Influence of intravenous amifostine on xerostomia, tumor control, and survival after radiotherapy for head-and- neck cancer: 2-year follow-up of a prospective, randomized, phase III trial.
OBJECTIVE
To evaluate chronic xerostomia and tumor control 18 and 24 months after initial treatment with amifostine in a randomized controlled trial of patients with head-and-neck cancer; at 12 months after radiotherapy (RT), amifostine had been shown to reduce xerostomia without changing tumor control.


METHODS
Adults with head-and-neck cancer who underwent once-daily RT for 5-7 weeks (total dose, 50-70 Gy) received either open-label amifostine (200 mg/m2 i.v.) 15-30 min before each fraction of radiation (n = 150) or RT alone (control; n = 153).


RESULTS
Amifostine administration was associated with a reduced incidence of Grade > or =2 xerostomia over 2 years of follow-up (p = 0.002), an increase in the proportion of patients with meaningful (>0.1 g) unstimulated saliva production at 24 months (p = 0.011), and reduced mouth dryness scores on a patient benefit questionnaire at 24 months (p < 0.001). Locoregional control rate, progression-free survival, and overall survival were not significantly different between the amifostine group and the control group.


CONCLUSIONS
Amifostine administration during head-and-neck RT reduces the severity and duration of xerostomia 2 years after treatment and does not seem to compromise locoregional control rates, progression-free survival, or overall survival.
Wasserman
Todd H
TH
Department of Radiation Oncology, Washington University, St. Louis, MO 63110-1046, USA. wasserman@bellsouth.net
Brizel
David M
DM
Henke
Michael
M
Monnier
Alain
A
Eschwege
Francois
F
Sauer
Rolf
R
Strnad
Vratislav
V
D000328:Adult; D004999:Amifostine / Q000627:therapeutic use*; D002294:Carcinoma, Squamous Cell / Q000401:mortality / Q000532:radiotherapy*; D002908:Chronic Disease; D005260:Female; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000401:mortality / Q000532:radiotherapy*; D006801:Humans; D007262:Infusions, Intravenous; D008297:Male; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D012463:Saliva / Q000378:metabolism; D015996:Survival Rate; D014987:Xerostomia / Q000188:drug therapy* / Q000209:etiology / Q000401:mortality
D011837:Radiation-Protective Agents; D004999:Amifostine