Sorafenib (Nexavar) tablets significantly improved overall survival by 47.3% (HR = 0.68; P = .014) in patients in the Asia-Pacific region with advanced hepatocellular carcinoma (HCC) vs those receiving placebo. Nexavar also significantly improved time to progression in these patients by 74% (HR = 0.57; P = .001). These data, presented at this year’s Chicago ASCO meeting (abstract 4509), further confirm sorafenib’s efficacy in liver cancer.
Key Study Findings
The international, phase III, randomized trial evaluated efficacy and safety of sorafenib vs placebo in 226 Asian patients with advanced HCC who had not received prior systemic therapy. The study was designed to compare overall survival, time to progression, time to symptomatic progression, response as defined by Response Evaluation Criteria in Solid Tumors (RECIST) and safety in patients receiving sorafenib vs placebo. Median overall survival was 6.5 months in patients treated with sorafenib vs 4.2 months for those taking placebo. The survival benefit was seen across multiple patient subsets analyzed, including age, extrahepatic spread, and/or macroscopic vascular invasion.
“Liver cancer in the Asia-Pacific region continues to grow because of a high incidence of chronic hepatitis B viral infections, which now impact approximately 275 million people in the region,” said Ann-Lii Cheng, md, phd, Department of Internal Medicine and Department of Oncology, National Taiwan University Hospital, Taipei, Taiwan, and principal investigator of the trial. “Nexavar demonstrated a clear survival benefit in Asia-Pacific patients and had comparable results to last year’s SHARP trial [Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol], despite these patients in the Asia-Pacific trial having poorer health status and more metastases.”
Time to Progression and Disease Control Rate
Additional results from the trial are as follows:
• Median time to progression was 2.8 months in sorafenib-treated patients vs 1.4 months for those taking placebo.
• Median time to symptomatic progression was 3.5 months in patients treated with sorafenib vs 3.4 months for those taking placebo.
• Disease control rate (complete response plus partial response plus stable disease ≥ 12 weeks) was 35% in sorafenib-treated patients vs 16% for those taking placebo.