title: Timing of salvage hormonal therapy in prostate cancer patients with unfavorable prognosis treated with radiotherapy: a secondary analysis of Radiation Therapy Oncology Group 85-31.
abstract: OBJECTIVE
  Radiation Therapy Oncology Group 85-31 was a randomized trial comparing radiotherapy (RT) alone vs. RT plus adjuvant androgen suppression for life in unfavorable-prognosis carcinoma of the prostate. We examined the impact of early initiation of salvage hormonal therapy (HT) in relapsing patients randomized to RT alone arm.
  
  
  METHODS
  Patients were divided into two groups: early salvage HT and late salvage HT. The early salvage group was defined as receiving HT with a prostate-specific antigen (PSA) level of less than 10 ng/mL, and the late salvage HT group had a PSA level of 10 ng/mL or greater. The outcomes were overall survival (OS), cause-specific mortality (CSM), and local failure (LF). The Kaplan-Meier estimation and log-rank test were used for OS, and the cumulative incidence estimation and Gray's test were used for CSM and LF. Proportional hazards regression models were used to compare the outcomes adjusted for other covariates.
  
  
  RESULTS
  The median follow-up times of surviving patients in the early and late salvage HT groups were about 11 and 13 years, respectively. The late salvage HT group had significantly more post-prostatectomy patients and patients with high Gleason scores. After adjustment for all covariates, OS was significantly longer in the early salvage HT group (hazard ratio, 1.5; p = 0.01). However, there were no statistically significant differences in LF or CSM between the groups.
  
  
  CONCLUSIONS
  The early introduction of salvage HT resulted in improved OS but not improved CSM and LF. A randomized trial to define the optimal salvage hormonal timing is warranted in this group of patients with PSA recurrence after RT.
authors.affiliation: McGill University Health Centre, Montreal, Quebec, Canada. luis.souhami@muhc.mcgill.ca
authors.forename: Luis
authors.initials: L
authors.lastname: Souhami
authors.forename: Kyounghwa
authors.initials: K
authors.lastname: Bae
authors.forename: Miljenko
authors.initials: M
authors.lastname: Pilepich
authors.forename: Howard
authors.initials: H
authors.lastname: Sandler
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000627:therapeutic use; D002423:Cause of Death; D005500:Follow-Up Studies; D017273:Goserelin / Q000627:therapeutic use; D006801:Humans; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000097:blood / Q000188:drug therapy* / Q000401:mortality; D011379:Prognosis; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000097:blood / Q000188:drug therapy* / Q000401:mortality / Q000532:radiotherapy; D012016:Reference Values; D016879:Salvage Therapy / Q000379:methods* / Q000401:mortality; D016019:Survival Analysis; D013997:Time Factors
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D017273:Goserelin; D017430:Prostate-Specific Antigen