Long-term follow-up of a randomized trial on adjuvant chemotherapy and hormonal therapy in locally advanced breast cancer.

Abstract

To study the effects on survival, disease-free survival, and locoregional control of adjuvant hormonal and chemotherapy in patients with locally advanced breast cancer after a minimal follow-up period of 14 years. A total of 118 patients were randomized between radiotherapy alone (arm I); radiotherapy, 12 courses of cyclophosphamide, methotrexate, and 5-fluorouracil (CMF), and tamoxifen (arm II); adriamycine, vincristine (AV) alternated with CMF, then radiotherapy, followed by four cycles of chemotherapy (AV/CMF); and tamoxifen during the entire treatment period (arm III). No improvement in survival, disease-free survival, or locoregional control was observed. After 6 years of follow-up, the overall survival curves grew apart, resulting in differences in 10-year survival rates: 15% (confidence interval-3%, 33%) between arms III and I. Owing to the relatively small numbers of patients involved, the relative value of the three treatment modalities cannot be established completely.