Poster Presentations

Session Title: LIVER TUMORS b) CLINICAL (EPIDEMIOLOGY, DIAGNOSIS, MANAGEMENT)
Presentation Date: Apr 25, 2009

IMPACT OF PRIOR TACE/TAE ON THE EFFICACY AND SAFETY OF SORAFENIB IN PATIENTS WITH ADVANCED HEPATOCELLULAR CARCNIOMA (HCC) FROM THE ASIA-PACIFIC REGION

W.Y. Tak¹, S. Yu², C.J. Tsao³, T.S. Yang⁴, J.S. Kim⁵, S. Qin⁶, K. Burock⁷, J. Zou⁸, D. Voliotis⁹, A.L. Cheng^10
1Kyungpook National University Hospital, Daegu, South Korea, ²Tongji Hospital, Tongji Medical College, Huazhong University of Science and Technology, Wuhan, China, ³Chi Mei Medical Center, Liou Ying Campus, Tainan, Taiwan R.O.C., ⁴Chang Gung Memorial Hospital, Tao-Yuan, Taiwan R.O.C., ⁵Korea University Guro Hospital, Seoul, South Korea, ⁶Nanjing 81 Hospital, Nanjing, China, ⁷Bayer Schering Pharma, Wuppertal, Germany, ⁸Bayer Schering Pharma, Shanghai, China, ⁹Bayer HealthCare Pharmaceuticals, Montville, CT, USA, ¹⁰National Taiwan University Hospital, Taipei, Taiwan R.O.C.

Background and aims: Results of a multinational phase III, randomized, double-blind, placebo-controlled trial of patients from the Asia-Pacific (AP) region demonstrated that sorafenib is effective and safe for the treatment of advanced HCC (Cheng A-L, et al. ASCO 2008). Transarterial chemoembolization/transarterial embolization (TACE/TAE) are commonly used procedures for the treatment of intermediate-stage HCC. Therefore, it is of interest to analyze the efficacy and safety of sorafenib in patients who had received prior TACE/TAE.
Methods: Patients (N=226) with advanced HCC, ECOG PS 0-2, Child-Pugh class A, and no prior systemic therapy were randomized 2:1 to sorafenib 400 mg BID or placebo. Endpoints included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 days from first demonstration of response), time-to-progression (TTP), and safety.
Results: Median TTP, OS, and DCR by subset are shown in the table. The incidence of grade 3/4 drug-related adverse events (AEs) was consistent in the subgroups and overall population. The most common grade 3/4 AEs in the sorafenib subgroups were hand-foot skin reaction and diarrhea. Although the baseline patient characteristics of the subsets mirrored those of the overall population, there were imbalances between the placebo and sorafenib arms in each subset for ECOG PS and presence of macroscopic vascular invasion/extrahepatic spread, which may have resulted in placebo-treated patients of the prior TACE/TAE subgroup and sorafenib-treated patients of the other subgroup having a better prognosis.
Conclusions: Sorafenib was effective and safe in patients from the AP region with advanced HCC, regardless of whether or not they had received prior TACE or TAE. This analysis, however, is limited by an imbalance in baseline patient characteristics of factors known to be prognostic of outcome in HCC. Studies with larger sample sizes stratified by prior treatment are warranted to confirm these findings.