Taxotere Wins FDA Approval for Advanced Gastric Cancer

ROCKVILLE, Maryland-The FDA has approved the use of Taxotere (docetaxel, Sanofi-Aventis) in combination with cisplatin and fluorouracil (5-FU) for the treatment of advanced gastric cancer, including cancer of the gastroesophageal junction, in patients who have not received prior chemotherapy for their advanced disease. According to the company, Taxotere is the first drug approved for advanced stomach cancer in more than a decade that has demonstrated a survival advantage.

FDA granted approval on the basis of data from TAX 325, a randomized, international phase III clinical trial and the largest study conducted in previously untreated advanced gastric cancer patients. Taxotere was initially approved in 1996 for treating advanced breast cancer and later for use as adjuvant therapy of breast cancer and in patients with advanced non-small-cell lung cancer and advanced prostate cancer.

TAX 325 randomized 445 patients to receive Taxotere plus cisplatin/5-FU or the standard treatment of cisplatin/5-FU. Median follow-up was 23 months. Time to tumor progression, the primary endpoint, was 5.6 months in the Taxotere arm vs 3.7 months in patients receiving the standard treatment (P = .0004), a hazard ratio of 1.47. The Taxotere group had an overall survival of 9.2 months vs 8.6 months for the standard treatment arm (P ≤ .02), a hazard ratio of 1.29.

In the TAX 325 study, 81.4% of the Taxotere-treated patients had at least one grade 3-4 adverse event vs 76.4% in the standard treatment arm. Neutropenia was the most common grade 3-4 event in the Taxotere group. (The protocol did not allow primary prophylaxis with G-CSF.) The most common side effects of all grades in the Taxotere arm were anemia, neutropenia, diarrhea, and nausea, and, in the control arm, anemia, neutropenia, and nausea and vomiting.