Increased survival in hepatocellular carcinoma with iodine-125 implantation plus radiofrequency ablation: A prospective randomized controlled trial

Increased survival in hepatocellular carcinoma with iodine-125 implantation plus radiofrequency ablation: A prospective randomized controlled trial
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Iodine-125 植入加射频消融可提高肝细胞癌的生存率:一项前瞻性随机对照试验

DOI:
10.1016/j.jhep.2014.07.026
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发表时间:
2014-12-01
影响因子:
25.7
通讯作者:
Xiang, Guoan
Xiang, Guoan
中科院分区:
医学1区
文献类型:
--
作者:
Chen, Kaiyun;Chen, Guihua;Xiang, Guoan

文献摘要

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背景与目的:本研究的目的是评价联合射频消融(RFA)联合经皮碘125(I-125)粒子植入治疗肝癌的无进展生存率是否优于单纯使用RFA的无进展生存率。方法:136例肝癌患者随机分为射频消融联合经皮碘125粒子植入(RFA-I-125,n=68)和单纯RFA(n=68)。两组共91例患者均有乙肝病毒感染。结果:RFA-I-125组1、3、5年复发率分别为4.5%、22.1%、39.8%,单纯RFA组复发率分别为14.8%、35.3%、57.4%。射频消融组的复发率显著低于单纯射频消融组(HR,0.508;95%CI,0.317~0.815;经对数等级检验,p=0.004)。射频消融组的局部复发率和肝内复发率显著低于单纯射频消融组(对数等级检验分别为7.3%和17.6%,P=0.012;22.0%和32.3%,P=0.041)。RFA-I-125组1、3、5年生存率分别为100%、86.7%、66.1%,单纯RFA组分别为95.6%、75.0%、47.0%。射频消融组的生存率显著高于单纯射频消融组(HR,0.502;95%CI,0.313~0.806;经对数等级检验,p=0.003)。COX回归模型显示,治疗组和肿瘤大小均为复发相关和总体生存相关的预后因素。结论:对于63 cm的小肝癌患者,RFA-I-125和RFA-I-125在总生存率和累积复发方面有显著差异。与单独使用RFA相比,RFA-I-125治疗促进了更好的局部和肝脏内肿瘤控制和长期存活率。ClinicalTrials.gov标识:NCT01717729。(C)2014年欧洲肝脏研究协会。爱思唯尔出版,版权所有。
Background & Aims: The purpose of this study was to evaluate whether use of combined radiofrequency ablation (RFA) and percutaneous iodine-125 (I-125) seed implantation results in better progression-free survival compared with the use of RFA alone in patients with hepatocellular carcinoma.Methods: 136 patients were randomly assigned to undergo HCC treatment with RFA and percutaneous iodine-125 seed implantation (RFA-I-125, n = 68) or RFA-only (n = 68). A total of 91 patients had hepatitis B viral infection in both groups. Rates of tumour recurrence and overall survival were evaluated.Results: The probabilities of recurrence at 1-, 3-, and 5-years were 4.5%, 22.1%, and 39.8% in the RFA-I-125 group; and 14.8%, 35.3%, and 57.4% in the RFA-only group, respectively. The recurrence rate in the RFA-I-125 group was significantly lower than in the RFA-only group (HR, 0.508; 95% CI, 0.317-0.815; p = 0.004 by log-rank test). Local and intrahepatic recurrence was significantly lower in the RFA-I-125 group than in the RFA-only group (7.3% vs. 22.0%, p = 0.012 by log-rank test; 17.6% vs. 32.3%, p = 0.041 by log-rank test). The probabilities of survival at 1-, 3-, and 5-years were 100%, 86.7%, and 66.1% in the RFA-I-125 group and 95.6%, 75.0%, and 47.0% in the RFA-only group, respectively. The survival rate in the RFA-I-125 group was significantly better than in the RFA-only group (HR, 0.502; 95% CI, 0.313-0.806; p = 0.003 by log-rank test). Cox regression model indicated that the treatment group and tumour size were both recurrence-related and overall survival-related prognostic factors.Conclusions: There were significant differences in overall survival and cumulative recurrence between RFA-I-125 and RFA-only for patients with small HCCs (63 cm). Treatment with RFA-I-125 facilitated better local and intrahepatic tumour control and long-term survival compared with treatment of RFA alone. ClinicalTrials.gov Identifier: NCT01717729. (C) 2014 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved.