Sanjeeva P. Kalva MD, Presenter: Research grant, AngioDynamics, Inc

Kalpana Yeddula MBBS, Abstract Co-Author: Nothing to Disclose

Shams Iftikhar Iqbal MD, Abstract Co-Author: Nothing to Disclose

Bhanusupriya Somarouthu MD, Abstract Co-Author: Nothing to Disclose

Suvranu Ganguli MD, Abstract Co-Author: Nothing to Disclose

Benjamin John Pomerantz MD, Abstract Co-Author: Nothing to Disclose

Stephan Wicky MD, Abstract Co-Author: Consultant, Johnson & Johnson

Lawrence Blaszkowsky MD, Abstract Co-Author: Nothing to Disclose

Andrew X. Zhu MD, PhD, Abstract Co-Author: Nothing to Disclose

To assess the safety and efficacy of trans-arterial chemoembolization with drug-eluting beads (TACE-DEB) loaded with doxorubicin for unresectable hepatocellular carcinoma (HCC).

In this IRB-approved retrospective study, 77 patients (64M; median age 60y) with unresectable HCC were treated with TACE-DEB. HCC was biopsy-proven in 58 and diagnosed with a combination of AFP levels and imaging in 19. Patients with Child-Pugh A, B, and C cirrhosis were 47, 28 and 2 respectively. Seventeen patients had received prior loco-regional therapies. Tumor was multifocal in 46. Six patients had branch portal vein thrombosis. TACE-DEB was performed using up to two vials of 300-500µ LC beads loaded with 50 mg of doxorubicin each. 77 patients underwent 130 total procedures, with one TACE-DEB procedure performed in 52 patients, two performed in 25, three performed in 8 and four performed in one patient. Safety was assessed by noting any complications, assessing post-procedure renal function, and calculating 30-day mortality. Response rate (RR) was assessed using RECIST and EASL criteria on CT/MRI at 1 month. Overall median survival from initial diagnosis and from initial TACE-DEB and the survival rate at 6, 12 and 24 months were calculated.

TACE-DEB was technically successful in all patients. Mean hospital stay after the procedure was one day. Thirty day mortality was 1.2%. Fourteen percent had transient mild renal dysfunction post-procedure. At 1 month, CR+PR were 36.5%, SD 56.3% and PD 7%. Seventy two percent had >50% necrosis. Overall median survival from the initial diagnosis and from initial TACE-DEB was 808 days (95% CI, 625-929) and 441 days (95% CI, 312-590) respectively. Post-diagnosis, Child A patients had better survival than Child B (884 vs. 625 days); however, a difference in survival was not observed following TACE-DEB (445 vs. 441). The survival rates at 6, 12 and 24 months were 80.3%, 53.3% and 19.4% respectively.

Trans-arterial chemoembolization with drug-eluting beads loaded with doxorubicin is safe and well tolerated in patients with unresectable HCC. Its efficacy is comparable to historical controls. Following the TACE-DEB, Child B patient had similar survival to Child A patients.

This data supports safety and effectiveness of TACE-DEB in HCC. Child B patients had similar survival as those of Child A. TACE-DEB can be safe and effective even in high risk patients.

Kalva, S, Yeddula, K, Iqbal, S, Somarouthu, B, Ganguli, S, Pomerantz, B, Wicky, S, Blaszkowsky, L, Zhu, A, Transarterial Chemoembolization with Drug-eluting Beads Loaded with Doxorubicin for Unresectable Hepatocellular Carcinoma.  Radiological Society of North America 2010 Scientific Assembly and Annual Meeting, November 28 - December 3, 2010 ,Chicago IL. http://archive.rsna.org/2010/9009225.html