Doxorubicin-eluting bead-enhanced radiofrequency ablation of hepatocellular carcinoma: A pilot clinical study q Riccardo Lencioni 1, * , Laura Crocetti 1 , Pasquale Petruzzi 1 , Claudio Vignali 1 , Elena Bozzi 1 , Clotilde Della Pina 1 , Irene Bargellini 1 , Dania Cioni 1 , Filippo Oliveri 2 , Paolo De Simone 3 , Carlo Bartolozzi 1 , Maurizia Brunetto 2 , Franco Filipponi 3 1 Division of Diagnostic and Interventional Radiology, Department of Oncology and Radiology, Cisanello University Hospital – Building No. 9, Via Paradisa 2, IT-56124 Pisa, Italy 2 Division of Hepatology, Department of Liver Transplantation, Hepatology, and Infectious Diseases, Cisanello University Hospital, Via Paradisa 2, IT-56124 Pisa, Italy 3 Division of Liver Transplantation, Department of Liver Transplantation, Hepatology, and Infectious Diseases, Cisanello University Hospital, Via Paradisa 2, IT-56124 Pisa, Italy Background/ Aims: Experimental studies have shown synergy between radiofrequency (RF) ablation and adjuvant chemo- therapy in animal tumour models. We aimed to assess safety and efficacy of doxorubicin-eluting 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 tumour after standard RF ablation underwent intraarterial 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 cm 3 ± 35.7 after RF ablation to 75.5 cm 3 ± 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 tumour volume was observed in 6 (30%) of 20 patients, and local tumour progression in 2 (10%) of 20. Conclusions: Intraarterial DEB administration substantially enhances 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. Ó 2008 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved. Keywords: Hepatocellular carcinoma; Radiofrequency ablation; Doxorubicin 1. Introduction Hepatocellular carcinoma (HCC) is the sixth most common cause of cancer, and its incidence is increasing worldwide because of the dissemination of hepatitis B and C virus infection [1]. Patients with cirrhosis are at the highest risk of developing HCC and should be mon- itored every six months to diagnose the tumour at an early, asymptomatic stage [2,3]. Patients with early-stage HCC – as defined by the Barcelona Clinic Liver Cancer staging system – can 0168-8278/$34.00 Ó 2008 European Association for the Study of the Liver. Published by Elsevier B.V. All rights reserved. doi:10.1016/j.jhep.2008.03.021 Received 27 December 2007; received in revised form 1 March 2008; accepted 26 March 2008; available online 24 April 2008 Associate Editor: M. Colombo q The authors who have taken part in the research of this paper declared that they do not have a relationship with the manufacturers of the drug involved either in the past or present and they did not receive funding from the manufacturers to carry out their research. * Corresponding author. Tel.: +39 050 992 509; fax: +39 050 551 461. E-mail address: lencioni@med.unipi.it (R. Lencioni). Abbreviations: HCC, hepatocellular carcinoma; RF, radiofre- quency; DEB, doxorubicin eluting bead; ECOG, Eastern Cooperative Oncology Group; ASA, American Society of Anesthesiologists; CT, computed tomography; MR, magnetic resonance; CR, complete res- ponse; IR, incomplete response; PD, progressive disease. www.elsevier.com/locate/jhep Journal of Hepatology 49 (2008) 217–222