Weekly docetaxel in patients with recurrent and/or metastatic squamous cell carcinoma of the head and neck.

ABSTRACT

BACKGROUND: Single-agent docetaxel, administered as a 3-weekly infusion has encouraging clinical activity against squamous cell carcinoma of the head and neck (SCCHN). Weekly administration of docetaxel is feasible and showed a favorable toxicity profile in phase I studies. We studied a weekly docetaxel regimen in heavily pretreated patients with head and neck cancer. PATIENTS AND METHODS: A total of 30 patients with proven metastatic or recurrent SCCHN were treated with docetaxel 36 mg/m weekly for 6 weeks in an 8-week schedule. Dexamethasone 20 mg or methylprednisolone 32 mg was administered 12 and 3 hours before docetaxel. No prophylactic antibiotics or growth factors were given. The primary end point was objective response rate and the secondary end points included time to progression and overall survival. RESULTS: Patients received a median of 6 administrations (range, 1-27). A partial response was documented in 2 patients (6.7%). The disease control rate defined the percentage of patients with responding or stable disease was 33.3%. The median progression-free survival was 7.4 weeks (95% confidence interval, 5.5-9.3 weeks) and the median overall survival was 17.9 weeks (95% confidence interval, 10.1-25.6 weeks). There were no episodes of grade 4 neutropenia, thrombocytopenia, or nonhematological toxicity. CONCLUSIONS: Weekly docetaxel at a dose of 36 mg/m has a mild to moderate toxicity profile in SCCHN patients. However, the response rate in predominantly pretreated patients is low and the overall survival is short.