广泛期小细胞肺癌免疫治疗的真实世界结果  

Real-world results of immunotherapy for extensive-stage small-cell lung cancer

作　　者：王梓瑞 金潇 赵晓鹏 殷悦 赵微[1] Wang Zirui;Jin Xiao;Zhao Xiaopeng;Yin Yue;Zhao Wei(Senior Department of Respiratory and Critical Care Medicine,Chinese PLA General Hospital,Beijing 100091,China)

机构地区：[1]解放军总医院呼吸与危重症医学部,北京100091

出　　处：《国际呼吸杂志》2025年第3期216-226,共11页International Journal of Respiration

摘　　要：目的分析接受程序性死亡受体1(PD-1)/程序性死亡受体配体1(PD-L1)免疫检查点抑制剂(ICI)治疗的广泛期小细胞肺癌(ES-SCLC)患者免疫治疗获益情况、免疫相关不良反应(irAE)发生的特点、与治疗反应和预后之间的关系,以及治疗过程中糖皮质激素的使用对免疫疗效的影响。方法本研究为回顾性队列研究。采用目的抽样法选取2020年1月至2022年12月解放军总医院第一医学中心接受PD-1/PD-L1 ICI治疗的115例ES-SCLC患者。根据是否出现irAE分为irAE组(33例)和非irAE组(82例)。记录患者的基本临床信息(性别、年龄、吸烟史、基础疾病),以及治疗相关的临床信息[患者治疗前基线情况:肿瘤转移情况、美国东部肿瘤协作组体力状况评分、心电图、肺功能、血常规、肝肾功能、凝血功能、甲状腺功能、动脉血气分析、肿瘤标志物等信息;抗肿瘤治疗情况:免疫治疗用药、联合治疗情况(化疗、放疗)、既往治疗情况(化疗、放疗)、治疗期间是否伴随糖皮质激素治疗、发生irAE后是否给予糖皮质激素治疗、ICI治疗的治疗线;免疫治疗的疗效评价:客观缓解率(ORR)、疾病控制率(DCR)、无进展生存期(PFS)和总生存期(OS);irAE情况:类型、发生时间、严重分级、处置、重启免疫治疗与否、重启免疫治疗药物剂量]。随访截止日期为2024年6月。采用Kaplan-Meier法绘制OS和PFS的生存曲线,并且采用Log-rank法进行比较。采用单因素和多因素Cox回归分析ES-SCLC患者疾病进展和生存的影响因素。结果本研究共纳入115例ES-SCLC患者,其中男100例(87.0%),女15例(13.0%);年龄(60.90±9.96)岁,年龄范围31~84岁。2组患者性别、年龄、吸烟史、美国东部肿瘤协作组体力状况评分、肺部基础疾病、高血压、糖尿病、胸膜转移或有胸腔积液方面比较差异均无统计学意义(均P>0.05)。非irAE组患者远处器官转移多于irAE组,差异有统计学意义(χ^(2ObjectiveTo analyze the treatment benefits,characteristics of immune-related adverse events(irAEs),and their relationship with treatment response and prognosis in patients with extensive-stage small cell lung cancer(ES-SCLC)treated with immune checkpoint inhibitors(ICIs)of programmed death receptor 1(PD-1)/programmed death-ligand 1(PD-L1).Additionally,to evaluate the impact of glucocorticoid use during the treatment of ES-SCLC on the efficacy of immunotherapy.MethodsThis was a retrospective cohort study including 115 ES-SCLC patients treated with ICIs of PD-1/PD-L1 at the First Medical Centre of the General Hospital of the People′s Liberation Army(PLA)from January 2020 to December 2022.Patients were divided into the irAE(n=33)and non-irAE(n=82)groups based on the presence and absence of irAEs.The following data were collected:baseline characteristics(gender,age,smoking history,comorbidities);pretreatment status(tumor metastasis,the Eastern Cooperative Oncology Group performance status score,electrocardiogram,lung function,blood tests,liver/renal function,coagulation,thyroid function,arterial blood gas,tumor markers);treatment details(immunotherapy agents,combination therapies,previous treatments,glucocorticoid use during treatment and after the occurrence of irAEs,ICI treatment);efficacy outcomes(objective response rate[ORR],disease control rate[DCR],progression-free survival[PFS],overall survival[OS]);and irAE characteristics(type,timing,severity,management,immunotherapy continuation).The follow-up ended in June 2024.Kaplan-Meier curves of the OS and PFS were plotted,and compared using the Log-rank tests.Influencing factors for the progression and survival of ES-SCLC were analyzed by univariate and multivariate Cox regression.ResultsAmong 115 ES-SCLC patients,there were 100(87.0%)males and 15(13.0%)females with an average age of 60.9±9.96(31-84)years.No significant differences were found in the gender,age,smoking history,the Eastern Cooperative Oncology Group performance status score,baseline lung diseases,hy

关 键 词：小细胞肺癌 免疫检查点抑制剂 治疗结果 广泛期 免疫相关不良反应 

分 类 号：R734.2[医药卫生—肿瘤]