Objectives: This phase II study was conducted to assess the efficacy of docetaxel plus gemcitabine in locally recurrent and/or metastatic squamous cell carcinoma of the head and neck.
Patients and methods: Forty patients with pharynx or larynx cancer were included and treated with an intravenous infusion of docetaxel 75 mg/m2 on day 8 and gemcitabine 1000 mg/m2 day 1 and day 8 every 3 weeks for 6 cycles.
Results: Among the 40 patients included, 17 had metastatic disease and 18 had received prior chemotherapy. Thirty-two patients were assessable for response. The overall response rate was 20.0% (95% confidence interval [CI], 9.0%-35.7%), with 8 (20.0%) partial responses. Thirteen patients (32.5%) had stable disease, whereas 11 patients (27.5%) had progressive disease. The median response duration was 6.5 months (95% CI, 5.8-7.2). Grade 3 or 4 neutropenia was observed in 18 patients (45.0%). Three treatment-related deaths due to infection were reported.
Conclusion: The docetaxel and gemcitabine combination is an active treatment of recurrent or metastatic head and neck cancer. However, this regimen is associated with a high hematologic toxicity. A new schedule of administration must be explored.