title: Predictors for rectal and intestinal acute toxicities during prostate cancer high-dose 3D-CRT: results of a prospective multicenter study.
abstract: OBJECTIVE
  To find predictors for rectal and intestinal acute toxicity in patients with prostate cancer treated with > or =70 Gy conformal radiotherapy.
  
  
  METHODS
  Between July 2002 and March 2004, 1,132 patients were entered into a cooperative study (AIROPROS01-02). Toxicity was scored using the Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer scale and by considering the changes (before and after treatment) of the scores of a self-administered questionnaire on rectal/intestinal toxicity. The correlation with a number of parameters was assessed by univariate and multivariate analyses. Concerning the questionnaire, only moderate/severe complications were considered.
  
  
  RESULTS
  Of 1,132 patients, 1,123 were evaluable. Of these patients, 375, 265, and 28 had Grade 1, 2, and 3 Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer toxicity, respectively. The mean rectal dose was the most predictive parameter (p = 0.0004; odds ratio, 1.035) for Grade 2 or worse toxicity, and the use of anticoagulants/antiaggregants (p = 0.02; odds ratio, 0.63) and hormonal therapy (p = 0.04, odds ratio, 0.65) were protective. The questionnaire-based scoring revealed that a greater mean rectal dose was associated with a greater risk of bleeding; larger irradiated volumes were associated with frequency, tenesmus, incontinence, and bleeding; hormonal therapy was protective against frequency and tenesmus; hemorrhoids were associated with a greater risk of tenesmus and bleeding; and diabetes associated highly with diarrhea.
  
  
  CONCLUSIONS
  The mean rectal dose correlated with acute rectal/intestinal toxicity in three-dimensional conformal radiotherapy for prostate cancer, and hormonal therapy and the use of anticoagulants/antiaggregants were protective. According to the moderate/severe injury scores on the self-assessed questionnaire, several clinical and dose-volume parameters were independently predictive for particular symptoms.
authors.affiliation: Department of Radiotherapy, Ospedale di Circolo, Varese, Italy.
authors.forename: Vittorio
authors.initials: V
authors.lastname: Vavassori
authors.forename: Claudio
authors.initials: C
authors.lastname: Fiorino
authors.forename: Tiziana
authors.initials: T
authors.lastname: Rancati
authors.forename: Alessandro
authors.initials: A
authors.lastname: Magli
authors.forename: Gianni
authors.initials: G
authors.lastname: Fellin
authors.forename: Michela
authors.initials: M
authors.lastname: Baccolini
authors.forename: Carla
authors.initials: C
authors.lastname: Bianchi
authors.forename: Emanuela
authors.initials: E
authors.lastname: Cagna
authors.forename: Flora A
authors.initials: FA
authors.lastname: Mauro
authors.forename: Angelo F
authors.initials: AF
authors.lastname: Monti
authors.forename: Fernando
authors.initials: F
authors.lastname: Munoz
authors.forename: Michele
authors.initials: M
authors.lastname: Stasi
authors.forename: Paola
authors.initials: P
authors.lastname: Franzone
authors.forename: Riccardo
authors.initials: R
authors.lastname: Valdagni
mesh_terms: D000925:Anticoagulants / Q000009:adverse effects; D016009:Chi-Square Distribution; D006484:Hemorrhoids / Q000150:complications; D006801:Humans; D007422:Intestines / Q000528:radiation effects; D008297:Male; D010975:Platelet Aggregation Inhibitors / Q000009:adverse effects; D011446:Prospective Studies; D011471:Prostatic Neoplasms / Q000532:radiotherapy*; D011832:Radiation Injuries / Q000209:etiology*; D011879:Radiotherapy Dosage; D020266:Radiotherapy, Conformal / Q000009:adverse effects*; D012007:Rectum / Q000528:radiation effects*; D012044:Regression Analysis; D012307:Risk Factors
chemical_list: D000925:Anticoagulants; D010975:Platelet Aggregation Inhibitors