Abstract | BACKGROUND: METHODS: In 2 multiinstitutional prospective trials, 683 postmenopausal patients were randomized to receive either fadrozole HCL, 1 mg twice daily, or megestrol acetate, 40 mg 4 times daily, in a double blind fashion after progression on first-line hormonal therapy. Objective response rates, time to progression, survival and safety of the two regimens were compared. RESULTS: Results of intent-to-treat analyses are presented in this study. No significant differences were detected between the two treatment groups in time to progression, objective response rates, duration of response, and survival in either trial. There were no clinically meaningful differences between the treatment groups in the incidence and severity of adverse experiences, except that weight gain, fluid retention, and dyspnea were observed in more patients in the megestrol acetate group compared with those receiving fadrozole HCL, whereas nausea and vomiting were observed in more patients in the fadrozole HCL group compared with those receiving megestrol acetate. CONCLUSIONS:
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Authors | A U Buzdar, R Smith, C Vogel, P Bonomi, A M Keller, G Favis, M Mulagha, J Cooper |
Journal | Cancer
(Cancer)
Vol. 77
Issue 12
Pg. 2503-13
(Jun 15 1996)
ISSN: 0008-543X [Print] United States |
PMID | 8640699
(Publication Type: Clinical Trial, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
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Chemical References |
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Topics |
- Adult
- Aged
- Breast Neoplasms
(drug therapy)
- Carcinoma
(drug therapy)
- Double-Blind Method
- Fadrozole
(adverse effects, therapeutic use)
- Female
- Humans
- Megestrol
(adverse effects, therapeutic use)
- Menopause
- Middle Aged
- Prognosis
- Prospective Studies
- Survival Analysis
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