The US Food and Drug Administration (FDA) has approved Taxotere (docetaxel, manufactured by Sanofi-Aventis) for combination therapy with cisplatin and 5-fluorouracil to treat locally advanced Squamous Cell Carcinoma of the Head and Neck (SCCHN) prior to chemoradiotherapy and surgery. All patients involved in the clinical trial had inoperable tumors or potentially operable tumors but unlikely to be cured by surgery alone. Approval was based on results of TAX 324, a Phase 3 randomized open-label international trial involving over 500 patients assigned to either a Taxotere/Platinum/Fluorouracil (TPF) arm or a platinum/fluorouracil arm (PF). Taxotere-added arm showed longer median overall survival (O.S.) rate of 70.6 months versus non-Taxotere arm of 30.1 months. Both arms had similar grade 3/4 toxicities although Taxotere-treated arm had more febrile neutropenia, neutropenic infection, and grade 3/4 neutropenia. Non-taxotere treated arm had more grade 3/4 thrombocytopenia, stomatitis, lethargy, and vomiting. Other grade 3/4 events common to both treatments included nausea, anorexia and constipation. Taxotere is already approved for treating breast cancer, lung cancer, prostate cancer, and gastric (stomach) cancer. Source: sanofi-aventis.
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Today, the Food and Drug Administration (FDA) has approved Taxotere or docetaxel (made by sanofi-aventis) for combination treatment of patients advanced head and neck cancer, also known as squamous cell carcinoma of the head and neck or SCCHN. The drug is to be used in combination with cisplatin and fluorouracil prior to radiotherapy. (More …)