Takayama Tadatoshi, Hasegawa Kiyoshi, Izumi Namiki, Kudo Masatoshi, Shimada Mitsuo, Yamanaka Naoki, Inomata Masafumi, Kaneko Shuichi, Nakayama Hisashi, Kawaguchi Yoshikuni, Kashiwabara Kosuke, Tateishi Ryosuke, Shiina Shuichiro, Koike Kazuhiko, Matsuyama Yutaka, Omata Masao, Makuuchi Masatoshi, Kokudo Norihiro
Department of Digestive Surgery, Nihon University School of Medicine, Tokyo, Japan.
Hepato-Biliary-Pancreatic Surgery Division, Department of Surgery, Graduate School of Medicine, the University of Tokyo, Tokyo, Japan.
Liver Cancer. 2021 Dec 29;11(3):209-218. doi: 10.1159/000521665. eCollection 2022 Jun.
It remains unclear which surgery or radiofrequency ablation (RFA) is the more effective treatment for small hepatocellular carcinoma (HCC). We aimed to compare survival between patients undergoing surgery (surgery group) and patients undergoing RFA (RFA group).
We conducted a randomized controlled trial involving 49 institutions in Japan. Patients with Child-Pugh scores ≤7, largest HCC diameter ≤3 cm, and ≤3 HCC nodules were considered eligible. The co-primary endpoints were recurrence-free survival (RFS) and overall survival (OS). The current study reports the final result of RFS, and the follow-up of OS is still ongoing.
During 2009-2015, 308 patients were registered. After excluding ineligible patients, the surgery and RFA groups included 150 and 151 patients, respectively. Baseline factors did not differ significantly between the groups. In both groups, 90% of patients had solitary HCC. The median largest HCC diameter was 1.8 cm (interquartile range [IQR], 1.5-2.2 cm) in the surgery group and 1.8 cm (IQR, 1.5-2.3 cm) in the RFA group. The median procedure duration (274 vs. 40 min, < 0.01) and the median duration of hospital stay (17 days vs. 10 days, < 0.01) were longer in the surgery group than in the RFA group. RFS did not differ significantly between the groups as the median RFS was 3.5 (95% confidence interval [CI], 2.6-5.1) years in the surgery group and 3.0 (95% CI, 2.4-5.6) years in the RFA group (hazard ratio, 0.92; 95% CI, 0.67-1.25; = 0.58).
DISCUSSION/CONCLUSION: Our study did not show which surgery or RFA is the better treatment option for small HCC.
目前尚不清楚哪种手术或射频消融（RFA）对小肝细胞癌（HCC）的治疗效果更佳。我们旨在比较接受手术治疗的患者（手术组）和接受RFA治疗的患者（RFA组）的生存率。
我们在日本的49家机构进行了一项随机对照试验。符合条件的患者为Child-Pugh评分≤7、最大肝癌直径≤3 cm且肝癌结节≤3个。共同主要终点为无复发生存期（RFS）和总生存期（OS）。本研究报告了RFS的最终结果，OS的随访仍在进行中。
在2009年至2015年期间，登记了308例患者。排除不符合条件的患者后，手术组和RFA组分别包括150例和151例患者。两组间的基线因素无显著差异。两组中，90%的患者患有单发肝癌。手术组最大肝癌直径的中位数为1.8 cm（四分位间距[IQR]，1.5 - 2.2 cm），RFA组为1.8 cm（IQR，1.5 - 2.3 cm）。手术组的中位手术持续时间（274分钟对40分钟，<0.01）和中位住院时间（17天对10天，<0.01）均长于RFA组。两组间的RFS无显著差异，手术组的中位RFS为3.5（95%置信区间[CI]，2.6 - 5.1）年，RFA组为3.0（95%CI，2.4 - 5.6）年（风险比，0.92；95%CI，0.67 - 1.25；P = 0.58）。
讨论/结论：我们的研究未表明哪种手术或RFA是小肝癌的更佳治疗选择。
