1.Clinical efficacy of Huangkui capsules in the treatment of targeted drug-related proteinuria in patients with hepatocellular carcinoma
Miao LI ; Jia YUAN ; Chu LIU ; Maopei CHEN ; Xin XU ; Ningling GE ; Yi CHEN ; Lan ZHANG ; Rongxin CHEN ; Yan WANG
Chinese Journal of Clinical Medicine 2026;33(1):88-94
Objective To investigate the therapeutic effect of Huangkui capsules on targeted drug-related proteinuria in patients with hepatocellular carcinoma (HCC). Methods A retrospective analysis was conducted on clinical data of HCC patients with targeted drug-related proteinuria from June 2023 to December 2024 at Zhongshan Hospital, Fudan University. According to the treatment plan, patients were divided into the conventional treatment group and the Huangkui combination treatment group (Huangkui capsules combined with conventional treatment), and the clinical efficacy between the two groups was compared. The logistic regression analysis was used to identify the main factors affecting treatment efficacy. Results The Huangkui combination treatment group (n=29) showed a significantly higher overall effective rate (79.3% vs 42.3%, P=0.005), and an earlier proteinuria improvement (median time: 3 months vs 6 months, P=0.008) than the conventional treatment group (n=26) . The multivariate logistic regression analysis showed angiotensin-converting enzyme inhibitor (ACEI) or angiotensin Ⅱ receptor blocker (ARB) using (OR=0.190, 95%CI 0.045-0.808, P=0.025), targeted drug adjustment (OR=0.132, 95%CI 0.030-0.581, P=0.007), and Huangkui capsules using (OR=0.168, 95%CI 0.039-0.730, P=0.017) were protective factors for treatment efficacy of targeted drug-related proteinuria. Conclusions On the basis of conventional treatment, additive treatment with Huangkui capsules can alleviate targeted drug-related proteinuria faster and more effectively in HCC patients.
2.Impact of number of positive regional lymph nodes in N1 stage on the prognosis of patients with non-small cell lung cancer: A propensity score matching study
Dandan LIU ; Jiachen WANG ; Lidan CHANG ; Jia CHEN ; Ranran KONG ; Shiyuan LIU ; Minxia ZHU ; Jiantao JIANG ; Shaomin LI ; Zhengshui XU
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):63-71
Objective To explore the impact of number of positive regional lymph nodes (nPRLN) in N1 stage on the prognosis of non-small cell lung cancer (NSCLC) patients. Methods Patients with TxN1M0 stage NSCLC who underwent lobectomy and mediastinal lymph node dissection from 2010 to 2015 were screened from SEER database (17 Regs, 2022nov sub). The optimal cutoff value of nPRLN was determined using X-tile software, and patients were divided into 2 groups according to the cutoff value: a nPRLN≤optimal cutoff group and a nPRLN>optimal cutoff group. The influence of confounding factors was minimized by propensity score matching (PSM) at a ratio of 1 : 1. Kaplan-Meier curves and Cox proportional hazards models were used to evaluate overall survival (OS) and lung cancer-specific survival (LCSS) of patients. Results A total of 1316 patients with TxN1M0 stage NSCLC were included, including 662 males and 654 females, with a median age of 67 (60, 73) years. The optimal cutoff value of nPRLN was 3, with 1165 patients in the nPRLN≤3 group and 151 patients in the nPRLN>3 group. After PSM, there were 138 patients in each group. Regardless of before or after PSM, OS and LCSS of patients in the nPRLN≤3 group were superior to those in the nPRLN>3 group (P<0.001). N1 stage nPRLN>3 was an independent prognostic risk factor for OS [HR=1.52, 95%CI (1.22, 1.89), P<0.001] and LCSS [HR=1.72, 95%CI (1.36, 2.18), P<0.001]. Conclusion N1 stage nPRLN>3 is an independent prognostic risk factor for NSCLC patients in TxN1M0 stage, which may provide new evidence for future revision of TNM staging N1 stage subclassification.
3.Preoperative evaluation of lung function in patients with lung cancer using two-phase dual-energy CT perfusion imaging
Lifang LING ; Yizhen JIA ; Qinmin HAO ; Wenzheng XU ; Zhibo WANG ; Jun WANG ; Liang CHEN ; Mei YUAN
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2026;33(01):79-86
Objective To explore the application value of dual-phase dual-energy CT (DECT) perfusion imaging in preoperative lung function assessment of lung cancer patients. Methods Data were collected from patients with stageⅠA non-small cell lung cancer who underwent surgical treatment in the Department of Thoracic Surgery, the First Affiliated Hospital of Nanjing Medical University, from November 2022 to June 2024. All patients underwent DECT perfusion imaging and pulmonary function testing (PFT) before surgery. PFT observation indicators included ventilation function indicators such as forced expiratory volume in one second (FEV1), forced vital capacity (FVC), 1-second rate (FEV1/FVC), maximal voluntary ventilation (MVV), and diffusion function indicators such as diffusing capacity for carbon monoxide (DLCO) and DLCO per liter of alveolar volume (DLCO/VA). The software eXamine was used to obtain quantitative parameters of DECT perfusion imaging, including volume parameters and perfusion parameters of both lungs and each lung lobe. The correlation between the volume parameters and perfusion parameters of both lungs and the ventilation and diffusion function indicators of the patients, as well as the differences in quantitative parameters of each lung lobe, was analyzed. Results The end-inspiration lung volume and biphasic volume difference were strongly positively correlated with FEV1 and FVC (r=0.636, r=0.682, r=0.614, r=0.624, P<0.001) and moderately positively correlated with MVV and DLCO (r=0.499, r=0.514, r=0.549, r=0.447, P<0.001); the end-expiration lung volume was weakly negatively correlated with DLCO/VA (r=−0.295, P=0.026); the volume ratio was positively correlated with FEV1, FVC, MVV, and MVV% (r=0.424, r=0.399, r=0.415, r=0.310, P<0.05); the end-inspiration iodine content was weakly positively correlated with DLCO/VA% (rs=0.292, P=0.030); the end-expiration iodine content was weakly positively correlated with FEV1, FVC, MVV, DLCO%, and DLCO/VA (r=0.307, r=0.299, r=0.295, r=0.366, r=0.320, P<0.05) and moderately positively correlated with DLCO (r=0.439, P<0.001); the end-inspiration iodine concentration was negatively correlated with FEV1, FVC, MVV, and MVV% (rs=−0.407, rs=−0.426, rs=−0.352, rs=−0.277, P<0.05); the end-expiratory phase iodine concentration was moderately positively correlated with DLCO/VA (r=0.403, P=0.002); both the iodine concentration difference and the iodine concentration ratio were moderately positively correlated with FEV1, FEV1%, FVC, MVV, MVV% (P<0.05). The lung volume and iodine concentration ratio values were both highest in the left upper lung lobe and lowest in the right middle lung lobe; the differences in lung volume, lung volume ratio, intrapulmonary iodine content, and intrapulmonary iodine concentration were all highest in the lower lobes of both lungs and lowest in the middle lobe of the right lung. Conclusion Dual-phase DECT perfusion imaging can accurately assess overall lung function and quantify regional lung function.
4.Effect of Dictamni Cortex on Intestinal Barrier Damage by Untargeted Metabolomics and Targeted Metabolomics for Short-chain Fatty Acids
Xiaomin XU ; Donghua YU ; Yu WANG ; Pingping CHEN ; Jiameixue WO ; Suxia JIA ; Wenkai HU ; Fang LU ; Shumin LIU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(20):40-47
ObjectiveThis study aims to investigate the effect of Dictamni Cortex on intestinal barrier damage in rats and its mechanism by untargeted metabolomics and targeted metabolomics for short-chain fatty acids (SCFAs). MethodsRats were randomly divided into a control group, a high-dose group of Dictamni Cortex (8.1 g·kg-1), a medium-dose group (2.7 g·kg-1), and a low-dose group (0.9 g·kg-1). Except for the control group, the other groups were administered different doses of Dictamni Cortex by gavage for eight consecutive weeks. Hematoxylin-eosin (HE) staining was used to observe the pathological changes in the ileal tissue. Enzyme-linked immunosorbent assay (ELISA) was employed to detect the level of cytokines, including tumor necrosis factor-α (TNF-α), interleukin-6 (IL-6), and interleukin-1β (IL-1β), in the ileal tissue of rats. Quantitative real-time fluorescence polymerase chain reaction (Real-time PCR) technology was used to detect the expression level of tight junction proteins, including zonula occludens-1 (ZO-1), Occludin, and Claudin-1 mRNAs, in the ileal tissue of rats to preliminarily explore the effects of Dictamni Cortex on intestinal damage. The dose with the most significant toxic phenotype was selected to further reveal the effects of Dictamni Cortex on the metabolic profile of ileal tissue in rats by non-targeted metabolomics combined with targeted metabolomics for SCFAs. ResultsCompared with the control group, all doses of Dictamni Cortex induced varying degrees of pathological damage in the ileum, increased TNF-α (P<0.01), IL-6 (P<0.01), and IL-1β (P<0.01) levels in the ileal tissue, and decreased the expression level of ZO-1 (P<0.05, P<0.01), Occludin (P<0.01), and Claudin-1 (P<0.05) in the ileal tissue, with the high-dose group showing the most significant toxic phenotypes. The damage mechanisms of the high-dose group of Dictamni Cortex on the ileal tissue were further explored by integrating non-targeted metabolomics and targeted metabolomics for SCFAs. The non-targeted metabolomics results showed that 21 differential metabolites were identified in the control group and the high-dose group. Compared with that in the control group, after Dictamni Cortex intervention, the level of 14 metabolites was significantly increased (P<0.05, P<0.01), and the level of seven metabolites was significantly decreased (P<0.05, P<0.01) in the ileal contents. These metabolites collectively acted on 10 related metabolic pathways, including glycerophospholipids and primary bile acid biosynthesis. The quantitative data of targeted metabolomics for SCFAs showed that Dictamni Cortex intervention disrupted the level of propionic acid, butyric acid, acetic acid, caproic acid, isobutyric acid, isovaleric acid, valeric acid, and isocaproic acid in the ileal contents of rats. Compared with those in the control group, the level of isobutyric acid, isovaleric acid, and valeric acid were significantly increased, while the level of propionic acid, butyric acid, and acetic acid were significantly decreased in the ileal contents of rats after Dictamni Cortex intervention (P<0.05, P<0.01). ConclusionDictamni Cortex can induce intestinal damage by regulating glycerophospholipid metabolism, primary bile acid biosynthesis, and metabolic pathways for SCFAs.
5.Effect of postoperative radiotherapy after complete resection in patients with stage ⅢA-N2 non-small cell lung cancer: A propensity score matching analysis
Zhengshui XU ; Minxia ZHU ; Jiantao JIANG ; Shiyuan LIU ; Jia CHEN ; Danjie ZHANG ; Jianzhong LI ; Liangzhang SUN ; Shaomin LI
Chinese Journal of Clinical Thoracic and Cardiovascular Surgery 2025;32(07):1006-1012
Objective To evaluate the value of postoperative radiotherapy (PORT) in patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy. Methods Patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy were chosen from the SEER Research Plus Database [17 Registries, November 2012 Submission (2000-2019)]. The patients were divided into a PORT group and a non-PORT group according to whether the PORT was used. To balance baseline characteristics between non-PORT and PORT groups, R software was used to conduct a propensity score matching (PSM) with a ratio of 1 : 1 and a matching tolerance of 0.01. Both the Cox regression analysis and Kaplan-Meier survival analysis were conducted to evaluate the value of PORT in terms of overall survival (OS) and disease-specific survival (DSS). Results In total, 2468 patients with stage ⅢA-N2 non-small cell lung cancer were enrolled, including 1078 males and 1390 females with a median age of 65 (58-71) years. There were 1336 patients in the PORT group, and 1132 patients in the non-PORT group. Cox regression analysis showed that PORT was not significantly associated with OS (multivariate analysis: HR=1.051, 95%CI 0.949-1.164, P=0.338) and DSS (multivariate analysis: HR=1.094, 95%CI 0.976-1.225, P=0.123). No statistical difference was found in the OS or DSS between non-PORT group and PORT group after PSM analysis (P>0.05). Conclusion PORT does not have a survival benefit for patients with stage ⅢA-N2 non-small cell lung cancer who received complete resection and chemotherapy.
6.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza, and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter, prospective, non-randomized, parallel, controlled trial was conducted from October 2021 to May 2022 in five hospitals, including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness (ILI) cases were collected, and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention, they were assigned to the observation group (108 cases) or the control group (108 cases). Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine (TCM) symptom score scale for influenza, influenza-related emergency (outpatient) visit rate, influenza hospitalization rate, and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled, with 108 in the observation group and 108 in the control group. Primary outcomes: (1) Incidence of ILI: The incidence was 12.0% (13/108) in the observation group and 23.1% (25/108) in the control group, with the observation group showing a significantly lower incidence (χ2=4.6, P<0.05). (2) Influenza confirmation rate: 3.7% (4/108) in the observation group and 4.6% (5/108) in the control group, with no statistically significant difference. Secondary outcomes: (1) TCM symptom score scale: after onset, nasal congestion and runny nose scores differed significantly between the two groups (P<0.05), while other symptoms such as fever, sore throat, and cough showed no significant differences. (2) Influenza-related emergency (outpatient) visit rate: 84.6% (11 cases) in the observation group and 96.0% (24 cases) in the control group, with no significant difference. (3) Time to onset after exposure: The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group, with a statistically significant difference (P<0.05). ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions, Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.
7.Development and reliability-validity testing of ICU Nurses′ Work Stressors Scale
Jia XU ; Guanjie CHEN ; Xiaoqing LI ; Yun YU
China Occupational Medicine 2025;52(3):264-269
Objective To develop a scale suitable for assessing work stressors among intensive care unit (ICU) nurses and to examine its reliability and validity. Methods The initial questionnaire of the ICU Nurses' Work Stressors Scale was constructed through literature review, ICU nurse interviews, and Delphi expert consultation. A total of 434 ICU nurses were selected as the validation subjects using the convenient sampling method. Item analysis, exploratory factor analysis, and confirmatory factor analysis were conducted to finalize the version of the ICU Nurses' Work Stressors Scale and evaluate its reliability and validity. Results The ICU Nurses' Work Stressors Scale included six dimensions and 34 items. Exploratory factor analysis extracted six common factors with a cumulative variance contribution rate of 77.8%. The results of confirmatory factor analysis demonstrated good model fit. The scale-level content validity index of the scale was 0.965, with item-level content validity index ranging from 0.850 to 1.000. The overall Cronbach's α coefficient of the questionnaire was 0.958, and the test-retest reliability was 0.986. In a survey of 434 ICU nurses testing with the scale, the total score ranged from 22.0-160.0 (82.6±20.6) points. The scores of each dimension including nursing profession, workload, working environment, patient care, family factors and interpersonal relationship were (14.5±4.2), (21.9±5.8), (7.0±2.1), (14.1±4.2), (6.3±2.5) and (18.8±5.7) points, respectively. Conclusion ICU Nurses' Work Stressors Scale demonstrates good reliability and validity and can serve as an effective tool for evaluating work stress among ICU nurses.
8.Clinical Efficacy of Xiaoji Hufei Formula in Protecting Children with Close Contact Exposure to Influenza: A Multicenter,Prospective, Non-randomized, Parallel, Controlled Trial
Jing WANG ; Jianping LIU ; Tiegang LIU ; Hong WANG ; Yingxin FU ; Jing LI ; Huaqing TAN ; Yingqi XU ; Yanan MA ; Wei WANG ; Jia WANG ; Haipeng CHEN ; Yuanshuo TIAN ; Yang WANG ; Chen BAI ; Zhendong WANG ; Qianqian LI ; He YU ; Xueyan MA ; Fei DONG ; Liqun WU ; Xiaohong GU
Chinese Journal of Experimental Traditional Medical Formulae 2025;31(21):223-230
ObjectiveTo evaluate the efficacy and safety of Xiaoji Hufei Formula in protecting children with close contact exposure to influenza, and to provide reference and evidence-based support for better clinical prevention and treatment of influenza in children. MethodsA multicenter, prospective, non-randomized, parallel, controlled trial was conducted from October 2021 to May 2022 in five hospitals, including Dongfang Hospital of Beijing University of Chinese Medicine. Confirmed influenza cases and influenza-like illness (ILI) cases were collected, and eligible children with close contact exposure to these cases were recruited in the outpatient clinics. According to whether the enrolled close contacts were willing to take Xiaoji Hufei formula for influenza prevention, they were assigned to the observation group (108 cases) or the control group (108 cases). Follow-up visits were conducted on days 7 and 14 after enrollment. The primary outcomes were the incidence of ILI and the rate of laboratory-confirmed influenza. Secondary outcomes included traditional Chinese medicine (TCM) symptom score scale for influenza, influenza-related emergency (outpatient) visit rate, influenza hospitalization rate, and time to onset after exposure to influenza cases. ResultsA total of 216 participants were enrolled, with 108 in the observation group and 108 in the control group. Primary outcomes: (1) Incidence of ILI: The incidence was 12.0% (13/108) in the observation group and 23.1% (25/108) in the control group, with the observation group showing a significantly lower incidence (χ2=4.6, P<0.05). (2) Influenza confirmation rate: 3.7% (4/108) in the observation group and 4.6% (5/108) in the control group, with no statistically significant difference. Secondary outcomes: (1) TCM symptom score scale: after onset, nasal congestion and runny nose scores differed significantly between the two groups (P<0.05), while other symptoms such as fever, sore throat, and cough showed no significant differences. (2) Influenza-related emergency (outpatient) visit rate: 84.6% (11 cases) in the observation group and 96.0% (24 cases) in the control group, with no significant difference. (3) Time to onset after exposure: The median onset time after exposure to index patients was 7 days in the observation group and 4 days in the control group, with a statistically significant difference (P<0.05). ConclusionIn previously healthy children exposed to infectious influenza cases under unprotected conditions, Xiaoji Hufei formula prophylaxis significantly reduced the incidence of ILI. Xiaoji Hufei Formula can be recommended as a specific preventive prescription for influenza in children.
9.Study on the mechanism of Cuscuta chinensis flavonoids promoting decidualization and improving recurrent spontaneous abortion
Fang FANG ; Ying CUI ; Jialü HUANG ; Lili CHEN ; Jia XU ; Yunhui WAN
China Pharmacy 2025;36(19):2379-2386
OBJECTIVE To explore the mechanism by which Cuscuta chinensis flavonoids (CCF) promote decidualization and improve recurrent spontaneous abortion (RSA). METHODS HTR-8/SVneo cells in logarithmic growth phase were randomly divided into blank group, lipopolysaccharide (LPS) group, CCF group, SGK2 inhibitor (GSK650394, abbreviated as “GSK”) group and CCF+GSK group. Each group was treated with the corresponding agents accordingly. HTR-8/SVneo cells with SGK2 knockdown were randomly divided into small interfering RNA of SGK2 (siSGK2) group and siSGK2+CCF group; additionally, blank group and LPS group were established; each group was treated with the corresponding agents accordingly. The cell survival rate, expression levels of WNK signaling pathway- and decidualization-related proteins and mRNAs, as well as mitochondrial membrane potential levels, were assessed in each group before and after SGK2 knockdown. RSA mice model was constructed and randomly divided into model group, CCF low-dose group, CCF high-dose group, GSK group, and combined dosing group, with 4 mice in each group. Other 4 normal pregnant female mice were selected as the control group. The number of implanted embryos, viable fetuses, and lost embryos in mice was recorded. The morphological changes of endometrium and decidualization were observed, and WNK signaling pathway- and decidualization-related proteins and mRNAs expressing levels as well as mitochondrial membrane potential levels were all detected. RESULTS Compared with the blank group, the cell survival rate, as well as the protein and mRNA expression levels of SGK2, WNK1, WNK4, prolactin, insulin-like growth factor- binding protein-1, oxidative stress responsive kinase 1, and Ste20-like proline-/alanine-rich kinase were significantly reduced in the LPS group (P<0.05); compared with the LPS group, the cell survival rate and the expression levels of the above- mentioned proteins and mRNAs were significantly increased in the CCF group, while the cell survival rate and the expression levels of the above-mentioned proteins and mRNAs were significantly decreased in the GSK group (P<0.05); compared with the CCF group, the cell survival rate and the expression levels of the above-mentioned proteins and mRNAs were significantly reduced in the CCF+GSK group (P<0.05). After knocking down SGK2, compared with the LPS group, the cell survival rate, red/green fluorescence intensity ratio, and the expression levels of the above-mentioned proteins and mRNAs were significantly reduced in the siSGK2 group (P<0.05); compared with the siSGK2 group, the cell survival rate, red/green fluorescence intensity ratio, and the expression levels of the above-mentioned proteins and mRNAs were significantly increased in the siSGK2+CCF group (P<0.05). The in vivo experimental results showed that CCF treatment can significantly improve the number of implanted embryos and viable fetuses in RSA model mice and reduce lost embryos, the expression levels of the above-mentioned proteins and mRNAs in endometrial tissue were significantly increased, and the red/green fluorescence intensity ratio was significantly increased (P< 0.05); the combined dosing group could reverse the effect of CCF (P<0.05). CONCLUSIONS CCF can activate SGK2, up- regulate the WNK signaling pathway, promote endometrial decidualization, and improve RSA.
10.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
Chinese Medical Journal 2025;138(14):1730-1740
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.
Humans
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Carcinoma, Non-Small-Cell Lung/metabolism*
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Male
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Female
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Retrospective Studies
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Middle Aged
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Lung Neoplasms/metabolism*
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Aged
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B7-H1 Antigen/metabolism*
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Programmed Cell Death 1 Receptor/metabolism*
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Adult
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Aged, 80 and over
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Immune Checkpoint Inhibitors/therapeutic use*

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