Abstract
PURPOSE: This study examines the safety and efficacy of transarterial chemoembolization using doxorubicin-loaded 30-60 µm QuadraSphere microspheres (DEM-TACE) for the treatment of hepatocellular carcinoma. MATERIALS AND METHODS: Over 10 weeks, patients with hepatocellular carcinoma. (Child-Pugh A/B: 65%/35%) were embolized with 30-60 µm QuadraSphere microspheres. Excluded patients had previous locoregional therapy, macrovascular invasion, extrahepatic disease, Child-Pugh score >B7, ECOG performance status >0, and total bilirubin >3 mg/dL. Technical success, minor and major complications, 30-day hospital readmission rate, and 30-day mortality were assessed. α-Fetoprotein levels before and after treatment were compared. Local response was evaluated by radiologic tumor response per modified Response Evaluation Criteria in Solid Tumors 1 month after treatment. RESULTS: Thirty tumors (mean size, 2.3 cm; range, 1.0-4.9 cm) were treated in 20 patients (16 male and 4 female; mean age, 64.7 years). There were no major complications. Thirty-day mortality was 0%. Minor complications included postembolization syndrome in 16.7% of cases and transient rise in liver enzymes requiring no therapy. Mean α-fetoprotein levels trended down following treatment (71.8±201.9 ng/mL vs 53.4±116.7 ng/mL), but were not statistically significant. Complete response was achieved in 30% of patients, partial response in 35%, stable disease in 30%, and progression of disease in 5%. Overall objective response was 65%. Mean follow-up was 10.4 months (range, 2-16.4 months). CONCLUSION: DEM-TACE with doxorubicin-loaded 30-60 µm QuadraSpheres is feasible, well tolerated, and associated with promising tumor response in early and intermediate stage disease.