Adjuvant therapy for operable breast cancer with medroxyprogesterone acetate alone in postmenopausal patients or in combination with CMF in premenopausal patients.

The present paper concerns two multicenter studies on adjuvant therapy with medroxyprogesterone acetate (MAP) for operable N+ breast cancer. The patients entered the study between April 1979 and March 1986. One hundred and fifty-one premenopausal patients were randomly assigned to receive either polychemotherapy (CMF) or CMF + MAP. One hundred and thirty-eight postmenopausal patients were randomized to receive either MAP h.d. or no treatment. CMF was administered according the following schedule: cyclophosphamide mg 100/ms p.o. 1-4 days; methotrexate mg 40/ms i.v. and fluorouracil mg 600/ms i.v. 1st and 8th days. The cycle was repeated six times every 28 days. MAP was administered at 1000 mg X 2/daily p.o. for 30 days and afterwards 500 mg X 2/daily for 5 months. In the premenopausal study after a median follow-up of 36 months no difference was observed in the incidence of recurrence, site of recurrence, actuarial 5-year disease-free survival (DFS) or overall survival (OS). In the postmenopausal study a statistically significant lower number of recurrences was observed in MAP-treatment patients after a median follow-up of 37 months. The effect of MAP was limited to patients with less than or equal to 3 metastatic axillary lymph nodes. In addition, there are suggestions that only patients with ER+ tumors draw some advantage from the treatment. On the other hand, no difference exists in the OS. The treatments were substantially well tolerated. The MAP + CMF regimen induces lower vomiting compared to the CMF alone. The most frequent MAP side-effects were vaginal spotting (16%) and tremors (12%). We conclude that MAP h.d., like tamoxifen and aminoglutethimide, can improve the DFS of operable N+ breast cancer in postmenopausal patients.

RCT Entities:   Population Interventions Outcomes