Journal
JOURNAL OF CLINICAL ONCOLOGY
Volume 19, Issue 1, Pages 62-71Publisher
LIPPINCOTT WILLIAMS & WILKINS
DOI: 10.1200/JCO.2001.19.1.62
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Funding
- NATIONAL CANCER INSTITUTE [U10CA011488] Funding Source: NIH RePORTER
- NCI NIH HHS [5U10 CA11488-17, 5U10 CA11488-16, 5U10 CA11488-15, 5U10 CA11488-18, 5U10 CA11488-14, 5U10 CA11488-19, 5U10 CA11488-13, 5U10 CA11488-20, 5U10 CA11488-21, 5U10 CA11488-22, 5U10 CA11488-23, 5U10 CA11488-12, 5U10 CA11488-11, 5U10 CA11488-24, 5U10 CA11488-25, 5U10 CA11488-26, 5U10 CA11488-27, 5U10 CA11488-28, 5U10 CA11488-29] Funding Source: Medline
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Purpose: Time to progression (TTP), overall survival, and quality of life (QL) were compared in patients with hormone-resistant prostate cancer (HRPC) treated with prednisone (5 mg orally, four times a day) or flutamide (250 mg orally, three times a day). Patients and Methods: Symptomatic patients were randomized to receive either prednisone (101 patients) or flutamide (100 patients). Subjective response was assessed based on performance status, the use of analgesics, and the need to apply alternative palliative treatment. prostate-specific antigen (PSA)-based biochemical response (greater than or equal to 50% reduction of baseline PSA) was recorded. At baseline and at 6-week intervals during follow-up, patients completed the European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire C-30. Results: There was no difference between the groups in median TTp (prednisone, 3.4 months; flutamide, 2.3 months) or overall survival (prednisone, 10.6 months; flutamide, 11.2 months). In the prednisone group, 56% of the patients experienced a subjective response, compared with 45% in the flutamide group (P = .18). The median response duration war 4.8 months for prednisone and 4.2 months for flutamide. A biochemical response was observed in 21% and 23% of the prednisone and flutamide groups, respectively. Gastrointestinal toxicity war the reason for trial discontinuation in seven patients receiving flutamide and two patients receiving prednisone. The QL assessment parameters favored the use of prednisone with statistically significant differences in pain, fatigue, role functioning, appetite loss, gastrointestinal distress, and overall QL. Conclusion: In symptomatic HRPC, treatment with prednisone or flutamide leads to similar rates of TTP and overall survival and no difference in subjective or biochemical response. The QL results favor the use of low-cost prednisone in patients with HRPC. J Clin Oncol 19:62-71. (C) 2001 by American Society of Clinical Oncology.
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