Abstract No. 142: Single centre phase II trial of transarterial chemoembolization with drug eluting beads for patients with unresectable hepatocellular carcinoma: Initial experience in the USA

arrhea 1/8(13%), ascites 1/8(13%), and resolved in 7/8 patients (88%). No grade 5 toxicities were seen. Mean index tumor size was 8.0cm (range 2.5-14.5). Patients who completed DEBTACE had 100% objective tumor response by EASL (lack of contrast enhancement) and partial response or stable disease by RECIST. Conclusion: Preliminary analysis reveals the combination of DEB-TACE and sorafenib appears to be safe as it did not result in any greater toxicities than with either therapy alone. Sorafenib will be dosed continuously in subsequent patients. Preliminary efficacy data are promising. Single arm is a limitation. These results support further evaluation of this combined therapeutic approach in the treatment of unresectable HCC. 11:27 AM

Abstract No. 142

Single centre phase II trial of transarterial chemoembolization with drug eluting beads for patients with unresectable hepatocellular carcinoma: Initial experience in the USA D. Reyes1, J.A. Vossen1, I. Kamel1, N. Azad2, T. Wahlin1, M. Torbenson3, M. Choti4, J.H. Geschwind1; 1Radiology, Johns Hopkins University School of Medicine, Baltimore, MD; 2 Medical Oncology, Johns Hopkins University School of Medicine, Baltimore, MD; 3Pathology, Johns Hopkins University School of Medicine, Baltimore, MD; 4Surgery, Johns Hopkins University School of Medicine, Baltimore, MD. Purpose: This prospective phase II pilot study evaluated safety and efficacy of transarterial chemoembolization (TACE) with drug eluting beads (DEBs) loaded with doxorubicin in patients with unresectable hepatocellular carcinoma (HCC). Materials and Methods: Twenty patients with unresectable HCC (75% Child’s A, 90% ECOG 0-2, 60% BCLC C, tumor size 6.9 cm) underwent 34 DEB-TACE (BioCompatibles, London) sessions. Primary endpoints were tumor response, assessed by contrast-enhanced MR imaging at 1month following treatment, using size (RECIST), contrast-enhancement (EASL) and apparent diffusion coefficient (ADC) values, and safety assessed by NCI CTCAE. Secondary endpoints included feasibility, progression-free survival and overall survival. Results: DEB-TACE was successfully performed in 34 sessions and demonstrated a favorable safety profile. On initial (1 month) post-procedural MR imaging, treated lesions had a mean decrease in size of 4% (p⫽0.1129). Using RECIST, partial response was achieved in 2 patients (10%) and 18 patients (90%) had stable disease. Treated tumors demonstrated a mean decrease in contrast-enhancement of 64% (p⬍0.0001). By EASL criteria, 12 patients (60%) had objective tumor response, and 8 (40%) had stable disease. No patients had progression of a treated lesion while undergoing treatment. At six months, the disease control rate was 95% using RECIST. Overall survival rates at 1 and 2 years were 65% and 55%; median overall survival was 26 months. Conclusion: DEB-TACE appears to be safe and effective in achieving local tumor control in patients with unresectable HCC. Study design limitations were the small sample size and non-randomization. 11:39 AM

Abstract No. 143

100-300␮M drug eluted bead with 100mg doxorubicin transcatheter chemoembolization for HCC; initial experience E. McIntosh1,2, R. Dhanasekaran1,2, D.A. Kooby3, C.A. Staley3, J. Kauh4, H.S. Kim1,2; 1Division of Interventional Radiology and Image Guided Medicine, Emory University School of Medicine, Atlanta, GA; 2Radiology, Emory University School of Medicine, Atlanta, GA; 3Division of Surgical Oncology, Emory S56

University School of Medicine, Atlanta, GA; 4Hematology and Medical Oncology, Emory University School of Medicine, Atlanta, GA. Purpose: To investigate the effect of 100-300␮m drug eluting bead (DEB) with 100mg Doxorubicin transarterial chemoembolization (TACE) for hepatocellular carcinoma (HCC). Materials and Methods: Consecutive patients with HCC treated with Doxorubicin DEB TACE in 2006-2009 were studied. Patients were divided into two groups based on a treatment protocol: 100-300␮m with maximum 100mg Doxorubicin DEB TACE vs. 300-500␮m and 500-700␮m with DEB TACE maximum 150mg Doxorubicin. Survival was obtained from date of diagnosis and date of first transcatheter therapy. 60 day, 90 day and 6 month cumulative survivals were calculated. Overall survival and substratification survival analyses were performed for Child Pugh score. Statistical analysis was performed using the Fisher exact test, independent t-test and Kaplan Meier estimator with log rank test. Results: 102 patients with HCC were treated with Doxorubicin DEB TACE. 58 patients (56.9%) were treated with 100-300␮m DEB TACE, and 44 patients (43.1%) were treated with 300-500␮m and 500-700␮m DEB TACE. Patient demographics, tumor burden, Child Pugh Class and MELD score were similar in both groups. Overall survival at 60 days, 90 days and 6 months were 98.9%, 91.3%, and 77.1% from diagnosis and 85.9%, 78.9%, and 69.7% from DEB TACE. There was a significant decrease in mortality from the first treatment in patients with 100-300␮m DEB vs. larger particle DEB (p⫽ 0.007, 0.001. 0.049). From date of diagnosis, there was a significant decrease in mortality with 100-300␮m DEB at 6 months (p ⫽ .007). When substratified by Child Pugh Class, there were no statistically significant improvements with 100-300␮m DEB TACE in Child A. In Child B and C, there was increased survival with 100-300␮m DEB at 6 months from diagnosis (p ⫽ 0.045, 0.049) and at 90 days from first TACE (p ⫽ 0.033, 0.014). Conclusion: Preliminary results indicate favorable survivals with 100-300␮m DEB TACE over larger particle DEB TACE.

Scientific Session 16 Venous Interventions and Thrombolysis Tuesday, March 16, 2010 4:00 PM - 6:00 PM Room: 5/6 4:00 PM

Abstract No. 144

Catheter-directed thrombolytic therapy for thoracic deep vein thrombosis is safe and effective in selected patients with and without cancer G. Maleux1, P. Marchal1, M. Palmers2, S. Heye1, P. Verhamme3, J. Vaninbroukx1, R. Verhaeghe3; 1Department of Radiology, University Hospitals Leuven, Leuven, Belgium; 2Sint-Trudo Hospital, Sint-Truiden, Belgium; 3 Department of Vascular Medicine, University Hospitals Leuven, Leuven, Belgium.