title: Intrarectal amifostine suspension may protect against acute proctitis during radiation therapy for prostate cancer: a pilot study.
abstract: OBJECTIVE
  Our goal was to test the ability of intrarectal amifostine to limit symptoms of radiation proctitis.
  
  
  METHODS
  The first 18 patients received 1 g of intrarectal amifostine suspension placed 30-45 min before each radiation treatment. The following 12 patients received 2 g of amifostine. Total dose prescribed ranged from 66 to 76 Gy. All patients were treated with three-dimensional conformal radiation therapy. The suspension remained intrarectal during treatment and was expelled after treatment. For gastrointestinal symptoms, during treatment and follow-up, all patients had a Radiation Therapy Oncology Group (RTOG) grade recorded.
  
  
  RESULTS
  Median follow-up was 18 months (range, 6-24 months). With 2 g vs. 1 g amifostine, there was a nearly significant decrease in RTOG Grade 2 acute rectal toxicity. Seven weeks after the start of radiation therapy, the incidence of Grade 2 toxicity was 33% in the 1-g group (6/18) compared with 0% (0/12) in the 2-g group (p=0.06). No Grade 3 toxicity or greater occurred in this study.
  
  
  CONCLUSIONS
  This trial suggests greater rectal radioprotection from acute effects with 2 g vs. 1 g amifostine suspension. Further studies should be conducted in populations at higher risk for developing symptomatic acute and late proctitis.
authors.affiliation: Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892, USA.
authors.forename: Anurag K
authors.initials: AK
authors.lastname: Singh
authors.forename: Cynthia
authors.initials: C
authors.lastname: Ménard
authors.forename: Peter
authors.initials: P
authors.lastname: Guion
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Simone
authors.forename: Sharon
authors.initials: S
authors.lastname: Smith
authors.forename: Nancy Sears
authors.initials: NS
authors.lastname: Crouse
authors.forename: Denise J
authors.initials: DJ
authors.lastname: Godette
authors.forename: Theresa
authors.initials: T
authors.lastname: Cooley-Zgela
authors.forename: Linda C
authors.initials: LC
authors.lastname: Sciuto
authors.forename: Jonathan
authors.initials: J
authors.lastname: Coleman
authors.forename: Peter
authors.initials: P
authors.lastname: Pinto
authors.forename: Paul S
authors.initials: PS
authors.lastname: Albert
authors.forename: Kevin
authors.initials: K
authors.lastname: Camphausen
authors.forename: C Norman
authors.initials: CN
authors.lastname: Coleman
mesh_terms: D000285:Administration, Rectal; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage*; D006801:Humans; D008297:Male; D010865:Pilot Projects; D011349:Proctitis / Q000209:etiology / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000517:prevention & control*; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D020266:Radiotherapy, Conformal; D012007:Rectum / Q000528:radiation effects*; D018709:Statistics, Nonparametric
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine