Background: The objective of the study was to investigate the efficacy and tolerability of weekly docetaxel in patients with platinum-refractory recurrent or metastatic squamous cell carcinoma of the head and neck (SCCHN).
Methods: Patients fulfilling the following criteria were enrolled: histologically confirmed SCCHN; documented progressive disease (PD) after platinum-based treatment; Eastern Cooperative Oncology Group (ECOG) 0-2; measurable disease; not candidates for local therapy. Docetaxel (35 mg/m(2)) was administered for 3 weeks, every 4 weeks for a maximum of 6 cycles.
Results: A total of 23 patients were treated. All patients were assessable for toxicity and response. The overall response rate was 13.0% (3/23) and disease control rate was 34.7% (8/23). Median progression-free and overall survival (OS) was 9 (95% CI, 7.6-10.4 weeks) and 29 weeks (95% CI, 10.8-47.1 weeks), respectively. Most common hematological toxicities were grade 1-2 anemia (6/23, 26.1%) and nonhematological toxicities were mild and manageable. There was no treatment-related death.
Conclusion: Weekly docetaxel regimen had good clinical activity with an acceptable toxicity in patients with platinum-refractory SCCHN.