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.