Oral Anticancer Agent Battles Gastric Cancer

The trial enrolled 1,059 Japanese patients with early stage gastric cancer (stage II and III), who were randomly allocated to receive adjuvant oral S-1 anticancer agent for 12 months or surgery alone. Results of the large randomized phase III adjuvant gastric cancer trial versus surgery alone (ACTS-GC) study showed that post-surgical adjuvant S-1 administration reduced the relative risk of death in early stage gastric cancer patients by a significant 32% as compared to curative surgery alone. The reduction in the relative risk of relapse with S-1 was 38%. For all randomized patients, the three year relapse-free survival was 72.2% in the S-1 arm and 60.1% for surgery alone. The results of the interim study were announced at the 2007 Gastrointestinal Cancers Symposium, held during January 2007 in Orlando (FL, USA).

Based on the interim efficacy analysis the study's data and safety monitoring committee (DSMC) recommended to the investigators that the study be stopped. The results indicate that for all randomized patients overall survival at three 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. The most common grade 3 or 4 adverse reactions for nausea, vomiting, diarrhea, anorexia, and hematological reactions were below or equal to 6%.

S-1 is a novel oral fluorouracil anticancer product that combines three pharmacological agents: tegafur, gimeracil, and oteracil. S-1 is a product of Taiho (Tokyo, Japan), and is currently used in Japan for the treatment of gastric, colorectal, head and neck, non-small cell lung, and metastatic breast and pancreas cancers. Sanofi-aventis (Paris, France) is collaborating on the current phase III clinical trials and is leading the future clinical development and commercialization of the product in the United States, Europe, and other countries.




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