In a randomized study sf 213 evaluable patients, a combination of hormone and polychemotherapy was compared with polychemotherapy alone. Three types of hormonal treatment were employed. The choice was dependent upon menopausal status or previous hormonal therapy. Forty-two pre-menopausal women were treated either with oophorectomy plus a modified five-drug "Cooper" combination or with the chemotherapy regimen alone. Oral methotrexate, cyclophosphamide and prednisone for two weeks was alternated with two-week courses of I.V. fluorouracil, vincristine, and oral prednisone. Nineteen patients treated with the combined modality demonstrated a CR + PR in 74%, a minor PR in 16%, and NC + P in 10%. The respective rates in 23 premenopausal women receiving chemotherapy only were 43%, 22%, and 35%. Median time to progression was 9.5 months and median survival was 19.9 months in the combined group vs 7.8 months and 13.2 months, respectively, in the "chemotherapy only" group. Forty-eight post-menopausal patients without previous hormonal therapy were treated with diethylstilbestrol and the same cytostatic therapy as described; 48 patients received chemotherapy alone.
CR + PR in the combined group is 63%, minor PR 21%, NC + P 16%, median remission duration 8.4 months, median survival 26.7 months. The corresponding results in the "chemotherapy only" group are 5496, 25%, and 21%, with 10.6 months median remission duration and 19.2 mooths median survival. Seventy-five post-menopausal patients with previous hormonal therapy, mainly oophorectomy (53 patients), received either chemotherapy plus a progesterone (38 patients) or cytostatic drugs only (37 patients). Results in the combined group are: CR + PR 53%, minor PR 2496, NC + P 23%; median remission duration 8.9 months, median survival 18.1 months; in the "chemotherapy only" group the corresponding figures are: 63%, ll%, 27%; 10.0 months, 22.8 months. These results are further analyzed according to dominant metastatic site, age groups, and intervals from diagnosis to the beginning of protocol therapy.