Sanofi-Aventis announced that following a priority review of the supplemental new drug application (sNDA), the US Food and Drug Administration (FDA) has approved docetaxel(Drug information on docetaxel) (Taxotere) in combination with cisplatin(Drug information on cisplatin) and fluorouracil(Drug information on fluorouracil) (5-FU) for the treatment of patients with advanced stomach (gastric) cancer, including cancer of the gastro-esophageal junction, who have not received prior chemotherapy for advanced disease. This is the first FDA approval of an advanced stomach cancer treatment demonstrating a survival advantage in more than a decade, thereby offering physicians and their patients an important new option for treating this disease.
The FDA based its decision on results from the TAX 325 study, the largest international phase III clinical trial in previously untreated advanced stomach cancer, involving 445 patients. Patients treated with the docetaxel-based TCF chemotherapy regimen (docetaxel plus cisplatin and 5-FU) experienced a significant 23% reduction in the risk of death compared to patients who received a current standard treatment with CF (cisplatin and 5-FU), with a median follow-up of 23 months). The median overall survival was significantly longer with the docetaxel-containing regimen (9.2 vs 8.6 months, P < .02), with a hazard ratio of 1.29 (95% confidence interval [CI] = 1.04-1.61). Time to disease progression was nearly 2 months longer in the docetaxel-containing arm (5.6 vs 3.7 months, P = .0004; hazard ratio = 1.47, CF/TCF 95% CI = 1.19-1.83).
New Standard of Treatment
"For many years, patients with gastric cancer had limited options for the treatment of their disease," said Jaffer A. Ajani, MD, professor, GI Medical Oncology, The University of Texas M. D. Anderson Cancer Center, Houston, Texas, Principal Investigator of the TAX 325 study "With the approval of this Taxotere-based regimen in this cancer, a new standard of treatment is now available for advanced gastric cancer patients."
ACS Launches Cancer Information Blog
The American Cancer Society has launched a Web log, or blog, authored by J. Leonard Lichtenfeld, MD, the Society's deputy chief medical officer. Dr. Len's Cancer Blog (www.cancer.org/drlen) covers breaking cancer news and provides commentary on new research, scientific developments, and other cancer breakthroughs. The blog attempts to make complex medical and scientific information understandable for a general audience and is the latest tool from the Society to raise awareness of cancer risk, prevention, and early detection through commentary on breaking news in the treatment of cancer.