[A controlled clinical trial on adjuvant therapy by preoperative irradiation or postoperative cyclophosphamide in breast cancer (author's transl)].

A randomized clinical trial on adjuvant treatment of operable breast cancer in female aged between 35 and 70 years was performed from 1962 to 1972. Criteria for admission into the trial were: unequivocal clinical evidence of breast cancer stage T1-3 NC-3; no general or technical contraindications against standard radical mastectomy type Rotter-Halsted; no contraindications against radiation or cytostatic treatment: 435 patients entered the trial and 372 patients were evaluable. Of these 126 were treated by surgery, 126 by surgery followed by cyclophosphamide (100 mg/kg BW in daily intravenous doses of 200 mg), and 120 by preoperative radiation therapy (about 5500 rad tumour dose by telecobalt) and surgery. The crude 5-year survival rate was 58.7 percent, 57.1 percent, and 57.5 percent respectively. The number of local recurrences and local node metastases was 29.4% after surgery, 23.0% after surgery combined with chemotherapy, and 12,5% after surgery combined with preoperative radiation therapy. This significant reduction in locoregional recurrences was most impressive in the supraclavicular node region. In the irradiated group, the mean diameter of tumours in the surgical specimen was obviously smaller and in 11 cases the tumour in the breast was completely destroyed.