Poster Presentations

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

IMPACT OF LUNG AND LYMPH NODE METASTASIS ON EFFICACY AND SAFETY FOLLOWING TREATMENT WITH SORAFENIB IN PATIENTS WITH HEPATOCELLULAR CARCINOMA FROM THE ASIA-PACIFIC REGION

H. Pan¹, Z. Guan², Y.K. Kang³, Z. Chen⁴, C.J. Tsao⁵, A.L. Cheng⁶, J.S. Kim⁷, K. Burock⁸, J. Zou⁹, D. Voliotis¹⁰, S. Qin^11
1Sir Run Run Shaw Hospital, Medical School of Zhejiang University, Hangzhou, China, ²Sun Yat-sen University Cancer Center, Guangzhou, China, ³ASAN Medical Center, Songpa-gu, Seoul, South Korea, ⁴First Affiliated Hospital of Anhui Medical University, Hefei, China, ⁵Chi Mei Medical Center, Liou Ying Campus, Tainan, ⁶National Taiwan University Hospital, Taipei, Taiwan R.O.C., ⁷Korea University Guro Hospital, Seoul, South Korea, ⁸Bayer Schering Pharma, Wuppertal, Germany, ⁹Bayer Schering Pharma, Shanghai, China, ¹⁰Bayer HealthCare Pharmaceuticals, Montville, NJ, USA, ¹¹Nanjing 81 Hospital, Nanjing, China

Background and aims: Results of a multinational, phase III, randomized, double-blind, placebo-controlled trial in a population made up entirely of patients from the Asia-Pacific (AP) region, indicate that sorafenib is effective and safe for the treatment of advanced hepatocellular carcinoma (HCC). Early metastasis is a prominent feature of HCC, and is associated with poor prognosis and advanced disease. We performed subset analyses to evaluate the efficacy and safety of sorafenib in patients with or without lung metastasis and those with or without lymph node (LN) metastasis at baseline.
Methods: Patients (N=226) with advanced, unresectable, measurable HCC, ECOG PS 0-2, Child-Pugh class A, and no prior systemic therapy for HCC 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) across subgroups was consistent with that reported for the overall population. The most common grade 3/4 AEs in the sorafenib subpopulations were hand-foot skin reaction and diarrhea.
Conclusions: Sorafenib was effective and safe in patients from the AP region with advanced HCC, regardless of the presence of lung or LN metastasis at baseline. These results are consistent with those for the overall study population. Further studies with larger sample sizes are warranted to confirm the efficacy and safety of sorafenib in these patient subsets.