Results of the large randomized phase III study (ACTS-GC) announced at the 2007 Gastrointestinal Cancers Symposium in Orlando, USA, showed that the investigational oral anticancer agent S-1 reduced significantly the relative risk of death in early stage gastric cancer patients by a significant 32% as compared to curative surgery alone (p = 0.0024).
Based on the first interim efficacy analysis (N=1059) in June 2006, the study's data and safety monitoring committee (DSMC) recommended to the investigators that the study be stopped. The results (N= 1059) indicates that for all randomized patients overall survival at 3-years was 80.5% for patients receiving S-1 and 70.1% for patients undergoing surgery alone, with a hazard ratio (HR) of 0.68 (95%CI, 0.52-0.87, p=0.0024). The most common grade 3 or 4 adverse reactions for nausea, vomiting, diarrhea, anorexia and hematological reactions were below or equal to 6%.
The Steering Committee of the GI Symposium has granted a Public Health Exception for the S-1 abstract. In the case of a Public Health Exception, the research data should be made public as soon as possible so that physicians and patients may immediately begin to make treatment decisions based on the new information. This is applicable in the countries where the drug is approved.
This drug is currently in Phase III clinical development in the U.S. and not yet approved by the U.S. Food and Drug Administration.
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