Lee Hae Won, Lee Jeong Min, Yoon Jung-Hwan, Kim Yoon Jun, Park Joong-Won, Park Sang-Jae, Kim Seong Hoon, Yi Nam-Joon, Suh Kyung-Suk
Department of Surgery, Seoul National University College of Medicine, Seoul, Korea.
Department of Surgery, Seoul Metropolitan Government - Seoul National University Boramae Medical Center, Seoul, Korea.
Ann Surg Treat Res. 2018 Feb;94(2):74-82. doi: 10.4174/astr.2018.94.2.74. Epub 2018 Jan 30.
Although there are several prospective clinical studies comparing radiofrequency ablation (RFA) and hepatic resection (HR) for the treatment of hepatocellular carcinoma, there are few trials that have been performed in strictly homogeneous patients.
Patients who were newly diagnosed with a solitary hepatocellular carcinoma were randomized to the HR or RFA group. Inclusion criteria were as follows: age ≥ 20 years but ≤ 70 years, Child-Pugh class A, maximal diameter of the tumor ≥ 2 cm but ≤ 4 cm, no previous treatment history, and platelet count > 80,000/mm.
Although the study was early terminated, 29 and 34 patients were enrolled in the HR and RFA groups, respectively, and prospectively followed on an intention-to-treat basis. The 5-year overall survival rates were 83.4% and 86.2% in the HR and RFA groups, respectively, which were not significantly different (P = 0.812 by log-rank, P = 0.990 by Breslow). The 3- and 5-year disease-free survival rates in the HR group were significantly superior to those in the RFA group (66.7%, 44.4% . 44.1%, 31.2%, P = 0.071 by log-rank, P = 0.023 by Breslow). Intrahepatic local recurrence tended to develop more frequently in the RFA group (P = 0.042), while the frequency of intrahepatic distant and extrahepatic recurrence was similar bet ween the 2 groups. There were no significant differences in the frequency and severity of complications between the 2 groups.
HR was significantly superior to RFA in terms of disease-free survival; however, the overall survival was excellent in both groups.
尽管有多项前瞻性临床研究比较了射频消融（RFA）和肝切除术（HR）治疗肝细胞癌的效果，但在严格同质的患者中进行的试验很少。
新诊断为孤立性肝细胞癌的患者被随机分为HR组或RFA组。纳入标准如下：年龄≥20岁但≤70岁，Child-Pugh A级，肿瘤最大直径≥2 cm但≤4 cm，无既往治疗史，血小板计数>80,000/mm。
尽管该研究提前终止，但HR组和RFA组分别有29例和34例患者入组，并按照意向性分析原则进行前瞻性随访。HR组和RFA组的5年总生存率分别为83.4%和86.2%，差异无统计学意义（对数秩检验P = 0.812，Breslow检验P = 0.990）。HR组的3年和5年无病生存率显著高于RFA组（66.7%，44.4% 对 44.1%，31.2%，对数秩检验P = 0.071，Breslow检验P = 0.023）。RFA组肝内局部复发倾向于更频繁发生（P = 0.042），而两组肝内远处和肝外复发的频率相似。两组并发症的发生率和严重程度无显著差异。
在无病生存方面，HR显著优于RFA；然而，两组的总生存率都很高。
