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Sorafenib is Well-Tolerated in Liver Cancer

By Jill Stein

PRAGUE, CZECH REPUBLIC -- November 17, 2006 -- The oral, dual-action multi-kinase inhibitor sorafenib (NexavarŽ) showed favourable tolerability in a study of Japanese patients with hepatocellular carcinoma (HCC), researchers reported at the American Association for Cancer Research 18^th Symposium on Molecular Targets and Cancer Therapeutics - National Cancer Institute - 18^th European Organisation for Research and Treatment of Cancer (AACR-NCI-EORTC).

Junji Furuse, MD, professor, division of hepatobiliary and pancreatic cancer, National Cancer Center Hospital East, Chiba, Japan, presented results in 27 patients with histologically confirmed, unresectable HCC who were treated with sorafenib. All subjects had Child-Pugh status A or B and adequate organ function.

According to the study protocol, a single dose of sorafenib was administered followed by a 7-day washout period. Patients then received the same dose of sorafenib (200 mg or 400 mg) twice daily for 28 consecutive days in each treatment cycle until disease progression or unacceptable toxicity.

The tolerability at each dose level was correlated with Child-Pugh class. Efficacy was assessed by the Response Evaluation Criteria in Solid tumours (RECIST).

Most patients in the study were men, and the median age was about 70 years. All patients had an Eastern Cooperative Oncology Group (ECOG) performance status of 0.

Results showed no substantial difference in pharmacokinetics between Child-Pugh A and B or between HCC patients and other advanced solid tumour patients despite inter-subject variabilities.

Both doses of sorafenib were generally well tolerated. The incidence and severity of drug-related adverse events were similar in patients receiving multiple-dose sorafenib and between Child-Pugh classifications.

Common drug toxicities included elevated lipase in 85.2% of patients, rash/desquamation in 40.7%, and hand-foot skin reaction in 33.3%.

One (4%) patient achieved a partial response, 20 (83%) had stable disease, and 3 (13%) had progressive disease.

Median progression-free survival for the entire study cohort was 4.9 months, and median overall survival was 14.2 months.

Dr. Furuse said in his poster presentation that the encouraging safety profile and early antitumour activity shown in this trial provide a rationale for additional studies of sorafenib in HCC.

Hepatocellular carcinoma is the fifth most common malignancy worldwide, with an estimated 667,000 cases in 2005.

On the basis of its significant progression-free survival benefit over placebo, sorafenib has been approved for the treatment of advanced renal cell carcinoma in the United States, Canada, Switzerland, Mexico, Chile, Brazil, Korea, and Argentina.

Sorafenib has also received marketing approval from the European Commission for the treatment of patients with advanced renal cell carcinoma who have failed prior interferon or interleukin-2 therapy or are ineligible for cytokine therapy.

The study was sponsored by Bayer Pharmaceuticals.


[Presentation title: Phase I Study of Sorafenib in Patients with Hepatocellular Carcinoma. Abstract 370]

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