title: Acute toxicity of conventional radiation therapy for high-risk prostate cancer in EORTC trial 22863.
abstract: OBJECTIVE
  We analysed the acute toxicity observed in the European Organisation for Research and Treatment of Cancer (EORTC) randomised trial 22863 comparing conventional external irradiation with or without an agonist analogue of gonadotropin-releasing hormone in high-risk prostate cancer patients.
  
  
  METHODS
  Four hundred five patients that received a dose of at least 30 Gy were considered evaluable for acute toxicity assessment. Toxicity was grouped in a few categories: general, genito-urinary, and lower gastro-intestinal. Univariate and multivariate analyses were performed using the World Health Organisation (WHO) toxicity score and grouping together toxicity scores in different bimodal and trimodal groups.
  
  
  RESULTS
  Overall, our data show that age, previous surgery and irradiation dose are important predictive factors for acute toxicity, but not the use of combined hormone therapy. Fifteen percent of patients suffered of moderate to severe acute toxicity (WHO G3-G4). Life threatening toxicity was observed in six cases (1.5%).
  
  
  CONCLUSIONS
  The assessment of toxicity combining in different groups the original five scores scale produced conflicting results similar to those commonly reported in literature. Interpretation of the role of pre-treatment factors with uneven distribution in the study requires careful evaluation. These data obtained with conventional curative irradiation of high-risk prostate cancer patients are proposed for comparison with results achieved using modern state-of-the-art irradiation techniques.
authors.affiliation: EORTC Data Center, Avenue E. Mounier 83, 1200, Brussels, Belgium. azu@eortc.be
authors.forename: A
authors.initials: A
authors.lastname: Zurlo
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: G
authors.initials: G
authors.lastname: van Tienhoven
authors.forename: L
authors.initials: L
authors.lastname: Blank
authors.forename: P
authors.initials: P
authors.lastname: Warde
authors.forename: J
authors.initials: J
authors.lastname: Dubois
authors.forename: W
authors.initials: W
authors.lastname: Jeanneret
authors.forename: G
authors.initials: G
authors.lastname: Storme
authors.forename: J
authors.initials: J
authors.lastname: Bernier
authors.forename: A
authors.initials: A
authors.lastname: Kuten
authors.forename: M
authors.initials: M
authors.lastname: Pierart
authors.forename: M
authors.initials: M
authors.lastname: Bolla
mesh_terms: D000328:Adult; D000368:Aged; D016009:Chi-Square Distribution; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011878:Radiotherapy / Q000009:adverse effects*; D011879:Radiotherapy Dosage; D012306:Risk; D018709:Statistics, Nonparametric; D016896:Treatment Outcome