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.

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Three prospectively planned and controlled cooperative clinical studies in the use of combination drug therapy for metastatic breast cancer are reported. Each study contained two drug regimen arms. A total of 326 evaluable patients was treated with one of the five various drug combinations employed. As the number of drugs used in each regimen was increased from two to five, a concommitant increase in remission rates from 50% to 75% was observed. Remission duration of approximately 8 months and survival from the onset of treatment, however, remained relatively constant at 13 to 16 months in all drug regimens. Patients achieving tumor remission survived an average of three times longer than those with progressive disease under therapy. The results are correlated to patient age and predominant metastatic type. Subjective improvement was definitely related to objective tumor regression or stabilization. Treatment was relatively well tolerated and well applicable to outpatient care. Dosage adjustments were often necessary during the initial phases of therapy. Combined cystostatic drug therapy is highly effective in the prognostically worst forms of metastatic breast cancer, and is the treatment of choice for younger patients with visceral type metastases.Comer 36:120&1219, 1975. REAST CANCER IS THE MOST COMMON MALIC-B nancy in women. It develops in approximately every 20th woman and is unique in its markedly variable course. Metastases frequently first appear 5 to 10 years after the initial diagnosis and treatment.2JJ Considering the number of primarily inoperable cases, as well as the number of relapses occurring beyond the commonly used 5-year observation

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