Department of Surgery, University of Hong Kong, Hong Kong, China.
Department of Surgery, Queen Mary Hospital, Hong Kong, China.
Br J Surg. 2017 Dec;104(13):1775-1784. doi: 10.1002/bjs.10677. Epub 2017 Nov 1.
Hepatic resection and radiofrequency ablation (RFA) are treatment options for early-stage hepatocellular carcinoma (HCC). Whether tumour recurrence and long-term survival favour either treatment has not been established. This randomized trial aimed to test the hypothesis that RFA is superior to hepatic resection in terms of lower tumour recurrence rate and better long-term survival.
Patients with early-stage HCC (solitary tumour no larger than 5 cm; or no more than 3 tumours, each 3 cm or smaller) were randomized into hepatic resection and RFA groups. Demographic and clinical characteristics, and short- and long-term outcome measures were compared between groups. Primary and secondary outcome measures were overall tumour recurrence and survival respectively.
Clinicopathological data were similar in the two groups, which each contained 109 patients. The RFA group had a shorter treatment duration, less blood loss and shorter hospital stay than the resection group. Mortality and morbidity rates were similar in the two groups. The overall tumour recurrence rate was similar in the resection and RFA groups (71·3 versus 81·7 per cent respectively). The 1-, 3-, 5- and 10-year overall survival rates were 94·5, 80·6, 66·5 and 47·6 per cent respectively in the resection group, compared with 95·4, 82·3, 66·4 and 41·8 per cent in the RFA group (P = 0·531). Corresponding disease-free survival rates were 74·1, 50·9, 41·5 and 31·9 per cent in the resection group, and 70·6, 46·6, 33·6 and 18·6 per cent in the RFA group (P = 0·072).
RFA for early-stage HCC is not superior to hepatic resection, in terms of tumour recurrence, overall survival and disease-free survival. Registration number: HKUCTR-10 (http://www.hkuctr.com).
肝切除术和射频消融术（RFA）是治疗早期肝细胞癌（HCC）的选择。尚未确定肿瘤复发和长期生存情况是否有利于任何一种治疗。这项随机试验旨在检验 RFA 在肿瘤复发率较低和长期生存情况较好方面优于肝切除术的假设。
将早期 HCC（单发肿瘤不超过 5cm；或不超过 3 个肿瘤，每个肿瘤 3cm 或更小）患者随机分为肝切除术和 RFA 组。比较两组患者的人口统计学和临床特征以及短期和长期预后指标。主要和次要预后指标分别为总体肿瘤复发和生存情况。
两组患者的临床病理数据相似，每组均包含 109 例患者。RFA 组的治疗时间更短，出血量更少，住院时间更短。两组的死亡率和发病率相似。两组的总体肿瘤复发率相似（分别为 71.3%和 81.7%）。肝切除术组的 1、3、5 和 10 年总生存率分别为 94.5%、80.6%、66.5%和 47.6%，RFA 组分别为 95.4%、82.3%、66.4%和 41.8%（P=0.531）。相应的无病生存率分别为肝切除术组 74.1%、50.9%、41.5%和 31.9%，RFA 组 70.6%、46.6%、33.6%和 18.6%（P=0.072）。
对于早期 HCC，RFA 并不优于肝切除术，在肿瘤复发、总体生存和无病生存方面均无优势。注册号：HKUCTR-10（http://www.hkuctr.com）。
