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

Journal Article · Sun Feb 14 23:00:00 EST 2010 · Cardiovascular and Interventional Radiology

DOI:https://doi.org/10.1007/S00270-009-9711-7· OSTI ID:21429059

Lammer, Johannes ^[1]; Malagari, Katarina ^[2]; Vogl, Thomas ^[3]; Pilleul, Frank ^[4]; Denys, Alban ^[5]; Watkinson, Anthony ^[6]; Pitton, Michael ^[7]; Sergent, Geraldine ^[8]; Pfammatter, Thomas ^[9]; Terraz, Sylvain ^[10]; Benhamou, Yves ^[11]; Avajon, Yves ^[12]; Gruenberger, Thomas ^[13]; Pomoni, Maria ^[2]; Langenberger, Herbert ^[1]; Schuchmann, Marcus ^[7]; Dumortier, Jerome ^[4]; Mueller, Christian ^[13]; Chevallier, Patrick ^[14]; Lencioni, Riccardo ^[15]

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1. Medical University Vienna, Cardiovascular and Interventional Radiology (Austria)
2. University of Athens (Greece)
3. Goethe University (Germany)
4. CHU, Hopital Edouard Herriot, Hospices Civils de Lyon (France)
5. CHU Vaudois (Switzerland)
6. Royal Devon and Exeter Hospital, The Peninsula Medical School (United Kingdom)
7. Guttenberg University (Germany)
8. Hopital Huriez (France)
9. Universitaetsspital Zuerich (Switzerland)
10. Hopitaux Universitaires de Geneve (Switzerland)
11. Hopital La Pitie-Salpetriere (France)
12. Hopital Paul Brousse (France)
13. Medical University Vienna (Austria)
14. Hopital Archet II (France)
15. Cisanello University Hospital (Italy)

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.

• OSTI ID: 21429059
• Journal Information: Cardiovascular and Interventional Radiology, Journal Name: Cardiovascular and Interventional Radiology Journal Issue: 1 Vol. 33; ISSN 0174-1551; ISSN CAIRDG
• Country of Publication: United States
• Language: English

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62 RADIOLOGY AND NUCLEAR MEDICINE
ANTI-INFECTIVE AGENTS
ANTIBIOTICS
ANTINEOPLASTIC DRUGS
CARCINOMAS
DISEASES
DOXORUBICIN
DRUGS
EMBOLI
HEPATOMAS
NEOPLASMS
ORGANIC COMPOUNDS