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Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck

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Background

A phase I/II trial of concurrent docetaxel and radiation for head and neck cancer was conducted to estimate the recommended dose schedule of docetaxel, and then to evaluate the therapeutic benefit.

Methods

Patients received radiation in 2.0-Gy single daily fractions to a total dose of 60 Gy. Docetaxel was administered weekly for 6 consecutive weeks.

Results

Docetaxel 15 mg/m2 was considered the maximum tolerated dose (MTD). The recommended dose was decided as 10 mg/m2. The phase II study was conducted using docetaxel at 10 mg/m2. Thirty-nine patients were enrolled. The overall response rate was 96.9%. The prognosis of the complete response (CR) patients was significantly better than that of the partial response (PR) patients. Grade 3 or 4 adverse events consisted of lymphopenia, stomatitis, and anorexia. Thirty-two of the 35 eligible patients showed high compliance, of over 90%, and their toxicities were manageable.

Conclusion

Even low-dose docetaxel shows a strong effect in combination with radiation, with a high survival rate in CR patients. The effect on survival will be assessed by further follow-up.

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Authors and Affiliations

Authors

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Correspondence to Masato Fujii.

Additional information

Yukio Inuyama for the Japan Cooperative Head and Neck Oncology Group (JCHNOG)

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Fujii, M., Tsukuda, M., Satake, B. et al. Phase I/II trial of weekly docetaxel and concomitant radiotherapy for squamous cell carcinoma of the head and neck. Int J Clin Oncol 9, 107–112 (2004). https://doi.org/10.1007/s10147-003-0375-z

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  • DOI: https://doi.org/10.1007/s10147-003-0375-z

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