A dose‐response evaluation of androgens in the treatment of metastatic breast cancer

Abstract

A comparative double‐blind clinical trial of two androgens, one at two dose levels the other at three dose levels, in the treatment of metastatic breast cancer, was conducted by 10 members of the Cooperative Breast Cancer Group. The two androgens studied were dromostanolone propionate at 100 mg and 200 mg three times weekly and 7α‐methyl‐19‐nortestosterone acetate at 10 mg, 33 mg, and 100 mg weekly. The latter compound is a much more potent androgen and the hypothesis to be tested was whether or not a much more potent an androgen could induce a greater incidence of regressions. The rates of regression observed in this study were as follows: dromostanolone propionate at 100 mg, 22%, at 200 mg, 16% (the p value for the difference is 0.325); 7α‐methyl 19‐nortestosterone acetate at 10 mg, 15%, at 33 mg, 22%, and at 100 mg, 28% (the difference between the lowest and highest dose‐response rates being 0.05%). This study suggests that at least a log dose increase of a potent androgen is required to obtain an increased objective remission rate, whereas a one tenth of a log dose increase of a weaker androgen is not associated with an increased response rate. Abnormalities occurring during therapy with 7α‐methyl‐19‐ndrtestosterone acetate, whether drug‐and/ or disease‐related, decreased with increasing doses. The reason for this is not clear. No difference in total survival was observed between any of the treatment groups, but patients who had regressions had longer median survival than those who were classified as failures to therapy. Copyright © 1973 American Cancer Society