© 1998 by Oxford University Press
Journal of the National Cancer Institute, Vol. 90, No. 20, 1537-1544,
October 21, 1998
©Copyright 1998 Oxford University Press
ARTICLES |
Quality of Life in Advanced Prostate Cancer: Results of a Randomized Therapeutic Trial
Affiliations of authors: C. M. Moinpour, L. C. Lovato, M. Yee, B. A. Blumenstein, Southwest Oncology Group Statistical Center, Fred Hutchinson Cancer Research Center, Seattle, WA; M. J. Savage, Mercy Medical Center, Baltimore, MD; A. Troxel, Columbia Presbyterian Cancer Center, New York, NY; M. Eisenberger, Johns Hopkins University School of Medicine, Baltimore, MD; R. W. Veith, Stanley S. Scott Cancer Center, Louisiana State University Medical Center-New Orleans; B. Higgins, Brooke Army Medical Center/Wilford Hall Medical Center, San Antonio, TX; R. Skeel, Medical College of Ohio, Toledo; E. D. Crawford, University of Colorado, Denver; F. L. Meyskens, Jr., University of California Irvine Chao Family Comprehensive Cancer Center, Irvine.
Reprint requests to: Southwest Oncology Group (S9039), Operations Office, 14980 Omicron Dr., San Antonio, TX 78245-3217.
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. [J Natl Cancer Inst 1998;90:1537-44]
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