Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial

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 qualityof-li...

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Bibliographic Details
Published in:JNCI : Journal of the National Cancer Institute 1998-10, Vol.90 (20), p.1537-1544
Main Authors: Moinpour, Carol M., Lovato, Laura C., Yee, Monica, Blumenstein, Brent A., Savage, Marguerite J., Troxel, Andrea, Eisenberger, Mario, Veith, Robert W., Higgins, Betsy, Skeel, Roland, Crawford, E. David, Meyskens, Frank L.
Format: Article
Language:English
Subjects:
Adult
Aged
Aged, 80 and over
Androgen Antagonists - adverse effects
Androgen Antagonists - therapeutic use
Antineoplastic Agents, Hormonal - adverse effects
Antineoplastic Agents, Hormonal - therapeutic use
Biological and medical sciences
Clinical trials
Cross-Sectional Studies
Diarrhea - chemically induced
Double-Blind Method
Flutamide - adverse effects
Flutamide - therapeutic use
Humans
Longitudinal Studies
Male
Medical sciences
Middle Aged
Nephrology. Urinary tract diseases
Orchiectomy
Pain - etiology
Prostate cancer
Prostatic Neoplasms - complications
Prostatic Neoplasms - drug therapy
Prostatic Neoplasms - psychology
Prostatic Neoplasms - surgery
Prostatic Neoplasms - therapy
Quality of Life
Surveys and Questionnaires
Treatment Outcome
Tumors of the urinary system
Urinary tract. Prostate gland
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Summary: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 qualityof-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 doubleblind 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
ISSN:0027-8874
1460-2105
DOI:10.1093/jnci/90.20.1537