Twenty-Five-Year Follow-up of a Randomized Trial Comparing Radical Mastectomy, Total Mastectomy, and Total Mastectomy Followed by Irradiation

Abstract

Background In 1976, we initiated a randomized tri- al to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. Methods A total of 1851 women for whom follow- up data were available and nodal status was known underwent randomly assigned treatment consisting of total mastectomy, lumpectomy alone, or lumpec- tomy and breast irradiation. Kaplan–Meier and cumu- lative-incidence estimates of the outcome were ob- tained. Results The cumulative incidence of recurrent tu- mor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast ir- radiation, as compared with 39.2 percent in the wom- en who underwent lumpectomy without irradiation (P<0.001). No significant differences were observed among the three groups of women with respect to disease-free survival, distant-disease–free survival, or overall survival. The hazard ratio for death among the women who underwent lumpectomy alone, as compared with those who underwent total mastecto- my, was 1.05 (95 percent confidence interval, 0.90 to 1.23; P=0.51). The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation, as compared with those who un- derwent total mastectomy, was 0.97 (95 percent con- fidence interval, 0.83 to 1.14; P=0.74). Among the lum- pectomy-treated women whose surgical specimens had tumor-free margins, the hazard ratio for death among the women who underwent postoperative breast irradiation, as compared with those who did not, was 0.91 (95 percent confidence interval, 0.77 to 1.06; P=0.23). Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer. This decrease was partially offset by an increase in deaths from other causes. Conclusions Lumpectomy followed by breast irra- diation continues to be appropriate therapy for wom- en with breast cancer, provided that the margins of resected specimens are free of tumor and an accept- able cosmetic result can be obtained. (N Engl J Med 2002;347:1233-41.)