Hormonal treatment of disseminated cancer of the female breast.

1. The University of California Medical Center at San Francisco is participating in a nationwide cooperative study attempting to improve hormonal therapy of disseminated breast cancer. A prospective protocol is followed in which the antitumor efficacy of an investigational compound is compared with that of a reference standard of known efficacy. Known variables (menopausal age and site of most significant metastasis) are randomized to distribute similar patients into experimental and control groups. Assignment of the therapeutic agent is made at random to avoid bias, and where feasible, neither patient nor investigator knows which compound is given.2. Primary hormonal therapy of objectively progressing disseminated breast cancer yields objective regressions in approximately 22 percent of patients treated with any of the following: testosterone propionate, 2-alpha methyldihydrotestosterone propionate (a derivative which produces less virilization) and oral diethylstilbestrol. The average duration of regression is 10 months.3. After primary hormonal therapy has ceased to be effective, secondary hormonal therapy produces fewer than 12 per cent objective regressions when conventional estrogens, androgens, corticoids, or surgical hypophysectomy are employed. The rate rises to 19-26 per cent if corticoids are combined with triiodothyronine, or if the less virilizing androgen, 2-alpha methyldihydrotestosterone propionate is used instead of other androgens. Surprisingly, hydrocortisone 30 mg. plus triiodothyronine 50 micrograms-an innocuous combination-proved as effective as doses producing Cushing's phenomena.