仑伐替尼联合程序性死亡受体-1抑制剂治疗晚期不可切除肝癌的疗效和安全性  

Efficacy and safety of lenvatinib combined with programmed cell death protein-1 inhibitors for unresectable hepatocellular carcinoma patients

作　　者：李新 冯涵 杜雅冰[1] 崔抗[1] 马望[1] 陈清江[1] LI Xin;FENG Han;DU Yabing;CUI Kang;MA Wang;CHEN Qingjiang(Department of Oncology,the First Affiliated Hospital of Zhengzhou University,Zhengzhou 450052,China)

机构地区：[1]郑州大学第一附属医院肿瘤科,河南郑州450052

出　　处：《肿瘤基础与临床》2023年第5期383-388,共6页journal of basic and clinical oncology

基　　金：国家自然科学基金资助项目(82073168)。

摘　　要：目的探讨晚期不可切除肝细胞癌患者应用仑伐替尼联合程序性死亡受体-1(PD-1)抑制剂治疗的疗效和安全性。方法纳入2019年2月至2021年12月在郑州大学第一附属医院应用仑伐替尼联合PD-1抑制剂治疗的53例和应用仑伐替尼治疗的50例晚期不可切除肝细胞癌患者,比较观察2组疗效和不良反应。结果仑伐替尼联合治疗组客观缓解率为32.1%,疾病控制率为77.4%,仑伐替尼单药治疗组分别为18.0%、72.0%,差异无统计学意义(χ^(2)=2.701,P=0.100;χ^(2)=0.391,P=0.532)。仑伐替尼联合治疗组中位疾病无进展生存时间(9.4个月)长于仑伐替尼单药治疗组(7.5个月),差异有统计学意义(χ^(2)=7.274,P=0.007)。仑伐替尼联合治疗组中位总生存时间(19.2个月)长于仑伐替尼单药治疗组(15.1个月),差异有统计学意义(χ^(2)=6.202,P=0.013)。2组最常见的不良反应均为乏力、高血压、食欲不振,最常见的Ⅲ级不良反应是高血压,尚未观察到Ⅳ级不良反应。结论与仑伐替尼单药相比,仑伐替尼联合PD-1抑制剂在晚期不可切除肝细胞癌患者中具有可靠的疗效和安全性。Objective To investigate the efficacy and safety of lenvatinib combined with programmed cell death protein-1(PD-1)inhibitors in the treatment of advanced unresectable hepatocellular carcinoma.Methods From February 2019 to December 2021,the clinical data of 53 patients treated with Lenvatinib combined with PD-1 inhibitor and 50 patients treated with lenvatinib from the First Affiliated Hospital of Zhengzhou University were collected,and all the patients had advanced unresectable hepatocellular carcinoma.The efficacy and treatment-related adverse events of the patients was evaluated based on clinical data.Results The objective response rate was 32.1%,and the disease control rate(DCR)was 77.4%in the lenvatinib combination treatment group,and were 18.0%and 72.0%in the lenvatinib monotherapy group(χ^(2)=2.701,P=0.100;χ^(2)=0.391,P=0.532).The median progression-free survival in the lenvatinib combination treatment group(9.4 months)was longer than that in the lenvatinib monotherapy group(7.5 months),which had statistical significance between the two groups(χ^(2)=7.274,P=0.007).The median overall survival in the lenvatinib combination treatment group(19.2 months)was longer than that in the lenvatinib monotherapy group(15.1 months),which had statistical significance between the two groups(χ^(2)=6.202,P=0.013).Malaise,hypertension and inappetence were the most frequent adverse events in both groups,and hypertension was the most frequent adverse event in gradeⅢ.GradeⅣadverse events had not been observed in either group.Conclusion Lenvatinib combined with PD-1 inhibitors has reliable efficacy and safety compared with lenvatinib monotherapy in patients with advanced unresectable hepatocellular carcinoma.

关 键 词：肝细胞癌 仑伐替尼 免疫治疗 安全性 

分 类 号：R735.7[医药卫生—肿瘤]