Docetaxel is a chemotherapy drug that is used to treat several forms of cancer including head and neck cancer.
In October 2006, the United States Food and Drugs Administration (US FDA) approved the use of docetaxel in combination with cisplatin and fluorouracil as an induction therapy for locally advanced squamous cell cancers of the head and neck (also called SCCHN).
The safety and efficacy of these drugs were tested in a multicenter clinical trial of 358 patients with inoperable, locally advanced SCCHN that had not previously been treated.
The patients either received docetaxel 75 mg/m2 plus cisplatin 75 mg/m2, followed by an infusion of 5-flourouracil 750 mg/m2 over five days (TPF group) or cisplatin 100 mg/m2, followed by 5-flourouracil infusion at 1000 mg/m2 for five days (PF group).
Each of these regimens were administered every three weeks for four cycles of treatment. Between four and seven weeks after the treatment cycles were completed, patients with disease that had not progressed received radiotherapy. Surgery was performed just after chemotherapy, before or after radiotherapy. The primary efficacy endpoint was progression-free survival from the point of randomization to one of the regimens.
The results demonstrated a significantly greater increase in progression-free survival in the TPF group than in the PF group, at a median of 11.4 versus 8.3 months. The median overall survival was also longer with the TPF regimen compared with the PF regimen, at 18.6 versus 14.2 months.