Estrogen receptor status and adjuvant polychemotherapy or antiestrogen therapy in patients with high-risk breast cancer.

This pilot study includes 115 consecutive patients admitted in the period from 1978 to 1981. Patients eligible for this study were at high risk according to the TNM classification with stages pT1-pT3 and pN+, MO. Primary therapy included modified radical mastectomy and axillary-node clearance, one or more ipsilateral nodes being involved in routine histology. All tumors were assayed for estrogen and progesterone receptors. According to the result of the estrogen receptor assay, estrogen-receptor-positive patients were treated with Tamoxifen 30 mg/day for a period of 2 years. Estrogen-receptor-negative patients were treated with cytoxan, methotrexate, and 5-fluorouracil or adriblastin, cytoxan. After a median observation time of 36 months, overall there have been 31 recurrences: 9 = 17.3% in the estrogen-receptor-positive group and 22 = 34.9% in the estrogen-receptor-negative group. The analysis of different subgroups showed no significant differences, either in relation to axillary lymph-node status or in relation to menopausal status in the endocrine-treated compared with the polychemotherapy group. This result suggests, especially in the subgroup of patients with involvement of one to three axillary nodes, that estrogen-receptor-positive and estrogen-receptor-negative patients should be considered as separate groups when adjuvant therapy is indicated. Possibly hormone-receptor-positive patients may benefit from endocrine therapy and do not need polychemotherapy.