M-06: Drug-Eluting Bead (DEB) Versus Conventional Transarterial Chemoembolization for Intermediate Stage Hepatobiliary Malignancies

Poster Presenter

Henrietta Chioma Ofuluozor

Student
Touro College of Pharmacy
United States

Objectives

To evaluate the safety and efficacy of a drug delivery system loaded with chemotherapeutic agents plus transarterial chemoembolization (TACE) vs conventional TACE in the treatment of intermediate stage hepatobiliary malignancies specifically hepatocellular carcinoma (HCC).

ORAL PRESENTATION: 2:25PM

Method

A systematic review was performed. Literature searches were conducted in PubMed, EMBASE, and the Cochrane Library, with supplementary “instructions for use” obtained after contacting BTG International Ltd, the manufacturer of the drug-eluting beads. Eligible studies discussed safety and efficacy.

Results

Six studies established proper inclusion and exclusion criteria in accordance with the manufacturer’s guide. Inclusion criteria consisted of a diagnosis of intermediate stage HCC without prior biliary surgery. Contraindications for use included pediatric patients, patients with child-pugh class B, class C cirrhosis, a bilirubin level > 3.0 mg/dL, serum creatinine > 2.0 mg/dL, presence or likely onset of vasospasm or hemorrhage. PRECISION V, an international, multicenter, prospective, randomized, single-blind phase II study, analyzed patients over 18 years of age with HCC unsuitable for resection or percutaneous ablation. The primary endpoint was an increase in tumor contact time with a decrease in systemic side effects in the treatment arms of TACE plus doxorubicin-loaded drug eluting beads vs conventional TACE plus doxorubicin. The drug eluting bead group showed improved tolerability, with a significant reduction in liver toxicity (p < 0.001) and a significantly lower rate of doxorubicin-related side effects (p = 0.0001). The “Precision Italia” study compared the 2-year survival of patients in both treatment arms previously stated and found that the drug eluting bead plus TACE (DEB-TACE) group had a survival rate of 56.8% and the conventional TACE (cTACE) group had a rate of 55.4% with a non-statistically significant p-value of 0.949.

Conclusion

Drug eluting beads are relatively new embolic agents that allow sustained release of chemotherapeutic agents and minimize side effects. The advantages of DEB-TACE include better synergistic effects with embolization, minimized cytotoxic effects, and systemic toxicity compared with cTACE. This advantage could result in a more cost effective treatment approach as number of hospitalizations due to side effects may decrease.