Source: DGNews  |  Posted 3 years ago

NEW YORK -- December 17, 2008 -- Sorafenib significantly increases overall survival in Asian-Pacific patients with advanced hepatocellular carcinoma -- a group for which surgical treatments can be limited -- according to findings of a phase 3 study published early online and in the January 2009 edition of The Lancet Oncology.

The safety and efficacy of sorafenib in patients from Europe and North America with hepatocellular carcinoma were shown earlier this year in the phase 3 Sorafenib Hepatocellular Carcinoma Assessment Randomised Protocol (SHARP) trial, leading to the approval of the drug in the United States and Europe.

However, regulatory approval in China requires evidence from a parallel study in patients from the Asia-Pacific region; these patients have a very different incidence of hepatitis B virus (HBV) infection compared with the SHARP trial population (73% vs 12%).

Therefore, Ann-Lii Cheng, National Taiwan University Hospital, Taipei, Taiwan, and colleagues assessed the efficacy and safety of sorafenib in 226 patients from 23 centres in China, South Korea, and Taiwan in a randomised, double-blind, placebo-controlled phase 3 trial.

A total of 150 patients received sorafenib 400 mg twice daily in 6-week cycles, and 76 patients received a placebo. Patients in the treatment group had a median overall survival of 6.5 months (95% confidence interval [CI], 5.56-7.56) compared with 4.2 months (95% CI, 3.75-5.46) in the placebo group -- a significant difference. Sorafenib treatment also significantly prolonged the time to progression and disease control rate.

Sorafenib treatment was generally well tolerated, but patients did have some adverse side effects. Approximately 10% of patients had a grade 3 or 4 skin reaction on the hands and feet, 6% had grade 3 or 4 diarrhoea, and 3% had grade 3 or 4 fatigue.

“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,” said Dr. Cheng.

SOURCE: The Lancet Oncology