Abstract

Results are summarized for two phase II studies of docetaxel as first-line therapy for advanced squamous cell carcinoma of the head and neck (SCCHN) and one study of docetaxel as second-line therapy for advanced soft tissue sarcomas. In all three studies, docetaxel was administered at a dose of 100 mg/m2 by intravenous infusion over 1 h every 3 weeks. A total of 62 patients were enrolled in the SCCHN trials, of whom 57 were evaluable for response. The combined overall response rate in the SCCHN patients was 35%. Median duration of overall response was 6.5 months in the EORTC-ECTG study. In the DFCI study, median durations of complete and partial remission were 6.75 months and 4.45 months, respectively. These results are at least comparable to those achieved with other single-agent therapies in this setting. In the soft tissue sarcoma study, 29 of the 31 patients enrolled were evaluable for response. Five patients (17%) achieved a partial response to docetaxel as second-line therapy and a further nine (31%) had stable disease. Median duration of response in these patients with soft tissue sarcomas was 5 months. Again, these results are similar to those seen with the three most active single agents in soft tissue sarcomas when used as second-line therapy. Docetaxel may therefore represent a useful drug in both advanced SCCHN and soft tissue sarcomas.

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