[11] Lumpectomy plus tamoxifen with or without irradiation in women 70 years of age or older with early breast cancer: a report of further follow-up.

Hughes KS, Schnaper LA, Berry D, Hodgson L, Cirrincione C, McCormick B, Shank B, Champion LA, Smith TJ, Smith BL, Shapiro C, Muss HB, Winer E, Hudis C, Wood W, Henderson IC, Sugarbaker D, Norton L.. Massachusetts General Hospital, Boston, MA; Greater Baltimore Medical Center, Balimore, MD; Cancer and Leukemia Group B Statistical Center, Durham, NC; Memorial Sloan-Kettering Cancer Center, New York, NY; Mount Sinai School of Medicine, New York, NY; Sutter Health, Alta Bates Comprehensive Cancer Center, Berkeley, CA; Morristown Memorial Hospital, Morristown, NJ; Ohio State University, Columbus, OH; Vermont Cancer Center, University of Vermont, Burlington, VT; Dana Farber Partners Cancer Center, Boston, MA; Emory University School of Medicine, Atlanta, GA; University of California at San Francisco, San Francisco, CA; CALGB; RTOG; ECOG

Background: In women 70 and older with clinical stage I breast cancer undergoing lumpectomy, tamoxifen (Tam) may be as effective as tamoxifen plus radiation (TamRT). In 2004, we reported the results with a median follow-up (FU) of 5 years. Here we update the results at a median FU of 7.9 years.
Materials and methods: Between July 1994 and February 1999, we randomly assigned 636 women 70 and older with clinical stage I, estrogen-receptor-positive (ER+) breast cancer treated by lumpectomy to TamRT (317 women) or Tam (319 women). Primary end points were time to locoregional recurrence, frequency of mastectomy for recurrence, breast-cancer-specific mortality, time to distant metastasis, and all-cause mortality.
Results: The only significant difference between the two groups was in the incidence of locoregional recurrence, 3 (1%) TamRT and 23 (7%) Tam, p<0.001). (breast recurrence 3 (1%) TamRT and 20 (6.3%)Tam. Axillary recurrence 0 in TamRT and 4 (1.2%) Tam [1 patient in Tam had breast and axillary recurrence]). The incidence of mastectomy [3 (1%) TamRT, 9 (3%) Tam, p=0.07] did not reach statistical significance. There was no significant difference with regard to distant metastases [9 (3%) TamRT, 11 (3%) Tam, p=0.59]. Breast cancer specific mortality was low [5 (2%) TamRT, 5 (2%) Tam, p=0.92], while all-cause mortality was quite high [86 (27%) TamRT, 82 (26%) Tam, p=0.841. Assessment of cosmetic results and adverse events uniformly rated TamRT inferior to Tam.
Discussion: While radiation produces a 5.3% decrease in breast recurrence in this population, it does not impact ultimate breast conservation, distant metastases or death from other causes. Over 26% of patients have died, of whom only approximately 6% died of breast cancer. Tamoxifen without radiation is a reasonable option for women 70 and older with T1N0 estrogen receptor positive breast cancer.

Thursday, December 14, 2006 3:15 PM

General Session 2 (2:00 PM-3:30 PM)