Postoperative radiotherapy after radical prostatectomy for high-risk prostate cancer: long-term results of a randomised controlled trial (EORTC trial 22911)

Michel Bolla*, Hein van Poppel, Bertrand Tombal, Kris Vekemans, Luigi Da Pozzo, Theo M. de Reijke, Antony Verbaeys, Jean-Francois Bosset, Roland van Velthoven, Marc Colombel, Cees van de Beek, Paul Verhagen, Alphonsus van den Bergh, Cora Sternberg, Thomas Gasser, Geertjan van Tienhoven, Pierre Scalliet, Karin Haustermans, Laurence Collette, European Org Res Treatment Canc

*Corresponding author for this work

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Abstract

Background We report the long-term results of a trial of immediate postoperative irradiation versus a wait-and-see policy in patients with prostate cancer extending beyond the prostate, to confirm whether previously reported progression-free survival was sustained.

Methods This randomised, phase 3, controlled trial recruited patients aged 75 years or younger with untreated cT0-3 prostate cancer (WHO performance status 0 or 1) from 37 institutions across Europe. Eligible patients were randomly assigned centrally (1:1) to postoperative irradiation (60 Gy of conventional irradiation to the surgical bed for 6 weeks) or to a wait-and-see policy until biochemical progression (increase in prostate-specific antigen >0.2 mu g/L confirmed twice at least 2 weeks apart). We analysed the primary endpoint, biochemical progression-free survival, by intention to treat (two-sided test for difference at alpha=0.05, adjusted for one interim analysis) and did exploratory analyses of heterogeneity of effect. This trial is registered with ClinicalTrials.gov, number NCT00002511.

Findings 1005 patients were randomly assigned to a wait-and-see policy (n=503) or postoperative irradiation (n=502) and were followed up for a median of 10.6 years (range 2 months to 16.6 years). Postoperative irradiation significantly improved biochemical progression-free survival compared with the wait-and-see policy (198 [39.4%] of 502 patients in postoperative irradiation group vs 311 [61.8%] of 503 patients in wait-and-see group had biochemical or clinical progression or died; HR 0.49 [95% CI 0.41-0.59]; p

Interpretation Results at median follow-up of 10.6 years show that conventional postoperative irradiation significantly improves biochemical progression-free survival and local control compared with a wait-and-see policy, supporting results at 5 year follow-up; however, improvements in clinical progression-free survival were not maintained. Exploratory analyses suggest that postoperative irradiation might improve clinical progression-free survival in patients younger than 70 years and in those with positive surgical margins, but could have a detrimental effect in patients aged 70 years or older.

Original languageEnglish
Pages (from-to)2018-2027
Number of pages10
JournalLANCET
Volume380
Issue number9858
DOIs
Publication statusPublished - 8-Dec-2012

Keywords

  • ADJUVANT RADIOTHERAPY
  • CLINICAL-TRIAL
  • BIOCHEMICAL RECURRENCE
  • MULTIVARIATE-ANALYSIS
  • RADIATION-THERAPY
  • FOLLOW-UP
  • PROGRESSION
  • DEFINITION
  • GUIDELINES
  • BENEFIT

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