title: Is the efficacy of hormonal therapy affected by lymph node status? data from the bicalutamide (Casodex) Early Prostate Cancer program.
abstract: OBJECTIVE
  To report an exploratory subgroup analysis assessing the extent to which the overall benefit found in the Early Prostate Cancer program is dependent on lymph node status at randomization. The program is ongoing, and the overall survival data are immature. The first combined analysis of the bicalutamide (Casodex) Early Prostate Cancer program at 3 years' median follow-up showed that bicalutamide, 150 mg once daily, plus standard care (radical prostatectomy, radiotherapy, or watchful waiting), significantly reduced the risk of objective progression and prostate-specific antigen (PSA) doubling in patients with localized/locally advanced prostate cancer.
  
  
  METHODS
  Men (n = 8113) with localized/locally advanced disease received bicalutamide 150 mg or placebo once daily, plus standard care. The time to event data (objective progression, PSA doubling) was analyzed by lymph node status at randomization.
  
  
  RESULTS
  Compared with standard care alone, bicalutamide significantly reduced the risk of objective progression, irrespective of lymph node status, with the most pronounced reduction in patients with N+ (hazard ratio [HR] 0.29; 95% confidence interval [CI] 0.15 to 0.56) compared with those with N0 (HR 0.59; 95% CI 0.48 to 0.73) and Nx (HR 0.60; 95% CI 0.50 to 0.72) disease. The largest decrease in risk of PSA doubling with bicalutamide was observed in N+ disease (HR 0.16; 95% CI 0.09 to 0.29), with significantly reduced risks seen in N0 (HR 0.45; 95% CI 0.40 to 0.51) and Nx (HR 0.38; 95% CI 0.33 to 0.44) disease.
  
  
  CONCLUSIONS
  The greatest reduction in the risk of objective progression and PSA doubling with bicalutamide was seen in patients with N+ disease. However, bicalutamide also provided a statistically significant benefit in those with N0 and Nx disease.
authors.affiliation: Department of Urology, University of Copenhagen, Rigshospitalet, Copenhagen, Denmark.
authors.forename: Peter
authors.initials: P
authors.lastname: Iversen
authors.forename: Manfred P
authors.initials: MP
authors.lastname: Wirth
authors.forename: William A
authors.initials: WA
authors.lastname: See
authors.forename: David G
authors.initials: DG
authors.lastname: McLeod
authors.forename: Ira
authors.initials: I
authors.lastname: Klimberg
authors.forename: Donald
authors.initials: D
authors.lastname: Gleason
authors.forename: Gerald
authors.initials: G
authors.lastname: Chodak
authors.forename: James
authors.initials: J
authors.lastname: Montie
authors.forename: Chris
authors.initials: C
authors.lastname: Tyrrell
authors.forename: D M A
authors.initials: DM
authors.lastname: Wallace
authors.forename: Karl P J
authors.initials: KP
authors.lastname: Delaere
authors.forename: Per
authors.initials: P
authors.lastname: Lundmo
authors.forename: Teuvo L J
authors.initials: TL
authors.lastname: Tammela
authors.forename: Jan-Erik
authors.initials: JE
authors.lastname: Johansson
authors.forename: Tom
authors.initials: T
authors.lastname: Morris
authors.forename: Kevin
authors.initials: K
authors.lastname: Carroll
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000627:therapeutic use; D000813:Anilides / Q000627:therapeutic use*; D000970:Antineoplastic Agents / Q000627:therapeutic use*; D018450:Disease Progression; D006801:Humans; D008207:Lymphatic Metastasis / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009367:Neoplasm Staging; D009570:Nitriles; D017430:Prostate-Specific Antigen / Q000097:blood; D011468:Prostatectomy; D011471:Prostatic Neoplasms / Q000097:blood / Q000473:pathology* / Q000628:therapy*; D012044:Regression Analysis; D014105:Tosyl Compounds
chemical_list: D000726:Androgen Antagonists; D000813:Anilides; D000970:Antineoplastic Agents; D009570:Nitriles; D014105:Tosyl Compounds; C053541:bicalutamide; D017430:Prostate-Specific Antigen