title: Does hormone therapy reduce disease recurrence in prostate cancer patients receiving dose-escalated radiation therapy? An analysis of Radiation Therapy Oncology Group 94-06.
abstract: OBJECTIVE
  The purpose of this study was to evaluate the effect on freedom from biochemical failure (bNED) or disease-free survival (DFS) by adding hormone therapy (HT) to dose-escalated radiation therapy (HDRT).
  
  
  METHODS
  We used 883 analyzable prostate cancer patients who enrolled on Radiation Therapy Oncology Group (RTOG) 94-06, a Phase I/II dose escalation trial, and whose mean planning target volume dose exceeded 73.8 Gy (mean, 78.5 Gy; maximum, 84.3 Gy). We defined biochemical failure according to the Phoenix definition.
  
  
  RESULTS
  A total of 259 men started HT 2 to 3 months before HDRT, but not longer than 6 months, and 66 men with high-risk prostate cancer received HT for a longer duration. At 5 years, the biochemical failure rates after HDRT alone were 12%, 18%, and 29% for low-, intermediate-, and high-risk patients, respectively (p < 0.0001). Cox proportional hazards regression analysis adjusted for covariates revealed that pretreatment PSA level was a significant factor, whereas risk group, Gleason score, T-stage, and age were not. When the patients were stratified by risk groups, the Cox proportion hazards regression model (after adjusting for pretreatment PSA, biopsy Gleason score, and T stage) did not reveal a significant effect on bNED or DFS by adding HT to HDRT CONCLUSION: The addition of HT did not significantly improve bNED survival or DFS in all prostate cancer patients receiving HDRT, but did approach significance in high-risk patient subgroup. The result of this study is hypothesis generating and requires testing in a prospective randomized trial.
authors.affiliation: Department of Radiation Oncology, University of California-Davis School of Medicine, Davis, CA, USA. richard.valicenti@ucdmc.ucdavis.edu
authors.forename: Richard K
authors.initials: RK
authors.lastname: Valicenti
authors.forename: Kwounghwa
authors.initials: K
authors.lastname: Bae
authors.forename: Jeff
authors.initials: J
authors.lastname: Michalski
authors.forename: Howard
authors.initials: H
authors.lastname: Sandler
authors.forename: William
authors.initials: W
authors.lastname: Shipley
authors.forename: Alex
authors.initials: A
authors.lastname: Lin
authors.forename: James
authors.initials: J
authors.lastname: Cox
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D018572:Disease-Free Survival; D005500:Follow-Up Studies; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000401:mortality / Q000517:prevention & control*; D009367:Neoplasm Staging; D011446:Prospective Studies; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000473:pathology / Q000517:prevention & control* / Q000532:radiotherapy; D011879:Radiotherapy Dosage; D012044:Regression Analysis
chemical_list: D017430:Prostate-Specific Antigen