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Transarterial Chemoembolization of Unresectable Hepatocellular Carcinoma with Drug Eluting Beads: Results of an Open-Label Study of 62 Patients

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Abstract

The purpose of this study was to assess the safety and efficacy of doxorubicin-loaded beads (DC Beads) delivered by transarterial embolization for the treatment of unresectable hepatocellular carcinoma (HCC). This open-label, single-center, single-arm study included 62 cirrhotic patients with documented single unresectable HCC. Mean tumor diameter was 5.6 cm (range, 3–9 cm) classified as Okuda stages 1 (n = 53) and 2 (n = 9). Patients received repeat embolizations with doxorubicin-loaded beads every 3 months (maximum of three). The maximum doxorubicin dose was 150 mg per embolization, loaded in DC Beads of 100–300 or 300–500 μm. Regarding efficacy, overall, an objective response according to the European Association for the Study of the Liver criteria was observed in 59.6%, 81.8%, and 70.8% across three treatments. A complete response was observed in 4.8% after the first procedure and 3.6% and 8.3% after the second and third procedures, respectively. At 9 months a complete response was seen in 12.2%, an objective response in 80.7%, progressive disease in 6.8%, and 12.2% showed stable disease. Mean tumor necrosis ranged from 77.4% to 83.9% (range, 28.6%–100%) across three treatments. α-Fetoprotein levels showed a mean decrease of 1123 ng/ml (95% CI = 846–1399; p = 3 × 10–11) after the first session and remained stable after the second and third embolizations (42 and 70 ng/ml decrease, respectively). Regarding safety, bilirubin, γ-glutamyl transferase, aspartate aminotransferase, alanine aminotransferase, and alkaline phosphatase showed only transient increases during the study period. Severe procedure-related complications were seen in 3.2% (cholecystitis, n = 1; liver abscess, n = 1). Postembolization syndrome was observed in all patients. We conclude that hemoembolization using doxorubicin-loaded DC Beads is a safe and effective treatment of HCC as demonstrated by the low complication rate, increased tumor response, and sustained reduction of α-fetoprotein levels.

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Acknowledgments

We would like to thank the scientific department of Biocompatibles UK Ltd. (Farnham, Surrey, UK), particularly Eva Gallardo, Samantha Ryan, and Brenda Hall, for their valuable assistance with the statistical analysis and preparation of the manuscript.

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Authors and Affiliations

  1. Second Department of Radiology, University of Athens, 1 Rimini Str., Haidari, 12462, Athens, Greece

    Katerina Malagari, Katerina Chatzimichael, Efthymia Alexopoulou, Alexios Kelekis & Athanasios Gouliamos

  2. Second Clinic of Internal Medicine and Hepatology, University of Athens, and Department of Internal Medicine and Hepatology, Ippokration Hospital University of Athens, 11 Vassilisis Sofias Str., Athens, Greece

    Spyridon Dourakis

  3. Department of Surgery, Agia Olga Hospital, Athens, Greece

    Spyridon Delis

  4. Biocompatibles UK, Inc., Farnham, Surrey, UK

    Brenda Hall

  5. Research Centre of Radiology and Imaging, University of Athens, Evgenidion Hospital, 20 Papadiamandopoulou Str., 11538, Athens, Greece

    Dimitrios Kelekis

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  1. Katerina Malagari
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  2. Katerina Chatzimichael
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Correspondence to Katerina Malagari.

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Malagari, K., Chatzimichael, K., Alexopoulou, E. et al. Transarterial Chemoembolization of Unresectable Hepatocellular Carcinoma with Drug Eluting Beads: Results of an Open-Label Study of 62 Patients. Cardiovasc Intervent Radiol 31, 269–280 (2008). https://doi.org/10.1007/s00270-007-9226-z

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