国产细胞程序性死亡受体1抑制剂卡瑞利珠单抗联合阿帕替尼一线治疗中晚期原发性肝癌的疗效研究  

Efficacy of China-produced Camrelizumab with Apatinib for First-line Treatment in Middle and Advanced Stages of Primary Liver Cancer

作　　者：徐金发[1] 宋文灿[1] 郑中显[1] 鲍瑜[1] 华高艳 蔡清 侍伟伟[1] 章秀芳 张建华 童舟[1] 夏国安[2] 刘飞[2] 刘林涛 肖克胜 XU Jinfa;SONG Wencan;ZHENG Zhongxian;BAO Yu;HUA Gaoyan;CAI Qing;SHI Weiwei;ZHANG Xiufang;ZHANG Jianhua;TONG Zhou;XIA Guoan;LIU Fei;LIU Lintao;XIAO Kesheng(Department of Oncology,the People's Hospital of Chizhou,Chizhou 247099,China;Department of Oncology,Chizhou Second People's Hospital,Chizhou 247099,China;Department of Oncology,Dongzhi County People's Hospital,Chizhou 247299,China;Department of Oncology,Shitai County People's Hospital,Chizhou 245199,China)

机构地区：[1]安徽省池州市人民医院肿瘤科,247099 [2]安徽省池州市第二人民医院肿瘤科,247099 [3]安徽省池州市东至县人民医院肿瘤科,247299 [4]安徽省池州市石台县人民医院肿瘤科,245199

出　　处：《中国全科医学》2022年第26期3258-3262,共5页Chinese General Practice

基　　金：国家自然科学基金资助项目(82172651);池州市科技攻关项目(KJ-201807)。

摘　　要：背景以细胞程序性死亡受体1(PD-1)和细胞程序性死亡配体1(PD-L1)抑制剂类为代表的免疫靶向治疗在多种肿瘤治疗中显示较高的有效率,我国已获批上市的PD-1/PD-L1抑制剂类抗肿瘤药物应用时间相对较短。目的探讨国产PD-1抑制剂卡瑞利珠单抗联合阿帕替尼一线治疗中晚期原发性肝癌的疗效和安全性。方法纳入池州市4家医院(池州市人民医院、池州市第二人民医院、东至县人民医院、石台县人民医院)肿瘤科2018年6月至2021年1月收治的中晚期原发性肝癌患者86例,其均初始服用甲磺酸阿帕替尼片同时联用卡瑞利珠单抗静脉滴注。评估患者治疗1、3个月时的临床疗效,并对患者进行随访,随访终点为患者疾病出现进展、全因死亡或2021-08-31。统计患者治疗期间毒副作用发生情况。结果86例患者中无因严重毒副作用退出研究者。患者治疗1、3个月总缓解率(ORR)分别为58.14%(50/86)和65.12%(56/86),疾病控制率(DCR)分别为76.74%(66/86)和82.56%(68/86)。截至2021-08-31,86例患者的随访时间为4~26个月,平均随访时间为(12±6)个月,共35例患者死亡,所有患者中位无进展生存期(PFS)为8〔95%CI(5.18,11.89)〕个月,中位总生存期(OS)为12〔95%CI(8.97,15.97)〕个月。86例患者治疗期间出现的主要毒副作用为胃肠道反应〔52例(60.47%)〕、继发性高血压〔31例(36.05%)〕、手足综合征〔18例(20.93%)〕和蛋白尿〔12例(13.95%)〕,其中胃肠道反应〔6例(6.98%)〕、继发性高血压〔2例(2.33%)〕和手足综合征〔1例(1.16%)〕出现3~5级毒副作用。结论国产PD-1抑制剂卡瑞利珠单抗联合阿帕替尼一线治疗中晚期原发性肝癌的疗效良好,毒副作用相对可控。Background Targeted therapies and immunotherapies,represented by programmed cell death protein 1(PD-1)and programmed cell death-ligand 1(PD-L1)inhibitors,have demonstrated high efficacies in multiple cancers.China-produced PD-1/PD-L1 inhibitors have been approved for use recently.Objective To investigate the efficacy and safety of China-produced camrelizumab,a PD-1 inhibitor,in combination with apatinib in the first-line treatment of middle and advanced stages of primary liver cancer.Methods Eighty-six patients with middle and advanced stages of primary liver cancer were selected from the oncology department of four hospitals in Chizhou(the People's Hospital of Chizhou,Chizhou Second People's Hospital,Dongzhi County People's Hospital,Shitai County People's Hospital)from June 2018 to January 2021.All patients were initially treated with apatinib mesylate tablets and intravenous infusion of China-produced camrelizumab,and followed up till August 31,2021 with disease progression or all-cause death as the endpoint.Clinical efficacies were assessed at the end of the first and third months of treatment.The treatment-emergent adverse events were counted.Results There were no dropouts due to serious treatment-emergent adverse events.The overall response rate(ORR)and disease control rate(DCR)in the patients were 58.14%(50/86)and 65.12%(56/86),respectively,at the end of the first month of treatment,and were 76.74%(66/86)and 82.56%(68/86),respectively,at the end of the third month of treatment.The follow-up period for them ranged from four to 26 months,with a mean value follow-up time of(12±6)months.A total of 35 patients died during the follow-up.The median progression-free survival was 8〔95%CI(5.18,11.89)〕months,and the median overall survival was 12〔95%CI(8.97,15.97)〕months in all patients.The major treatment-emergent adverse events included gastrointestinal reactions〔52(60.47%)〕,secondary hypertension〔31(36.05%)〕,hand-foot syndrome〔18(20.93%)〕and proteinuria〔12(13.95%)〕,among which gastrointesti

关 键 词：肝肿瘤 程序性细胞死亡受体1 免疫检查点抑制剂 卡瑞利珠 阿帕替尼 治疗结果 

分 类 号：R735.7[医药卫生—肿瘤]