title: Early proctoscopy is a surrogate endpoint of late rectal toxicity in prostate cancer treated with radiotherapy.
abstract: OBJECTIVE
  To predict the grade and incidence of late clinical rectal toxicity through short-term (1 year) mucosal alterations.
  
  
  METHODS
  Patients with prostate adenocarcinoma treated with curative or adjuvant radiotherapy underwent proctoscopy a year after the course of radiotherapy. Mucosal changes were classified by the Vienna Rectoscopy Score (VRS). Late toxicity data were analyzed according to the Kaplan-Meier method. Comparison between prognosis groups was performed by log-rank analysis.
  
  
  RESULTS
  After a median follow-up time of 45 months (range, 18-99), the 3-year incidence of grade ≥ 2 rectal late toxicity according to the criteria of the European Organization for Research and Treatment of Cancer and the Radiation Therapy Oncology Group was 24%, with all patients (24/24; 100%) experiencing rectal bleeding. The occurrence of grade ≥ 2 clinical rectal late toxicity was higher in patients with grade ≥ 2 (32% vs. 15 %, p = 0.02) or grade ≥ 3 VRS telangiectasia (47% vs. 17%, p ≤ 0.01) and an overall VRS score of ≥ 2 (31% vs. 16 %, p = 0.04) or ≥ 3 (48% vs. 17%, p = 0.01) at the 1-year proctoscopy.
  
  
  CONCLUSIONS
  Early proctoscopy (1 year) predicts late rectal bleeding and therefore can be used as a surrogate endpoint for late rectal toxicity in studies aimed at reducing this frequent complication.
authors.affiliation: Radiotherapy Unit, Fondazione di Ricerca e Cura Giovanni Paolo II, Università Cattolica del S Cuore, Campobasso, Italy.
authors.forename: Edy
authors.initials: E
authors.lastname: Ippolito
authors.forename: Mariangela
authors.initials: M
authors.lastname: Massaccesi
authors.forename: Cinzia
authors.initials: C
authors.lastname: Digesù
authors.forename: Francesco
authors.initials: F
authors.lastname: Deodato
authors.forename: Gabriella
authors.initials: G
authors.lastname: Macchia
authors.forename: Giuseppe Antonio
authors.initials: GA
authors.lastname: Pirozzi
authors.forename: Savino
authors.initials: S
authors.lastname: Cilla
authors.forename: Daniele
authors.initials: D
authors.lastname: Cuscunà
authors.forename: Alessandra
authors.initials: A
authors.lastname: Di Lallo
authors.forename: Gian Carlo
authors.initials: GC
authors.lastname: Mattiucci
authors.forename: Giovanna
authors.initials: G
authors.lastname: Mantini
authors.forename: Fabio
authors.initials: F
authors.lastname: Pacelli
authors.forename: Vincenzo
authors.initials: V
authors.lastname: Valentini
authors.forename: Numa
authors.initials: N
authors.lastname: Cellini
authors.forename: Marcello
authors.initials: M
authors.lastname: Ingrosso
authors.forename: Alessio Giuseppe
authors.initials: AG
authors.lastname: Morganti
mesh_terms: D000230:Adenocarcinoma / Q000532:radiotherapy*; D006471:Gastrointestinal Hemorrhage / Q000175:diagnosis / Q000209:etiology; D006801:Humans; D007413:Intestinal Mucosa / Q000528:radiation effects; D008297:Male; D011351:Proctoscopy; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000150:complications / Q000175:diagnosis*; D011879:Radiotherapy Dosage; D012002:Rectal Diseases / Q000175:diagnosis* / Q000209:etiology; D012007:Rectum / Q000528:radiation effects*; D013684:Telangiectasis / Q000175:diagnosis / Q000209:etiology