MULTICENTER CROSS-OVER STUDY OF AMINOGLUTETHIMIDE AND TRILOSTANE IN ADVANCED POSTMENOPAUSAL BREAST-CANCER

Trilostane and Aminoglutethimide, each given with a physiological repl acement dose of hydrocortisone, were randomly allocated to 72 eligible postmenopausal advanced breast cancer patients; following treatment f ailure on either drug the patient continued with the other drug, if in a suitable clinical condition. Thirty-eight patients initially receiv ed Trilostane of whom 19 subsequently received Aminoglutethimide; 34 p atients initially had Aminoglutethimide and seven of these then receiv ed Trilostane. Both groups of patients were comparable in all respects . There was no difference in the objective response rate to either dru g, Trilostane 11/38 = 29%, Aminoglutethemide 12/34 = 35%, nor in the a verage time to disease progression for the two drugs, Trilostane 64 we eks, Aminoglutethemide 68 weeks. Of the 26 patients who received both drugs, four showed a response to both suggesting no cross resistance. Side effects were seen to both drugs in approximately half of the pati ents, but were mainly gastro-intestinal with Trilostane and rash and d rowsiness with Aminoglutethimide. There was no evidence of cross over patient susceptibility to side effects.