The Use of Tamoxifen and Raloxifene for the Prevention of Breast Cancer

  • D. Lawrence Wickerham
  • Joseph P. Costantino
  • Victor G. Vogel
  • Walter M. Cronin
  • Reena S. Cecchini
  • Leslie G. Ford
  • Norman Wolmark
Part of the Recent Results in Cancer Research book series (RECENTCANCER, volume 181)

Abstract

The NSABP Study of Tamoxifen and Raloxifene (STAR), launched in 1999, compared tamoxifen with raloxifene in a population of healthy postmenopausal women at increased risk for breast cancer to determine the relative effects on the risk of invasive breast cancer. To be eligible for participation, a woman had to be healthy with at least a 5-year predicted breast cancer risk of 1.66% based on the Gail model or a history of lobular carcinoma in situ (LCIS) treated by local excision alone. All participants were at least 35 years of age and postmenopausal. Between July 1999 and November 2004, 19,747 participants were randomized to receive either tamoxifen (20 mg, plus placebo) or raloxifene (60 mg, plus placebo) daily for a 5-year period. The mean age of the participants was 58.5 years; 93% were white and 51.6% had a hysterectomy prior to entering the study. Of the women, 71% had one or more first degree female relatives (mother, sister, daughter) with a history of breast cancer and 9.2% of the women had a personal history of LCIS. A history of atypical hyperplasia of the breast was noted in 22.7% of the participants. The mean predicted 5-year risk of developing breast cancer among the study population was 4.03% (SD, 2.17%) with a lifetime predicted risk of 16%. The mean time of follow-up is 3.9 years (SD, 1.6 years). There was no difference between the effect of tamoxifen and the effect of raloxifene on the incidence of invasive breast cancer; there were 163 cases of invasive breast cancer in the tamoxifen-treated group and 168 cases in those women assigned to raloxifene (incidence 4.30 per 1,000 vs 4.41 per 1,000; RR 1.02; 95% CI, 082–1.28). There were fewer cases of noninvasive breast cancer (LCIS and ductal carcinoma in situ [DCIS]) in the tamoxifen group (57 cases) than in the raloxifene group (80 cases), although the difference is not yet statistically significant (incidence 1.51 vs 2.11 per 1,000; RR, 1.40; 95% CI, 0.98–2.00). There were 36 cases of uterine cancer with tamoxifen and 23 cases with raloxifene (RR, 0.63; 95% CI, 0.35–1.08).

Keywords

Breast Cancer Invasive Breast Cancer Selective Estrogen Receptor Modulator National Surgical Adjuvant Breast Gail Model 
These keywords were added by machine and not by the authors. This process is experimental and the keywords may be updated as the learning algorithm improves.

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Copyright information

© Springer-Verlag Berlin Heidelberg 2009

Authors and Affiliations

  • D. Lawrence Wickerham
    • 1
  • Joseph P. Costantino
    • 1
  • Victor G. Vogel
    • 1
  • Walter M. Cronin
    • 1
    • 2
  • Reena S. Cecchini
    • 1
    • 2
  • Leslie G. Ford
    • 3
  • Norman Wolmark
    • 4
  1. 1.Operations Center National Surgical Adjuvant Breast and Bowel Project (NSABP)PittsburghUSA
  2. 2.Department of BiostatisticsGraduate School of Public Health University of PittsburghPittsburghUSA
  3. 3.Division of Cancer Prevention National Cancer Institute NIHBethesdaUSA
  4. 4.Allegheny General HospitalPittsburghUSA

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