Impact of lymph node metastases on outcome following treatment with sorafenib in patients with hepatocellular carcinoma (HCC): Subset analysis from the phase III SHARP trial

e15547 Background: Results from the Sorafenib HCC Assessment Randomized Protocol (SHARP) study, a multinational, randomized, placebo-controlled, phase III trial, demonstrated that sorafenib is effective and safe for patients with advanced HCC (Llovet et al, N Engl J Med, 2008). As lymph nodes are among the most common sites of metastasis in patients with HCC, we performed subset analyses to evaluate the efficacy and safety of sorafenib in patients with or without lymph node metastases at baseline. Methods: Patients (N=602) with advanced, unresectable, measurable HCC, ECOG PS 0–2, Child-Pugh class A, and no prior systemic therapy for HCC were randomized 1:1 to receive either sorafenib 400 mg BID or placebo. End points included overall survival (OS), disease-control rate (DCR; defined as complete/partial response or stable disease by RECIST, maintained for ≥28 d 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 across subgroups was consistent with that reported for the overall population. The most common grade 3/4 adverse events in the sorafenib populations were hand-foot skin reaction and diarrhea. Conclusions: Sorafenib prolonged OS and TTP in patients with advanced HCC, whether or not lymph node metastases were present at baseline. The safety profile of sorafenib in patients with lymph node metastases was comparable with that for the overall study population. [Table: see text] [Table: see text]