Bland Embolization in Patients with Unresectable Hepatocellular Carcinoma Using Precise, Tightly Size-Calibrated, Anti-Inflammatory Microparticles: First Clinical Experience and One-Year Follow-Up

The purpose of this study is to report on the feasibility, local response, and 1-year clinical outcome of bland transarterial embolization (TAE) with 40- and 100-mu m Embozene microspheres in patients affected by unresectable hepatocellular carcinoma (HCC). Up to January 2009, 53 patients underwent superselective TAE for a total of 74 lesions. Diagnosis of HCC was based on multidetector computed tomography (MDCT), alpha-fetoprotein, and biopsy. MDCT was performed 24 after treatment and repeated at 1 month, 3 months, and then every 6 months. Local efficacy was defined according to RECIST criteria. Technical success was always achieved. Local results at 1-month, 3- to 6-month, and 6- to 12-month follow-up were 62%, 37%, and 16%, respectively, for stable disease and 35%, 56%, and 51%, respectively, for partial response. Complete response (no evidence of lesion) has been observed only at late follow-up (three lesions; 7%). To date, 20 of 53 patients have had at least 1 year of follow-up, with an overall survival rate of 96%. Hepatic progressive disease (i.e., new nodules) was observed in 14 of 20 patients due to underlying liver disease. Minor complications were observed in four patients. A major complication occurred in one patient, who died unexpectedly 24 h after TAE due to pulmonary embolism of necrotic pathologic tissue and passage of particles through a disrupted hepatic vein. Local results as well as 1-year clinical outcome after TAE with Embozene microspheres are veryly encouraging, however, further studies, a larger patient population, and a longer follow-up are mandatory to assess the real clinical impact.