• Kevin S Hughes, Lauren A Schnaper, Donald Berry, Constance Cirrincione, Beryl McCormick, Brenda Shank, Judith Wheeler, Lorraine A Champion, Thomas J Smith, Barbara L Smith, Charles Shapiro, Hyman B Muss, Eric Winer, Clifford Hudis, William Wood, David Sugarbaker, I Craig Henderson, Larry Norton, Cancer and Leukemia Group B, Radiation Therapy Oncology Group, and Eastern Cooperative Oncology Group.
• Avon Comprehensive Breast Evaluation Center, Breast/Ovarian Cancer Genetics and Risk Assessment Program, Massachusetts General Hospital, Division of Surgical Oncology, Boston 02114, USA. kshughes@partners.org
• N. Engl. J. Med. 2004 Sep 2; 351 (10): 971-7.

BackgroundIn women 70 years of age or older who have early breast cancer, it is unclear whether lumpectomy plus tamoxifen is as effective as lumpectomy followed by tamoxifen plus radiation therapy.MethodsBetween July 1994 and February 1999, we randomly assigned 636 women who were 70 years of age or older and who had clinical stage I (T1N0M0 according to the tumor-node-metastasis classification), estrogen-receptor-positive breast carcinoma treated by lumpectomy to receive tamoxifen plus radiation therapy (317 women) or tamoxifen alone (319 women). Primary end points were the time to local or regional recurrence, the frequency of mastectomy for recurrence, breast-cancer-specific survival, the time to distant metastasis, and overall survival.ResultsThe only significant difference between the two groups was in the rate of local or regional recurrence at five years (1 percent in the group given tamoxifen plus irradiation and 4 percent in the group given tamoxifen alone, P<0.001). There were no significant differences between the two groups with regard to the rates of mastectomy for local recurrence, distant metastases, or five-year rates of overall survival (87 percent in the group given tamoxifen plus irradiation and 86 percent in the tamoxifen group, P=0.94). Assessment by physicians and patients of cosmetic results and adverse events uniformly rated tamoxifen plus irradiation inferior to tamoxifen alone.ConclusionsLumpectomy plus adjuvant therapy with tamoxifen alone is a realistic choice for the treatment of women 70 years of age or older who have early, estrogen-receptor-positive breast cancer.Copyright 2004 Massachusetts Medical Society

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