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

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 surgery, and 55 (57.9%) underwent RFA. In the SURF-Cohort trial, baseline factors were imbalanced between groups. After adjusting with the inverse probability of treatment weighting analysis, OS and RFS showed no significant difference (P = .77 and P = .08). CONCLUSION The SURF trial did not demonstrate that surgery was superior to RFA for small HCC.