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

被引:48
作者
Fujii M. [1 ]
Tsukuda M. [2 ]
Satake B. [3 ]
Kubota A. [4 ]
Kida A. [5 ]
Kohno N. [6 ]
Okami K. [7 ]
Inuyama Y. [8 ]
机构
[1] Department of Otolaryngology, School of Medicine, Keio University, Shinjuku-ku, Tokyo 160-8582
[2] Department of Otolaryngology, Yokohama City Univ. Sch. of Medicine, Yokohama
[3] Department of Head and Neck, Gunma Cancer Center, Gunma
[4] Department of Head and Neck, Kanagawa Cancer Center, Yokohama
[5] Dept. of Otorinol., Head/Neck Surg., Nihon University School of Medicine, Tokyo
[6] Dept. Otolaryngol., Head/Neck Surg., Kyorin University School of Medicine, Tokyo
[7] Department of Otolaryngology, Tokai University, School of Medicine, Isehara
[8] Dept. Otolaryngol./Head/Neck Surg., Hokkaido Univ. Grad. Sch. of Med., Sapporo
关键词
Concurrent chemoradiotherapy; Docetaxel; Head and neck cancer; Phase I trial; Phase II trial;
D O I
10.1007/s10147-003-0375-z
中图分类号
学科分类号
摘要
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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页码:107 / 112
页数:5
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