A clinical trial in the management of operable cancer of the breast.

The results of a randomized controlled clinical trial in the management of operable breast cancer are given. Between 1964 and 1971 498 women, aged 35-69 years, were treated within the trial protocol. Those under 60 years of age on entry underwent ovarian ablation, usually by surgery, and were allocated randomly to treatment by either radical mastectomy (RM) or simple mastectomy and postoperative radiotherapy (SM). Follow-up data for the first 12 years are presented and show that survival in the radical mastectomy group is significantly better (P less than 0.05), particularly in clinical stage 1 disease. The pattern of survival once recurrence was detected also showed interesting differences between the two treatment groups. Overall there was a significantly prolonged survival after detection of recurrence in the RM group (P less than 0.05) which was most marked when local recurrence and distant metastases coincided (P less than 0.01). The duration of survival once recurrence had taken place was independent of tumour size, clinical stage of the disease or menstrual status at the time of presentation, but was directly proportional to the duration of the disease-free inerval (P less than 0.01).