Radiotherapy alone, versus radiotherapy with amifostine 3 times weekly, versus radiotherapy with amifostine 5 times weekly: A prospective randomized study in squamous cell head and neck cancer

BACKGROUND. The main objective of this study was to investigate whether non-daily intravenous administration of amifostine was as effective as daily intravenous administration with regard to the reduction of the incidence of Grade 2 or greater xerostomia in patients with head and neck cancer. METHODS. Ninety-one patients who received bilateral irradiation for head and neck cancer were included. Thirty patients received no armfostine (AMI-0), 31 patients received amifostine at a dose of 200 mg/m(2) 3 times weekly (AMI-3), and 30 patients received amifostine at a dose of 200 mg/m(2) daily (5 times weekly) (AMI-5). Acute and late xerostomia and quality of life (QOL) were assessed at baseline, 6 weeks later, and at 6-month intervals from 6 months to 24 months postradiotherapy. RESULTS. Grade 2 or greater late xerostomia differed significantly at 6 months (AMI-0 74% vs. AMI-3 67% vs. AMI-5 52%; P = .03), but not thereafter. During follow-up, patient-rated xerostomia deteriorated more in AMI-0 patients (mean difference score:, 52 for AMI-0 compared with 25 for AMI-3, and 29 for AMI-5; P = .01). Nausea and emesis were reported most frequently as side effect, but Grade 2 or greater toxicity was observed in only 4 patients. However, 28% of patients discontinued amifostine before the end of radiotherapy. CONCLUSIONS. Long-term, patient-rated xerostomia was less for the AMI-3 and AMI-5 groups through 2-year follow-up, but no difference was noted between the AMI-3 and AMI-5 groups. For late xerostomia according to the Radiation Therapy Oncology Group criteria, the same effect was observed at 6 months, but not thereafter.