Safety and Feasibility of Chemoembolization with Doxorubicin-Loaded Small Calibrated Microspheres in Patients with Hepatocellular Carcinoma: Results of the MIRACLE I Prospective Multicenter Study

• DOI: 10.1007/s00270-017-1839-2
• Publication Date: 2017-11-22T17:45:17Z
• Authors: Götz Richter; Boris Radeleff; Christian Stroszc...; Philippe Pereira; Thomas Helmberger; Mark Barakat; Peter Huppert
• Keywords: Miracle

The MIRACLE I pilot study was designed as a preliminary investigation of safety and efficacy Embozene TANDEM microspheres loaded with doxorubicin for treatment locally untreatable (i.e., unresectable not suitable local thermal ablation) hepatocellular carcinoma (HCC). Patients HCC (mono- or bilobar disease, ECOG performance status 0–2, Child–Pugh score < 11) were eligible this single-arm multicenter study. DEB-TACE performed 75 µm 150 mg doxorubicin. Twenty-five subjects 41 tumors treated (mean age 65 years); 16, 52, 32% had BCLC A, B, C status, respectively. A 64%, B 32%, 4%; 40% ascites. About 92% disease localized to one liver lobe. Most (72%) underwent ≤ 2 procedures. Average dose 124.5 ± 36.1 (median mg) per procedure. Two patients procedure-related SAE (liver necrosis, worsening insufficiency) within 30 days the first Six-month freedom from death 68% (one hepatic encephalopathy, five deaths). Tumor response stable achieved in 95% (20/21) subjects. Freedom tumor progression at 6 months 76%. one-year survival rate 56% overall 73% among without ascites baseline. results suggest that can provide good control heterogeneous group HCC. Level 2b, Individual cohort