title: Acute toxicity of curative radiotherapy for intermediate- and high-risk localised prostate cancer in the EORTC trial 22991.
abstract: BACKGROUND
  This trial randomly assessed short-term adjuvant hormonal therapy added to radiotherapy (RT) for intermediate- and high-risk (UICC 1997 cT2a or cT1b-c with high PSA or Gleason score) localised prostate cancer. We report acute toxicity (CTCAE v2) assessed weekly during RT in relation to radiation parameters.
  
  
  METHODS
  Centres selected the RT dose (70, 74 or 78Gy) and RT technique. Statistical significance is at 0.05.
  
  
  RESULTS
  Of 791 patients, 652 received 3D-CRT (70Gy: 195, 74Gy: 376, 78Gy: 81) and 139 received IMRT (74Gy: 28, 78Gy: 111). During RT, grade 3 gastrointestinal (GI) and genitourinary (GU) toxicities were reported by 7 (0.8%) and 50 (6.3%) patients, respectively. No grade 4 was reported. The risk of grade 2 GI toxicity increased significantly with increasing D50%-rectum (p=0.004) and that of grade 2 GU toxicity correlated only to Dmax-bladder (p=0.051). 3D-RT technique, increasing total dose and V95% >400 cc increased D50% and Dmax. One month after RT, only 14 patients (1.8%) reported grade 3 toxicity. AST did not seem to influence the risk of GU or GI acute toxicity.
  
  
  CONCLUSIONS
  RT up to 78Gy was well tolerated. Dmax-bladder and D50%-rectum influenced the risk of grade 2 GU toxicity and GI toxicity, respectively. Both were lower with IMRT but remained high for an irradiated RT volume>400 cc for 3D-RT and for a dose of 78Gy. Hormonal treatment did not influence acute toxicity.
authors.affiliation: EORTC Headquarters, Belgium. Oscar.Matzinger@chuv.ch
authors.forename: O
authors.initials: O
authors.lastname: Matzinger
authors.forename: F
authors.initials: F
authors.lastname: Duclos
authors.forename: A
authors.initials: A
authors.lastname: van den Bergh
authors.forename: C
authors.initials: C
authors.lastname: Carrie
authors.forename: S
authors.initials: S
authors.lastname: Villà
authors.forename: P
authors.initials: P
authors.lastname: Kitsios
authors.forename: P
authors.initials: P
authors.lastname: Poortmans
authors.forename: S
authors.initials: S
authors.lastname: Sundar
authors.forename: E M
authors.initials: EM
authors.lastname: van der Steen-Banasik
authors.forename: A
authors.initials: A
authors.lastname: Gulyban
authors.forename: L
authors.initials: L
authors.lastname: Collette
authors.forename: M
authors.initials: M
authors.lastname: Bolla
mesh_terms: D000208:Acute Disease; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D005767:Gastrointestinal Diseases / Q000209:etiology; D006801:Humans; D008297:Male; D008875:Middle Aged; D011471:Prostatic Neoplasms / Q000188:drug therapy / Q000532:radiotherapy*; D011785:Quality Assurance, Health Care; D011832:Radiation Injuries / Q000150:complications*; D011878:Radiotherapy / Q000009:adverse effects; D014570:Urologic Diseases / Q000209:etiology
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal