Development and validation of a Nomogram for predicting severe irAEs in advanced NSCLC patients undergoing immunotherapy based on clinical features and inflammatory indicators_Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Authors：

YANG Juan ¹ , SUN Xiaoxuan ² , WANG Bin ¹ ,  GUO Xintao ¹

1. Department of Cardiothoracic Surgery, Tianjin Fourth Central Hospital, Tianjin, 300140, P. R. China;
2. Department of Pulmonary Oncology, Tianjin Cancer Hospital Airport Hospital, Tianjin, 300070, P. R China;

Corresponding?author：

GUO Xintao, Email: dszhxyy@126.com

Keywords：

Advanced non-small cell lung cancer; immunotherapy; severe immune-related adverse events; neutrophil-to-lymphocyte ratio; interleukin-6; C-reactive protein; predictive models

DOI：

10.7507/1007-4848.202509043

Video：

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Objective To develop and validate a Nomogram for predicting severe immune-related adverse events (irAEs) in patients with advanced non-small cell lung cancer (NSCLC) undergoing immunotherapy based on clinical features and inflammatory indicators. Methods A total of 423 patients with advanced NSCLC treated with immunotherapy between January 2023 and January 2025 at Tianjin Fourth Center Hospital and Tianjin Cancer Hospital Airport Hospital were enrolled. Patients were divided into a severe irAEs group (≥grade 3, n=76) and a non-severe irAEs group (n=347), then randomly allocated into training and validation cohorts (7:3 ratio) . Clinical data, neutrophil-to-lymphocyte ratio (NLR), and interleukin-6/C-reactive protein (IL-6/CRP) levels were collected. Independent risk factors for severe irAEs during immunotherapy in advanced NSCLC were identified through logistic regression analysis, and a nomogram model was constructed accordingly. The discriminative ability, accuracy, and clinical utility of the model were evaluated using receiver operating characteristic (ROC) curves, calibration curves, and decision curve analysis (DCA). Results Among the 423 included patients [274 males, 149 females, aged 44-78 (60.77±5.91) years], the overall incidence of irAEs was 57.92% (245/423), with severe irAEs occurring in 17.97% (76/423). Multivariate analysis revealed that Eastern Cooperative Oncology Group (ECOG) performance score ≥2, programmed death-ligand 1 (PD-L1) expression [tumor proportion score (TPS) ≥50%], combination therapy regimen, low NLR values, and high IL-6/CRP ratio were independent risk factors for severe irAEs during immunotherapy in advanced NSCLC (P<0.05). The area under the ROC curve (AUC) was 0.948 [95%CI (0.912, 0.985)] in the training cohort and 0.946 [95%CI (0.917, 0.976)] in the validation cohort. Calibration curves and DCA demonstrated good consistency and clinical net benefit of the model. Conclusion The nomogram integrating clinical features and inflammatory markers effectively predicts the risk of severe irAEs in advanced NSCLC patients receiving immunotherapy, exhibiting excellent discrimination, calibration, and clinical practicality.

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28.	Matsas S, Junior PNA, Giglio AD. Prognostic role of platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR) in advanced gastric cancer treated with immunotherapy: a systematic review and meta-analysis. J Clin Oncol, 2024, 42(3_suppl): 397-397.
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1. Bray F, Laversanne M, Sung H, et al. Global cancer statistics 2022: GLOBOCAN estimates of incidence and mortality worldwide for 36 cancers in 185 countries. CA Cancer J Clin, 2024, 74(3): 229-263.
2. Wang S, Cai M, Xiong Y, et al. Grade≥3 hematologic adverse events of immunotherapy in advanced NSCLC patients: a systematic review and meta-analysis. Eur J Clin Pharmacol, 2025, 81(4): 479-493.
3. 郭昊欣, 吳文博, 薛文飛, 等. 全身免疫炎癥指數聯合C反應蛋白/白蛋白對非小細胞肺癌的預后價值. 中國免疫學雜志, 2025, 41(7): 1605-1609.Guo HX, Wu WB, Xue WF, et al. Systemic immunoinflammatory index combined with ratio of C-reactive protein to albumin to evaluate prognosis of patients with non-small cell lung cancer. Chin J Immunol, 2025, 41(7): 1605-1609.
4. 羅家江. 溫陽散結湯聯合免疫治療對表皮生長因子受體突變晚期非小細胞肺癌患者臨床預后的作用分析. 中華中醫藥學刊, 2025, 43(3): 178-181.Luo JJ. Effect of Wenyang Sanjie Decoction combined with immunotherapy on clinical prognosis of advanced non-small cell lung cancer patients with epidermal growth factor receptor mutation. Chin Arch Tradit Chin Med, 2025, 43(3): 178-181.
5. Xu M, Wang Y, Wang K, et al. Efficacy of immune checkpoint inhibitor rechallenge in initial immunotherapy responders with advanced non-small cell lung cancer: a single-center retrospective study. Invest New Drugs, 2024, 42(6): 703-715.
6. Facchinetti F, Camerini A, Bennati C, et al. A prospective study on clinicians' attitudes and survival outcomes for patients with advanced NSCLC and poor performance status in the immunotherapy era: PICASSO (GOIRC-04-2020). Lung Cancer, 2025, 204: 108580.
7. Jeong H, Koh J, Kim S, et al. Cell-intrinsic PD-L1 signaling drives immunosuppression by myeloid-derived suppressor cells through IL-6/Jak/Stat3 in PD-L1-high lung cancer. J Immunother Cancer, 2025, 13(3): e010612.
8. 劉瑤, 田建輝, 楊蘊. 非小細胞肺癌免疫治療獲得性耐藥研究進展. 中國腫瘤生物治療雜志, 2025, 32(4): 437-441.Liu Y, Tian JH, Yang Y. Research progress on immunotherapy-acquired drug resistance in non-small cell carcinoma. Chin J Cancer Biother, 2025, 32(4): 437-441.
9. 李媛, 郭凌川, 袁勇, 等. PD-L1檢測指導中國非小細胞肺癌患者免疫治療的成本效果分析. 中國癌癥雜志, 2025, 35(2): 237-248.Li Y, Guo LC, Yuan Y, et al. Cost-effectiveness analysis of PD-L1 detection guiding immunotherapy in Chinese patients with non-small cell lung cancer. Chin J Cancer, 2025, 35(2): 237-248.
10. De Giglio A, De Biase D, Favorito V, et al. STK11 mutations correlate with poor prognosis for advanced NSCLC treated with first-line immunotherapy or chemo-immunotherapy according to KRAS, TP53, KEAP1, and SMARCA4 status. Lung Cancer, 2025, 199: 108058.
11. 徐年興, 魏東, 喬俊杰, 等. CD8+、IL-6和PaO2對不可切除ⅢB/C和Ⅳ期非小細胞肺癌免疫治療觸發放射召回性肺炎的預測價值. 山東大學學報 (醫學版), 2025, 63(2): 29-35.Xu NX, Wei D, Qiao JJ, et al. Predictive value of CD8, IL-6, and PaO2 for immunotherapy-triggered radiation recall pneumonitis in unresectable stage ⅢB/C and Ⅳ non-small cell lung cancer. J Shandong Univ (Health Sci), 2025, 63(2): 29-35.
12. Ozawa Y, Koh Y, Shibaki R, et al. Uncovering the role of tumor cGAS expression in predicting response to PD-1/L1 inhibitors in non-small cell lung cancer. Cancer Immunol Immunother, 2025, 74(1): 7.
13. 中國臨床腫瘤學會指南工作委員會. 中國臨床腫瘤學會(CSCO)免疫檢查點抑制劑相關的毒性管理指南(2021)[M]. 北京: 人民衛生出版社, 2021: 33-118.Guidelines Working Committee of Chinese Society of Clinical Oncology. Guidelines of Chinese Society of Clinical Oncology (CSCO) for management of immune checkpoint inhibitor-related toxicity (2021). Beijing: People's Medical Publishing House, 2021: 33-118.
14. Eisenhauer EA, Therasse P, Bogaerts J, et al. New response evaluation criteria in solid tumours: revised RECIST guideline (version 1. 1). Eur J Cancer, 2009, 45(2): 228-247.
15. 江山, 王樂朋, 陳大川, 等. iSEND免疫評分聯合LIPI在評估非小細胞肺癌免疫治療預后中的價值. 中國腫瘤生物治療雜志, 2025, 32(1): 79-84.Jiang SH, Wang LP, Chen DC, et al. Value of iSEND immune score combined with LIPI in evaluating prognosis of non-small cell lung cancer immunotherapy. Chin J Cancer Biother, 2025, 32(1): 79-84.
16. 張耀文, 溫晶媛, 汪晨宇, 等. 放療在免疫聯合化療一線治療非小細胞肺癌寡轉移患者中的應用價值. 中華放射醫學與防護雜志, 2025, 45(2): 91-100.Zhang YW, Wen JY, Wang CY, et al. Role of radiotherapy in combined immunotherapy and chemotherapy as first-line treatment for oligometastatic non-small cell lung cancer. Chin J Radiol Med Prot, 2025, 45(2): 91-100.
17. Park JS, Lee ME, Jang WS, et al. Effect of cytoreductive nephrectomy on efficacy of immunotherapy in metastatic renal cell carcinoma by decreasing IL-6 to modulate tumor-associated macrophage and myeloid-derived suppressor cell. J Clin Oncol, 2024, 42(4): 457-457.
18. 國家老年醫學中心, 北京腫瘤學會肺癌專業委員會, 中華老年醫學雜志編輯委員會. 老年晚期非小細胞肺癌免疫檢查點抑制劑治療中國專家共識(2025版). 中華老年醫學雜志, 2025, 44(6): 677-690.National Geriatrics Center, Lung Cancer Committee of Beijing Cancer Society, Editorial Board of Chinese Journal of Geriatrics. Chinese expert consensus on immune checkpoint inhibitor therapy for elderly patients with advanced non-small cell lung cancer (2025 edition). Chin J Geriatr, 2025, 44(6): 677-690.
19. 田夢婕, 梁新軍. 晚期非小細胞肺癌免疫治療不良反應及其與療效的相關性. 安徽醫科大學學報, 2025, 60(4): 755-760.Tian MJ, Liang XJ. Adverse effects of immunotherapy in advanced non-small cell lung cancer and their correlation with efficacy. J Anhui Med Univ, 2025, 60(4): 755-760.
20. Cook S, Samuel V, Meyers DE, et al. Immune-related adverse events and survival among patients with metastatic NSCLC treated with immune checkpoint inhibitors. JAMA Netw Open, 2024, 7(1): e2352302.
21. Murata D, Azuma K, Murotani K, et al. Characterization of pre- and on-treatment soluble immune mediators and tumor microenvironment in NSCLC patients receiving PD-1/L1 inhibitor monotherapy. Cancer Immunol Immunother, 2024, 73(11): 214.
22. 王一博, 王新娟, 程琳, 等. 晚期非小細胞肺癌患者應用免疫治療后出現甲狀腺功能異常與療效的相關性分析. 中國肺癌雜志, 2023, 26(5): 369-376.Wang YB, Wang XJ, Cheng L, et al. Correlation analysis between thyroid function abnormality and efficacy in patients with advanced non-small cell lung cancer after immunotherapy. Chin J Lung Cancer, 2023, 26(5): 369-376.
23. Fau S, Zalogo EF. Enhancing immunotherapy outcomes in advanced NSCLC: role of sleep hygiene education and physical exercise as non-pharmacological interventions. J Psychosom Res, 2025, 188: 111993.
24. Kashiwada T, Takano R, Ando F, et al. Lysosomal degradation of PD-L1 is associated with immune-related adverse events during anti-PD-L1 immunotherapy in NSCLC patients. Front Pharmacol, 2024, 15: 1384733.
25. 邱麗亮, 程玖玲, 王華啟. NSCLC患者免疫檢查點抑制劑相關性肺炎臨床特點及其危險因素分析. 解放軍醫學雜志, 2024, 49(8): 861-867.Qiu LL, Cheng JL, Wang HQ. Analysis of clinical characteristics and risk factors of immune checkpoint inhibitor-associated pneumonia in NSCLC patients. Med J Chin People's Liber Army, 2024, 49(8): 861-867.
26. Wang H, Yang R, Zhou K, et al. Association between pretreatment C-reactive protein level and survival in non-small cell lung cancer patients treated with immune checkpoint inhibitors: a meta-analysis. Int Immunopharmacol, 2023, 124(Pt B): 110937.
27. 郭琳, 區頌雷, 張韶巖, 等. PCI后非小細胞肺癌患者新輔助免疫治療聯合化療的效果分析. 中華醫學雜志, 2025, 105(19): 1549-1552.Guo L, Ou SL, Zhang SY, et al. Analysis of efficacy of neoadjuvant immunotherapy combined with chemotherapy in non-small cell lung cancer patients after percutaneous coronary intervention. Chin Med J, 2025, 105(19): 1549-1552.
28. Matsas S, Junior PNA, Giglio AD. Prognostic role of platelet-to-lymphocyte ratio (PLR) and neutrophil-to-lymphocyte ratio (NLR) in advanced gastric cancer treated with immunotherapy: a systematic review and meta-analysis. J Clin Oncol, 2024, 42(3_suppl): 397-397.
29. 王晨, 李艷, 管燕, 等. EGFR-TKIs治療失敗非小細胞肺癌患者采用免疫聯合化療及貝伐珠單抗治療的療效及影響因素. 中華醫學雜志, 2023, 103(16): 1210-1216.Wang CH, Li Y, Guan Y, et al. Efficacy and safety of epidermal growth factor receptor tyrosine kinase inhibitors combined with chemotherapy as first-line treatment for epidermal growth factor receptor-mutant advanced non-small cell lung cancer. Chin Med J, 2023, 103(16): 1210-1216.
30. 陳麗, 陳俊濤, 榮劉濤. 循環Hcy、NLR、VEGF-C、CYFRA21-1聯合檢測對非小細胞肺癌淋巴結轉移的預測價值. 臨床和實驗醫學雜志, 2024, 23(17): 1861-1864.Chen L, Chen JT, Rong LT. Predictive value of combined detection of circulating Hcy, NLR, VEGF-C and CYFRA21-1 for lymph node metastasis of non-small cell lung cancer. J Clin Exp Med, 2024, 23(17): 1861-1864.
31. Mehra T, Dongre K, Boesing M, et al. Pre-treatment comorbidities, C-reactive protein and eosinophil count, and immune-related adverse events as predictors of survival with checkpoint inhibition for multiple tumour entities. Cancer Med, 2023, 12(11): 12253-12262.
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Chinese Journal of Clinical Thoracic and Cardiovascular Surgery

Latest ArticlesDevelopment and validation of a Nomogram for predicting severe irAEs in advanced NSCLC patients undergoing immunotherapy based on clinical features and inflammatory indicators

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