Clinical Investigation

CardioVascular and Interventional Radiology

, Volume 33, Issue 1, pp 41-52

First online:

Open Access This content is freely available online to anyone, anywhere at any time.

Prospective Randomized Study of Doxorubicin-Eluting-Bead Embolization in the Treatment of Hepatocellular Carcinoma: Results of the PRECISION V Study

  • Johannes LammerAffiliated withCardiovascular and Interventional Radiology, Medical University Vienna Email author 
  • , Katarina MalagariAffiliated withUniversity of Athens
  • , Thomas VoglAffiliated withGoethe University
  • , Frank PilleulAffiliated withHospices Civils de Lyon, CHU, Hopital Edouard Herriot
  • , Alban DenysAffiliated withCHU Vaudois
  • , Anthony WatkinsonAffiliated withThe Peninsula Medical School, Royal Devon and Exeter Hospital
  • , Michael PittonAffiliated withGuttenberg University
  • , Geraldine SergentAffiliated withHôpital Huriez
  • , Thomas PfammatterAffiliated withUniversitätsspital Zürich
    • , Sylvain TerrazAffiliated withHopitaux Universitaires de Geneve
    • , Yves BenhamouAffiliated withHôpital La Pitiè-Salpetrière
    • , Yves AvajonAffiliated withHôpital Paul Brousse
    • , Thomas GruenbergerAffiliated withMedical University Vienna
    • , Maria PomoniAffiliated withUniversity of Athens
    • , Herbert LangenbergerAffiliated withCardiovascular and Interventional Radiology, Medical University Vienna
    • , Marcus SchuchmannAffiliated withGuttenberg University
    • , Jerome DumortierAffiliated withHospices Civils de Lyon, CHU, Hopital Edouard Herriot
    • , Christian MuellerAffiliated withMedical University Vienna
    • , Patrick ChevallierAffiliated withHôpital Archet II
    • , Riccardo LencioniAffiliated withCisanello University Hospital
    • , On Behalf of the PRECISION V Investigators

Abstract

Transcatheter arterial chemoembolization (TACE) offers a survival benefit to patients with intermediate hepatocellular carcinoma (HCC). A widely accepted TACE regimen includes administration of doxorubicin-oil emulsion followed by gelatine sponge—conventional TACE. Recently, a drug-eluting bead (DC Bead®) has been developed to enhance tumor drug delivery and reduce systemic availability. This randomized trial compares conventional TACE (cTACE) with TACE with DC Bead for the treatment of cirrhotic patients with HCC. Two hundred twelve patients with Child-Pugh A/B cirrhosis and large and/or multinodular, unresectable, N0, M0 HCCs were randomized to receive TACE with DC Bead loaded with doxorubicin or cTACE with doxorubicin. Randomization was stratified according to Child-Pugh status (A/B), performance status (ECOG 0/1), bilobar disease (yes/no), and prior curative treatment (yes/no). The primary endpoint was tumor response (EASL) at 6 months following independent, blinded review of MRI studies. The drug-eluting bead group showed higher rates of complete response, objective response, and disease control compared with the cTACE group (27% vs. 22%, 52% vs. 44%, and 63% vs. 52%, respectively). The hypothesis of superiority was not met (one-sided P = 0.11). However, patients with Child-Pugh B, ECOG 1, bilobar disease, and recurrent disease showed a significant increase in objective response (P = 0.038) compared to cTACE. DC Bead was associated with improved tolerability, with a significant reduction in serious liver toxicity (P < 0.001) and a significantly lower rate of doxorubicin-related side effects (P = 0.0001). TACE with DC Bead and doxorubicin is safe and effective in the treatment of HCC and offers a benefit to patients with more advanced disease.

Keywords

Chemoembolization Hepatocellular carcinoma Doxorubicin Drug-eluting beads