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Sorafenib Effective in Patients With Liver Cancer Infected With Hepatitis B: Presented at ESMO

By Ed Susman

STOCKHOLM, Sweden -- September 14, 2008 -- Sorafenib therapy for patients with hepatocellular carcinoma who are infected with hepatitis B virus appears to be as effective in treating cancer as it is in patients without the hepatitis B infection, according to research presented here at the 33rd European Society for Medical Oncology Congress (ESMO).

"The results of this subset analysis support the utility of sorafenib in a broad range of patients with different etiologic classes of hepatocellular carcinoma," said Zhong-Zhen Guan, MD, Sun Yat-Sen University Cancer Center, Guangzhou, China, speaking here on September 13 at a discussion of his poster presentation.

Dr. Guan and colleagues dissected data from a multinational, double-blind, placebo-controlled trial conducted in patients from the Asia-Pacific region with advanced hepatocellular carcinoma. In that study, sorafenib 400 mg twice/day significantly prolonged overall survival and time to progression compared with placebo.

The researchers identified 165 patients who were positive for hepatitis B virus, 106 of whom had been assigned to sorafenib and 59 of whom had been assigned to placebo in the phase 3 trial. Overall, 226 patients in the trial were all from China, South Korea, and Taiwan.

"Among hepatitis B virus-positive patients, overall survival and time to progression were longer with sorafenib than with placebo of 30% and 48%, respectively," Dr. Guan reported.

Overall survival in the total group studied was 6.5 months if the patients were on sorafenib, 4.2 months if they were assigned to placebo. If patients were infected with hepatitis B virus and were receiving sorafenib, their survival was 5.9 months. If patients were infected with hepatitis B virus and had been assigned to placebo, however, their overall survival was only 4.1 months.

Time to progression was 2.7 months among patients infected with hepatitis B virus receiving sorafenib and 1.4 months if these patients were on placebo.

"Sorafenib was effective for the treatment of advanced hepatocellular carcinoma in patients from the Asia-Pacific region, irrespective of the hepatitis B virus status," Dr. Guan concluded.

Funding for this study was provided by Bayer AG and Onyx Pharmaceuticals, Inc.

[Presentation title: Sorafenib Is Effective in Hepatitis B-Positive Patients With Hepatocellular Carcinoma (HCC): Subgroup Analysis of a Randomized, Doubleblind, Phase III Trial Performed in the Asia-Pacific Region. Abstract 512PD]

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