A randomized phase II study of drug-eluting beads versus transarterial chemoembolization for unresectable hepatocellular carcinoma.

BACKGROUND Transcatheter arterial chemoembolization (TACE) is the standard treatment in selected patients with unresectable hepatocellular carcinoma (HCC). Drug-eluting particles are developed to reduce side effects and improve efficacy. We present safety data of a prospective randomized phase II study with doxorubicin-eluting superabsorbent polymer (SAP) microspheres. MATERIAL AND METHODS We prospectively included 30 HCC patients with different Barcelona Clinic Liver Cancer (BCLC) stages (A = 3, B = 19, C = 8) and randomly assigned them to receive conventional TACE (n = 14) (control group) or doxorubicin-eluting SAP microspheres (n = 16). The doxorubicin plasma level was assessed at different time points, biochemical analysis was performed, and side effects were reported following the Common Toxicity Criteria. Tumor response was assessed at 6 weeks according to the modified Response Evaluation Criteria in Solid Tumors (RECIST) criteria. RESULTS There was a significantly lower plasma peak concentration (Cmax) of doxorubicin and smaller area under the curve (AUC) with SAP microspheres (mean Cmax 495 ± 293.9 ng/ml, mean AUC 69.7 ± 26.9 ng/ml min) compared to controls (mean Cmax 1,928 ± 560.8 ng/ml, mean AUC 165 ± 32.3 ng/ml/min; both p < 0.001). Furthermore, there were less grade 3 and no grade 4 adverse events in the SAP microsphere group. Tumor response was comparable between the groups. CONCLUSIONS TACE with SAP microspheres leads to low plasma levels of the cytotoxic drug and therefore minimizes toxicity compared to conventional TACE.