Abstract

In a phase II clinical trial, 38 postmenopausal women with advanced breast cancer were treated with aminoglutethimide and replacement hydrocortisone. All women had previously received up to 4 modalities of endocrine therapy. Seventeen patients had also been treated with cytostatic drugs. Twenty-five percent of the 29 evaluable patients experienced objective tumor regression, lasting from 11 to more than 18 months. In 29% the disease was stabilized for 3 to more than 15 months. Toxicity was significant, necessitating drug withdrawal in 3 patients. One patient died within 3 weeks of therapy from multiple perforated gastric ulcers. Two patients developed herpes zoster within 4 weeks of treatment. Many side effects were minor and transient. However, treatment resulted in overt primary hypothyroidism in 25% of the evaluable patients and in a strongly increased need of acenocoumarin in all 3 patients on anticoagulant therapy.

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