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

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.

Chemoembolization for Hepatocellular Carcinoma

“…8 Clinical studies have shown that DEB loaded with doxorubicin has a safe pharmacokinetic profile with lower systemic drug exposure and significantly reduced liver toxicity compared with conventional TACE. [9][10][11] Despite these advances and technical refinements, the long-term survival of patients managed with TACE are not fully satisfactory, mainly as a result of the high rates of tumor recurrence. TACE exerts therapeutic effects only in the treated territory; thus other HCC undetected at the time of the procedure may progress or new tumors may develop.…”

Lipiodol transarterial chemoembolization for hepatocellular carcinoma: A systematic review of efficacy and safety data

“…(19) 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 microspheres-have been proposed and are currently undergoing clinical investigation. (20,21) Therefore, we performed a systematic literature review of the available evidence on the efficacy and safety of lipiodol TACE in treatment of HCC.…”

Hepatotoxicity after Transarterial Chemoembolization and Transjugular Intrahepatic Portosystemic Shunt: Do Two Rights Make a Wrong?

“…Transarterial chemoembolization has become a commonly employed treatment for HCC (9)(10)(11). However, hepatic dysfunction is frequently observed after chemoembolization (12,13).…”