Comparison of drug-eluting bead transarterial chemoembolization combined with apatinib versus drugeluting bead transarterial chemoembolization for the treatment of unresectable hepatocellular carcinoma:a randomized,prospective,multicenter phase III trial  

作　　者：Xuhua Duan Hao Li Donglin Kuang Pengfei Chen Mengfan Zhang Tengfei Li Dechao Jiao Yanliang Li Xiang He Cheng Xing Haibo Wang Yaoxian Liu Limin Xie Shixi Zhang Qiang Zhang Peixin Zhu Yongchuang Chang Jichen Xie Jianzhuang Ren Xinwei Han 

机构地区：[1]Department of Interventional Radiology,The First Affiliated Hospital of Zhengzhou University,Zhengzhou,Henan,China [2]Department of Interventional and Oncology,Dengzhou People’s Hospital,Nanyang,Henan,China [3]Department of Medical Imaging,Huaihe Hospital of Henan University,Kaifeng,Henan,China [4]Department of Interventional Radiology,Zhoukou Central Hospital,Zhoukou,Henan,China [5]Department of Interventional Radiology,Zhengzhou Central Hospital,Zhengzhou,Henan,China [6]Department of Interventional Radiology,Luohe Central Hospital,Luohe,Henan,China [7]Department of Interventional Radiology,Shangqiu First People’s Hospital,Shangqiu,Henan,China [8]Department of Infection,Shangqiu Municipal Hospital,Shangqiu,Henan,China [9]Department of Interventional Radiology,Anyang District Hospital,Anyang,Henan,China [10]Department of Interventional Radiology,General Hospital of Pingmei Shenma Group,Pingdingshan,Henan,China [11]Department of Interventional Radiology,The People’s Hospital of Anyang city,Anyang,Henan,China [12]Department of Interventional Radiology,The Fifth People’s Hospital of Puyang City,Puyang,Henan,China

出　　处：《Signal Transduction and Targeted Therapy》2024年第12期5684-5692,共9页信号转导与靶向治疗(英文)

基　　金：supported by the National Natural Science Foundation of China(No.U2004119);Major Science and Technology Projects in Henan Province(No.221100310100);the Henan Province Medical Science and Technology Public Relations Plan Province Department joint construction project(No.SBGJ202102100).

摘　　要：This randomized,prospective,multicenter(12 centers in China)phase III trial(Chinese Clinical Trial Registry#ChiCTR2000041170)compared drug-eluting bead transarterial chemoembolization(DEB-TACE)combined with apatinib and DEB-TACE monotherapy for patients with unresectable hepatocellular carcinoma(uHCC).Progression-free survival(PFS)was the primary endpoint.Overall survival(OS),mRECIST-based objective response rates(ORR)and disease control rates(DCR),and treatment-related adverse events(TRAEs)were secondary endpoints.Totally 243 cases were randomized,with 122 and 121 in the DEB-TACE+apatinib and DEBTACE groups,respectively.Cases administered DEB-TACE+apatinib displayed markedly improved median PFS(7.1 months[95%CI 6.6-8.3]vs.5.2 months[95%CI 5.0-5.9])and OS(23.3 months[95%CI 20.7-29.6]vs.18.9 months[95%CI 17.9-20.1]compared with those treated with DEB-TACE(both p<0.001).Additionally,patients administered DEB-TACE+apatinib had elevated ORR(56.6%vs.38.8%)and DCR(89.3%vs.80.2%)versus the DEB-TACE group(both p<0.001).Majority of TRAEs were mild and manageable.Regarding DEB-TACE-related TRAEs,the rates of hepatic artery thinning and spasms were elevated during the second DEB-TACE in cases administered DEB-TACE+apatinib vs.DEB-TACE.The commonest apatinib-related TRAEs in the DEB-TACE+apatinib group included hypertension,hand-foot syndrome,fatigue,and diarrhea.In conclusion,DEB-TACE plus apatinib demonstrates superior PFS versus DEB-TACE monotherapy in uHCC cases,maintaining a favorable safety profile with similar occurrences of AEs.

关 键 词：elevated RANDOMIZED markedly 

分 类 号：R73[医药卫生—肿瘤]