title: Intrarectal amifostine during external beam radiation therapy for prostate cancer produces significant improvements in Quality of Life measured by EPIC score.
abstract: OBJECTIVE
  To test whether intrarectal amifostine limits symptoms of radiation proctitis, measured by using the Radiation Therapy Oncology Group (RTOG) gastrointestinal (GI) toxicity score and the Expanded Prostate Cancer Index Composite (EPIC) score.
  
  
  METHODS
  Patients with localized prostate cancer received amifostine as a rectal suspension 30-45 minutes before daily three-dimensional conformal radiation therapy. The first 18 patients received 1 g of amifostine, and the next 12 patients received 2 g. Toxicity was assessed at baseline, during treatment, and at follow-up visits by using RTOG grading and the EPIC Quality of Life (QoL) 50-item questionnaire. The Bowel Function subset of the bowel domain (EPIC-BF), which targets symptom severity, and the Bowel Bother subset of the bowel domain (EPIC-BB), which assesses QoL, were evaluated and compared with the RTOG GI toxicity score.
  
  
  RESULTS
  Median follow-up was 30 months (range, 18-36 months). Overall, EPIC-BF and EPIC-BB scores both tracked closely with the RTOG GI toxicity score. Seven weeks after the start of radiation therapy, the incidence of RTOG Grade 2 toxicity was 33% in the 1-g group (6/18 patients) compared with 0% (0/12 patients) in the 2-g group and tended toward statistical significance (p = 0.06). A significant difference between amifostine groups was observed using the EPIC-BF score at 7 weeks (p = 0.04). A difference in EPIC-BB scores between dose groups was evident at 7 weeks (p = 0.07) and was significant at 12 months (p = 0.04).
  
  
  CONCLUSIONS
  Higher doses of amifostine produced significant improvements in acute and late bowel QoL (up to 1 year after therapy), measured using the EPIC score.
authors.affiliation: Radiation Oncology Branch, National Cancer Institute, National Institutes of Health, Department of Health and Human Services, Bethesda, MD 20892, USA.
authors.forename: Nicole L
authors.initials: NL
authors.lastname: Simone
authors.forename: Cynthia
authors.initials: C
authors.lastname: Ménard
authors.forename: Benjamin P
authors.initials: BP
authors.lastname: Soule
authors.forename: Paul S
authors.initials: PS
authors.lastname: Albert
authors.forename: Peter
authors.initials: P
authors.lastname: Guion
authors.forename: Sharon
authors.initials: S
authors.lastname: Smith
authors.forename: Denise
authors.initials: D
authors.lastname: Godette
authors.forename: Nancy S
authors.initials: NS
authors.lastname: Crouse
authors.forename: Linda C
authors.initials: LC
authors.lastname: Sciuto
authors.forename: Theresa
authors.initials: T
authors.lastname: Cooley-Zgela
authors.forename: Kevin
authors.initials: K
authors.lastname: Camphausen
authors.forename: C Norman
authors.initials: CN
authors.lastname: Coleman
authors.forename: Anurag K
authors.initials: AK
authors.lastname: Singh
mesh_terms: D000230:Adenocarcinoma / Q000532:radiotherapy; D000285:Administration, Rectal; D000368:Aged; D004999:Amifostine / Q000008:administration & dosage*; D004305:Dose-Response Relationship, Drug; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D011349:Proctitis / Q000517:prevention & control*; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011788:Quality of Life; D011832:Radiation Injuries / Q000517:prevention & control; D011837:Radiation-Protective Agents / Q000008:administration & dosage*; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D012007:Rectum / Q000528:radiation effects; D012720:Severity of Illness Index; D011795:Surveys and Questionnaires
chemical_list: D011837:Radiation-Protective Agents; D004999:Amifostine