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

Journal Article · Tue Nov 15 04:00:00 EST 2005 · International Journal of Radiation Oncology, Biology and Physics

DOI:https://doi.org/10.1016/j.ijrobp.2005.07.966· OSTI ID:20706238

Wasserman, Todd H ^[1]; Brizel, David M ^[2]; Henke, Michael ^[3]; Monnier, Alain ^[4]; Eschwege, Francois ^[5]; Sauer, Rolf ^[6]; Strnad, Vratislav ^[6]

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1. Department of Radiation Oncology, Washington University, St. Louis, MO (United States)
2. Department of Radiation Oncology, Duke University Medical Center, Durham, NC (United States)
3. Clinic of Radiation Oncology, University of Freiburg, Freiburg (Germany)
4. Medical Oncology and Radiotherapy at the Centre Hospitalier Andre-Boulloche, Montbeliard (France)
5. Department of Radiotherapy, Institute Gustave-Roussy, Villejuif Cedex (France)
6. Department of Radiation Oncology, University of Erlangen, Erlangen (Germany)

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/m{sup 2} 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 {>=}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.

• OSTI ID: 20706238
• Journal Information: International Journal of Radiation Oncology, Biology and Physics, Journal Name: International Journal of Radiation Oncology, Biology and Physics Journal Issue: 4 Vol. 63; ISSN IOBPD3; ISSN 0360-3016
• Country of Publication: United States
• Language: English

Related Subjects

62 RADIOLOGY AND NUCLEAR MEDICINE
CONTROL
HEAD
NECK
NEOPLASMS
ORAL CAVITY
PATIENTS
RADIATION DOSES
RADIOTHERAPY
SALIVA