Twenty-Year Follow-up of a Randomized Trial Comparing Total Mastectomy, Lumpectomy, and Lumpectomy plus Irradiation for the Treatment of Invasive Breast Cancer
Bernard Fisher, M.D., Stewart Anderson, Ph.D., John Bryant, Ph.D., Richard G. Margolese, M.D., Melvin Deutsch, M.D., Edwin R. Fisher, M.D., Jong-Hyeon Jeong, Ph.D., and Norman Wolmark, M.D.
Background In 1976, we initiated a randomized trial to determinewhether lumpectomy with or without radiation therapy was aseffective as total mastectomy for the treatment of invasivebreast cancer.
Methods A total of 1851 women for whom follow-up data were availableand nodal status was known underwent randomly assigned treatmentconsisting of total mastectomy, lumpectomy alone, or lumpectomyand breast irradiation. KaplanMeier and cumulative-incidenceestimates of the outcome were obtained.
Results The cumulative incidence of recurrent tumor in the ipsilateralbreast was 14.3 percent in the women who underwent lumpectomyand breast irradiation, as compared with 39.2 percent in thewomen who underwent lumpectomy without irradiation (P<0.001).No significant differences were observed among the three groupsof women with respect to disease-free survival, distant-diseasefreesurvival, or overall survival. The hazard ratio for death amongthe women who underwent lumpectomy alone, as compared with thosewho underwent total mastectomy, was 1.05 (95 percent confidenceinterval, 0.90 to 1.23; P=0.51). The hazard ratio for deathamong the women who underwent lumpectomy followed by breastirradiation, 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 specimenshad tumor-free margins, the hazard ratio for death among thewomen who underwent postoperative breast irradiation, as comparedwith those who did not, was 0.91 (95 percent confidence interval,0.77 to 1.06; P=0.23). Radiation therapy was associated witha marginally significant decrease in deaths due to breast cancer.This decrease was partially offset by an increase in deathsfrom other causes.
Conclusions Lumpectomy followed by breast irradiation continuesto be appropriate therapy for women with breast cancer, providedthat the margins of resected specimens are free of tumor andan acceptable cosmetic result can be obtained.
Source Information
From the National Surgical Adjuvant Breast and Bowel Project (B.F., S.A., J.B., R.G.M., M.D., E.R.F., J.-H.J., N.W.) and the University of Pittsburgh (B.F., S.A., J.B., M.D., J.-H.J.) both in Pittsburgh.
Address reprint requests to Dr. Fisher at the NSABP, 4 Allegheny Ctr., Suite 602, Pittsburgh, PA 15212-5234, or at bernard.fisher{at}nsabp.org.
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