Hypofractionated high-dose radiation therapy for prostate cancer: long-term results of a multi-institutional phase II trial

Int J Radiat Oncol Biol Phys. 2012 Nov 15;84(4):e483-90. doi: 10.1016/j.ijrobp.2012.04.012. Epub 2012 Jun 5.

Abstract

Purpose: To report late gastrointestinal (GI) and genitourinary (GU) toxicity, biochemical and clinical outcomes, and overall survival after hypofractionated radiation therapy for prostate cancer (PC).

Methods and materials: Three institutions included 113 patients with T1 to T3N0M0 PC in a phase II study. Patients were treated with 56 Gy in 16 fractions over 4 weeks. Late toxicity was scored using Radiation Therapy Oncology Group/European Organization for Research and Treatment of Cancer criteria extended with additional symptoms. Biochemical outcome was reported according to the Phoenix definition for biochemical failure.

Results: The incidence of late GI and GU toxicity was low. The 3-year actuarial risk of developing late GU and GI toxicity of grade≥2 was 13% and 8% respectively. Five-year biochemical non-evidence of disease (bNED) was 94%. Risk group, T stage, and deviation from planned hormone treatment were significant predictive factors for bNED. Deviation from hormone treatment remained significant in multivariate analysis. Five-year clinical non evidence of disease and overall survival was 95% and 91% respectively. No patient died from PC.

Conclusions: Hypofractionated high-dose radiation therapy is a valuable treatment option for patients with PC, with excellent biochemical and clinical outcome and low toxicity.

Publication types

  • Clinical Trial, Phase II
  • Multicenter Study

MeSH terms

  • Adult
  • Aged
  • Analysis of Variance
  • Androgen Antagonists / adverse effects
  • Androgen Antagonists / therapeutic use
  • Dose Fractionation, Radiation
  • Femur Head / radiation effects
  • Gastrointestinal Tract / radiation effects
  • Humans
  • Incidence
  • Italien
  • Male
  • Middle Aged
  • Organs at Risk / diagnostic imaging
  • Organs at Risk / radiation effects
  • Prospective Studies
  • Prostate-Specific Antigen / blood
  • Prostatic Neoplasms / drug therapy
  • Prostatic Neoplasms / radiotherapy*
  • Radiation Injuries / epidemiology
  • Radiography
  • Rectum / radiation effects
  • Time Factors
  • Urinary Bladder / radiation effects
  • Urination Disorders / etiology
  • Urogenital System / radiation effects

Substances

  • Androgen Antagonists
  • Prostate-Specific Antigen