TACE Sequential to Radiofrequency Ablation versus RFA Alone in Hepatocellular Carcinoma Within Milan Criteria.

Abstract

Objective: This study aimed to compare the efficacy and safety of transarterial chemoembolization followed by radiofrequency ablation (cTACE-RFA) versus RFA alone in patients with early-stage hepatocellular carcinoma (HCC) within the Milan criteria.

Methods: A retrospective analysis included 343 patients with Milan criteria-compliant HCC. After 1:1 propensity score matching (PSM), 93 patients underwent cTACE-RFA, and 93 received RFA alone. Primary endpoints were overall survival (OS) and local progression-free survival (LPFS).

Results: The TACE-RFA group demonstrated significantly superior 1-, 3-, and 5-year LPFS rates (84.9%, 58.1%, 36.6%) compared to the RFA group (75.3%, 44.1%, 16.1%; HR=0.54, 95% CI: 0.37-0.79, P=0.001). However, no significant 1-, 3-, and 5-year OS difference (HR = 1.06, 95% CI: 0.61-1.83, p = 0.843) was observed between cTACE-RFA (95.7%, 80.6%, 59.1%) and RFA alone group (96.8%, 78.5%, 61.3%). Subgroup analyses revealed significant OS improvements with cTACE-RFA in tumor with high-risk locations (HR = 0.38; 95% CI: 0.17-0.85, p = 0.018) and diameter 3-5 cm: (HR = 0.28; 95% CI: 0.12-0.64, p = 0.003). cTACE-RFA group also was observed significant LPFS improvements for tumors in high-risk locations (HR=0.48, 95% CI: 0.30-0.77, p=0.002) or 3-5 cm in size (HR=0.25, 95% CI: 0.15-0.41, p<0.001). Complication rates were comparable, with no procedure-related mortality and similar severe adverse event incidences (P=0.516).

Conclusion: cTACE-RFA significantly prolongs LPFS compared to RFA alone in early HCC, particularly for tumors >3 cm or in high-risk locations, without increasing major complications.