Lumpectomy plus Tamoxifen with or without Irradiation in Women 70 Years of Age or Older with Early Breast Cancer
Kevin S. Hughes, M.D., Lauren A. Schnaper, M.D., Donald Berry, Ph.D., Constance Cirrincione, M.S., Beryl McCormick, M.D., Brenda Shank, M.D., Ph.D., Judith Wheeler, B.A., Lorraine A. Champion, M.B., Ch.B., Thomas J. Smith, M.D., Barbara L. Smith, M.D., Ph.D., Charles Shapiro, M.D., Hyman B. Muss, M.D., Eric Winer, M.D., Clifford Hudis, M.D., William Wood, M.D., David Sugarbaker, M.D., I. Craig Henderson, M.D., Larry Norton, M.D., for the Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and Eastern Cooperative Oncology Group
Background In women 70 years of age or older who have earlybreast cancer, it is unclear whether lumpectomy plus tamoxifenis as effective as lumpectomy followed by tamoxifen plus radiationtherapy.
Methods Between July 1994 and February 1999, we randomly assigned636 women who were 70 years of age or older and who had clinicalstage I (T1N0M0 according to the tumor–node–metastasisclassification), estrogen-receptor–positive breast carcinomatreated by lumpectomy to receive tamoxifen plus radiation therapy(317 women) or tamoxifen alone (319 women). Primary end pointswere the time to local or regional recurrence, the frequencyof mastectomy for recurrence, breast-cancer–specific survival,the time to distant metastasis, and overall survival.
Results The only significant difference between the two groupswas in the rate of local or regional recurrence at five years(1 percent in the group given tamoxifen plus irradiation and4 percent in the group given tamoxifen alone, P<0.001). Therewere no significant differences between the two groups withregard to the rates of mastectomy for local recurrence, distantmetastases, or five-year rates of overall survival (87 percentin the group given tamoxifen plus irradiation and 86 percentin the tamoxifen group, P=0.94). Assessment by physicians andpatients of cosmetic results and adverse events uniformly ratedtamoxifen plus irradiation inferior to tamoxifen alone.
Conclusions Lumpectomy plus adjuvant therapy with tamoxifenalone is a realistic choice for the treatment of women 70 yearsof age or older who have early, estrogen-receptor–positivebreast cancer.
Source Information
From Massachusetts General Hospital, Boston (K.S.H., B.L.S.); Greater Baltimore Medical Center, Baltimore (L.A.S.); Cancer and Leukemia Group B Statistical Center, Durham, N.C. (D.B., C.C., J.W.); Memorial Sloan-Kettering Cancer Center, New York (B.M., C.H., L.N.); Mount Sinai School of Medicine, New York (B.S.); Sutter Health, Alta Bates Comprehensive Cancer Center, Berkeley, Calif. (L.A.C.); Morristown Memorial Hospital, Morristown, N.J. (T.J.S.); Ohio State University, Columbus (C.S.); Vermont Cancer Center, University of Vermont, Burlington (H.B.M.); Dana–Farber Partners Cancer Center, Boston (E.W., D.S.); Emory University School of Medicine, Atlanta (W.W.); and the University of California at San Francisco, Mountain View, Calif. (I.C.H.).
Address reprint requests to Dr. Hughes at the Avon Comprehensive Breast Evaluation Center, Breast/Ovarian Cancer Genetics and Risk Assessment Program, Massachusetts General Hospital, Division of Surgical Oncology, 100 Blossom St., Cox 626, Boston, MA 02114, or at kshughes{at}partners.org.
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