QUALITY-OF-LIFE IN ADVANCED PROSTATE-CANCER - RESULTS OF A RANDOMIZEDTHERAPEUTIC TRIAL

Background: For patients with metastatic prostate cancer, treatment is primarily palliative, relying mainly on the suppression of systemic a ndrogen hormone levels. To help document the achievement of palliation and to characterize positive and negative effects of treatment, we ev aluated quality-of-life (QOL) parameters in patients with metastatic p rostate cancer who were randomly assigned to two methods of androgen d eprivation. Methods: Patients (n = 739) with stage M-1 (bone or soft t issue metastasis) prostate cancer were enrolled in a QOL protocol that was a companion to Southwest Oncology Group INT-0105, a randomized do uble-blind trial comparing treatment with bilateral orchiectomy (surgi cal castration) plus either flutamide or placebo. Patients completed a comprehensive battery of QOL questionnaires at random assignment to t reatment 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 t wo-sided. Results: Questionnaire return rates for this study never dro pped below 80%; only 2% of the patients did not submit baseline QOL as sessments. Cross-sectional analyses (corrected for multiple testing) i dentified statistically significant differences that favored orchiecto my 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 pa rameters favored the group receiving placebo but were not statisticall y significant after adjustment for multiple testing. Conclusions: We f ound a consistent pattern of better QOL outcomes at each follow-up ass essment during the first 6 months of treatment for orchiectomized pati ents with metastatic prostate cancer who received placebo versus fluta mide, Improvement over time was evident in both treatment groups but m ore so for patients receiving placebo.