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

Yoshikuni Kawaguchi, Kiyoshi Hasegawa, Kosuke Kashiwabara, Yukiyasu Okamura, Masayuki Kurosaki, M. Kudo, Mitsuo Shimada, Naoki Yamanaka et al.

Journal of Clinical Oncology, 2025

1,094 participants · 19 citations

Abstract

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…

How strong is the evidence?

Evidence Hub reads this as a randomized trial, done in people. Its evidence level is 2 of 5 (High · randomized trial). Randomized trials of a reasonable size are the strongest single-study design. Reported size: 1,094 participants or records.

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