title: Effect of amifostine on patient assessed clinical benefit in irradiated head and neck cancer.
abstract: OBJECTIVE
  To determine if head and neck (H/N) cancer patients receiving daily amifostine during radiation therapy (RT) experienced clinical benefit (improvement in their ability to carry out normal functions with reduced discomfort) compared to nonamifostine treated patients.
  
  
  METHODS
  This was an open-label, multi-institutional randomized trial in 303 H/N cancer patients treated with RT +amifostine. Clinical benefit was measured using an 8-item validated Patient Benefit Questionnaire (PBQ) during and up to 11 months after RT.
  
  
  RESULTS
  301 patients completed one or more PBQ assessments. Amifostine patients had significantly better PBQ scores (p < 0.05) than controls. The improvement in PBQ scores was most significant during chronic xerostomia.
  
  
  CONCLUSIONS
  Amifostine use results in improved Patient Benefit Questionnaire (PBQ) scores, which is indicative of improved oral toxicity related outcomes and improved clinical benefit. Less oral toxicity should lead to preservation of late dental and oral health, and improvements in activities such as diet, nutrition, and sleep.
authors.affiliation: Mallinckrodt Institute of Radiology, Washington University Medical Center, St. Louis, MO, USA.
authors.forename: T
authors.initials: T
authors.lastname: Wasserman
authors.forename: J I
authors.initials: JI
authors.lastname: Mackowiak
authors.forename: D M
authors.initials: DM
authors.lastname: Brizel
authors.forename: W
authors.initials: W
authors.lastname: Oster
authors.forename: J
authors.initials: J
authors.lastname: Zhang
authors.forename: P J
authors.initials: PJ
authors.lastname: Peeples
authors.forename: R
authors.initials: R
authors.lastname: Sauer
mesh_terms: D000203:Activities of Daily Living; D000328:Adult; D000368:Aged; D004999:Amifostine / Q000627:therapeutic use*; D003131:Combined Modality Therapy; D003627:Data Interpretation, Statistical; D005500:Follow-Up Studies; D006258:Head and Neck Neoplasms / Q000532:radiotherapy*; D006801:Humans; D008137:Longitudinal Studies; D008875:Middle Aged; D011837:Radiation-Protective Agents / Q000627:therapeutic use*; D012463:Saliva / Q000378:metabolism; D011795:Surveys and Questionnaires; D016896:Treatment Outcome; D014987:Xerostomia / Q000517:prevention & control*
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine