Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer

doi:10.1056/NEJM199806183382503

Volume 338:1798-1804		June 18, 1998		Number 25

Hyperfractionated Irradiation with or without Concurrent Chemotherapy for Locally Advanced Head and Neck Cancer

David M. Brizel, M.D., Mary E. Albers, M.D., Samuel R. Fisher, M.D., Richard L. Scher, M.D., William J. Richtsmeier, M.D., Ph.D., Vera Hars, M.S., Stephen L. George, Ph.D., Andrew T. Huang, M.D., and Leonard R. Prosnitz, M.D.

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ABSTRACT

Background Radiotherapy is often the primary treatment for advancedhead and neck cancer, but the rates of locoregional recurrenceare high and survival is poor. We investigated whether hyperfractionatedirradiation plus concurrent chemotherapy (combined treatment)is superior to hyperfractionated irradiation alone.

Methods Patients with advanced head and neck cancer who weretreated only with hyperfractionated irradiation received 125cGy twice daily, for a total of 7500 cGy. Patients in the combined-treatmentgroup received 125 cGy twice daily, for a total of 7000 cGy,and five days of treatment with 12 mg of cisplatin per squaremeter of body-surface area per day and 600 mg of fluorouracilper square meter per day during weeks 1 and 6 of irradiation.Two cycles of cisplatin and fluorouracil were given to mostpatients after the completion of radiotherapy.

Results Of 122 patients who underwent randomization, 116 wereincluded in the analysis. Most patients in both treatment groupshad unresectable disease. The median follow-up was 41 months(range, 19 to 86). At three years the rate of overall survivalwas 55 percent in the combined-therapy group and 34 percentin the hyperfractionation group (P=0.07). The relapse-free survivalrate was higher in the combined-treatment group (61 percentvs. 41 percent, P=0.08). The rate of locoregional control ofdisease at three years was 70 percent in the combined-treatmentgroup and 44 percent in the hyperfractionation group (P=0.01).Confluent mucositis developed in 77 percent and 75 percent ofthe two groups, respectively. Severe complications occurredin three patients in the hyperfractionation group and five patientsin the combined-treatment group.

Conclusions Combined treatment for advanced head and neck canceris more efficacious and not more toxic than hyperfractionatedirradiation alone.

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From the Departments of Radiation Oncology (D.M.B., L.R.P.), Medicine (M.E.A., A.T.H.), and Surgery (S.R.F., R.L.S., W.J.R.) and the Department of Community and Family Medicine, Division of Biometry (V.H., S.L.G.), Duke Comprehensive Cancer Center, Duke University Medical Center, Durham, N.C.

Address reprint requests to Dr. Brizel at the Department of Radiation Oncology, Box 3085, Duke University Medical Center, Durham, NC 27710.

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