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

• Published in: International journal of clinical oncology 2004-04, Vol.9 (2), p.107-112
• Main Authors: Fujii, Masato, Tsukuda, Mamoru, Satake, Bunsuke, Kubota, Akira, Kida, Akinori, Kohno, Naoyuki, Okami, Kenji, Inuyama, Yukio
• Format: Article
• Language: English
• Subjects: Adult; Aged; Antineoplastic Agents, Phytogenic - therapeutic use; Carcinoma, Squamous Cell - drug therapy; Carcinoma, Squamous Cell - pathology; Carcinoma, Squamous Cell - radiotherapy; Combined Modality Therapy; Dose-Response Relationship, Drug; Drug therapy; Female; Head and Neck Neoplasms - drug therapy; Head and Neck Neoplasms - pathology; Head and Neck Neoplasms - radiotherapy; Humans; Male; Medical prognosis; Medical research; Middle Aged; Neoplasm Staging; Taxoids - therapeutic use; Treatment Outcome
• ISSN: 1341-9625; 1437-7772
• DOI: 10.1007/s10147-003-0375-z

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. 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. Docetaxel 15 mg/m(2) was considered the maximum tolerated dose (MTD). The recommended dose was decided as 10 mg/m(2). The phase II study was conducted using docetaxel at 10 mg/m(2). 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. 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.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.