Todd Doyle, MD
OncoLink Assistant Editor
Ultima Vez Modificado: 1 de noviembre del 1999
Presenter: Brizel DM et al
Affiliation: Duke University Medical Center
Xerostomia (dry mouth) is a difficult and often permanent complication of head and neck radiotherapy. Life long consequences include difficulty with eating, speaking, and dental complications. This phase III randomized trial of radiation therapy with or without amifostine was performed to evaluate the ability of the radioprotectant drug to decrease acute and long term morbidity.
In addition to acute and chronic xerostomia, both acute and chronic mucositis were evaluated for potential improvement with amifostine. An additional end point that was examined was preservation of the anti-tumor activity of radiation, which could theoretically have been decreased by amifostine.
Three hundred fifteen patients were enrolled, stratified for prognostic factors and randomized to either receive or not receive daily intravenous amifostine. Both post operative and definitively treated patients were evaluated for incidence of grade 2 or higher acute xerostomia, grade 3 or higher mucositis, and grade 2 or higher late xerostomia (1 year after treatment).
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