8-YEAR RESULTS OF A PROSPECTIVE NONRANDOMIZED STUDY ON THERAPY OF SMALL BREAST-CANCER

In this report, the results of the first controlled clinical trial on breast cancer in Germany, begun in 1983, are presented after a median follow-up of 8 years. Four-year results have been previously published . In pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with tumorectomy plus radiotherapy to the remaining br east tissue. The study design, originally planned as a comprehensive c ohort study including randomised and non-randomised patients, had to b e changed into a prospective observation study due to the low randomis ation rate. 1036 out of 1119 recruited patients were evaluable. After a median follow-up of 97 months, 237 events (local recurrence, regiona l recurrence, distant metastases, contralateral breast cancer or death of the patient without previous recurrence) occurred. With the except ion of death without recurrence, the events were evenly distributed am ong the two treatment groups. The 8-year local recurrence rate of the whole patient population is 8.8%. Out of all prognostic factors examin ed, only tumour size and grade had a significant influence on recurren t disease. Event-free survival decreased in cases with 'uncertain' tum our margins, whereas the width of the margin has no influence on disea se recurrence. Based on 151 deaths observed so far, there was no signi ficant difference in overall survival between the two treatment groups . The 8-year results of this study are in accordance with the 4-year r esults reported previously and with those of other breast-conserving t reatment trials. There was no significant difference between the two t reatment groups with regard to event-free and overall survival. Incomp lete tumorectomy had a negative influence on recurrence. (C) 1998 Else vier Science Ltd. All rights reserved.