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 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.
Jellema
Anke Petra
AP
Department of Radiation Oncology, Vrije Universiteit University Medical Center, Amsterdam, the Netherlands. a.p.jellema@amc.uva.nl
Slotman
Ben J
BJ
Muller
Martin J
MJ
Leemans
C Rene
CR
Smeele
Ludi E
LE
Hoekman
Klaas
K
Aaronson
Neil K
NK
Langendijk
Johannes A
JA
D000328:Adult; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage* / Q000009:adverse effects / Q000627:therapeutic use; D002294:Carcinoma, Squamous Cell / Q000188:drug therapy* / Q000532:radiotherapy*; D004334:Drug Administration Schedule; D005260:Female; D006258:Head and Neck Neoplasms / Q000188:drug therapy* / Q000532:radiotherapy*; D006801:Humans; D008297:Male; D008875:Middle Aged; D018714:Radiotherapy, Adjuvant; D014987:Xerostomia / Q000150:complications / Q000209:etiology
D004999:Amifostine