Acute Toxicity of Curative Radiotherapy for Intermediate- And High-Risk Localised Prostate Cancer in the EORTC Trial 22991

Eur J Cancer. 2009 Nov;45(16):2825-34. doi: 10.1016/j.ejca.2009.07.009. Epub 2009 Aug 12.


Introduction: 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.

Patients and 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.

Conclusion: 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.

Publication types

  • Multicenter Study
  • Randomized Controlled Trial
  • Research Support, N.I.H., Extramural
  • Research Support, Non-U.S. Gov't

MeSH terms

  • Acute Disease
  • Adult
  • Aged
  • Aged, 80 and over
  • Androgen Antagonists / therapeutic use
  • Antineoplastic Agents, Hormonal / therapeutic use
  • Gastrointestinal Diseases / etiology
  • Humans
  • Male
  • Middle Aged
  • Prostatic Neoplasms / drug therapy
  • Prostatic Neoplasms / radiotherapy*
  • Quality Assurance, Health Care
  • Radiation Injuries / complications*
  • Radiotherapy / adverse effects
  • Urologic Diseases / etiology


  • Androgen Antagonists
  • Antineoplastic Agents, Hormonal