Safety Profile of Sequential Transcatheter Chemoembolization with DC Bead^sup (TM)^: Results of 237 Hepatocellular Carcinoma (HCC) Patients

Complications of chemoembolization performed with DC Bead^sup (TM)^ loaded with doxorubicin (DEBDOX) of diameters 100-300 μm and 300-500 μm are presented in this paper. These diameters are currently the smallest available in drug-eluting technology. Included are 237 patients who were treated with sequential DEBDOX with doxorubicin loaded at 37.5 mg/ml of DC Bead. The National Cancer Institute Common Terminology Criteria for Adverse Events (version 3.0) were used to categorize complications. Thirty-day mortality was 1.26% (3/237). Incidence of grade 5 complications was 1.26% (3/237). Overall, grade 4 complications resulted in 5.48% (13/237) (irreversible liver failure, cholecystitis). Grade 2 liver function deterioration developed in 10 patients (4.2%). Cholecystitis/grade 2 and 4 incidents were observed in 3.6-5.06% across sessions (overall 13 patients; 5.48%). Postembolization Syndrome (PES) grade 1 or 2 was observed in up to 86.5%; however, grade 2 was observed in 25-42.19% across treatments. Pleural effusion was seen in eight patients (overall 3.37%; grade 1 in 1.8-3.7% across treatments; grade 3 in 0.42%). Grade 1 procedure-related laboratory pancreatitis was seen in 0.45%, and grade 2 gastrointestinal bleeding was seen in 0.84%. Procedure-associated skin erythema/grade 1 was seen in 0.84%. There was no correlation of liver failure or transient liver function deterioration with the diameter of the beads (p = 0.25-0.37 and p = 0.14-0.89, respectively). Stratifying with the diameter of the beads correlation values was: for cholecystitis (p = 0.11-0.96 across treatments), PES (p = 0.35-0.83), temporary/grade 1 elevation of liver enzymes (p = 0.002-0.0001), and bilirubin (p = 0.04-0.99). DEBDOX chemoembolization is safe and small calibres do not result in increased complication rates compared with results of series using larger diameters of beads.[PUBLICATION ABSTRACT]