卡瑞利珠单克隆抗体联合阿帕替尼二线治疗不可切除肝细胞癌的临床疗效及安全性分析:一项多中心回顾性研究  

Clinical efficacy and safety analysis of camrelizumab combined with apatinib as a second-line therapy for unresectable hepatocellular carcinoma:a multicenter retrospective study

作　　者：袁国盛 何伟猛 胡晓云[1] 李祺[1] 臧梦雅 程笑[2] 黄维 阮健[4] 王俊洁 侯金林[1] 陈锦章[1] Yuan Guosheng;He Weimeng;Hu Xiaoyun;Li Qi;Zang Mengya;Cheng Xiao;Huang Wei;Ruan Jian;Wang Junjie;Hou Jinlin;Chen Jinzhang(Department of Infectious Diseases and Hepatology,Nanfang Hospital,Southern Medical University,Guangzhou 510515,China;Department of Hepatology,Zengcheng Branch of Nanfang Hospital,Southern Medical University,Zengcheng 511300,China;Department of Oncology,Shunde Hospital,Southern Medical University,Shunde 528300,China;Department of Medical Oncology,the First Affiliated Hospital,School of Medicine,Zhejiang University,Hangzhou 310000,China;Department of Infectious Disease,the Second Affiliated Hospital of Guangzhou Medical University,Guangzhou 510260,China)

机构地区：[1]南方医科大学南方医院感染内科,广州510515 [2]南方医科大学南方医院增城分院肝病科,增城511300 [3]南方医科大学南方医院顺德医院肿瘤科,顺德528300 [4]浙江大学第一附属医院肿瘤内科,杭州310000 [5]广州医科大学附属第二医院传染科,广州510260

出　　处：《中华肝脏病杂志》2021年第4期326-331,共6页Chinese Journal of Hepatology

基　　金：广东省自然科学基金面上项目(2021A1515012518);南方医科大学南方医院临床研究启动专项(2020CR019、2020CR021)。

摘　　要：目的分析卡瑞利珠单克隆抗体(单抗)联合阿帕替尼二线治疗不可切除肝细胞癌(HCC)的临床疗效及安全性。方法纳入94例接受卡瑞利珠单抗联合阿帕替尼二线治疗的中晚期HCC患者。记录患者治疗前的血常规、血液生化指标、肿瘤分期、肿瘤影像学特征、既往接受的治疗策略等临床资料,随访患者的影像学复查结果、治疗过程中出现的不良反应,直至患者随访截止或失访或死亡。采用Kaplan-Meier法分析患者临床疗效。结果截至末次随访,94例接受卡瑞利珠单抗联合阿帕替尼二线治疗的中晚期HCC患者,其中15例患者失访、31例死亡、48例生存。总客观缓解率为31.9%;总疾病控制率为71.3%。中位无疾病进展时间为6.6个月;中位疾病进展时间尚未获得;1年累积生存率为62.3%。3级以上不良事件主要有血小板减少(7.4%)、腹痛(4.3%)、肝炎活动(4.3%)、白细胞减少(4.3%)、腹泻(3.2%)、手足综合征(3.2%);不良反应均得到有效控制。结论卡瑞利珠单抗联合阿帕替尼治疗中晚期HCC患者可有效延长患者生存期,且耐受性良好。Objective To analyze the clinical efficacy and safety of camrelizumab combined with apatinib as a second-line therapy for unresectable hepatocellular carcinoma(HCC).Methods Ninety-four cases with mid-and advanced-stage HCC who received camrelizumab combined with apatinib as second-line treatment were enrolled.Routine blood test,blood biochemical indexes,tumor stage,tumor imaging characteristics,previous treatment strategies and other clinical data before treatment were documented.Imaging examination follow-up results and adverse reactions during treatment were followed up until the end of follow-up or loss of follow-up or death.Kaplan-Meier method was used to analyze the clinical efficacy.Results As of the last follow-up,94 cases with mid-and advanced-stage HCC had received camrelizumab combined with apatinib as second-line treatment.Among them,15 cases were lost to follow-up,31 cases died,and 48 cases survived.The overall remission rate was 31.9%.The overall disease control rate was 71.3%.The median time to disease-free progression was 6.6 months.The median time to disease progression was not yet available.The 1-year cumulative survival rate was 62.3%.Grade 3 and above adverse reactions mainly included were thrombocytopenia(7.4%),abdominal pain(4.3%),active hepatitis(4.3%),leukopenia(4.3%),diarrhea(3.2%),hand-foot syndrome(3.2%).All adverse reactions were effectively controlled.Conclusion Camrelizumab combined with apatinib can effectively prolong the survival period of patients with mid-and advanced-stage HCC,and it is well tolerated.

关 键 词：肝细胞癌 安全性 临床疗效 卡瑞利珠单克隆抗体 阿帕替尼 

分 类 号：R735.7[医药卫生—肿瘤]