Rodrigo Arrangoiz MS, MD, FACS, FSSO

The NSABP P-2, or the Study of Tamoxifen and Raloxifene trial (STAR trial):
- Enrolled 19,747 postmenopausal women:
  - With a 5-year Gail risk assessment score of ≧ 1.66%:
    - For the development of invasive breast cancer at 5 years
- The women were randomized to receive:
  - 20 mg of tamoxifen plus placebo or 60 mg of raloxifene plus placebo
- The updated results of the STAR trial:
  - Median follow-up 81 months
  - Reported more cases of invasive breast cancer in the raloxifene group than the tamoxifen group:
    - Risk ratio [RR]: 1.24; 95% confidence interval [CI]: 1.05–1.47:
      - Demonstrating that raloxifene is about 76% as effective as tamoxifen in reducing breast cancer risk
  - There were significantly fewer cases of invasive uterine cancer with raloxifene compared to tamoxifen:
    - RR: 0.55; 95% CI, 0.36–0.83
  - Thromboembolic events occurred less often in the raloxifene group:
    - RR: 0.75; 95% CI: 0.6–0.93
  - There were fewer cataracts and cataract surgeries in the women taking raloxifene:
    - RR: 0.79; 95% CI: 0.68–0.92
  - Importantly, there was no significant difference in mortality between the two groups.

References

1. Vogel VG, Costantino JP, Wickerham DL, Cronin WM, Cecchini RS, Atkins JN, et al; for the National Surgical Adjuvant Breast and Bowel Project (NSABP). Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: the NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial. JAMA. 2006;295(23):2727-2741.

2. Vogel VG. The NSABP Study of Tamoxifen and Raloxifene (STAR) trial. Expert Rev Anticancer Ther. 2009;9(1):51-60.

3. Mamounas EP, Wicherham DL, Fisher B, Geyer CE, Julian TB, Wolmark N. The NSABP experience. In: Kuerer HM, ed. Kuerer’s Breast Surgical Oncology. New York, NY: McGraw-Hill Companies; 2010:475-508.