A prospective randomized dose response evaluation of Delta-l-testololactone (NSC 23759) in women with advanced breast cancer was done according to the protocol of the Cooperative Breast Cancer Group. The results showed a significant difference in the remission rates between the lowest and the two higher dose levels: 200 mg, 5Jll8 (4.2%); LOO0 mg, 18/123 (14.6%); and 2000 mg, 15/121 (12.4%). The incidence of severe side effects was lowest with the 1000 mg dose. Responders had a mean duration of disease that was significantly longer than the corresponding mean for failures, and lived significantly longer than failures. Delta-l-testololactone is effective for the palliative primary treatment of women with advanced breast cancer. It has the unique advantage of having no significant metabolic, masculinizing, or feminizing hormonal activity. If the metastases are visceral and a patient fails to respond favorably to the 1000 mg dosage, an increase to 2000 mg per day should be considered.ELTA-1 -TESTOLOLACTONE (1 7 A-OXA-D-HOMO-D 1,4-androstadiene-3, 17-dione; Teslafl: NSC 23759), Fig. 1, an hormonally inactive testosterone derivative, has been used in several dosages for the treatment of women with advanced breast cancer for over a decade. This
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