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.

Abstract

PURPOSE:

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 AND MATERIALS:

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.

• Authors: Todd H Wasserman, David M Brizel, Michael Henke, Alain Monnier, Francois Eschwege, Rolf Sauer, Vratislav Strnad
• Journal: International journal of radiation oncology, biology, physics (Int J Radiat Oncol Biol Phys) Vol. 63 Issue 4 Pg. 985-90 (Nov 15 2005) ISSN: 0360-3016 [Print] United States
• PMID: 16253773 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)

Chemical References

• Radiation-Protective Agents
• Amifostine

Topics

• Adult
• Amifostine (therapeutic use)
• Carcinoma, Squamous Cell (mortality, radiotherapy)
• Chronic Disease
• Female
• Follow-Up Studies
• Head and Neck Neoplasms (mortality, radiotherapy)
• Humans
• Infusions, Intravenous
• Male
• Radiation-Protective Agents (therapeutic use)
• Saliva (metabolism)
• Survival Rate
• Xerostomia (drug therapy, etiology, mortality)