Radiotherapy alone, versus radiotherapy with amifostine 3 times weekly, versus radiotherapy with amifostine 5 times weekly

Abstract

BACKGROUND. The main objective of this study was to investigate whether nondaily 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 amifostine (AMI‐0), 31 patients received amifostine at a dose of 200 mg/m2 3 times weekly (AMI‐3), and 30 patients received amifostine at a dose of 200 mg/m2 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. Cancer 2006. © 2006 American Cancer Society.

Randomized phase 2 study of subcutaneous amifostine versus epoetin‐α given 3 times weekly during concurrent chemotherapy and hyperfractionated radiotherapy for limited‐disease small cell lung cancer

“…One group compared the radioprotectvie effects of 2 different administration schedules of amifostine in patients with head and neck cancer who were undergoing radiotherapy. 29 They found that the late radioprotectvie properties of amifostine on a schedule of 3 times a week appear to be similar to those of the daily administration of amifostine. In addition, Komaki et al 30 evaluated the cytoprotective ability of amifostine for esophagitis and hematologic and pulmonary toxicities in a randomized study of patients with stage II or III NSCLC who were receiving concurrent chemoradiotherapy.…”

Reirradiation in squamous cell head and neck cancer: recent developments and future directions

“…The radioprotective properties of amifostine have been confirmed in a number of prospective randomized studies [43,44].…”

Supportive care in head and neck oncology

“…Three studies [22][23][24] showed significant reductions in grade 2 or greater acute or late xerostomia, but they were not placebo-controlled. On the contrary, in the setting of platinum-based chemoradiation, a placebo-controlled study [25] did not show significant reductions in grade 2 or greater acute or late xerostomia in 132 patients.…”