Case presented by Dr Polkinghorn 80 yo man: Active dancer, but weight loss & RUQ pain 5/10: USN = large masses in R liver  biopsy ? “NSCLC”, but nonsmoker and no lung primary ↑AFP, re-eval of pathology = HCC (K-ras wt, EGFR-neg) Not a surgical candidate  TACE x 3 At progression, offer sorafenib, but family declines Patient expired just last week

Doxorubicin plus sorafenib vs doxorubicin alone in patients with advanced hepatocellular carcinoma: a randomized trial Abou-Alfa GK et al. JAMA 2010;304(19):62154-60.

Ongoing Phase III Trials: HCC - Metastatic Study Phase Target Accrual Design Study Endpoints CALGB 80802 III 480 (open) Sorafenib +/- doxorubicin OS BRISK-PS 190 Brivanib/BSC or placebo/BSC www.ClinicalTrials.gov, January 2011.

Efficacy and Safety of Sorafenib in Patients with Advanced Hepatocellular Carcinoma: Subgroup Analyses of the SHARP and Asia-Pacific (AP) Trials by Baseline Transaminase (ALT/AST) Alpha-Fetoprotein (AFP) and Bilirubin (Bil) Levels Raoul J et al. Proc ESMO 2010;Abstract 750P.

SHARP: Outcome by baseline LFTs/AFP Population Overall Survival (Mo) HR SOR PLA All patients 10.7 7.9 0.69 No  of ALT/AST (<1.8 ULN) 11.6 8.8 0.68 Moderate  of ALT/AST (>3.0-5.0 ULN) 6.3 4.6 0.71 Normal AFP 12.4 9.5 0.76 Elevated AFP 9.4 7.0 0.72 Normal bilirubin 11.1 9.1 0.70 Elevated bilirubin 6.2 5.0 0.77 Raoul J et al. Proc ESMO 2010;Abstract 750P.

Case presented by Dr Polkinghorn 80 yo man: Active dancer, but weight loss & RUQ pain 5/10: USN = large masses in R liver  biopsy ? “NSCLC”, but nonsmoker and no lung primary ↑AFP, re-eval of pathology = HCC (K-ras wt, EGFR-neg) Not a surgical candidate  TACE x 3 At progression, offer sorafenib, but family declines Patient expired just last week 6