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Study of Tamoxifen and Raloxifene STAR

Larry Wickerham, MD NSABP STAR Project Officer. Study of Tamoxifen and Raloxifene STAR. 50. 40. 30. 20. 10. 0. NSABP P1 Study. Invasive Breast Cancer. Noninvasive Breast Cancer. 50. # Events Placebo 250 Tamoxifen 145. # Events Placebo 93 Tamoxifen 60. 40. 30.

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Study of Tamoxifen and Raloxifene STAR

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  1. Larry Wickerham, MD NSABP STAR Project Officer Study of Tamoxifen and RaloxifeneSTAR

  2. 50 40 30 20 10 0 NSABP P1 Study Invasive Breast Cancer Noninvasive Breast Cancer 50 # Events Placebo 250 Tamoxifen 145 # Events Placebo 93 Tamoxifen 60 40 30 Cumulative Rate/1000 P= 0.008 20 P < 0.0001 10 0 Time to Breast Cancer (Years)

  3. Study DesignSTAR Risk-Eligible Postmenopausal Women • STRATIFICATION • Age • Gail Model Risk • Race • History of LCIS • Hysterectomy Tamoxifen 20 mg/day x 5 years Raloxifene 60 mg/day x 5 years

  4. Inclusion and Exclusion CriteriaSTAR • Inclusion • At least 35 years of age • Postmenopausal • Risk eligible Lobular carcinoma in situ or 5-year Gail risk of breast cancer >1.66% • Exclusion History of: • Invasive breast cancer • Ductal carcinoma in situ • DVT, PE • CVA, TIA • Uncontrolled diabetes, hypertension or atrial fibrillation

  5. Primary AimsSTAR • The primary aim of the study was to determine which of the following three statements is true: • Compared to tamoxifen, raloxifene significantly reduces the incidence rate of IBC • Compared to raloxifene, tamoxifen significantly reduces the incidence rate of IBC • The statistical superiority of one of the treatments cannot be demonstrated and the choice of therapy should be based on benefit/risk considerations

  6. Primary ObjectiveSTAR • Evaluate the effect of raloxifene versus tamoxifen in reducing the incidence of invasive breast cancer in postmenopausal women who are at increased risk.

  7. Secondary Objectives STAR • Non-invasive breast cancer • Endometrial cancer • Ischemic heart disease • Fractures of the hip, spine or wrist • Toxicity and side effects

  8. Screening, Accrual and Follow-upSTAR • Screened 184,460 • Eligible 96,368 • Randomized 19,747 • Woman-years of follow-up 79,173 • Average follow-up (years) 4.06

  9. Baseline CharacteristicsSTAR • Age (mean) 58.5 • Caucasian 93% • Hysterectomy 51% • First degree relative(s)with breast cancer 71% • History of • Lobular carcinoma in situ 9% • Atypical hyperplasia 23% • 5-year predicted Gail risk ofinvasive breast cancer (mean) 4.03%

  10. Effects on Invasive Breast Cancer STAR RR (95% CI) = 1.02 (0.82, 1.27)

  11. Invasive Breast CancerSTAR 325 173 168

  12. 80 72 63 49 44 33 Invasive Breast Cancer by 5-year Predicted RiskSTAR

  13. Invasive Breast Cancer Tumor CharacteristicsSTAR

  14. 35 34 47 41 Invasive Breast Cancer in Women with aHistory of LCIS or Atypical Hyperplasia STAR

  15. Non-Invasive Breast CancerSTAR

  16. Non-Invasive Breast CancerSTAR

  17. Uterine Cancer STAR

  18. Uterine Hyperplasia and HysterectomySTAR

  19. Ischemic Heart Disease STAR

  20. Osteoporotic Fractures STAR *Columns not additive because one patient may have had fractures at multiple sites.

  21. MortalitySTAR

  22. Venous Thromboembolic EventsSTAR

  23. RR = 0.78 (95% CI = 0.68–0.91) 435 RR = 0.81 (95% CI = 0.68–0.96) 343 295 240 Cataracts and Cataract Surgery During Follow-upSTAR

  24. Summary STAR • Compared with tamoxifen, raloxifene was: • similar in decreasing the risk of invasive breast cancer • not as effective at decreasing the risk of non-invasive breast cancer • associated with fewer: • adverse events related to uterus • VTEs • cataracts and cataract surgery

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