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Patients were treated with lumpectomy, an operation that involved removal of enough normal breast tissue to ensure that the margins of the resected specimen were free of tumor. In 1973, we began to design a second randomized trial, B-06, to evaluate the efficacy of breast-conserving surgery in women with stage I or II breast tumors that were 4 cm or less in diameter. The 25-year findings from that study 1 showed that there was no significant difference in survival between women treated with the Halsted radical mastectomy and those treated with less extensive surgery.
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In 1971, the National Surgical Adjuvant Breast and Bowel Project (NSABP) initiated the B-04 study, a randomized clinical trial conducted to resolve controversy over the surgical management of breast cancer. Lumpectomy followed by breast irradiation continues to be appropriate therapy for women with breast cancer, provided that the margins of resected specimens are free of tumor and an acceptable cosmetic result can be obtained. This decrease was partially offset by an increase in deaths from other causes.
Radiation therapy was associated with a marginally significant decrease in deaths due to breast cancer.
Among the lumpectomy-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). The hazard ratio for death among the women who underwent lumpectomy followed by breast irradiation, as compared with those who underwent total mastectomy, was 0.97 (95 percent confidence interval, 0.83 to 1.14 P=0.74). The hazard ratio for death among the women who underwent lumpectomy alone, as compared with those who underwent total mastectomy, was 1.05 (95 percent confidence interval, 0.90 to 1.23 P=0.51). 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 cumulative incidence of recurrent tumor in the ipsilateral breast was 14.3 percent in the women who underwent lumpectomy and breast irradiation, as compared with 39.2 percent in the women who underwent lumpectomy without irradiation (P<0.001). Kaplan–Meier and cumulative-incidence estimates of the outcome were obtained. MethodsĪ 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 lumpectomy and breast irradiation. In 1976, we initiated a randomized trial to determine whether lumpectomy with or without radiation therapy was as effective as total mastectomy for the treatment of invasive breast cancer. The most trusted, influential source of new medical knowledge and clinical best practices in the world.
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