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Vogel VG , Costantino JP , Wickerham DL , Cronin WM , Cecchini RS , Atkins JN , Bevers TB , Fehrenbacher L , Pajon ER , Wade JL , Robidoux A , Margolese RG , James J , Runowicz CD , Ganz PA , Reis SE , McCaskill-Stevens W , Ford LG , Jordan VC , Wolmark N , Natl Surgical Adjuvant Breast Bowe
Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing Breast Cancer
Cancer Prevention Research. 2010 Jun;3(6) :696-706
PMID: ISI:000278374900005    PMCID: PMC2935331   
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The selective estrogen-receptor modulator (SERM) tamoxifen became the first U. S. Food and Drug Administration (FDA)-approved agent for reducing breast cancer risk but did not gain wide acceptance for prevention, largely because it increased endometrial cancer and thromboembolic events. The FDA approved the SERM raloxifene for breast cancer risk reduction following its demonstrated effectiveness in preventing invasive breast cancer in the Study of Tamoxifen and Raloxifene (STAR). Raloxifene caused less toxicity (versus tamoxifen), including reduced thromboembolic events and endometrial cancer. In this report, we present an updated analysis with an 81-month median follow-up. STAR women were randomly assigned to receive either tamoxifen (20 mg/d) or raloxifene (60 mg/d) for 5 years. The risk ratio (RR; raloxifene: tamoxifen) for invasive breast cancer was 1.24 (95% confidence interval [CI], 1.05-1.47) and for noninvasive disease, 1.22 (95% CI, 0.95-1.59). Compared with initial results, the RRs widened for invasive and narrowed for noninvasive breast cancer. Toxicity RRs (raloxifene: tamoxifen) were 0.55 (95% CI, 0.36-0.83; P = 0.003) for endometrial cancer (this difference was not significant in the initial results), 0.19 (95% CI, 0.12-0.29) for uterine hyperplasia, and 0.75 (95% CI, 0.60-0.93) for thromboembolic events. There were no significant mortality differences. Long-term raloxifene retained 76% of the effectiveness of tamoxifen in preventing invasive disease and grew closer over time to tamoxifen in preventing noninvasive disease, with far less toxicity (e.g., highly significantly less endometrial cancer). These results have important public health implications and clarify that both raloxifene and tamoxifen are good preventive choices for postmenopausal women with elevated risk for breast cancer. Cancer Prev Res; 3(6); 696-706. (C) 2010 AACR.
Vogel, Victor G. Costantino, Joseph P. Wickerham, D. Lawrence Cronin, Walter M. Cecchini, Reena S. Atkins, James N. Bevers, Therese B. Fehrenbacher, Louis Pajon, Eduardo R. Wade, James L., III Robidoux, Andre Margolese, Richard G. James, Joan Runowicz, Carolyn D. Ganz, Patricia A. Reis, Steven E. McCaskill-Stevens, Worta Ford, Leslie G. Jordan, V. Craig Wolmark, Norman National Cancer Institute, Department of Health and Human Services [U10-CA-12027, U10-CA-69651, U10-CA37377, U10-CA-69974] Public Health Service grants U10-CA-12027, U10-CA-69651, U10-CA37377, and U10-CA-69974 from the National Cancer Institute, Department of Health and Human Services. 27 Amer assoc cancer research; 615 chestnut st, 17th floor, philadelphia, pa 19106-4404 usa 605vk