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Phase I Trial of Gefitinib in Combination With Radiation or Chemoradiation for Patients With Locally Advanced Squamous Cell Head and Neck Cancer

Changhu Chen, Madeleine Kane, John Song, John Campana, Adam Raben, Kenneth Hu, Louis Harrison, Harry Quon, Janet Dancey, Anna Baron, Sherif Said, S. Gail Eckhardt, David Raben

From the Departments of Radiation Oncology, Medical Oncology, Otolaryngology, Preventive Medicine and Biometrics, and Pathology, University of Colorado, Aurora, CO; Department of Radiation Oncology, Christiana Hospital Medical Center, Wilmington, DE; Department of Radiation Oncology, Beth Israel Medical Center, New York, NY; Department of Radiation Oncology, University of Pennsylvania Medical Center, Philadelphia, PA; and National Cancer Institute, Bethesda, MD

Address reprint requests to David Raben, MD, Department of Radiation Oncology, University of Colorado Health Sciences Center, 1665 N Ursula St, Mail Stop F706, Aurora, CO 80045; e-mail: David.Raben{at}uchsc.edu

Purpose To establish the safety and toxicity profile of daily gefitinib with radiation alone or with concurrent chemoradiotherapy in previously untreated patients with locally advanced squamous cell head and neck cancer (LAHNC).

Patients and Methods Patients with intermediate-stage LAHNC were treated with concomitant boost radiation (RT) alone with escalating doses of daily gefitinib (250 or 500 mg; cohort I). Once a safety profile was determined with RT alone, patients with high-risk disease were then treated with daily gefitinib (250 or 500 mg), weekly cisplatin (CDDP; 30 mg/m²), and once-daily RT (cohort II). Patients also received post-RT gefitinib at 250 mg daily for a period of up to 2 years.

Results Twenty-three patients were enrolled and assessable for toxicity. No dose-limiting toxicities (DLTs) were observed in patients treated in cohort I at either 250 or 500 mg of gefitinib daily with concomitant boost RT to 72 Gy. In patients receiving chemoradiotherapy and gefitinib (cohort II), DLTs included one grade 4 diarrhea and one grade 4 neutropenic fever. Fifteen patients started maintenance gefitinib, and eight (53%) experienced grade 1 to 2 acne-like skin rash and diarrhea, but no grade 3 or 4 toxicity occurred.

Conclusion Gefitinib (250 or 500 mg daily) was well tolerated with concomitant boost RT or concurrent chemoradiotherapy with weekly CDDP. Protracted administration of gefitinib for up to 2 years at 250 mg daily was also tolerated well.

Supported by the National Cancer Institute Clinical Trials Evaluation Program.

Presented in part at the 47th Annual Meeting of the American Society for Therapeutic Radiology and Oncology, October 16-20, 2005, Denver, CO.

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

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