BACKGROUND: In this phase II study, the efficacy and toxicity of a triple chemotherapy with docetaxel, cisplatin and 5- Fluorouracil (TPF) was evaluated in the adjuvant therapy of locoregionally advanced cancer of the head and neck. This represented the first use of polychemotherapy as single adjuvant therapy after surgery. PATIENTS AND METHODS: Twenty patients with stage II-IV (UICC) squamous cell carcinoma of the head and neck (SCCHN) were treated by surgery of the primary and the regional lymph nodes. Four weeks after surgery, all patients received 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 beginning of the chemotherapy was 0-1 according to the Eastern Cooperative Oncology Group (ECOG). RESULTS: Fifty-eight cycles were administered to the 20 patients. The major acute toxicities were mucositis (2 patients) and febrile neutropenia (4 patients). One patient dropped out after the first cycle because of severe mucositis. After a median follow-up of 16.5 months (range, 1-41 months), the median time to progression was 20 months (range, 16-22 months). The estimated overall survival according to Kaplan-Meier at the median time of follow-up was 90%. No distant metastases were detectable after the adjuvant chemotherapy with TPF in locally advanced SCCHN, neither were late effects observed. CONCLUSION: TPF was tolerated, with an acceptable toxicity profile, in patients with a good performance status. The preliminary results appear to justify further investigations to evaluate the efficacy of this modality in the adjuvant setting.
