Following a priority review of a supplemental New Drug Application, the FDA has approved docetaxel concentrate (Taxotere Injection, sanofi aventis) in combination with cisplatin and 5-fluo-rouracil to treat advanced stomach cancer, including gastroesophageal junction cancer, in patients who have not received prior chemotherapy for advanced disease.
This is the first FDA approval of a therapy for advanced stomach cancer that has shown a survival advantage in more than a decade. Stomach cancer is the fourth most common type of cancer worldwide.
The docetaxel-based regimen demonstrated a 23% reduction in the risk of death. About 80% of the treated patients experienced at least one severe adverse event (usually neutropenia), compared with 75.4% in the control arm. Dexamethasone is administered before treatment to reduce the risk of edema and allergic reactions.
Pregnant women and women of child-bearing age should not use docetaxel.