Tamoxifen with or without Breast Irradiation in Women 50 Years of Age or Older with Early Breast Cancer
Anthony W. Fyles, M.D., David R. McCready, M.D., Lee A. Manchul, M.D., Maureen E. Trudeau, M.D., Patricia Merante, R.N., Melania Pintilie, M.Sc., Lorna M. Weir, M.D., and Ivo A. Olivotto, M.D.
Background We determined the effect of breast irradiation plustamoxifen on disease-free survival and local relapse in women50 years of age or older who had T1 or T2 node-negative breastcancer.
Methods Between December 1992 and June 2000, 769 women withearly breast cancer (tumor diameter, 5 cm or less) were randomlyassigned to receive breast irradiation plus tamoxifen (386 women)or tamoxifen alone (383 women). The median follow-up was 5.6years.
Results The rate of local relapse at five years was 7.7 percentin the tamoxifen group and 0.6 percent in the group given tamoxifenplus irradiation (hazard ratio, 8.3; 95 percent confidence interval,3.3 to 21.2; P<0.001), with corresponding five-year disease-freesurvival rates of 84 percent and 91 percent (P=0.004). A plannedsubgroup analysis of 611 women with T1, receptor-positive tumorsindicated a benefit from radiotherapy (five-year rates of localrelapse, 0.4 percent with tamoxifen plus radiotherapy and 5.9percent with tamoxifen alone; P<0.001). Overall, there wasa significant difference in the rate of axillary relapse atfive years (2.5 percent in the tamoxifen group and 0.5 percentin the group given tamoxifen plus irradiation, P=0.049), butno significant difference in the rates of distant relapse oroverall survival.
Conclusions As compared with tamoxifen alone, radiotherapy plustamoxifen significantly reduces the risk of breast and axillaryrecurrence after lumpectomy in women with small, node-negative,hormone-receptor–positive breast cancers.
Source Information
From Princess Margaret Hospital (A.W.F., D.R.M., L.A.M., P.M., M.P.) and Sunnybrook and Women's College Health Sciences Centre (M.E.T.), University of Toronto, Toronto; and the British Columbia Cancer Agency, Vancouver (L.M.W.) and Victoria (I.A.O.) — all in Canada.
Address reprint requests to Dr. Fyles at the Department of Radiation Oncology, Princess Margaret Hospital, 610 University Ave., Toronto, ON M5G 2M9, Canada, or at anthony.fyles{at}rmp.uhn.on.ca.
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