扶正抗癌方联合程序性死亡蛋白1抑制剂治疗Ⅲ/Ⅳ期非小细胞肺癌的临床疗效及预后影响因素的真实世界研究  

A real-world study on the clinical efficacy and influencing factors of TCM therapy of Fuzheng Kang'ai Decoction combined with PD-1 inhibitors in treating stageⅢandⅣNSCLC

作　　者：钟越彤 杨恬恬 龙顺钦[1,2,3] 吴万垠 杨小兵[1,2,3] Zhong Yuetong;Yang Tiantian;Long Shunqin;Wu Wanyin;Yang Xiaobing(The Second Clinical College of Guangzhou University of Chinese Medicine,Guangzhou 510405,China;The Second Affiliated Hospital of Guangzhou University of Chinese Medicine(Guangdong Provincial Hospital of Traditional Chinese Medicine),Guangzhou 510120,China;State Key Laboratory of Dampness Syndrome of Chinese Medicine,the Second Affiliated Hospital of Guangzhou University of Chinese Medicine,Guangzhou 510120,China)

机构地区：[1]广州中医药大学第二临床医学院,广州510405 [2]广州中医药大学第二附属医院(广东省中医院),广州510120 [3]省部共建中医湿证国家重点实验室(广州中医药大学第二附属医院),广州510120

出　　处：《国际中医中药杂志》2024年第4期426-433,共8页International Journal of Traditional Chinese Medicine

基　　金：2021年度省部共建中医湿证国家重点实验室重点项目(SZ2021ZZ38)。

摘　　要：目的探讨真实世界扶正抗癌方联合程序性死亡蛋白1(PD-1)抑制剂对Ⅲ/Ⅳ期非小细胞肺癌(NSCLC)临床疗效及预后的影响。方法回顾性收集2018年8月-2021年3月广东省中医院肿瘤科住院期间初次使用PD-1抑制剂治疗的晚期NSCLC患者的临床资料,若纳入患者未出现死亡,则前瞻性随访患者生存状态至2022年9月,记录客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)、总生存时间(OS)、不良反应,采用Kaplan-Meier法绘制生存曲线并评估中位PFS及中位OS,采用Cox比例回归风险模型进行多因素分析。结果66例患者纳入本研究,其中ORR为33.3%(22/66),DCR为86.4%(57/66),中位PFS为9.90个月,中位OS为31.83个月。单因素分析显示,中位PFS与TNM分期、肝转移、PD-L1表达水平、肺免疫预后指数(LIPI)、中医证型有关(P值分别为0.004、0.033、0.040、0.004、0.001)。多因素Cox回归分析显示,TNM分期[HR(95%CI)为4.179(1.781,9.804)]、PD-L1表达水平为1%~49%时[HR(95%CI)为0.346(0.127,0.940)]及≥50%时[HR(95%CI)为0.074(0.019,0.288)]、LIPI[HR(95%CI)为14.515(2.939,71.681)]、中医证型中阳气亏虚证[HR(95%CI)为5.954(2.093,16.940)]为PFS独立影响因素。总体及3级以上不良反应发生率分别为68.2%(45/66)和9.1%(6/66)。结论扶正抗癌方联合PD-1抑制剂对Ⅲ/Ⅳ期NSCLC患者具有较好的临床疗效,不良反应可控。TNM分期、肝转移、PD-L1表达水平、LIPI、中医证型可用于中药联合免疫治疗Ⅲ/Ⅳ期NSCLC的早期预测。Objective To investigate the clinical efficacy and safety of programmed death protein 1(PD-1)inhibitos combined with Fuzheng Kang'ai Decoction in patients with stageⅢorⅣnon-small cell lung cancer(NSCLC)and identify factors that influence progression and prognosis in real world.Methods Objective response rate(ORR),disease control rate(DCR),progression free survival(PFS),total survival time(OS)and adverse events of patients with advanced or metastatic NSCLC who received PD-1 inhibitors for the first time in the Department of Oncology,Guangdong Provincial Hospital of Chinese Medicine from August 2018 to March 2021 were retrospectively analyzed,and was prospectively followed up until September 2022.Kaplan-Meier method was used to plot survival curves and evaluate median PFS and median OS,while Cox proportional hazards regression model was used for multivariate analysis.Results The final 66 patients were included in the study,with an ORR of 33.3%(22/66),a DCR of 86.4%(57/66),a median PFS of 9.90 months,and a median OS of 31.83 months.Univariate analysis showed that median PFS was associated with TNM stage,liver metastasis,PD-L1 expression level,lung immune prognostic index(LIPI),and traditional Chinese medicine syndrome types(P values were 0.004,0.033,0.040,0.004,and 0.001,respectively).Multivariate Cox regression analysis showed that TNM stage[HR(95%CI)=4.179(1.781,9.804)],PD-L1 expression level 1%-49%[HR(95%CI)=0.346(0.127,0.940)]or≥50%[HR(95%CI)=0.074(0.019,0.288)],LIPI[HR(95%CI)=14.515(2.939,71.681)],and TCM characteristics of deficiency of yang qi[HR(95%CI)=5.954(2.093,16.940)]were independent influencing factors for PFS.The overall and grade 3-5 treatment-related adverse events were 68.2%(45/66)and 9.1%(6/66),respectively.Conclusions Fuzheng Kang'ai Decoction combined with PD-1 inhibitors is an effective and tolerable therapy for patients with advanced or metastatic NSCLC.TNM stage,liver metastasis,PD-L1 expression,LIPI and TCM characteristics are early predictors of clinical efficacy for patients with sta

关 键 词：癌 非小细胞肺 免疫检查点抑制剂 扶正抗癌方 中医药疗法 

分 类 号：R734.2[医药卫生—肿瘤]