Aminoglutethimide without hydrocortisone in the treatment of postmenopausal patients with advanced breast cancer

In a phase II study, 38 evaluable patients with advanced progressive breast cancer were treated with 4 X 250 mg of aminoglutethimide per day without hydrocortisone supplementation. Partial remissions were observed in five patients (13%), with a median duration of 9 months (range, 7-15), and stable disease was observed in 17 patients (45%), with a median duration of 4 months (range, 2-11). The recorded side effects (CNS, cutaneous, gastrointestinal) were tolerable and transient and required drug discontinuation in only four patients. Serial determinations of serum hormone levels during aminoglutethimide treatment revealed a significant decrease in estradiol and an increase in gonadotropins, testosterone, and progesterone. No patients had adrenal insufficiency. In contrast, despite prolonged aminoglutethimide treatment and persisting hypoestrogenemia, both cortisol levels and adrenal responses to ACTH remained unaltered. It is concluded that aminoglutethimide alone is effective in the treatment of postmenopausal patients with breast cancer. Moreover, based on the present findings, a prospective randomized study is warranted to show that hydrocortisone supplementation appears to not be mandatory, either for increase in efficacy or for decrease in side effects of the treatment.