Transarterial chemoembolization (TACE) of hepatocellular carcinoma (HCC) with a novel radiopaque (RO) drug eluting bead (DEB).

366 Background: Preclinical studies have suggested that RO beads may offer advantages over standard microspheres used for TACE of HCC. The ability to image bead distribution during the procedure is expected to improve the coverage of the tumor minimizing off-target delivery. We conducted a retrospective analysis of efficacy and safety of RO DEB-TACE in patients with HCC. Methods: Forty-eight patients (38 males and 10 females, median age 64 years) with nodular, noninvasive HCC unsuitable for curative treatments, Child-Pugh A (n = 29) or B (n = 19) liver functional status, and ECOG PS 0-1 received DEB-TACE with injection of 2-4 ml of 70-150-micron RO microspheres (LC Bead LUMI; BTG-Biocompatibles) loaded with 37.5 mg/ml doxorubicin. Thirty-seven of 48 patients (77%) had unilobar disease and 11 of 48 (23%) bilobar tumors. The baseline sum tumor diameter was 5.3±2.6 cm (range, 1.2-14.5 cm). The primary endpoint was tumor response by mRECIST. Secondary endpoints were time to progression (TTP), overall survival (OS), and safety. Results: The number of treatments was 1 in 28 patients (58%), 2 in 16 (33%), and 3 in 4 (8%). The mean doxorubicin dose per treatment was 43.9±34.4mg (range, 3.3-150 mg). Best response was CR, PR, SD, and PD in 32, 10, 4 and 2 patients, respectively, for an objective response rate (ORR) of 87.5%. Median TTP was 8.5 months (95% CI, 6.7-not reached). Median OS was not reached in Child class A patients; in class B patients it was 19.5 months (95% CI, 6.0-not reached). There was one treatment-emergent grade 5 AE unrelated to treatment. Grade 3/4 AEs included pain (n = 4), fatigue (n = 2), and fever (n = 1). Grade 3/4 laboratory abnormalities were thrombocytopenia (n = 9), leukopenia (n = 3), elevation of transaminases (n = 3) or bilirubin (n = 3), and anemia (n = 2). Conclusions: In this first clinical study, treatment with RO DEB-TACE resulted in a high ORR and was well tolerated. The encouraging efficacy signal requires confirmation with long-term survival data.