Neoadjuvant hormone therapy for patients undergoing first-line radiation therapy


The Irish Clinical Oncology Research Group trial 97-01 was a randomized clinical trial designed to compare the long-term outcomes of patients treated with either 4 months or 8 months of hormonal therapy given before external beam radiotherapy for localized prostate cancer. Data from this trial were reported by Armstrong et al. in the August issue of the International Journal of Radiation Oncology Biology Physics.

The trial enrolled patients between 1997 and 2001, and the patients were stratified based on their PSA level, their Gleason score, and their clinical stage.

  • Intermediate-risk patient had just one of the following characteristics — a PSA level > 20 ng/ml; a Gleason score of 7 or higher, and clinical stage T3/4 disease.
  • High-risk patients had two or more of the same characteristics.

The stratification ensured that approximately equal numbers of intermediate- and high-risk patients were randomized to Arm 1 of the trial (in which patients received just 4 months of neoadjuvant hormone therapy) or Arm 2 (the 8-month arm).

The results of this trial are reported as follows:

  • 276 patients were enrolled in the trial and the data from 261 were appropriate for analysis.
  • The average (median) follow-up was 102 months.
  • The cumulative probability of overall survival at 5 years was 90 percent (range, 87-92 percent) in Arm 1 and 83 percent (range, 80-86 percent) in Arm 2.
  • The biochemical failure-free survival rate at 5 years was 66 percent (range, 62-71 percent) in Arm 1 and 63 percent (range, 58-67 percent) in Arm 2.
  • The overall survival, biochemical failure-free survival. and prostate cancer-specific survival did not differ significantly between the two treatment arms, overall or at 5 years.

The authors conclude that no statistically significant difference was observable in biochemical failure-free survival between groups of intermediate- and high-risk patients receiving 4 months or 8 months of neoadjuvant hormonal therapy before radiotherapy for localized prostate cancer.

This trial is probably too small to be able to resolve the issue of how much neoadjuvant hormone therapy is needed prior to radiation therapy for men with intermediate- and high-risk, localized prostate cancer. We would also hope that evolution in the ability to accurately deliver high doses of radiation to the prostate today (as compared to 10 year ago) would have helped to demonstrate better 5-year outcomes for these types of patients, regardless of the amount of neoadjuvant hormone therapy.

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