Results from a late-breaking abstract presented at the 2007 annual meeting of the American Society of Clinical Oncology (ASCO) indicate that Nexavar (sorafenib) significantly improves survival and doubles the time to progression among patients with advanced hepatocellular carcinoma (HCC). This is the first agent to ever demonstrate a significant improvement in survival in the treatment of HCC. 

Nexavar is an orally active, multi-kinase inhibitor approved for the treatment of advanced RCC, which has demonstrated broad-spectrum anti-cancer activity. 

The recent multinational, Phase III  placebo-controlled trial, referred to as the SHARP trial (Sorafenib HCC Assessment Randomized Protocol) included 602 patients with advanced HCC who had not received prior systemic therapy. Patients were randomized to receive sorafenib (400 mg BID) or placebo.

• Median survival was 46.3 weeks in the sorafenib group compared with 34.4 weeks in the control group (HR=0.69, p=0.00058).
• Median time to progression was nearly doubled in the sorafenib group (24 weeks) compared to the control group (12.3 weeks) (HR=0.58, p=0.000007).

The most common grades 3-4 events among patients treated with sorafenib and those on placebo were diarrhea (11% vs 2%), hand-foot skin reaction (8% vs 1%), fatigue (10% vs 15%), and bleeding (6% vs 9%), respectively. Serious side effects occurred in 52% of patients treated with sorafenib compared with 54% of patients on placebo.

The researchers concluded that although these results need to be confirmed through the peer-review process, sorafenib is the first agent to demonstrate an improvement in survival among patients with advanced HCC and has a manageable toxicity profile. The presenter stated that "Sorafenib is the new reference standard for systemic therapy of hepatocellular carcinoma patients."

Reference: Llovet J, et al. Sorafenib improves survival in advanced Hepatocellular Carcinoma (HCC): Results of a Phase III randomized placebo-controlled trial (SHARP trial). Proceedings from the American Society of Clinical Oncology Conference. Chicago,IL. 2007.  Late-Breaking Abstract (LBA) #1.