Combination chemotherapy with docetaxel, cisplatin, and 5-fluorouracil in previously treated patients with advanced/recurrent head and neck cancer - A phase II feasibility study

The purpose of this phase II feasibility trial was to determine the efficac y and toxicity of docetaxel combined with cisplatin and 5-fluorouracil in p atients with locally advanced and/or recurrent squamous cell carcinoma of t he head and neck. Nineteen patients entered the study. The majority had rec eived prior radiotherapy but were chemotherapy naive. Treatment consisted o f docetaxel 80 mg/m(2) day It cisplatin 40 mg/m(2) days 2 and 3, and fi-flu orouracil 1,000 mg/m(2) by continuous infusion days 1 to 3. The cycle was r epeated every 28 days. Most patients received granulocyte colony-stimulatin g factor, 150 mu g/m(2)/day subcutaneously between days 4 and 8. The median number of chemotherapy cycles per patient was four. Dose reduction was don e in three patients with no treatment delays. Of the 16 evaluable for respo nse, seven patients (44%) demonstrated an objective response, including two complete and five partial ones: eight patients (50%) had stable disease; a nd one patient had progressive disease. The median time to progression was 7.5 months (range: 4-17.5 months). The median survival was 11 months (range : 1-18 months) and 1-year survival was 49%. Febrile neutropenia was recorde d in 15% Of courses. There were no toxic deaths. In conclusion, the combina tion of docetaxel, cisplatin, and 5-fluorouracil is an active regimen again st previously treated squamous cell carcinoma of the head and neck with acc eptable toxicity.