Clinical

Sorafenib lengthens survival in liver cancer

Last Updated: 2008-12-23 15:02:23 -0400 (Reuters Health)

NEW YORK (Reuters Health) - The oral multikinase inhibitor sorafenib has been shown to lengthen median survival in Asian patients with advanced hepatocellular carcinoma.

In their report in the December 17 online issue of The Lancet Oncology, Dr. Ann-Lii Cheng of National Taiwan University Hospital, Taipei, and colleagues explain that the safety and efficacy of sorafenib have already been shown in a phase III trial in North America and Europe, where the majority of hepatocellular carcinoma cases are due to hepatitis C virus. In the Asia-Pacific region, however, 70% of hepatoma cases occur in patients with hepatitis B virus infection (HBV), and in order to get regulatory approval for the drug in China, a parallel study in that region was required.

In the phase III Asian trial, conducted in 23 centers in China, South Korea and Taiwan, 226 patients with advanced liver cancer who had not previously received any systemic therapy were randomized in a 2:1 fashion to receive oral sorafenib, 400 mg twice daily, or placebo, in 6-week cycles.

Median overall survival was 6.5 months in the treatment group versus 4.2 months in the placebo group (hazard ratio, 0.68), the investigators report. Median time to progression was 2.8 months in patients given sorafenib and 1.4 months in those who received placebo (hazard ratio, 0.57).

In a safety analysis involving 149 sorafenib-treated patients and 75 placebo patients, the incidence of treatment-emergent adverse effects was 98% and 95%, respectively. The most common drug-related adverse effects overall were skin reactions on the hands and feet, diarrhea, and fatigue. "The absolute risk of discontinuation due to adverse (drug-related) events was considered to be low," the authors write.

"Although other studies suggest that sorafenib might be less efficacious in patients with HBV, we do not agree with these conclusions, and believe that the large proportion of patients with HBV enrolled in our study supports the efficacy of sorafenib in this important patient subset," Dr. Cheng said in a press release.

Lancet Oncology 2008.