HYPERFRACTIONATED IRRADIATION WITH OR WITHOUT CONCURRENT CHEMOTHERAPYFOR LOCALLY ADVANCED HEAD AND NECK-CANCER

Background Radiotherapy is often the primary treatment for advanced he ad and neck cancer, but the rates of locoregional recurrence are high and survival is poor. We investigated whether hyperfractionated irradi ation plus concurrent chemotherapy (combined treatment) is superior to hyperfractionated irradiation alone. Methods Patients with advanced h ead and neck cancer who were treated only with hyperfractionated irrad iation received 125 cGy twice daily, for a total of 7500 cGy. Patients in the combined-treatment group received 125 cGy twice daily, for a t otal of 7000 cGy, and five days of treatment with 12 mg of cisplatin p er square meter of body-surface area per day and 600 mg of fluorouraci l per square meter per day during weeks 1 and 6 of irradiation. Two cy cles of cisplatin and fluorouracil were given to most patients after t he completion of radiotherapy. Results of 122 patients who underwent r andomization, 116 were included in the analysis. Most patients in both treatment groups had unresectable disease. The median follow-up was 4 1 months (range, 19 to 86). At three years the rate of overall surviva l was 55 percent in the combined-therapy group and 34 percent in the h yperfractionation group (P=0.07). The relapse-free survival rate was h igher in the combined-treatment group (61 percent vs. 41 percent, P=0. 08). The rate of locoregional control of disease at three years was 70 percent in the combined-treatment group and 44 percent in the hyperfr actionation group (P=0.01). Confluent mucositis developed in 77 percen t and 75 percent of the two groups, respectively. Severe complications occurred in three patients in the hyperfractionation group and five p atients in the combined-treatment group. Conclusions Combined treatmen t for advanced head and neck cancer is more efficacious and not more t oxic than hyperfractionated irradiation alone. (C) 1998, Massachusetts Medical Society.