title: Quality of life in advanced prostate cancer: results of a randomized therapeutic trial.
abstract: BACKGROUND
  For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic androgen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we evaluated quality-of-life (QOL) parameters in patients with metastatic prostate cancer who were randomly assigned to two methods of androgen deprivation.
  
  
  METHODS
  Patients (n = 739) with stage M1 (bone or soft tissue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized double-blind trial comparing treatment with bilateral orchiectomy (surgical castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to treatment and at 1, 3, and 6 months later. Data were collected on three treatment-specific symptoms (diarrhea, gas pain, and body image), on physical functioning, and on emotional functioning. All P values are two-sided.
  
  
  RESULTS
  Questionnaire return rates for this study never dropped below 80%; only 2% of the patients did not submit baseline QOL assessments. Cross-sectional analyses (corrected for multiple testing) identified statistically significant differences that favored orchiectomy plus placebo for two of the five primary QOL parameters as follows: patients receiving flutamide reported more diarrhea at 3 months (P = .001) and worse emotional functioning at 3 and 6 months (both P<.003). Longitudinal analyses replicated these findings. Other analyzed QOL parameters favored the group receiving placebo but were not statistically significant after adjustment for multiple testing.
  
  
  CONCLUSIONS
  We found a consistent pattern of better QOL outcomes at each follow-up assessment during the first 6 months of treatment for orchiectomized patients with metastatic prostate cancer who received placebo versus flutamide. Improvement over time was evident in both treatment groups but more so for patients receiving placebo.
authors.affiliation: Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA 98109-1024, USA.
authors.forename: C M
authors.initials: CM
authors.lastname: Moinpour
authors.forename: M J
authors.initials: MJ
authors.lastname: Savage
authors.forename: A
authors.initials: A
authors.lastname: Troxel
authors.forename: L C
authors.initials: LC
authors.lastname: Lovato
authors.forename: M
authors.initials: M
authors.lastname: Eisenberger
authors.forename: R W
authors.initials: RW
authors.lastname: Veith
authors.forename: B
authors.initials: B
authors.lastname: Higgins
authors.forename: R
authors.initials: R
authors.lastname: Skeel
authors.forename: M
authors.initials: M
authors.lastname: Yee
authors.forename: B A
authors.initials: BA
authors.lastname: Blumenstein
authors.forename: E D
authors.initials: ED
authors.lastname: Crawford
authors.forename: F L
authors.initials: FL
authors.lastname: Meyskens
mesh_terms: D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000726:Androgen Antagonists / Q000009:adverse effects / Q000627:therapeutic use*; D018931:Antineoplastic Agents, Hormonal / Q000009:adverse effects / Q000627:therapeutic use*; D003430:Cross-Sectional Studies; D003967:Diarrhea / Q000139:chemically induced; D004311:Double-Blind Method; D005485:Flutamide / Q000009:adverse effects / Q000627:therapeutic use*; D006801:Humans; D008137:Longitudinal Studies; D008297:Male; D008875:Middle Aged; D009919:Orchiectomy; D010146:Pain / Q000209:etiology; D011471:Prostatic Neoplasms / Q000150:complications / Q000188:drug therapy / Q000523:psychology* / Q000601:surgery / Q000628:therapy*; D011788:Quality of Life; D011795:Surveys and Questionnaires; D016896:Treatment Outcome
chemical_list: D000726:Androgen Antagonists; D018931:Antineoplastic Agents, Hormonal; D005485:Flutamide