Post embolization syndrome in doxorubicin eluting chemoembolization with DC bead.

BACKGROUND/AIMS: The investigation of post embolization syndrome (PES) in patients with hepatocellular carcinoma (HCC) after treatment with doxorubicin loaded DC Bead (DEB-DOX). METHODOLOGY: The study included 237 patients treated with sequential DEB-TACE performed at set time intervals every two months until 3 sessions/6 month f-u. Patients were ECOG 0-1, Child-Stage-A (n=116, 48.9%) and B (n=121, 51%). Embolizations were as selective as possible with DC Bead of 100-300µm in diameter followed by 300-500µm loaded with doxorubicin at 37.5mg/mL of hydrated bead (max:150mg). RESULTS: PES regardless of severity was observed in up to 86.5%. However grade 2 PES ranged between 25% and 42.19% across treatments. Temperatures above 38°C were seen in 22.7% to 38.3% across treatments. No statistically significant increase of PES was seen in beads of 100-300µm in diameter; incidence of fever and pain presented correlation with the extent of embolization (p=0.0001-0.006 across treatments). Baseline tumor diameter was associated with incidence of fever (p=0.0001-0.001). Duration of fever correlated with the extent of embolization (p=0.008). PES was not associated with elevation of liver enzymes and was correlated with degree of necrosis (p<0.001). CONCLUSIONS: PES after DEB-DOX represents tumor response to treatment and does not represent collateral healthy liver damage.

Safety profile of sequential transcatheter chemoembolization with DC Bead™: results of 237 hepatocellular carcinoma (HCC) patients.

INTRODUCTION: Complications of chemoembolization performed with DC Bead(™) 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. METHODS: 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. RESULTS: 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). CONCLUSIONS: DEBDOX chemoembolization is safe and small calibres do not result in increased complication rates compared with results of series using larger diameters of beads.