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According to a press release from Sanofi-Aventis and results presented at the 2007 annual meeting of the American Society of Clinical Oncology Gastrointestinal Cancers Symposium, the addition of the investigative agent S-1 following surgery significantly improves recurrence-free survival compared to surgery alone in the treatment of early gastric cancer.

It is estimated that approximately 23,000 people in the United States are diagnosed annually with gastric cancer, or cancer of the stomach. However, it is the second most common cause of cancer deaths worldwide.

Early gastric cancer refers to cancer that has not spread from the stomach to distant sites in the body. Standard treatment for early gastric cancer often includes surgery to remove as much of the cancer and surrounding tissue as possible.

Chemotherapy with or without radiation therapy is then administered to kill any cancer cells that may remain in the body. This is referred to as adjuvant therapy. Unfortunately, chemotherapy regimens may be difficult to tolerate for some patients. Researchers thus continue to evaluate ways treatment approaches where quality of life is preserved and optimal outcomes are achieved.

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S-1 is an oral agent that is not yet approved by the U.S. Food and Drug Administration (FDA). It is an agent that contains the active form of the commonly used chemotherapy agent 5-fluorouracil. In addition, S-1 contains agents that help prevent or reduce serious side effects typically associated with 5-fluorouracil.

Researchers from Japan recently conducted a Phase III clinical trial (phase prior to FDA approval) to directly compare surgery plus S-1 to surgery alone in patients with early gastric cancer. This trial included 1,059 patients with Stages III and III gastric cancer and over 100 medical institutions in Japan. Patients treated with surgery plus S-1 were directly compared to patients treated with surgery alone.

  • At three years recurrence-free survival was 72.2% for patients treated with S-1, compared to 60.1% for patients treated with surgery only.
  • S-1 was relatively well tolerated, with no safety concerns to delay its clinical progress.

The researchers concluded that addition of S-1 to surgery significantly improves recurrence-free survival compared to surgery alone in patients with early gastric cancer.

Reference: Sanofi-Aventis. S-1 oral anticancer agent improves patients’ survival in adjuvant gastric cancer trial versus surgery alone. Available at: Accessed January 2007.