Concomitant chemoradiotherapy as primary therapy for locoregionally advanced head and neck cancer

Purpose: to achieve locoregional control of head and neck cancer, survival, and organ preservation using intensive concomitant chemoradiotherapy. Patients and Methods: This study was a phase II trial of chemoradiotherapy with cisplatin 100 mg/m(2) every 28 days, infusional fluorouracil 800 mg/m( 2)/d for 5 days, hydroxyurea 1 g orally every 12 hours for 11 doses, and ra diotherapy twice daily at 1.5 Gy/fraction on days 1 through 5 (total dose, 15 Gy). Five days of treatment were followed by 9 days of rest, during whic h rime patients received granulocyte colony-stimulating factor. Five cycles (three with cisplatin) were administered over 10 weeks (total radiotherapy dose, less than or equal to 75 Gy). Adjuvant chemoprevention with retinoic acid and interferon alfa-SA was offered. Results: Seventy-six patients were treated (stage IV, 93%; N2, 54%; N3, 21% ). At a median follow-up of 38 months, the 3-year progression-free survival is 72%, locoregional control 92%, systemic control 83%, and overall surviv al 55%. toxicities included mucositis (grade 3, 45%; grade 4, 12%), neutrop enia (grade 4, 39%), and thrombocytopenia (grade 4, 53%). Surgery at the pr imary site was performed in 13 patients, and 39 had neck dissection. A majo rity of patients declined adjuvant chemoprevention. Pharmacokinetic paramet ers were not prognostic of tumor control. Quality of life declined during t reatment but returned from good to excellent by 12 months after treatment. Conclusion: intensive concomitant chemoradiotherapy leads to high locoregio nal control and survival rates with organ preservation and ct reversal of t he historical pattern of failure (distant > locoregional), Surgery after co ncomitant chemoradiotherapy is feasible. Compliance with adjuvant chemoprev ention is pear. Identification of less toxic regimens and improved distant disease control emerge as important future research goals. J Clin Oncol 18:7652-1661. (C) 2000 by American Society of Clinical Oncolog y.