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Sorafenib Boosts Survival in Patients With Advanced Liver Cancer: Presented at ECCO

By Jill Stein

BARCELONA, SPAIN -- September 28, 2007 -- Sorafenib significantly prolongs survival in patients with advanced hepatocellular carcinoma compared with placebo, investigators reported here at the 14th European Cancer Conference (ECCO).

Sorafenib is a multikinase inhibitor with multiple targets including Raf kinase and VEGFR, which regulate cell proliferation and angiogenesis. Inappropriate activation of these pathways is seen in a wide variety of tumor. Sorafenib is currently approved in the United States and other countries for treatment of advanced renal cell carcinoma.

In a presentation on September 27th, Josep Llovet, MD, Director of Hepatocellular Research, Liver Cancer Program, Mount Sinai School of Medicine, New York, New York, presented findings from the phase 3 Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP).

"Our results document that sorafenib is the first systemic therapy to extend survival in patients with hepatocellular carcinoma," Dr. Llovet noted.

The SHARP study evaluated 602 patients who were randomized to treatment with sorafenib 400 mg twice daily or placebo for 6 months.

Participants in the trial had advanced, histology-proven hepatocellular carcinoma, at least one measurable untreated lesion, Eastern Cooperative Oncology Group performance status of 2, and class A Child-Pugh classification of disease severity (well-compensated disease). They had not undergone prior systemic treatment.

Primary efficacy endpoints were overall survival and time to symptomatic progression.

The study was stopped prematurely when a planned interim analysis showed sorafenib's significant superiority over placebo.

Treatment duration was a median of 23 weeks in the sorafenib group and 19 weeks in the placebo group.

Median overall survival was 46 weeks in the sorafenib group and 34 weeks in the placebo group (HR = 0.69; P =.00058). Median time to progression was 24 weeks with sorafenib and 12 weeks with placebo (HR = 0.58; P =.000007). "This translated into a 44% increase in overall survival and a 73% prolongation in time to progression with sorafenib treatment," Dr. Llovet said.

Sorafenib was well tolerated and adverse effects were manageable, Dr. Llovet said.

"Presently available systemic therapies for hepatocellular carcinoma have no documented survival benefit," he said. "Our study establishes sorafenib as the new reference standard for systemic therapy in these patients."

Hepatocellular carcinoma is the fifth most common cancer globally with over 600,000 new cases diagnosed each year. The disease is the leading cause of death in patients with cirrhosis.


[Presentation title: Sorafenib Improves Survival in a Large Multicenter, Randomized, Placebo-Controlled Phase III Trial in Patients With Hepatocellular Carcinoma. Abstract 3507]

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