BACKGROUND: Between 1979-1987, the National @entity5 Institute conducted a randomized, prospective study of mastectomy (MT) versus breast conservation therapy (BCT) in the treatment of @entity1 with @entity0 . After a median potential follow-up of 18.4 years, the authors present the updated results. METHODS: After informed consent was obtained from each @entity1 , 237 evaluable @entity1 with clinical AJCC Stage I and @entity0 were enrolled on an institutionally reviewed protocol and randomly assigned to undergo modified radical MT (116 @entity1 ) or BCT (121 @entity1 ), which was comprised of lumpectomy, axillary lymph node dissection, and radiation therapy. Negative surgical margins in the lumpectomy arm were not required. The 237 randomized @entity1 were followed for a median potential follow-up of 18.4 years. The primary endpoints were overall survival and disease-free survival. RESULTS: At a median follow-up of 18.4 years, there was no detectable difference with regard to overall survival between @entity1 treated with MT and those treated with BCT (58% vs. 54%; P = 0.67 overall). Twenty-seven @entity1 in the BCT arm (22%) experienced an in-breast event. After censoring in-breast events in the BCT arm that were salvaged successfully by MT, disease-free survival also was found to be statistically similar (67% in the MT arm vs. 63% in the BCT arm; P = 0.64 overall). There was no statistically significant difference with regard to @entity0 between the two treatment arms (P = 0.70). CONCLUSIONS: After nearly 20 years of follow-up, there was no detectable difference in overall survival or disease-free survival in @entity1 with @entity0 who were treated with MT compared with those treated with BCT. For BCT @entity1 , long-term in-breast failures continued to occur throughout the duration of follow-up. There was no statistically significant difference in the incidence of @entity0 between the two treatment groups.

Eighteen-year results in the treatment of early @entity0 with mastectomy versus breast conservation therapy: the National XXXX Institute Randomized Trial.

@entity5 :: ('MESH:D009369', 'Disease') :: ['Cancer'] @entity1 :: ('9606', 'Species') :: ['women', 'patients', 'patient'] @entity0 :: ('MESH:D001943', 'Disease') :: ['early-stage breast carcinoma', 'Stage II breast carcinoma', 'contralateral breast carcinoma']
@entity5 :: (MESH:D009369,Disease) :: ['Cancer']
