Researchers from 23 medical centers in Asia have reported that Nexavar® (sorafenib) is effective in patients with advanced hepatocellular carcinoma (liver cancer). The results of this study were published in Lancet Oncology.
The liver is the largest organ inside of the body. It is located on the right side of the abdomen behind the ribs. The liver has many important functions, including removing harmful substances from the blood, making bile that helps in the digestion of fats from food, and storing glycogen (sugar) that the body can use for energy.
Cancer that begins in the liver (as opposed to spreading to the liver from another organ) is referred to as primary liver cancer. The most common type of primary liver cancer is hepatocellular carcinoma. Factors that contribute to the development of hepatocellular carcinoma include chronic infection with hepatitis C virus or hepatitis B virus, and long-term heavy alcohol use.
Nexavar is a targeted therapy that interferes with specific biological pathways associated with the growth and spread of cancer cells. Nexavar has been shown to be effective against hepatocellular carcinoma among patients in North America and Europe, but researchers also wanted to establish the effectiveness among patients in Asia. Asia has high rates of hepatocellular carcinoma, and many of these cases are linked to chronic infection with hepatitis B virus. In North America and Europe, hepatocellular carcinoma is more likely to be linked with hepatitis C virus.
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To evaluate the safety and efficacy of Nexavar, researchers conducted a Phase III clinical trial among 226 patients in China, South Korea, and Taiwan. The patients all had advanced hepatocellular carcinoma (cancer that could not be surgically removed or that had spread to other sites in the body). None of the patients had received prior systemic therapy. Patients were assigned to treatment with Nexavar or placebo.
- Overall survival was 6.5 months among patients treated with Nexavar and 4.2 months among patients treated with placebo.
- Time to cancer progression was 2.8 months in the Nexavar group compared with 1.4 months in the placebo group.
- The most common serious side effects in the Nexavar group were hand-foot skin reaction, diarrhea, and fatigue.
The researchers concluded that Nexavar is effective and generally well tolerated in this patient population, and that Nexavar “seems to be an appropriate option for the treatment of advanced hepatocellular carcinoma.”
Reference: Cheng A-L, Kang Y-K, Chen Z, et al. Efficacy and safety of sorafenib in patients in the Asia-Pacific region with advanced hepatocellular carcinoma: a phase III randomized, double-blind, placebo-controlled trial. Lancet Oncology. 2009;10:25-34.