Surgery Versus Ablation for Hepatocellular Carcinoma: A Randomized Controlled Trial (SURF-RCT Trial) and a Nonrandomized Prospective Observational Trial (SURF-Cohort Trial)

作者：Yoshikuni Kawaguchi, Kiyoshi Hasegawa, Kosuke Kashiwabara, Yukiyasu Okamura, Masayuki Kurosaki, Masatoshi Kudo, Mitsuo Shimada, Naoki Yamanaka, Masafumi Inomata, Taro Yamashita, Ryosuke Tateishi, Shuichiro Shiina, Mitsuhiro Fujishiro, Yutaka Matsuyama, Masao Omata, Norihiro Kokudo · 发表于：Journal of Clinical Oncology · 年份：2025 · DOI：10.1200/jco-24-02030 · 被引用次数：16 · 研究领域：Hepatocellular Carcinoma Treatment and Prognosis、Cholangiocarcinoma and Gallbladder Cancer Studies、Pancreatic and Hepatic Oncology Research

PURPOSE We conducted a randomized controlled trial (SURF-RCT) to evaluate the efficacy of surgery versus radiofrequency ablation (RFA) for hepatocellular carcinoma (HCC). Simultaneously, eligible patients who dissented from random assignment were enrolled in a nonrandomized prospective observational trial (SURF-Cohort). We aimed to report the final analyses of overall survival (OS) and updated recurrence-free survival (RFS) in the SURF-RCT and SURF-Cohort trials. METHODS The trials were conducted in 49 institutions in Japan. Patients with a largest HCC diameter of ≤3 cm and ≤3 HCC nodules were eligible. The co-primary end points were RFS and OS. RESULTS During 2009-2015, 1,094 patients were registered. After excluding ineligible patients, 302 and 753 patients were included in the SURF-RCT (surgery, n = 150; RFA, n = 152) and SURF-Cohort trial (surgery, n = 382; RFA, n = 371), respectively. In the SURF-RCT trial, 90% of patients had solitary HCC, and approximately 65% had an HCC diameter of ≤2.0 cm. Serious adverse effects occurred in 3.3% of the surgery group and none in the RFA group. The 5-year OS was 74.6% in the surgery group and 70.4% in the RFA group (hazard ratio [HR], 0.96; adjusted P = .84). The 5-year RFS was 42.9% in the surgery group and 42.7% in the RFA group (HR, 0.90; adjusted P = .84). In the surgery group, 86 patients had recurrences; 14 (16.3%) underwent surgery, and 50 (58.1%) underwent RFA. In the RFA group, 95 patients had recurrences; 8 (8.4%) underwent ...