Sorafenib Increases Survival In Patients With Late-Stage Liver Cancer
Editor's ChoiceMain Category: Liver Disease / Hepatitis
Also Included In: Cancer / Oncology; Clinical Trials / Drug Trials
Article Date: 28 Sep 2007 - 0:00 PDT
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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.
www.nexavar.com
Written by: Jill Stein
Jill Stein is a Paris based medical writer.
Jillstein03 at cs.com
Copyright: Medical News Today
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Sorafenib (Nexavar) Can Increase Survival In Patients With Late-Stage Liver Cancer
posted by Gregory D. Pawelski on 28 Sep 2007 at 5:38 pmCells are the most basic structure of the body. Cells make up tissues, and tissues make up organs, such as the lungs or liver. Each cell is surrounded by a membrane, a thin layer that separates the outside of the cell from the inside.
For a cell to perform necessary functions for the body and respond to its surroundings, it needs to communicate with other cells in the body. Communication occurs through chemical messages in a process called signal transduction. The purpose of these signals is to tell the cell what to do, such as when to grow, divide into two new cells, and die.
The "targets" that the new molecular drugs go after can be located on the "inside" or "outside" of a cancer cell. The most common targets on the outside are receptors, proteins that help relay chemical messages. And many targets on the inside are enzymes, proteins that help speed up chemical reactions in the body.
What Nexavar, Iressa, Tarceva, Sutent and Tykerb have in common is that they are small molecule drugs. Exciting results have come from studies of multitargeted tyrosine kinase inhibitors, small molecules that act on multiple receptors in the cancerous cells.
Targeted cancer therapies use drugs that block the growth and spread of cancer by interfering with specific molecules involved in carcinogenesis (the process by which normal cells become cancer cells) and tumor growth. By focusing on molecular and cellular changes that are specific to cancer, targeted cancer therapies may be more effective than current chemotherapy treatments, but not necessarily less toxic.
So it doesn't matter if there is a "target" molecule in the cell that the "targeted" drug is going after, if the drug either won't "get in" in the first place or if it gets pumped out/extruded or if it gets immediately metabolized inside the cell, drug "resistance" is multifactorial, and could cause more toxicity.
The eighty extra days is for the "group" in the study, not the "individual" patients treated in the real world. One person may live two days, another two-hundred additional days. What may work in some patients, may not work in other patients.
What's good for the group may not be good for the individual, affirms that in the tactic of using "fresh" biopsied cells to predict which cancer treatments will work best for the individual patient, this or any other molecular drug has to get inside the cells in order to "target" anything.
If a drug works extremely well for a certain percentage of cancer patients, identify which ones. If one drug or another is working for some people (not average populations) then obviously there are others out there who would also benefit.
Drug sensitivity tests support the idea that a marginal benefit in terms of overall survival is observed in cancer patients with normal prognoses, but there are "marked survival benefits" for cancer patients with poor prognoses.
What is needed is to sort out what's the best profile in terms of which patients benefit from this drug or any other drug. Can they be combined? What's the proper way to work with these new drugs?
Each of these new targeted drugs are not for everybody. The study of cell function analysis tells us that even when the disease is the same type, different patients' tumors respond differently to the same agents.
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