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ABSTRACT: Twenty-Year Follow-up of a Randomized Trial Comparing
Total Mastectomy, Lumpectomy, and Lumpectomy plus Irradiation
for the Treatment of Invasive Breast Cancer
Background: 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.
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 lumpectomy
and breast irradiation. Kaplan-Meier and cumulative-incidence
estimates of the outcome were obtained.
Results: 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).
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 mastectomy, 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 underwent total mastectomy, was 0.97
(95 percent confidence interval, 0.83 to 1.14; P=0.74). 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).
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 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.
[10/17/2002; New England Journal of Medicine]
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