Aminoglutethimide in advanced breast cancer: prospective, randomized comparison of two dose levels. Italian...

In a multicenter randomized clinical trial 106 post-menopausal patients with progressive metastatic breast cancer were allocated to receive 500 mg or 1000 mg Aminoglutethimide (AG) per os daily. Cortisone Acetate (CA) replacement dose was 37.5 mg/day orally in both groups. In 91 fully evaluable patients, no statistically significant difference was observed between the two therapeutic regimens, neither in terms of overall response (28 vs 35%) and by site responses, nor in terms of median time to progression (10.5 vs 14.5 months) and median overall survival (20 vs. 22 months). The tolerability was satisfactory in both regimens. Although no statistically significant differences occurred, in the low dose regimen we observed fewer patients with side-effects (25% vs 6%) and induced grade 3 side-effects (4% vs 9%). Our results confirm that AG daily doses of 500 and 1000 mg associated with corticosteroids have a comparable effect. Because of its slight but clinically noticeable better tolerability, the lower dose is the preferable regimen in the treatment of advanced breast cancer.