Randomised trial of chemo-endocrine therapy, endocrine therapy, and mastectomy alone in postmenopausal patients with operable breast cancer and axillary node metastasis.

Adjuvant therapy after total mastectomy and axillary clearance in postmenopausal women with breast cancer and axillary node metastasis was assessed; chemo-endocrine therapy (cyclophosphamide, methotrexate, fluorouracil, prednisone, and tamoxifen; CMFp + T) was compared with endocrine therapy (prednisone and tamoxifen; p + T), and with no adjuvant treatment in 463 patients aged less than or equal to 65 years. Endocrine therapy was compared with no adjuvant therapy in 320 patients aged 66-80 years. At median follow-up of 36 months, disease-free survival was significantly longer in CMFp + T patients than in p + T or control patients; p + T also significantly increased disease-free survival. There were no significant differences in overall survival between the randomised groups. In analyses of patterns of first failure, chemo-endocrine therapy reduced local, regional, and distant relapses, whereas endocrine therapy reduced local and regional recurrences only.