Concomitant radiochemotherapy in primary inoperable advanced head and neck cancer with 5-fluorouracil and mitomycin-C

Background. The purpose of this study was to evaluate the efficacy and toxicity of radiotherapy and concomitant 5-fluorouracil (5-FU) and mitomycin-C infusion in inoperable head and neck cancer. Methods. Seventy-six patients (86% men, 14% women), mean age 57 years, with primary inoperable head and neck cancer were treated with 70 Gy plus simultaneous intravenous chemotherapy with 5-FU (600 mg/m(2)/d, days 1 to 5) and mitomycin-C (10 mg/m(2), day 5 plus 36). Results. After a mean follow-up of 13 months, 31 patients were alive. Complete response (CR) was seen in 63%. The 1- and 2-year overall survival rates were 67.7% and 39.5%, and locoregional control rates were 51.7% and 35.6%. Pretreatment hemoglobin <13.9 g/dL was associated with lower locoregional control rates (p = .03). Therapy was well tolerated (grade 3 mucositis in 21%, grade 4 in 1%, grade 3 leukopenia in 11%). Conclusions. Our radiochemotherapy regimen offers a curative option for this group of patients with a poor prognosis. Hemoglobin levels before therapy have an influence on prognosis. (C) 2004 Wiley Periodicals, Inc.