Early Proctoscopy is a Surrogate Endpoint of Late Rectal Toxicity in Prostate Cancer Treated With Radiotherapy

• Published in: International journal of radiation oncology, biology, physics Vol. 83; no. 2; pp. e191 - e195
• Main Authors: Ippolito, Edy, M.D, Massaccesi, Mariangela, M.D, Digesù, Cinzia, M.D, Deodato, Francesco, M.D, Macchia, Gabriella, M.D, Pirozzi, Giuseppe Antonio, M.D, Cilla, Savino, M.P, Cuscunà, Daniele, M.D, Di Lallo, Alessandra, M.D, Mattiucci, Gian Carlo, M.D, Mantini, Giovanna, M.D, Pacelli, Fabio, M.D, Valentini, Vincenzo, M.D, Cellini, Numa, M.D, Ingrosso, Marcello, M.D, Morganti, Alessio Giuseppe, M.D
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 01.06.2012
• Subjects: Adenocarcinoma - radiotherapy; CARCINOMAS; Gastrointestinal Hemorrhage - diagnosis; Gastrointestinal Hemorrhage - etiology; Hematology, Oncology and Palliative Medicine; Humans; Intestinal Mucosa - radiation effects; Late toxicity; Male; PATIENTS; Proctoscopy; PROSTATE; Prostate cancer; Prostatic Neoplasms - radiotherapy; Radiation Injuries - complications; Radiation Injuries - diagnosis; Radiology; RADIOLOGY AND NUCLEAR MEDICINE; RADIOTHERAPY; Radiotherapy Dosage; Rectal bleeding; Rectal Diseases - diagnosis; Rectal Diseases - etiology; RECTUM; Rectum - radiation effects; Surrogate endpoint; Telangiectasis - diagnosis; Telangiectasis - etiology; TOXICITY; Rectal bleeding; Proctoscopy; Late toxicity; Radiotherapy; Prostate cancer; Surrogate endpoint
• ISSN: 0360-3016; 1879-355X
• DOI: 10.1016/j.ijrobp.2011.12.046

Purpose To predict the grade and incidence of late clinical rectal toxicity through short-term (1 year) mucosal alterations. Methods and Materials 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.