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Objective <p>This study aims to evaluate the clinical efficacy of combining spleen‑nourishing and qi‑tonifying therapy with programmed cell death protein 1 (PD‑1)/programmed death‑ligand 1 (PD‑L1) inhibitors in patients with stage IIIB–IV non‑small cell lung cancer (NSCLC), and to develop a survival prediction model based on progression‑free survival (PFS) and overall survival (OS).</p> Methods <p>A retrospective cohort of 246 patients with stage IIIB–IV NSCLC receiving immunotherapy at the Tumor Medicine Center of the First Hospital of Hunan University of Chinese Medicine from September 2019 to October 2024 is assembled. Patients are categorized into a traditional Chinese medicine (TCM) group (<i>n</i> = 174) or a control group (<i>n</i> = 72) according to use of TCM decoctions. Baseline clinical and pathological characteristics and treatment data are collected. Cox proportional hazards regression is used to analyze survival‑related factors. Kaplan–Meier curves and log‑rank tests are used to compare survival. Logistic regression is used to identify factors associated with the objective response rate (ORR). Survival prediction models based on PFS and OS are constructed and validated.</p> Results <p>Median PFS is 5.9 months in the TCM group versus 2.9 months in the control group (<i>P</i> &lt; 0.001), and median OS is 22.3 versus 14.8 months (<i>P</i> &lt; 0.001). On multivariable analysis, TCM intervention, PD‑L1 expression, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and cytokeratin fragment 21‑1 (CYFRA21‑1) are independent predictors of PFS; TCM intervention, brain metastasis, and carcinoembryonic antigen (CEA) independently influence OS. The 6‑month PFS rate, 1‑year PFS rate, and 1‑year OS rate are significantly higher in the TCM combination group than in controls (<i>P</i> &lt; 0.05). TCM intervention and sex are independent predictors of ORR (<i>P</i> &lt; 0.05). Model validation shows areas under the curve (AUCs) of 0.705 (PFS) and 0.636 (OS) in the prediction-model group, and 0.879 (PFS) and 0.765 (OS) for internal validation.</p> Conclusion <p>The addition of TCM to PD‑1/PD‑L1 inhibitors prolongs PFS and OS in patients with stage IIIB–IV NSCLC. A survival prediction model based on routine clinical characteristics demonstrates predictive utility, offering a potential tool to inform clinical decision‑making.</p>

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Clinical Retrospective Study on the Role of Spleen-Invigorating and Qi-Supporting Therapy in Non-Small Cell Lung Cancer Immunotherapy and Construction of Survival Prediction Model

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年12月2日

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  • Ziyi Chen,
  • Jiangnan Huang,
  • Chun Shen,
  • Yaoyao Li,
  • Zhi Wen,
  • Yinhui Sun,
  • Hua Liu,
  • Lihuai Wang

摘要

Objective

This study aims to evaluate the clinical efficacy of combining spleen‑nourishing and qi‑tonifying therapy with programmed cell death protein 1 (PD‑1)/programmed death‑ligand 1 (PD‑L1) inhibitors in patients with stage IIIB–IV non‑small cell lung cancer (NSCLC), and to develop a survival prediction model based on progression‑free survival (PFS) and overall survival (OS).

Methods

A retrospective cohort of 246 patients with stage IIIB–IV NSCLC receiving immunotherapy at the Tumor Medicine Center of the First Hospital of Hunan University of Chinese Medicine from September 2019 to October 2024 is assembled. Patients are categorized into a traditional Chinese medicine (TCM) group (n = 174) or a control group (n = 72) according to use of TCM decoctions. Baseline clinical and pathological characteristics and treatment data are collected. Cox proportional hazards regression is used to analyze survival‑related factors. Kaplan–Meier curves and log‑rank tests are used to compare survival. Logistic regression is used to identify factors associated with the objective response rate (ORR). Survival prediction models based on PFS and OS are constructed and validated.

Results

Median PFS is 5.9 months in the TCM group versus 2.9 months in the control group (P < 0.001), and median OS is 22.3 versus 14.8 months (P < 0.001). On multivariable analysis, TCM intervention, PD‑L1 expression, alkaline phosphatase (ALP), lactate dehydrogenase (LDH), and cytokeratin fragment 21‑1 (CYFRA21‑1) are independent predictors of PFS; TCM intervention, brain metastasis, and carcinoembryonic antigen (CEA) independently influence OS. The 6‑month PFS rate, 1‑year PFS rate, and 1‑year OS rate are significantly higher in the TCM combination group than in controls (P < 0.05). TCM intervention and sex are independent predictors of ORR (P < 0.05). Model validation shows areas under the curve (AUCs) of 0.705 (PFS) and 0.636 (OS) in the prediction-model group, and 0.879 (PFS) and 0.765 (OS) for internal validation.

Conclusion

The addition of TCM to PD‑1/PD‑L1 inhibitors prolongs PFS and OS in patients with stage IIIB–IV NSCLC. A survival prediction model based on routine clinical characteristics demonstrates predictive utility, offering a potential tool to inform clinical decision‑making.