Radiation therapy with concomitant hydroxyurea and fluorouracil in stage II and III head and neck cancer

Purpose: In 1986, a multi-institutional phase II trial was begun to study t he use of chemotherapy with concomitant radiation in patients with stage II and III head and neck cancer. End points were overall survival, progressio n-free survival, local/regional control, and toxicity in the setting of org an preservation with concomitant treatment. Methods: Eligible patients with stage II or III disease received chemothera py and radiation on a 2-week cycle, Chemotherapy consisted of continuous in fusion fluorouracil (5-FU) at 800 mg/m(2)/d for 5 consecutive days (days 1 to 5) and hydroxyurea (HU) at 1 g orally every 12 hours for 13 doses starri ng the evening before the start of irradiation. Radiation therapy was given as single 1.8- to 2.0-Gy fractions for 5 consecutive days (days 1 to 5) wi th chemotherapy. Each 5 days of treatment was followed by a 9-day break (da ys 6 to 14), during which no additional treatment was given. Treatment cycl es were repeated until the completion of the planned radiation dose (six to eight cycles). Results: between 1989 and 1996, 60 patients were enrolled. All patients wer e eligible for analysis, with a median follow-up of 52 months for surviving patients and 42 months for all patients, Grade 3 to 4 mucositis occurred i n 57% of patients. The 5 year-actuarial overall survival, progression-free survival, and local/regional control were 65%, 82%, and 86%, respectively. Eight patients developed local and/or regional recurrence after treatment. Surgical salvage was possible in three of these patients, Thus, the ultimat e 5-year local/regional control was 91%. Conclusion: Concomitant radiation and chemotherapy with 5-FU and HU is an e ffective regimen in patients with stage II and III head and neck cancer. Pr ogression-free survival and local/regional control appear to be superior to expected rates in patients treated with surgery and radiation. Further tes ting of this regimen in a phase III setting is indicated. (C) 1999 by Ameri can Society of Clinical Oncology.