ZHANG; Qing ZHOU; Xiaoxing GAO; Minjiang CHEN; Jing ZHAO; Wei ZHONG; Yan XU; Mengzhao WANG

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Programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in patients with advanced non-small cell lung cancer: A retrospective, multicenter, observational study.

Author: Yuequan SHI ¹ ; Xiaoyan LIU ¹ ; Anwen LIU ² ; Jian FANG ³ ; Qingwei MENG ⁴ ; Cuimin DING ⁵ ; Bin AI ⁶ ; Yangchun GU ⁷ ; Cuiying ZHANG ⁸ ; Chengzhi ZHOU ⁹ ; Yan WANG ¹⁰ ; Yongjie SHUI ¹¹ ; Siyuan YU ¹ ; Dongming ZHANG ¹ ; Jia LIU ¹ ; Haoran ZHANG ¹ ; Qing ZHOU ¹ ; Xiaoxing GAO ¹ ; Minjiang CHEN ¹ ; Jing ZHAO ¹ ; Wei ZHONG ¹ ; Yan XU ¹ ; Mengzhao WANG ¹
Author Information

1. Department of Respiratory and Critical Care Medicine, Peking Union Medical College Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100730, China.
2. Department of Oncology, The Second Affiliated Hospital of Nanchang University, Nanchang University, Nanchang, Jiangxi 330006, China.
3. Department of Thoracic Oncology II, Key Laboratory of Carcinogenesis and Translational Research (Ministry of Education/Beijing), Peking University Cancer Hospital and Institute, Beijing 100142, China.
4. Department of Medical Oncology, Harbin Medical University Cancer Hospital, Harbin, Heilongjiang 150081, China.
5. Department of Respiratory Medicine, The Fourth Hospital of Hebei Medical University, Shijiazhuang, Hebei 050033, China.
6. Department of Medical Oncology, Beijing Hospital, National Center of Gerontology, Institute of Geriatric Medicine, Chinese Academy of Medical Sciences, Beijing 100005, China.
7. Department of Medical Oncology and Radiation Sickness, Peking University Third Hospital, Beijing 100191, China.
8. Department of Medical Oncology, Cancer Center, People's Hospital, Hohhot, Inner Mongolia Autonomous Region 750306, China.
9. Department of Respiratory and Critical Care Medicine, State Key Laboratory of Respiratory Disease, National Clinical Research Center of Respiratory Disease, Guangzhou Institute of Respiratory Health, The First Affiliated Hospital of Guangzhou Medical University, Guangzhou Medical University, Guangzhou, Guangdong 510120, China.
10. Department of Medical Oncology, National Cancer Center, National Clinical Research Center for Cancer, Cancer Hospital, Chinese Academy of Medical Sciences & Peking Union Medical College, Beijing 100021, China.
11. Department of Radiation Oncology, The Second Affiliated Hospital, Zhejiang University School of Medicine, Hangzhou, Zhejiang 310009, China.
Publication Type:Observational Study
Keywords: Immune-related adverse events; Non-small cell lung cancer; Prognosis; Programmed cell death-1/programmed cell death-ligand 1; Tumor proportional score
MeSH: Humans; Carcinoma, Non-Small-Cell Lung/metabolism*; Male; Female; Retrospective Studies; Middle Aged; Lung Neoplasms/metabolism*; Aged; B7-H1 Antigen/metabolism*; Programmed Cell Death 1 Receptor/metabolism*; Adult; Aged, 80 and over; Immune Checkpoint Inhibitors/therapeutic use*
From: Chinese Medical Journal 2025;138(14):1730-1740
CountryChina
Language:English
Abstract: BACKGROUND:This study aimed to investigate programmed death-ligand 1 tumor proportion score in predicting the safety and efficacy of PD-1/PD-L1 antibody-based therapy in treating patients with advanced non-small cell lung cancer (NSCLC) in a real-world setting.
METHODS:This retrospective, multicenter, observational study enrolled adult patients who received PD-1/PD-L1 antibody-based therapy in China and met the following criteria: (1) had pathologically confirmed, unresectable stage III-IV NSCLC; (2) had a baseline PD-L1 tumor proportion score (TPS); and (3) had confirmed efficacy evaluation results after PD-1/PD-L1 treatment. Logistic regression, Kaplan-Meier analysis, and Cox regression were used to assess the progression-free survival (PFS), overall survival (OS), and immune-related adverse events (irAEs) as appropriate.
RESULTS:A total of 409 patients, 65.0% ( n = 266) with a positive PD-L1 TPS (≥1%) and 32.8% ( n = 134) with PD-L1 TPS ≥50%, were included in this study. Cox regression confirmed that patients with a PD-L1 TPS ≥1% had significantly improved PFS (hazard ratio [HR] 0.747, 95% confidence interval [CI] 0.573-0.975, P = 0.032). A total of 160 (39.1%) patients experienced 206 irAEs, and 27 (6.6%) patients experienced 31 grade 3-5 irAEs. The organs most frequently associated with irAEs were the skin (52/409, 12.7%), thyroid (40/409, 9.8%), and lung (34/409, 8.3%). Multivariate logistic regression revealed that a PD-L1 TPS ≥1% (odds ratio [OR] 1.713, 95% CI 1.054-2.784, P = 0.030) was an independent risk factor for irAEs. Other risk factors for irAEs included pretreatment absolute lymphocyte count >2.5 × 10 9 /L (OR 3.772, 95% CI 1.377-10.329, P = 0.010) and pretreatment absolute eosinophil count >0.2 × 10 9 /L (OR 2.006, 95% CI 1.219-3.302, P = 0.006). Moreover, patients who developed irAEs demonstrated improved PFS (13.7 months vs. 8.4 months, P <0.001) and OS (28.0 months vs. 18.0 months, P = 0.007) compared with patients without irAEs.
CONCLUSIONS:A positive PD-L1 TPS (≥1%) was associated with improved PFS and an increased risk of irAEs in a real-world setting. The onset of irAEs was associated with improved PFS and OS in patients with advanced NSCLC receiving PD-1/PD-L1-based therapy.