The FDA has approved the use of Taxotere (docetaxel) in combination with cisplatin and fluorouracil prior to radiotherapy for the induction treatment of patients with inoperable, locally advanced squamous cell carcinoma of the head and neck.
The FDA based its decision, a news release from the manufacturer, Sanofi-Aventis, noted, on the results of a Phase III, open-label, randomized trial of 358 patients with previously untreated, inoperable, locally advanced squamous cell head and neck cancer.
The patients were divided into two groups: one received Taxotere in combination with cisplatin and fluorouracil, and the other received only cisplatin and fluorouracil.
Chemotherapy was administered prior to radiation therapy, and surgery was allowed after chemotherapy, either before or after radiation therapy.
The results of the trial showed that patients receiving Taxotere lived longer (18.6 vs 14.2 months) and had a longer time to disease progression or death (11.4 months vs 8.3 months), compared with the group on cisplatin and fluorouracil alone.
The most common adverse events in the Taxotere-treated patients were decreases in white and red blood cells, loss of hair, inflammation of the mouth and esophagus, and nausea.