Subgroup analysis of patients with localized prostate cancer treated within the Dutch-randomized dose escalation trial

Radiother Oncol. 2010 Jul;96(1):13-8. doi: 10.1016/j.radonc.2010.02.022. Epub 2010 Mar 11.

Abstract

Purpose: To investigate the effect of dose escalation within prognostic risk groups in prostate cancer.

Patients and methods: Between 1997 and 2003, 664 patients with localized prostate cancer were randomly assigned to receive 68- or 78-Gy of radiotherapy. Two prognostic models were examined: a risk group model (low-, intermediate-, and high-risk) and PSA-level groupings. High-risk patients with hormonal therapy (HT) were analyzed separately. Outcome variable was freedom from failure (FFF) (clinical failure or PSA nadir+2 microg/L).

Results: In relation to the advantage of high-dose radiotherapy, intermediate-risk patients benefited most from dose escalation. However no significant heterogeneity could be demonstrated between the risk groups. For two types of PSA-level groupings: PSA<10 and > or = 10 microg/L, and <8, 8-18 and >8 microg/L, the test for heterogeneity was significant (p=0.03 and 0.05, respectively). Patients with PSA 8-18 microg/L (n=297, HR=0.59) derived the greatest benefit from dose escalation. No heterogeneity could be demonstrated for high-risk patients with and without HT.

Conclusion: Intermediate-risk group derived the greatest benefit for dose escalation. However, from this trial no indication was found to exclude low-risk or high-risk patients from high-dose radiotherapy. Patients could be selected for high-dose radiotherapy based on PSA-level groupings: for patients with a PSA<8 microg/L high-dose radiotherapy is probably not indicated, but should be confirmed in other randomized studies.

Publication types

  • Comparative Study
  • Randomized Controlled Trial

MeSH terms

  • Aged
  • Chi-Square Distribution
  • Dose Fractionation, Radiation
  • Dose-Response Relationship, Radiation
  • Follow-Up Studies
  • Humans
  • Kaplan-Meier Estimate
  • Male
  • Middle Aged
  • Neoplasm Staging
  • Netherlands
  • Proportional Hazards Models
  • Prostate-Specific Antigen / blood*
  • Prostatic Neoplasms / blood
  • Prostatic Neoplasms / mortality
  • Prostatic Neoplasms / pathology*
  • Prostatic Neoplasms / radiotherapy*
  • Radiotherapy Dosage
  • Radiotherapy, High-Energy
  • Risk Assessment
  • Survival Analysis
  • Treatment Outcome

Substances

  • Prostate-Specific Antigen