THERAPY OF SMALL BREAST-CANCER - 4-YEAR RESULTS OF A PROSPECTIVE NONRANDOMIZED STUDY

Background: In the early 1980s breast preservation was a rarely applie d therapeutic modality in the primary treatment of breast cancer in th e Federal Republic of Germany. Reports coming from retrospective studi es as well as preliminary results from randomized trials made it desir able to introduce breast preservation in the form of a controlled clin ical trial. Study design: In stage pT1 N0 M0 breast cancer, mastectomy as the standard treatment was to be compared with radiotherapy of the remaining breast tissue. The study design originally planned as a ran domized trial had to be changed into a prospective observation study d ue to the low randomization rate. Univariate analysis of prognostic va riables was the first step to a valid treatment comparison. Those fact ors determined as being significant were included together with the tr eatment effects in a multivariate analysis. A high therapeutic standar d was guaranteed by quality control. Results: 1036 out of 1119 recruit ed patients are evaluable. After a median follow-up of 48 months the f ollowing preliminary results can be reported. With the exception of de ath without recurrence from breast cancer, the 143 events are evenly d istributed among the two treatment groups. Locoregional recurrence of the whole patient population was 5 %. Out of all prognostic factors ex amined only tumor size and grading are significant in regard to recurr ent disease. Recurrence-free survival decreased in cases with 'uncerta in' tumor margins, whereas the width of the margin had no influence on recurrent disease. There was no significant difference in quality of life between the two treatment groups. Conclusions: The four-year resu lts of this study are in accordance with those of other breast preserv ation trials: There is no significant difference between the two treat ment groups in the occurrence of locoregional failure. Incomplete tumo rectomy has a negative influence on recurrence. Quality of life seems more dependent on the acceptance of the therapy by the patient than on the therapeutic modality itself. Breast preservation can also be perf ormed appropriately in smaller institutions if the therapeutic standar d is guaranteed by quality control.