The oral multikinase inhibitor inhibitor sorafenib (Nexavar) significantly improves survival compared to placebo in patients with advanced hepatocellular carcinoma, according to phase III results reported at the 14th European Cancer Conference (ECCO).
“Available systemic therapies for hepatocellular carcinoma have no proven survival advantage,” Josep Llovet, MD, Director of Hepatocellular Research in the Liver Cancer Program at Mount Sinai School of Medicine in New York, NY, said. “Based on our results, we believe that sorafenib represents the new reference standard for front-line systemic treatment of this malignancy.”
Dr. Llovet is the principal investigator of the Sorafenib Hepatocellular Carcinoma Assessment Randomized Protocol (SHARP) trial, which randomized 602 patients with advanced measurable hepatocellular carcinoma and no prior systemic therapy to six months’ treatment with sorafenib, 400 mg twice daily, or placebo.
The primary efficacy endpoints were overall survival and time to symptomatic progression.
The treatment groups were similar with respect to baseline demographic and clinical characteristics.
The trial was aborted by the data monitoring committee following a planned interim analysis which demonstrated sorafenib’s significant superiority over placebo.
Results showed a median survival of 10.7 months in the sorafenib-treated group versus 7.9 months in the placebo-treated group. “This amounts to a 44 percent improvement in survival time,” Dr. Llovet observed.
The investigators also documented a 73 percent prolongation in time to progression.
Sorafenib was well tolerated, and the rate of serious adverse events was similar in the two treatment groups.
Dr. Llovet said that there have been more than 100 unsuccessful clinical studies for advanced hepatocellular carcinoma over the last 30 years and added that sorafenib can be expected to benefit “these patients who have had few or no treatment options.”
The SHARP trial was conducted at more than 100 sites worldwide.
Hepatocellular carcinoma is the fifth most common malignancy worldwide and the third leading cause of cancer mortality. Nearly half of all cases of hepatocellular carcinoma are diagnosed at an advanced stage.
Written by: Jill Stein
Jill Stein is a Paris based medical writer.
Jillstein03 at cs.com