No abstract

Materials and Methods: The study was designed as prospective, single arm, multicenter registry study with target number of patients of 200. The primary endpoint of the study was 6-month tumor response assessed by mRECIST. The inclusion criteria of the study included: single nodular or multinodular HCCs, measurable lesion Z 1 cm, no evidence of vascular, biliary invasion or distant metastasis, performance status 0 or 1, Child-Pugh score 5-7. Review of medical records were performed to find any adverse event following the treatment. The study protocol was terminated when a patient had progression of disease, had additional treatment other than DEB-TACE, was lost to follow-up, was transferred to other institute or expired. Results: The patients were enrolled in the study between May 2011 and April 2013. On central review, 48 patients were excluded from analysis and 152 patients (M:F¼125:27, mean age 61) remained. Child-pugh class was dominantly A (143/ 152, 94.1%). The tumor was single nodular in 84 (55.3%) and BCLC stage was O in 15 (9.9%), A in 103 (67.8%) and B in 34 (22.4%). After first DEB-TACE procedure, 111 (73.0%) of the patients suffered from post-embolization syndrome (PES), and there was serious adverse event (SAE) in 8 (5.3%). Total 73 sessions of additional treatment was performed in 59 patients (38.8%). There were 2 patients with SAE after additional treatments. There was 51 (33.6%) patients with bile duct injury confirmed by follow-up imaging. According to mRECIST, 1month response was CR in 64 (42.1%), PR in 77 (50.6%), SD in 8 (5.3%) and PD in 3 (2.0%) patients. Before 6-month followup, the protocol was terminated in 45 (29.6%) patients. Total 120 patients (including patients with protocol termination with PD) were eligible for 6-month response evaluation, and the response was CR in 55 (45.8%), PR in 13 (10.8%) and SD in 2 (2.0%) and PD in 50 (41.7%). There was 2 mortality until 6month follow up. Conclusion:In nodular HCC, DEB-TACE had 92.7% 1month and 56.6% 6-month response rate. PES and bile duct injury was common, and there were 2 cases with mortality.