Phase II study of low dose aminoglutethimide 250 mg/day plus hydrocortisone in advanced postmenopausal breast cancer

Low dose aminoglutethimide 125 mg twice daily plus hydrocortisone 20 mg twice daily was shown to produce oestrogen and androgen suppression in postmenopausal women. A phase II study was carried out in 101 patients with advanced postmenopausal breast cancer. Objective response rates were 4% CR and 21% PR. Fourteen per cent had disease stabilization for more than 6 months (SD). Soft tissue sites showed the best response. Responses occurred in previous tamoxifen failures (28%) including SD. Toxicity was less than reported for higher dose regimens or low dose aminoglutethimide without hydrocortisone, particularly nausea and drowsiness. Survival from first relapse and start of therapy was not significantly different between PR and SD. This dosage regimen appears of comparable efficacy to previously reported higher dosage regimens with reduced toxicity compared to low dose regimens without hydrocortisone.