June 7, 2007 A trial designed and co-led by Dr. Jordi Bruix, head of the Hepatology Service of Hospital Clínic- IDIBAPS (Barcelona) and Dr. Josep Maria Llovet, ICREA researcher of the Hepatic Oncology Group, are planning a new treatment which increases the overall survival of patients suffering from advanced liver cancer. The results of this study, called SHARP (Sorafenib HCC --hepatocellular carcinoma-- Assessment Randomized Protocol) allow overall survival (OS) and time to symptom progression (TTSP) comparison between patients who were administered Sorafenib orally, (developed by BAYER) and another group of patients, treated with placebo. The results presented by Clínic-IDIBAPS investigators have been hand selected to be included on the Best of ASCO program. This is an educational initiative that condenses highlights from ASCO's Annual Meeting into a 1½ day program.
Results are consistent and significant. Overall survival of patients treated with Sorafenib was in average 10.7 months compared to 7.9 months within the group administered placebo. Thus, this treatment increases overall survival by more than 40% if compared to the placebo group. Furthermore, no differences were observed in the severe side effects rate between the treatment's two modalities. Obtained data imply an unprecedented therapeutic progress in the treatment of advanced liver cancer and involve a shift in this disease's paradigm. This treatment gives new hope for patients who, until now, could neither beneficiate from curative effects of therapies nor hope for survival improvement. From a scientific point of view, this drug, which delays tumor progression and improves survival, will be the base for future further research.
The SHARP study, an international phase III trial, lead by Hospital Clínic in collaboration with Mount Sinai, where Dr. Llovet is head of the Hepatic Cancer Research Program, started 5 years ago and included a total of 602 patients from 110 centers from the USA, South America, Europe, Australia and New Zealand. All participating patients suffered from advanced liver cancer and had not received any kind of therapy prior to the study.
As a consequence of the good results showed by patients treated with Sorafenib, researchers decided to end the study ahead of schedule in order to administer the drug also to the rest of patients participating in this trial.
Liver cancer and Sorafenib
Primary liver cancer, also known as hepatocellular carcinoma, is the most common of liver cancers. This is the fifth most common cancer worldwide and, in Spain, this disease has an incidence of 10-11 new cases per 100,000 inhabitants per year. The most affected patients are those suffering from acute cirrhosis caused by hepatitis B/ C infections or by excessive alcohol consumption.
Until now, patients suffering from liver cancer in an initial phase have benefited from procedures like resection, transplantation or ablation. Unfortunately, more than 60% of cases of liver cancer are detected in an advanced phase, making chemoembolisation the only available treatment. Chemoembolisation could only be applied to 15% of patients, and there was no other effective treatment for the rest of patients.
Sorafenib blocks a cellular cycle signal pathway, preventing not only the proliferation of tumor cells but also the formation of blood vessels supporting the tumor. Therefore, it delays tumor progression and, as a consequence, improves survival. This implies a hopeful change for patients since until now, treatments tried to eradicate the disease, whereas these new type of agents try to stop the progression of the disease. If new drugs or new combinations of drugs achieve total inhibition of cancer progression, cancer as a whole, and liver cancer in particular, will not necessarily give rise to death.
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The above story is reprinted from materials provided by Institut d'Investigacions Biomèdiques August Pi i Sunyer, via EurekAlert!, a service of AAAS.
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