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

By J. Lammer, K. Malagari, T. Vogl, F. Pilleul, A. Denys, A. Watkinson, Michael Pitton, G. Sergent, T. Pfammatter, S. Terraz and 10 more. Cardiovascular and Interventional Radiology, 2009

1,558 citations recorded by the source corpus.

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.

Subfields: Hepatology, Pulmonary and Respiratory Medicine

View Paper: https://www.semanticscholar.org/paper/15624e963a69269ba255bb262c62ce68f7030875

How researchers see this paper

The researchers whose trusted networks rank it highest, strongest advocate first. Every researcher gets a different order.

In Hepatology

Citations in the corpus

Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data (2016, background): “A comprehensive understanding of updated efficacy and safety data of lipiodol TACE in the treatment of HCC is important, especially considering that alternate options for regional hepatic tumor treatment—including arterial embolization with drug-eluting beads and internal radiation with yttrium-90 m”
Hepatocellular carcinoma: a review (2016, background): “Staging systems will assist Figure 1 TACE.”
Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2019, positive): “(149) Nonrandomized cohorts have reported OS exceeding 40 months with DEBs; however, DEB-TACE has not been shown to improve OS compared to conventional TACE in randomized trials or meta-analysis.(150,151) A lack of clinical benefit of combining systemic agents (sorafenib or brivinib) with TACE in in”
Global trends in hepatocellular carcinoma epidemiology: implications for screening, prevention and therapy (2023, background): “The introduction of TACE with drug-eluting beads (DEB-TACE) has been associated with a reduction in systemic drug-related adverse events but with similar oncological outcomes 218 .”
Asia–Pacific clinical practice guidelines on the management of hepatocellular carcinoma: a 2017 update (2017, background): “Although there is no significant benefit of DEB-TACE over conventional TACE with respect to objective response, selected patient groups such as those with Child–Pugh class B, ECOG performance status 1, bilobar disease, and recurrent disease showed a significant increase in objective response in DEB-”
Diagnosis, Staging, and Management of Hepatocellular Carcinoma: 2018 Practice Guidance by the American Association for the Study of Liver Diseases (2018, background): “(149) Nonrandomized cohorts have reported OS exceeding 40 months with DEBs; however, DEB-TACE has not been shown to improve OS compared to conventional TACE in randomized trials or meta-analysis.(150,151) A lack of clinical benefit of combining systemic agents (sorafenib or brivinib) with TACE in in”
EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. (2012, neutral): “A randomized phase II study comparing TACE and TACE-DEB reported a significant reduction in liver toxicity and drug-related adverse events for the latter arm, associated with a non-significant trend of better antitumoral effect [295].”
EASL-EORTC clinical practice guidelines: management of hepatocellular carcinoma. (2012, neutral): “A randomized phase II study comparing TACE and TACE-DEB reported a significant reduction in liver toxicity and drug-related adverse events for the latter arm, associated with a non-significant trend of better antitumoral effect [295].”