Full dose reirradiation combined with chemotherapy after salvage surgery in head and neck carcinoma

BACKGROUND, The purpose of this study was to analyze the tolerance and effi cacy of full dose reirradiation combined with chemotherapy in patients with head and neck carcinoma (HNC) with a high risk of recurrence after salvage surgery. METHODS, Between 1991 and 1996, 25 patients having a recurrence or a second primary tumor in a previously irradiated area (> 45 grays [Gy]) were enter ed in this prospective study. All of them received salvage surgery and had a positive surgical margin and/or lymph node involvement with capsular rupt ure (N+R+). Adjuvant radiochemotherapy was given, delivering 60 Gp per 30 f ractions with concomitant hydroxyurea and 5-fluorouracil. The median total cumulative dose of the 2 irradiations was 118 Gy. The median follow-up afte r the second irradiation was 66 months. RESULTS. During the reirradiation course, Grade 3 and 4 mucositis were obse rved in 40% and 12%, respectively. Analysis of late effects (> 6 months aft er reirradiation) showed that 16% of the patients had osteoradionecrosis an d 40% had Grade 2-3 cervical fibrosis (Radiation Therapy Oncology Group sco ring system). The patterns of failure were as follows: local only (n = 9), lymph node only (n = 2), local and lymph node only (n = 1), and metastatic (n = 4). The 4-year survival rate after reirradiation was 43% (95% confiden ce interval, 25-62). CONCLUSIONS, Full dose reirradiation combined with chemotherapy after salva ge surgery in high risk patients with HNC was feasible with an "acceptable" toxicity and led to a relatively good 5-year survival rate. These results prompted the authors to initiate a multicentric randomized trial that is on going (GETTEC-GORTEC 99-01) to evaluate the benefit of adjuvant radiochemot herapy in these types of patients. Cancer 2001;91:2071-6. (C) 2001 American Cancer Society.