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Journal of Clinical Oncology, Vol 19, Issue 3 (February), 2001: 800-811
© 2001 American Society for Clinical Oncology

Concurrent Paclitaxel and Radiation in the Treatment of Locally Advanced Head and Neck Cancer

By John B. Sunwoo, Laurie L. Herscher, Glenn S. Kroog, Giovana R. Thomas, Frank G. Ondrey, Dianne C. Duffey, Beth I. Solomon, Carol Boss, Paul S. Albert, Linda McCullugh, Susan Rudy, Chris Muir, Suoping Zhai, William D. Figg, John A. Cook, James B. Mitchell, Carter Van Waes

From the Head and Neck Surgery Branch, National Institute of Deafness and Other Communication Disorders; Speech and Language Pathology Section, Rehabilitation Medicine Department, Clinical Center; and Branches of Radiation Oncology, Radiation Biology, Biometric Research, and Medicine, National Cancer Institute, National Institutes of Health, Bethesda, MD.

Address reprint requests to Laurie L. Herscher, MD, Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, 9000 Rockville Pike, Bldg 10, Rm B3B69, Bethesda, MD 20892; email: herscher{at}mail.nih.gov

PURPOSE: To determine the feasibility of an organ preservation regimen consisting of infusional paclitaxel administered concurrently with radiotherapy to patients with locally advanced head and neck squamous cell carcinoma (HNSCC).

PATIENTS AND METHODS: Thirty-three previously untreated patients with stage III or IV tumors were enrolled onto the study. Paclitaxel was administered as a 120-hour continuous infusion every 3 weeks during the course of radiation therapy. Sixteen patients received a paclitaxel dose of 105 mg/m2, and 17 patients received 120 mg/m2. Radiation was delivered in a standard format at 1.8 Gy/d to a total dose of 70.2 to 72 Gy.

RESULTS: Three months after therapy, a 76% complete response (CR) at the primary site and a 70% overall CR was achieved. At 36 months, locoregional control was 55.7%, overall survival was 57.8%, and disease-free survival was 51.1%. The median survival duration for all 33 patients was greater than 50 months at the time of this report. Local toxicities including mucositis, dysphagia, and skin reactions were severe but tolerable. All patients retained functional speech, and all but four patients were swallowing food 3 months after treatment. Steady-state plasma concentrations for paclitaxel were not achieved during a 120-hour infusion, suggesting a nonlinear process. Tumor volume quantified by pretreatment computerized tomography imaging was associated with likelihood of response and survival.

CONCLUSION: Paclitaxel administered as a 120-hour continuous infusion in combination with radiotherapy is a feasible and promising treatment for patients with advanced HNSCC.


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