BACKGROUND: In this phase II study, for the first time the efficacy and toxicity of triple chemotherapy with docetaxel, cisplatin and 5-fluorouracil (TPF) in patients with recurrent head and neck cancer was evaluated. PATIENTS AND METHODS: Twenty-four patients with stage IV (UICC) recurrent squamous cell carcinoma of the head and neck (SCCHN), with different tumor sites, were treated with a polychemotherapy consisting of docetaxel 75 mg/m2 day 1, cisplatin 100 mg/m2 day 1 and 5-fluorouracil (5-FU) 1000 mg/m2 days 1 through 4 (total dose 4000 mg/m2) on days 1, 22 and 43, for a maximum of 3 cycles. The performance status of all patients at the start of the chemotherapy was 0-2, according to the Eastern Cooperative Oncology Group (ECOG). RESULTS: Sixty-eight cycles were administered to 24 patients. The reversible major acute toxicities were afebrile neutropenia in 6 patients and emesis in 4 patients. One patient died, probably because of myocardial infarction related to treatment. A remission was observed in 10 patients. Six patients showed a complete remission and 4 patients a partial remission. The median time to progression was 10 months (range, 4-42 months), the median overall survival after treatment was 13 months (range, 6-48 months) and the median recurrence-free survival was 12 months (range, 10-18 months). CONCLUSION: In terms of toxicity, TPF seems to be a feasible option for the treatment of recurrent SCCHN in patients with a compromised performance status. These results justify further investigations to evaluate the efficacy of this treatment.
