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Preliminary Results of Radiation Therapy Oncology Group 97-03: A Randomized Phase II Trial of Concurrent Radiation and Chemotherapy for Advanced Squamous Cell Carcinomas of the Head and Neck

From The University of Texas M.D. Anderson Cancer Center, Houston, TX; Radiation Therapy Oncology Group Headquarters; Fox Chase Cancer Center Philadelphia, PA; University of Chicago School of Medicine, Chicago, IL; the Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins, Baltimore, MD; Radiotherapy Associates of Sacramento, Sacramento, CA; University of Alabama, Birmingham, AL; New York University, New York, NY; Akron Hospital, Akron, OH; Medical College of Wisconsin, Milwaukee, WI

Address reprint requests to Adam S. Garden, MD, Department of Radiation Oncology, Unit 97, 1515 Holcombe Blvd, Houston, TX 77030; e-mail: agarden{at}mdanderson.org

PURPOSE: To define further the role of concurrent chemoradiotherapy for patients with advanced squamous carcinoma of the head and neck.

PATIENTS AND METHODS: The Radiation Therapy Oncology Group developed this three-arm randomized phase II trial. Patients with stage III or IV squamous carcinoma of the oral cavity, oropharynx, or hypopharynx were eligible. Each of three arms proposed a radiation schedule of 70 Gy in 35 fractions. Patients on arm 1 were to receive cisplatin 10 mg/m² daily and fluorouracil (FU) 400 mg/m² continuous infusion (CI) daily for the final 10 days of treatment. Treatment on arm 2 consisted of hydroxyurea 1 g every 12 hours and FU 800 mg/m²/d CI delivered with each fraction of radiation. Arm 3 patients were to receive weekly paclitaxel 30 mg/m² and cisplatin 20 mg/m². Patients randomly assigned to arms 1 and 3 were to receive their treatments every week; patients on arm 2 were to receive their therapy every other week.

RESULTS: Between 1997 and 1999, 241 patients were entered onto study; 231 were analyzable. Ninety-two percent, 79%, and 83% of patients on arms 1, 2, and 3, respectively, were able to complete their radiation as planned or with an acceptable variation. Fewer than 10% of patients had unacceptable deviations or incomplete chemotherapy in the three arms. Estimated 2-year disease-free and overall survival rates were 38.2% and 57.4% for arm 1, 48.6% and 69.4% for arm 2, and 51.3% and 66.6% for arm 3.

CONCLUSION: We have demonstrated that three different approaches of concurrent multiagent chemotherapy and radiation were feasible and could be delivered to patients in a multi-institutional setting with high compliance rates.

Supported by National Cancer Institute grants CA21661, CCOP U10, CA37422, Stat U10, and CA32115.

Presented at the 37th Annual Meeting of the American Society of Clinical Oncology, San Francisco, CA, May 12–15, 2001.

The contents of this article are solely the responsibility of the authors and do not necessarily represent the official views of the National Cancer Institute.

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

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