4-hydroxyandrostenedione – further clinical and extended endocrine observations

Abstract

4-Hydroxyandrostenedione (4-OHA) was administered (250 mg intramuscularly 2-weekly) in a phase 2 clinical trial to 20 postmenopausal patients with advanced breast cancer, who had failed other endocrine therapy. Seven out of 18 assessable patients (39%) responded with minimal toxicity. Endocrine studies demonstrated that the drug produced significant initial falls in oestradiol and oestrone levels, but that these levels rose toward pretreatment levels as the study progressed. Sex hormone binding globulin (SHBG) levels gradually fell during the study suggesting that the drug has a minor degree of androgenic activity albeit of no clinical significance. There was a transient reduction of adrenal steroid levels, which remained however within the normal range. There were no symptoms of adrenal insufficiency.