Background In women with breast cancer, the role of radicalmastectomy, as compared with less extensive surgery, has beena matter of debate. We report 25-year findings of a randomizedtrial initiated in 1971 to determine whether less extensivesurgery with or without radiation therapy was as effective asthe Halsted radical mastectomy.
Methods A total of 1079 women with clinically negative axillarynodes underwent radical mastectomy, total mastectomy withoutaxillary dissection but with postoperative irradiation, or totalmastectomy plus axillary dissection only if their nodes becamepositive. A total of 586 women with clinically positive axillarynodes either underwent radical mastectomy or underwent totalmastectomy without axillary dissection but with postoperativeirradiation. Kaplan–Meier and cumulative-incidence estimatesof outcome were obtained.
Results No significant differences were observed among the threegroups of women with negative nodes or between the two groupsof 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 hazardratio for death among those who were treated with total mastectomyand radiation as compared with those who underwent radical mastectomywas 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 mastectomywithout radiation as compared with those who underwent radicalmastectomy was 1.03 (95 percent confidence interval, 0.87 to1.23; P=0.72). Among women with positive nodes, the hazard ratiofor death among those who underwent total mastectomy and radiationas compared with those who underwent radical mastectomy was1.06 (95 percent confidence interval, 0.89 to 1.27; P=0.49).
Conclusions The findings validate earlier results showing noadvantage from radical mastectomy. Although differences of afew percentage points cannot be excluded, the findings failto show a significant survival advantage from removing occultpositive nodes at the time of initial surgery or from radiationtherapy.
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.
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.
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