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The influence of intravenous amifostine on xerostomia and survival during radiotherapy for head and neck cancer: Two year follow-up of a prospective randomized trial.

Publication ,  Journal Article
Brizel, DM; Wasserman, T
Published in: J Clin Oncol
July 15, 2004

5536 Background: Amifostine (A, Ethyol) reduced radiotherapy (RT)-induced xerostomia without diminishing tumor control at 12 months in a prospective, randomized trial of patients receiving head and neck RT (Brizel et al, J Clin Oncol 2000;18:3339-45). The FDA approved A for protection against xerostomia based on that trial. We now evaluate follow-up data 12-24 months after RT to further assess both long-term radioprotective effects of A and tumor control. METHODS: Adults with head and neck cancer who underwent once-daily fractionated RT for 5-7 weeks (total dose 50-70 Gy) received open-label intravenous A 200 mg/m(2) 15-30 minutes before each RT fraction (n=150) or no treatment before RT (control; C; n=153). Xerostomia, disease progression, and survival were assessed at 12, 18, and 24 months. RESULTS: Minimum followup for all survivors is now 2 years. A continued to result in diminished xerostomia during the second year of follow-up (Table), based on incidence of RTOG Grade ≥2 xerostomia and proportion of patients with meaningful (>0.1 g) unstimulated saliva production. Patients reported less mouth dryness (P<.001) and greater mean benefit overall (P=.053) with A vs C on a Patient Benefit Questionnaire. Locoregional tumor control, progression-free survival, and overall survival were similar between groups (Table). CONCLUSIONS: Amifostine provides radioprotection from xerostomia that continues for at least 2 years without evidence of change in tumor control. [Figure: see text] [Table: see text].

Duke Scholars

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

5536

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences
 

Published In

J Clin Oncol

EISSN

1527-7755

Publication Date

July 15, 2004

Volume

22

Issue

14_suppl

Start / End Page

5536

Location

United States

Related Subject Headings

  • Oncology & Carcinogenesis
  • 1112 Oncology and Carcinogenesis
  • 1103 Clinical Sciences