Eight‐year follow‐up of adjuvant therapy for stage II breast cancer

The 8‐year results of a prospective, randomized, clinical trial of 3 treatment regimens in 311 women with stage II breast cancer are reported. Cyclophosphamide, methotrexate, and 5‐fluorouracil (C) were compared with C plus the anti‐estrogen drug tamoxifen citrate (Nolvadex®) (CT) and CT plus Bacillus Calmette‐Guérin vaccinations (CTBCG) as adjuvant therapy postmastectomy. Estrogen receptors (ER) were measured in all primary tumors. The addition of Nolvadex® to chemotherapy significantly decreased the number of recurrences at 8 years. This decrease in recurrence was more pronounced in estrogen receptor‐positive patients as follows: (a) those with ≥ 4 positive lymph nodes; (b) those with tumor diameters ≥ 3 cm; and (c) postmenopausal women. Addition of Nolvadex® to C had no effect on disease‐free survival in patients with ER‐negative tumors. Immunotherapy with BCG vaccinations had no discernible effect on disease‐free survival. Estrogen receptor measurements in the primary tumor provide important prognostic information regardless of treatment. Estrogen receptor‐positive patients have a lower recurrence rate and lower mortality after 8 years. Both estrogen and progesterone receptor measurements have predictive value for response to endocrine therapy and should be determined in all patients with breast cancer.