Randomized clinical trial of megestrol acetate versus tamoxifen in paramenopausal or castrated women with advanced breast cancer

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Abstract
Fifty-five women with progressive metastatic breast cancer who were paramenopausal (1 to < 5 yr since last menstrual period) or castrated were randomized to receive megestrol acetate (150 mg mg/m2 daily in 3 divided doses) or tamoxifen (10 mg twice daily). The regression rate (complete plus partial) was higher for tamoxifen (26%) than for megestrol acetate (14%), but not significantly so. Analysis of time to treatment failure showed no significant difference (medians megestrol acetate, 65 days; tamoxifen, 58 days). There was a survival advantage associated with megestrol acetate (P = 0.02 after adjustment for stratification factors) that is difficult to interpret given the results of analysis of regression and time to treatment failure for the 2 agents.