信迪利单抗联合盐酸安罗替尼二线治疗晚期小细胞肺癌的前瞻性、单臂Ⅱ期临床研究  

Prospective,Single Arm,PhaseⅡClinical Study on the Second-line Treatment of Advanced Small Cell Lung Cancer with Sintilimab and Anrotinib Hydrochloride

作　　者：柳家荣 段玲 王文义 孙向春 杨刚 LIU Jiarong;DUAN Ling;WANG Wenyi(General Hospital of Pingmei Shenma Medical Group,Pingdingshan,467000)

机构地区：[1]平煤神马医疗集团总医院,467000

出　　处：《实用癌症杂志》2023年第5期839-842,共4页The Practical Journal of Cancer

基　　金：中国平煤神马集团基层专项课题(编号:4104022021180721)。

摘　　要：目的探讨信迪利单抗联合盐酸安罗替尼二线治疗晚期小细胞肺癌的临床效果。方法采用前瞻性、单臂Ⅱ期研究,选取36例进入二线治疗的晚期小细胞肺癌患者,均采取信迪利单抗联合盐酸安罗替尼治疗,治疗至无法耐受药物治疗的不良反应或疾病进展时停止用药。统计并观察晚期小细胞肺癌患者采取信迪利单抗联合盐酸安罗替尼治疗的临床疗效、不良反应以及生存情况。结果36例晚期小细胞肺癌患者经信迪利单抗联合盐酸安罗替尼治疗后疾病控制率为86.11%(31/36)。患者治疗期间的不良反应主要有血压异常、发热、乏力、胃肠功能紊乱、手足综合征、血小板减少症等,大部分Ⅰ~Ⅱ度,经对症处理均可耐受。运用Kaplan-Meier法检验36例晚期小细胞肺癌患者12个月内的生存情况,结果显示,患者中位生存时间估计值为10个月。结论信迪利单抗联合盐酸安罗替尼二线治疗晚期小细胞肺癌临床疗效确切,且不良反应患者可耐受。Objective To explore the clinical effect of sintilimab combined with anrotinib hydrochloride in the second-line treatment of advanced small cell lung cancer.Methods This was a prospective,single arm phase II clinical study.36 patients with advanced small cell lung cancer who received for second-line treatment were selected.All patients were treated with sintilimab combined with anrotinib hydrochloride.The drug was stopped when the drug was intolerable to the adverse reaction of drug treatment or the disease progressed.Clinical efficacy,adverse reaction and survival of patients with advanced small cell lung cancer treated with sintilimab combined with anrotinib hydrochloride were counted and observed.Results The disease control rate of 36 patients with advanced small cell lung cancer was 86.11%(31/36)after treatment with sintilimab combined with anrotinib hydrochloride.The adverse reactions of patients during treatment mainly included abnormal blood pressure,fever,fatigue,gastrointestinal dysfunction,hand-foot syndrome,thrombocytopenia,etc.Most of them were grade I to II,which could be tolerated after symptomatic treatment.Kaplan-Meier method was used to test the survival of 36 patients with advanced small cell lung cancer within 12 months.The results showed that the estimated median survival time of patients was 10 months.Conclusion Sintilimab combined with anrotinib hydrochloride is effective in the treatment of advanced small cell lung cancer,and the adverse reaction are tolerable.

关 键 词：晚期小细胞肺癌 信迪利单抗 盐酸安罗替尼 不良反应 

分 类 号：R734.2[医药卫生—肿瘤]