Doxorubicin Eluting Bead-Enhanced Radiofrequency Ablation of Hepatocellular Carcinoma: A Pilot Clinical Study

Background: Experimental studies have shown synergy between radiofrequency (RF) ablation and adjuvant chemotherapy in animal tumour models. We aimed to assess safety and efficacy of doxorubicin-eluding bead (DEB)-enhanced RF ablation in the treatment of human hepatocellular carcinoma (HCC). Methods: Twenty patients with single HCC ranging 3.3-7.0 cm (mean, 5.0 cm ±1.4) showing evidence of residual viable tumor after standard RF ablation underwent intra-arterial DEB administration (50-125 mg doxorubicin; mean, 60.2 mg ±21.8). Follow-up period ranged 6-20 months (mean, 12 months ±5). Results: No major complication occurred. No deterioration of liver function was observed. The volume of treatment-induced necrosis – as measured on imaging – increased from 48.1 cm3 ±35.7 after RF ablation to 75.5 cm3 ±52.4 after DEB administration, with an increase of 60.9% ±39.0. The enhanced effect resulted in confirmed complete response (CR) of the target lesion in 12 (60%) of 20 patients. Incomplete response with persistence of <10% of initial tumor volume was observed in 6 (30%) of 20 patients, and local tumor progression in 2 (10%) of 20. Conclusions: Intra-arterial DEB administration substantially increases the effect of RF ablation. DEB-enhanced RF ablation is safe and results in a high rate of CR in patients refractory to standard RF treatment.