帕博利珠单抗联合乐伐替尼转化治疗后序贯根治性手术在初始不可切除肝癌中的应用效果  

Efficacy of pembrolizumab combined with lenvatinib conversion therapy followed by sequential radical surgery in treatment of initially unresectable liver cancer

作　　者：杨帆 段昌虎 吴林 赵李飞 向俊西[2] 段建峰 Yang Fan;Duan Chang-hu;Wu Lin;Zhao Li-fei;Xiang Jun-xi;Duan Jian-feng(Department of Hepatobiliary,Pancreatic and Splenic Surgery,3201 Hospital,School of Medicine,Xi'an Jiaotong University,Hanzhong 723000,China;Department of Hepatobiliary Surgery,The First Affliated Hospital of Xi'an Jiaotong University,Xi'an 710061,China)

机构地区：[1]西安交通大学医学部附属三二〇一医院肝胆胰脾外科,汉中723000 [2]西安交通大学第一附属医院肝胆外科,西安710061

出　　处：《中国药物应用与监测》2024年第4期385-389,共5页Chinese Journal of Drug Application and Monitoring

摘　　要：目的 分析初始不可切除肝癌患者接受帕博利珠单抗联合乐伐替尼序贯根治性手术方案治疗的效果。方法 选取2020年1月至2023年1月在西安交通大学医学部附属三二〇一医院接受治疗的112例初始不可切除肝癌患者作为研究对象,根据患者治疗方案分组,将行帕博利珠单抗转化治疗序贯根治性手术的患者纳入单药组(53例),将行帕博利珠单抗联合乐伐替尼转化治疗序贯根治性手术的患者纳入联合组(59例),分析单药组和联合组的转化治疗效果,并对两组患者行根治性手术后的病理结果进行分析,对患者进行随访调查(随访时间至2024年2月29日),并采用Kaplan-Meier生存曲线分析单药组和联合组患者预后情况。结果 单药组转化治疗总有效率(32.08%)和联合组(42.37%)比较差异无统计学意义(χ^(2)=1.263,P>0.05)。单药组根治手术后病理学完全缓解和病理残留肿瘤比例≤10%(分别为24.53%、60.38%)与联合组(27.12%、62.71%)比较差异无统计学意义(χ^(2)=0.098,0.064,均P>0.05)。单药组未进展生存率(77.36%)和联合组(86.44%)比较差异无统计学意义(χ^(2)=1.570,P>0.05)。单药组总体生存率、中位生存时间、与中位无进展生存期(分别为60.37%、13.06个月、4.78个月)与联合组(分别为77.97%、未达到、9.83个月)比较差异有统计学意义(χ^(2)=4.0855,4.516,3.773,均P<0.05)。根治术前单药组和联合组患者均无未经控制的3级以上的药品不良反应事件(ADR),且术后均未见Clavien-Dindo 3级以上并发症,无围手术期死亡患者。单药组ADR总发生率(75.47%)和联合组(72.88%)比较差异无统计学意义(χ^(2)=0.098,P>0.05)。结论 帕博利珠单抗联合乐伐替尼转化治疗后序贯根治性手术方案,较单独使用帕博利珠单抗转化治疗后序贯根治性手术方案的患者远期生存效益较高,且ADR可控,可作为初始不可根治肝癌患者的治疗方式。Objective To investigate the efficacy of pembrolizumab combined with lenvatinib followed by radical surgery in treatment of patients with initially unresectable liver cancer.Methods A total of 112 patients with initially unresectable liver cancer treated in 3201 Hospital Affiliated to Xi’an Jiaotong University School of Medicine from January 2020 to January 2023 were selected as the research subjects.According to the patient's treatment plan,the pembrolizumab conversion therapy sequence was performed.Patients undergoing radical surgery were included in the monotherapy group(n=53),and those receiving conversion therapy with pembrolizumab combined with lenvatinib followed by radical surgery were included in the combination group(n=59).The effect of conversion therapy was investigated in the monotherapy group and the combination group and the pathological results of the two groups after radical surgery were also analyzed.Follow-up investigation was conducted in the patients(the followup time was until February 29,2024),and Kaplan-Meier survival curve analysis was performed to determine the prognosis of patients in both groups.Results There was no statistically significant difference in the total effective rate of conversion therapy between the monotherapy group(32.08%)and the combination group(42.37%)(χ^(2)=1.263,P>0.05).Furthermore,there was no statistically significant difference between the monotherapy group and the combination group(27.12%vs 62.71%)in the proportion of pathological complete response and pathological residual tumor≤10%after radical surgery(24.53%vs 60.38%)(χ^(2)=0.098,0.064,both P>0.05).No significant difference was found in progression-free survival rate between the monotherapy group(77.36%)and the combination group(86.44%)(χ^(2)=1.570,P>0.05).The overall survival rate,median survival time and median progression-free survival time of the monotherapy group were 60.37%,13.06 months and 4.78 months,respectively.They were 77.97%,being not reached and 9.83 months in the combination group(χ^(2

关 键 词：肝癌 帕博利珠单抗 乐伐替尼 根治性手术 化疗效果 

分 类 号：R735.7[医药卫生—肿瘤]