Purpose: To test the efficacy and safety of a triweekly reduced-dose docetaxel (60 mg/m(2)) regimen combined with a standard dose of cisplatin in patients with recurrent/metastatic (R/M) head and neck squamous cell carcinoma (HNSCC).
Patients and methods: Patients with R/M HNSCC were enrolled. All eligible patients received intravenous docetaxel 60 mg/m(2) combined with cisplatin 75 mg/m(2) on day 1 and then every 3 weeks thereafter. Treatment was continued until disease progression, patient intolerance, or death.
Results: In total, 58 patients were enrolled and 41 patients were evaluated. Among the evaluated population, one patient achieved a complete response (2.4%) and nine patients achieved a partial response (22%), resulting in an overall response rate of 24.4%. Furthermore, 17 patients had stable disease (41.5%), which corresponds to a disease control rate of 65.9%. With a median follow-up of 24 months (1-43 months), progression-free survival was 170 days (95% confidence interval 97.9-242.1) and the median overall survival was 265 days (95% confidence interval 89.0-441.0) in evaluable population. The most common toxicities (≥ grade III) were leucopenia (66.7%) and anemia (33.3%).
Conclusions: Triweekly reduced-dose docetaxel 60 mg/m(2) combined with cisplatin is effective and feasible for Taiwanese patients with R/M HNSCC. However, the hematologic toxicity of this regimen should be carefully monitored and managed.