Randomized clinical trial of chemoembolization plus radiofrequency ablation versus partial hepatectomy for hepatocellular carcinoma within the Milan criteria
Randomized clinical trial of chemoembolization plus radiofrequency ablation versus partial hepatectomy for hepatocellular carcinoma within the Milan criteria
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DOI：
10.1002/bjs.10061
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发表时间：
2016-03-01
影响因子：
9.6
通讯作者：
Wu, M. -C.
中科院分区：
文献类型：
--
作者：
Liu, H.;Wang, Z. -G.;Wu, M. -C.
背景资料：本研究的目的是比较序贯治疗经导管动脉化疗栓塞术（TACE）和经皮射频消融术（RFA）与部分肝切除术肝细胞癌（HCC）在米兰criteria.Methods：在一项随机临床试验中，肝癌患者在米兰标准，并随机1：1部分肝切除术组或TACE+ RFA组。主要结局是总生存率，次要结局是无复发生存率。部分肝切除术组的1年、3年和5年总生存率分别为97.0%、83.7%和61.9%，TACE+ RFA组分别为96.0%、67.2%和45.7%（P = 0.007）。1、3、5年无复发生存率分别为94.0%、68.2%、48.4%和83.0%、44.9%、35.5%（P = 0.026）。在考克斯比例风险回归分析中，HBV-DNA（风险比（HR）1.76; P = 0.006）、血小板计数（HR 1.00; P = 0.017）和肿瘤大小（HR 1.90; P < 0.001）是无复发生存期的独立预后因素，HBV-DNA（HR 1.61; P = 0.036）是总生存期的危险因素。部分肝切除术组的并发症发生率高于TACE+RFA组（分别为23.0%和11.0%; P = 0.024）。结论：对于符合米兰标准的HCC患者，部分肝切除术与TACE + RFA序贯治疗相比，总体和无复发生存率更高。
Background: This study aimed to compare sequential treatment by transcatheter arterial chemoembolization (TACE) and percutaneous radiofrequency ablation (RFA) with partial hepatectomy for hepatocellular carcinoma (HCC) within the Milan criteria.Methods: In a randomized clinical trial, patients with HCC within the Milan criteria were included and randomized 1 : 1 to the partial hepatectomy group or the TACE+ RFA group. The primary outcome was overall survival and the secondary outcome was recurrence-free survival.Results: Two hundred patients were enrolled. The 1-, 3- and 5-year overall survival rates were 97.0, 83.7 and 61.9 per cent for the partial hepatectomy group, and 96.0, 67.2 and 45.7 per cent for the TACE+ RFA group (P = 0.007). The 1-, 3- and 5-year recurrence-free survival rates were 94.0, 68.2 and 48.4 per cent, and 83.0, 44.9 and 35.5 per cent respectively (P = 0.026). On Cox proportional hazard regression analysis, HBV-DNA (hazard ratio (HR) 1.76; P = 0.006), platelet count (HR 1.00; P = 0.017) and tumour size (HR 1.90; P < 0.001) were independent prognostic factors for recurrence-free survival, and HBV-DNA (HR 1.61; P = 0.036) was a risk factor for overall survival. The incidence of complications in the partial hepatectomy group was higher than in the TACE+RFA group (23.0 versus 11.0 per cent respectively; P = 0.024).Conclusion: For patients with HCC within the Milan criteria, partial hepatectomy was associated with better overall and recurrence-free survival than sequential treatment with TACE and RFA.