Chemotherapy with or without oophorectomy in high-risk premenopausal patients with operable breast cancer

A prospective randomized trial to assess the impact of adding oophorectomy to adjuvant chemotherapy has been conducted in premenopausal patients with operable breast cancer and with metastases in four or more axillary lymph nodes. Following at least total mastectomy and axillary clearance, 327 evaluable patients were randomized to adjuvant oophorectomy followed by chemotherapy with cyclophosphamide (C), methotrexate (M), 5-fluorouracil (F), and prednisone (p) or to CMFp alone. At 48 months of median follow-up, no statistically significant differences between regimens in terms of disease-free survival or overall survival were demonstrated, even for patients with steroid hormone receptor-containing tumors. A high incidence of amenorrhea (89%) due to ovarian function suppression was observed for the group receiving CMFp alone. Supplementation of the adjuvant therapy regimen by surgical oophorectomy is rendered superfluous by this effect of cytotoxic treatment. The addition of oophorectomy to combination chemotherapy with CMFp cannot be recommended as adjuvant treatment for high-risk (four or more axillary lymph nodes involved) premenopausal patients with operable breast cancer.