SBRT联合卡瑞利珠单抗和阿帕替尼治疗晚期肝细胞癌的疗效及安全性  

Efficacy and safety of stereotactic body radiotherapy combined with karelizumab and apatinib in treatment of advanced hepatocellular carcinoma

作　　者：雷艳文 丁广成[1] 秦德华[1] 郭彦伟 王海霞[3] 张剑[2] 陈家富 罗青竹 郭文静 Lei Yan-Wen;Ding Guang-Cheng;Qin De-Hua;Guo Yan-Wei;Wang Hai-Xia;Zhang Jian;Chen Jia-Fu;Luo Qing Zhu;Guo Wen-Jing(Stereotactic Body Radiotherapy Center,the Fifth Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan 450000,China;Department of Oncology,the Fifth Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan 450000,China;Department of Radiation Oncology,People's Hospital of Zhengzhou,Zhengzhou,Henan 450000,China)

机构地区：[1]郑州大学第五附属医院立体定向放射治疗中心,河南郑州450000 [2]郑州大学第五附属医院肿瘤内科,河南郑州450000 [3]郑州人民医院放疗科,河南郑州450000

出　　处：《解放军医学杂志》2023年第12期1420-1426,共7页Medical Journal of Chinese People's Liberation Army

基　　金：国家科技重大专项课题(2018ZX10303502-001);河南省医学科技攻关计划联合共建项目(2018020256)。

摘　　要：目的探讨立体定向放射治疗(SBRT)联合卡瑞利珠单抗、阿帕替尼治疗晚期肝细胞癌(HCC)的疗效及安全性。方法回顾性分析2019年1月-2021年9月郑州大学第五附属医院和郑州人民医院收治的85例晚期HCC患者的临床资料,根据是否接受SBRT治疗分为观察组(n=31,采用SBRT联合卡瑞利珠单抗和阿帕替尼治疗)与对照组(n=54,采用卡瑞利珠单抗和阿帕替尼治疗)。采用倾向性评分匹配(PSM)均衡混杂因素,比较两组客观缓解率(ORR)、疾病控制率(DCR),采用Kaplan-Meier生存曲线比较两组6个月总生存率、1年总生存率、无进展生存期(PFS);使用常见不良事件标准(CTCAE)5.0版评估两组治疗方法的安全性。结果PSM前,两组年龄(P=0.043)、肝外转移数(P=0.028)和既往是否手术治疗(P=0.038)差异有统计学意义;PSM后,两组基线资料比较差异无统计学意义(P>0.05),两组各纳入27例患者。治疗后3个月,观察组和对照组ORR分别为66.7%、29.6%,差异有统计学意义(P=0.006),DCR分别为96.3%、85.2%,差异无统计学意义(P=0.175)。观察组和对照组6个月总生存率(96.3%vs.80.9%,P=0.001)、1年总生存率(75.0%vs.61.4%,P=0.034)和中位PFS(8个月vs.5个月,P=0.003)差异有统计学意义。多因素Cox回归分析显示,基线甲胎蛋白(AFP)≥400ng/ml是影响晚期HCC患者生存期的独立危险因素(HR>1,P<0.05);而三联疗法、既往使用靶向药物是晚期HCC患者生存期的保护因素(HR<1,P<0.05)。观察组4例出现3级不良反应,常见不良反应为消化不良(14.8%)等;对照组1例发生3级不良反应。两组不良反应发生率比较差异无统计学意义(P=0.639)。结论SBRT联合卡瑞利珠单抗、阿帕替尼治疗晚期HCC临床效果显著,不良反应可控,是一种安全、有效的治疗方法。Objective To investigate the efficacy and safety of stereotactic body radiotherapy(SBRT)combined with camrelizumab and apatinib in treatment of advanced hepatocellular carcinoma(HCC).Methods The clinical data were retrospectively analyzed of 85 patients with advanced HCC treated in the Fifth Affiliated Hospital of Zhengzhou University and People's Hospital of Zhengzhou from January 2019 to September 2021.They were divided into observation group(n=31,SBRT combined with camrelizumab and apatinib)and control group(n=54,treated with camrelizumab and apatinib)according to whether they received SBRT.The propensity score matching(PSM)was used to balance the influence of confounding factors.The objective remission rate(ORR)and disease control rate(DCR)were compared between the two groups.The 6-month overall survival rate,1-year overall survival rate and progression-free survival(PFS)were compared between the two groups by Kaplan-Meier method.The safety of the two groups was evaluated by Common Terminology Criteria for Adverse Events(CTCAE)version 5.0.Results Before PSM,there were significant differences in age(P=0.043),number of extrahepatic metastasis(P=0.028),and previous surgical treatment(P=0.038)between the two groups.After PSM,there was no significant difference in baseline characteristics between the two groups(P>0.05).After PSM,27 cases were included in each groups,and three months after treatment,the ORR in observation group and control group were 66.7%and 29.6%,respectively,showed difference with statistically significant(P=0.006);and the DCR in the both groups were 96.3%and 85.2%respectively,showed no statistically significant difference(P=0.175).There were statistical differences in 6-month overall survival rate(96.3%vs.80.9%,P=0.001),1-year overall survival rate(75.0%vs.61.4%,P=0.034)and median PFS(8 months vs.5 months,P=0.003)between the observation group and control group.Multi-factor Cox regression analysis showed that baseline alpha-fetoprotein(AFP)≥400 ng/ml was an independent risk factor for affectin

关 键 词：立体定向放射治疗 卡瑞利珠单抗 阿帕替尼 肝细胞癌 倾向性评分匹配 

分 类 号：R735.7[医药卫生—肿瘤]