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Previous Volume 347:567-575 August 22, 2002 Number 8 Next

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ABSTRACT

Background In women with breast cancer, the role of radical mastectomy, as compared with less extensive surgery, has been a matter of debate. We report 25-year findings of a randomized trial initiated in 1971 to determine whether less extensive surgery with or without radiation therapy was as effective as the Halsted radical mastectomy.

Methods A total of 1079 women with clinically negative axillary nodes underwent radical mastectomy, total mastectomy without axillary dissection but with postoperative irradiation, or total mastectomy plus axillary dissection only if their nodes became positive. A total of 586 women with clinically positive axillary nodes either underwent radical mastectomy or underwent total mastectomy without axillary dissection but with postoperative irradiation. Kaplan–Meier and cumulative-incidence estimates of outcome were obtained.

Results No significant differences were observed among the three groups of women with negative nodes or between the two groups of women with positive nodes with respect to disease-free survival, relapse-free survival, distant-disease–free survival, or overall survival. Among women with negative nodes, the hazard ratio for death among those who were treated with total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.08 (95 percent confidence interval, 0.91 to 1.28; P=0.38), and the hazard ratio for death among those who had total mastectomy without radiation as compared with those who underwent radical mastectomy was 1.03 (95 percent confidence interval, 0.87 to 1.23; P=0.72). Among women with positive nodes, the hazard ratio for death among those who underwent total mastectomy and radiation as compared with those who underwent radical mastectomy was 1.06 (95 percent confidence interval, 0.89 to 1.27; P=0.49).

Conclusions The findings validate earlier results showing no advantage from radical mastectomy. Although differences of a few percentage points cannot be excluded, the findings fail to show a significant survival advantage from removing occult positive nodes at the time of initial surgery or from radiation therapy.

Source Information

From the National Surgical Adjuvant Breast and Bowel Project (B.F., J.-H.J., S.A., J.B., E.R.F., N.W.) and the University of Pittsburgh (B.F., J.-H.J., S.A., J.B.) — both in Pittsburgh.

Address reprint requests to Dr. Bernard Fisher at the NSABP, 4 Allegheny Ctr., Suite 602, Pittsburgh, PA 15212-5234, or at bernard.fisher{at}nsabp.org.

Full Text of this Article

Related Letters:

Radical and Simple Mastectomy
Badwe R. A., Thorat M. A., Havaldar R. W., Komorowski A. L., Wysocki W., Somlo G., Levitt S. H., Fisher B., Anderson S., Bryant J.
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N Engl J Med 2002; 347:2170-2171, Dec 26, 2002. Correspondence

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