Source: DGNews  |  Posted 2 years ago

By Cameron Johnston

COPENHAGEN, Denmark -- April 29, 2009 -- Treatment with sorafenib was safe and effective in patients from the Asia-Pacific region with advanced hepatic cell carcinomas (HCC) compared with placebo, regardless of the presence of lung or lymph nodes metastasis at baseline, researchers stated here at the 44th Annual Meeting of the European Association for the Study of the Liver (EASL).

Hongming Pan MD, Centre for Oncology, Sir Run Run Shaw Hospital and the Medical School of Zhejiang University, Hangzhou, China, presented the subgroup analysis done on results from a multicentre, phase 3 trial conducted in China, Taiwan, and South Korea, on April 25.

Most studies on sorafenib have involved patients whose HCC resulted from chronic hepatitis C infection, but in Asia hepatitis B is the most common source of the disease. As well, previous studies had looked at sorafenib treatment in a predominantly Caucasian population, with few Asians involved.

The subgroup analysis included 226 patients, and of these, 112 had lung and 72 had lymph node metastasis at baseline. Many patients had both. A total of 150 patients were treated with oral sorafenib 400 mg BID over 6-week cycles, and 76 in the control group received the placebo.

Overall survival for patients with lung metastasis was 5.6 months for those receiving sorafenib versus 4.2 months for those who received a placebo. Overall survival for patients with lymph node metastasis was 5.6 months for those in the sorafenib arm versus 3.2 months for those in the placebo arm.

For patients without lung metastasis, overall survival time was 7.7 months in the sorafenib arm compared with 4.0 months for those in the placebo arm. For patients without lymph node metastasis, overall survival times were 7.3 months and 4.3 months for patients in the sorafenib arm and the control arm.

Time-to-disease progression followed a similar pattern and there was little difference between patients with lung metastasis or lymph node metastasis. Patients who had metastasis to either region died sooner than patients who did not have metastasis, and patients who were treated with sorafenib had longer time-to-progression compared with patients who received a placebo.

Side effects were more frequent among patients who were treated with sorafenib compared with those in the placebo arm, regardless of whether they had metastasis to the lung and/or lymph nodes. However, there was little difference in the rates of adverse events between patients who had the metastasis and those who did not. Hand-foot syndrome, diarrhoea, and alopecia were the most common adverse events experienced by sorafenib-treated patients.

In all, 29 patients out of 149 (19.5%) who received sorafenib discontinued treatment due to intolerable side effects, compared with 10 out of 75 (13%) who received the placebo.

While the improvement in overall survival seen in this population was smaller than what has been seen in a European population, these data are an encouraging sign in the struggle to help patients with metastatic cancer that has long been very difficult to treat, the authors said.

[Presentation title: Impact of Lung and Lymph Node Metastasis on Efficacy and Safety Following Treatment With Sorafenib in Patients With Hepatocellular Carcinoma From the Asia-Pacific Region. Poster 807]