This study was performed to determine the toxicity and effectiveness of megestrol acetate used with aminoglutethimide-hydrocortisone in the treatment of patients with metastatic breast cancer. Forty-five patients were treated, 29 of whom were fully eligible. Twelve of the 45 who had diabetes and/or hypertension were also analyzed. All had measurable sites of disease. The median age was 63 years, and the median time from first recurrence to on-study was 19 months. Approximately half the patients already had chemotherapy, and about 90% had hormone therapy for advanced disease. The most common side effects were skin rash, weight gain, hyperglycemia, and renal and neurologic problems. No life-threatening or lethal toxicities were reported. The overall response rate (complete or partial) among the fully eligible patients was 34% (90% confidence intervals from 20% to 51%), with a 5- month median duration of response. Patients with soft tissue, visceral, and osseous disease responded. Seventy-two percent of fully eligible patients have progressed or relapsed. The median time to failure of treatment was 6 months, and the median survival time was 15 months.
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