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Phase I/II Study of Docetaxel, Cisplatin, and Concomitant Boost Radiation for Locally Advanced Squamous Cell Cancer of the Head and Neck

Anne S. Tsao, Adam S. Garden, Merrill S. Kies, William Morrison, Lei Feng, J. Jack Lee, Fadlo Khuri, Ralph Zinner, Jeffery Myers, Vassiliki Papadimitrakopoulou, Jan Lewin, Gary L. Clayman, K. Kian Ang, Bonnie S. Glisson

From the Departments of Thoracic/Head and Neck Medical Oncology, Radiation Oncology, and Biostatistics and Applied Mathematics, The University of Texas M.D. Anderson Cancer Center, Houston, TX

Address reprint requests to Bonnie S. Glisson, MD, The University of Texas M.D. Anderson Cancer Center, 1515 Holcombe Blvd, Houston, TX 77030; email: bglisson{at}mdanderson.org

Purpose To investigate the feasibility of combining concomitant boost accelerated radiation with docetaxel and cisplatin and assess the regimen's toxicity, locoregional control rate, and survival in patients with locally advanced head and neck cancer (HNSCC).

Patients and Methods Patients with stage III-IV HNSCC were eligible. Phase I included two schedules of docetaxel and cisplatin: arm 1, once per week during weeks 1 to 4; arm 2, every 21 days for weeks 1 and 4. Radiation consisted of 72 Gy in 42 fractions over 6 weeks (concomitant boost).

Results Twenty patients were enrolled in phase I. The arm 1 maximum-tolerated dose (MTD) was defined at docetaxel 15 mg/m² and cisplatin 20 mg/m² based on prolonged mucositis in 29% of patients. The initial dose level in arm 2 was above the MTD. In total, 52 patients were treated using the arm 1 regimen in phase II. Acute toxicity included grade 3 mucositis and dermatitis in 81% and 44% of patients. The 2-year locoregional control rate was 71%. The 2-year progression-free and overall survival rates were 61% and 65%. Median survival was 37.8 months. Late effects included feeding tube dependence in 17% of patients alive and free of disease.

Conclusion Locoregional control, survival, and acute toxicity with this regimen were comparable with other trials utilizing taxanes and/or platins and concomitant conventional or altered fractionation radiation. Our data suggest that chemotherapy added to concomitant boost fractionation may increase rates of long-term feeding tube dependence. Phase III trials are needed to assess the contribution of concomitant boost fractionation to chemoradiotherapy.

Supported by a grant-in-aid from Aventis Pharmaceuticals Inc, Bridgewater, NJ, (B.S.G.) and National Institutes of Health Grant No. CCSG CA16672-27.

Presented in part at the 38th Annual Meeting of the American Society of Clinical Oncology, Orlando, Fl, May 18-21, 2002 and the 39th Annual Meeting of the American Society of Clinical Oncology, Chicago, IL, May 31-June 3, 2003.

Authors' disclosures of potential conflicts of interest and author contributions are found at the end of this article.

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