Aminoglutethimide in the treatment of advanced postmenopausal breast cancer.

A group of 213 unselected postmenopausal women with advanced breast cancer were treated with aminoglutethimide, 250 mg 4 times a day, and hydrocortisone, 20 mg 2 times a day. Follow-up is 10 months to 4 years from the start of treatment. In 190 assessable patients, there were 6 complete responses (CR), 47 partial responses (PR), 25 stable disease (SD), and 3 mixed responses. Overall objective response rate was 28% and with SD was 41%. Median duration of objective response was 14 months. Objective response by site was: soft tissue, 31%; nodes, 27%; bone 23: liver, 22%; and lung, 16%. A further 32% of patients with bone deposits had SD, and 19 of 60 patients with progressive disease had pain relief. Years after menopause, age and tumor-free interval did not affect response rates. Thirty-eight % of patients responding to previous endocrine therapy responded to aminoglutethimide compared with 19% of patients who had progressed on previous endocrine therapy. A group of 213 patients were assessable for toxicity. Main side effects were drowsiness (33%), rash (23%), and nausea (15%). Eleven patients stopped treatment because of toxicity. Median survival from start of treatment was 28 months for PR-CR and for SD and 10 months for progressive disease (p less than 0.001). Median survival from first metastasis was 43 months for PR-CR, 40 months for SD (not significantly different), and 22 months for progressive disease (p less than 0.001). Aminoglutethimide is an effective endocrine therapy in advanced postmenopausal breast cancer, particularly for bone deposits. Disease stabilization is associated with symptomatic and survival benefit similar to CR-PR.