肿瘤药学2025，Vol.15Issue(5)：589-599,11.DOI:10.3969/j.issn.2095-1264.2025.05.04
合并2型糖尿病的晚期非小细胞肺癌患者免疫治疗的临床特征与结局分析
Clinical characteristics and outcome analysis of immunotherapy in patients with advanced non-small cell lung cancer with type 2 diabetes mellitus
摘要
Abstract
Objective To evaluate the effect of type 2 diabetes mellitus(T2DM)on the efficacy and prognosis of patients with advanced non-small cell lung cancer(NSCLC)receiving immune checkpoint inhibitors(ICI)combined with chemo-therapy,and to explore the potential role of metformin in immunotherapy of these patients.Methods A retrospective analy-sis was conducted on 1 088 patients with advanced NSCLC who received at least two cycles of ICI therapy at Hunan Cancer Hospital between January 2020 and February 2025.Using propensity score matching(PSM),we compared the clinical char-acteristics,progression-free survival(PFS),and overall survival(OS)between the T2DM group(n=124)and the non-diabe-tes group(n=964).Survival analysis was performed using the Kaplan-Meier method with between-group comparisons by the Log-rank test.Hazard ratios(HR)and 95％confidence intervals(CI)were calculated using the Cox proportional haz-ards regression model.Results Before matching,the median PFS was significantly longer in the T2DM group(13.0 months)than in the non-diabetes group(8.5 months)(HR=0.71,95％CI:0.58～0.85,P=0.002 4).After PSM,the T2DM group main-tained a superior median PFS(13.0 months vs.10.7 months in the non-diabetes group,P＜0.05).A statistically significant difference in OS was observed before matching but not after matching.Subgroup analysis revealed that patients using met-formin had a significantly longer median PFS(18.3 months)compared to those not using metformin(9.2 months)(HR=0.63,n95％CI:0.41～0.97,P=0.041 6).Regarding safety,there was no significant difference in the overall incidence of any grade immune-related adverse events(irAEs)between the two groups(64.5％vs.68.4％,P=0.379).However,the incidence of grade ≥3 irAEs was significantly higher in the T2DM group(15.3％vs.6.8％,P=0.001),particularly the risk of transami-nase elevation(5.6％vs.1.6％,P=0.010).Conclusions Advanced NSCLC patients with comorbid T2DM receiving ICIs combined with chemotherapy exhibited significantly improved PFS,which was more pronounced among metformin users,suggesting that metformin may delay disease progression through metabolic modulation and immune mechanisms.However,T2DM comorbidity was also associated with a higher risk of severe immune-related toxicity,necessitating enhanced clini-cal monitoring.Although T2DM significantly influenced PFS,its impact on OS requires further investigation.Future studies should delve deeper into the interaction between diabetes and immunotherapy to provide more precise guidance for clinical practice.关键词
2型糖尿病/免疫检查点抑制剂/非小细胞肺癌/二甲双胍/不良反应Key words
Type 2 diabetes mellitus/Immune checkpoint inhibitors/Non-small cell lung cancer/Metformin/Adverse reactions分类
医药卫生引用本文复制引用
YANG Dan,ZENG Liang,ZHANG Yongchang,YANG Nong,SUN Yuanze,HUANG Zhe,RUAN Zhaohui,DAI Jiacheng,YAN Huan,TIAN Fang,ZHANG Yuda,HUANG Jiao..合并2型糖尿病的晚期非小细胞肺癌患者免疫治疗的临床特征与结局分析[J].肿瘤药学,2025,15(5):589-599,11.基金项目
国家自然科学基金(82222048). （82222048）
