Purpose: To evaluate the toxicity focussing on hepatic, gastrointestinal and cardiac parameters following PRECISION TACE with DC Bead? versus conventional transarterial chemoembolization (cTACE) in the treatment of intermediate-stage hepatocellular carcinoma (HCC).
Methods and Materials: This prospective, randomized, multicentre study was
conducted under best practice trial management and authorized by local institutional
review boards. Informed consent was obtained. 212 patients (185 men/27 women;
mean: 67 years) were randomized to be treated with DC Beads? or cTACE. The
majority of both groups presented in a more advanced stage. Safety was measured
by rate of adverse events (South West Oncology Group criteria) and changes in
laboratory parameters. Cardiotoxicity was assessed by means of left ventricular
ejection fraction (LVEF) in MRI or echocardiography. The results of the two groups
were compared using the chi-square test and Student`s t-test.
Results: Mean maximum alanine transaminase increase in the DC Bead group
was 50% in the cTACE group (p < 0.001) and 59% for aspartate transaminase
(p < 0.001). For bilirubin, mean increase was 5.30±15.13 vs. 13.53±73.89 µmol/L.
Concerning gastrointestinal disorders, 120 adverse events (AEs) occurred in 57/93
(61.3%) patients in the DC Bead group vs. 114 in 49/108 (45.4%) in cTACE. Concerning
hepatobiliary disorders, serious AEs occurred in 8/93 (8.6%) vs. 11/108
(10.2%) patients. LVEF showed an increase in the DC Bead group by +2.7±10.1
percentage points and a small decrease by -1.5±7.6 in the cTACE group, p=0.018.
Conclusion: PRECISION TACE is safe, even in more advanced HCC patients.
Serious liver and cardiac toxicity were significantly lower in the DC Bead group.