title: Comparative study of the clinical efficacy of two dosing regimens of flutamide.
abstract: OBJECTIVE
  We performed a randomized trial to compare the efficacy and toxicity of a new dose of flutamide (500 mg QD) with the currently recommended dose (250 mg q8h) in the treatment of advanced prostate cancer. The primary endpoints were percent of patients having normalization of prostate specific antigen (PSA), time to normalization, and percent change from baseline. Secondary endpoints were quality of life and toxicity.
  
  
  METHODS
  Altogether, 440 men aged 46 to 94 years (mean 71 years) with confirmed stage M(1) disease, documented PSA rise >0.2 ng/mL, ECOG status 0 to 2, no second neoplasm, no liver function tests > or = 1.5-fold normal values, and no previous treatment for metastatic disease were entered in the trial.
  
  
  RESULTS
  The PSA normalized by week 12 in 71% of the patients receiving 500-mg dose and 75% of those receiving the standard dose. The percent change in PSA was 89% and 96%, respectively. The treatment groups were not significantly different with respect to the incidence of adverse events: 71% v 68% in the 500-mg and 250-mg arms, respectively (P = 0.337).
  
  
  CONCLUSIONS
  When combined with castration, 500 mg of flutamide appears to be equally effective in lowering serum PSA and is not significantly more toxic than conventional dosing. The use of 500 mg QD instead of the standard 250 mg q8h would result in a cost savings of 30%.
authors.affiliation: Section of Urology, University of Kansas Medical Center, Kansas City, Kansas 66160-7390, USA. bthrasher@kumc.edu
authors.forename: J B
authors.initials: JB
authors.lastname: Thrasher
authors.forename: J
authors.initials: J
authors.lastname: Deeths
authors.forename: C
authors.initials: C
authors.lastname: Bennett
authors.forename: P
authors.initials: P
authors.lastname: Iyer
authors.forename: M K
authors.initials: MK
authors.lastname: Dineen
authors.forename: S
authors.initials: S
authors.lastname: Zhai
authors.forename: W D
authors.initials: WD
authors.lastname: Figg
authors.forename: D G
authors.initials: DG
authors.lastname: McLeod
mesh_terms: D000368:Aged; D000369:Aged, 80 and over; D018931:Antineoplastic Agents, Hormonal / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D005485:Flutamide / Q000008:administration & dosage* / Q000009:adverse effects / Q000493:pharmacokinetics / Q000627:therapeutic use; D017048:Health Care Costs; D006801:Humans; D008297:Male; D008875:Middle Aged; D017430:Prostate-Specific Antigen / Q000097:blood; D011471:Prostatic Neoplasms / Q000188:drug therapy* / Q000601:surgery; D011788:Quality of Life
chemical_list: D018931:Antineoplastic Agents, Hormonal; D005485:Flutamide; D017430:Prostate-Specific Antigen