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Study of Tamoxifen and Raloxifene (STAR): Initial Findings from the NSABP P-2 Breast Cancer Prevention Study D.L. Wickerham, J.P. Costantino, V. Vogel,

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Presentation on theme: "Study of Tamoxifen and Raloxifene (STAR): Initial Findings from the NSABP P-2 Breast Cancer Prevention Study D.L. Wickerham, J.P. Costantino, V. Vogel,"— Presentation transcript:

1 Study of Tamoxifen and Raloxifene (STAR): Initial Findings from the NSABP P-2 Breast Cancer Prevention Study D.L. Wickerham, J.P. Costantino, V. Vogel, W.M. Cronin, R.S. Cecchini, J. Atkins, T. Bevers, L. Fehrenbacher, W. McCaskill-Stevens, N. Wolmark ASCO 2006

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3 Risk-Eligible Postmenopausal Women STRATIFICATION Age Gail Model Risk Race History of LCIS TAMOXIFEN 20 mg/day x 5 years NSABP STAR Schema RALOXIFENE 60 mg/day x 5 years

4 STAR Trial Objectives Evaluate the effect of raloxifene vs. tamoxifen in reducing the incidence of: Invasive breast cancer Primary objective:

5 STAR Trial Objectives Noninvasive breast cancer Endometrial cancer Ischemic Heart Disease Fractures of the: –Hip –Spine –Wrist (Colles’) Secondary objectives:

6 STAR Summary of Screening, Accrual and Follow-Up Information Women screened for breast cancer risk Women who were breast cancer risk eligible Women randomly assigned treatment Total person-years of follow-up Average follow-up (months) ,828 19,747 96, ,460

7 P-2 STAR Age Distribution 9% % % <49 70+

8 P-2 STAR Racial/Ethnic Distribution (%) TAMRAL White93.5 African- American 2.0 Hispanic Other2.1

9 P-2 STAR 5-year Predicted Risk of Breast Cancer among Participants at Entry Gail model risk score 5+ 27% 2 to 3 30% <2 3 to 5 32% 11%

10 P-2 STAR First-Degree Relatives with Breast Cancer None 29% 1 52% 2 16% 3+ 3%

11 P-2 STAR Prior Hysterectomy51.5% (10,027)

12 P-2 STAR 1, LCIS AtypicalHyperplasia Total Number % of Randomized

13 RESULTS

14 Gail Model Projection TAMRaloxifene Av Ann Rate per 1000 P-2 STAR Average Annual Rate and Number of Invasive Breast Cancers * # of events 312*

15 P-2 STAR Cumulative Incidence of Invasive Breast Cancer Cumulative Incidence (per 1000) Time Since Randomization (months) At Risk by Year# ofRate/1000 Treatment036Eventsat 6 yrs.P-value Tamoxifen Raloxifene

16 <33 to 55+ Percent in 5 Years Av Ann Rate per 1000 Tamoxifen Raloxifene P-2 STAR Average Annual Rate and Number of Invasive Breast Cancers by 5-year Gail Model Risk

17 P-2 STAR Estrogen Receptor of Invasive Cancers PositiveNegative Percent Tamoxifen Raloxifene

18 P-2 STAR Tumor Size (cm) of Invasive Cancers <11.1 to 3>3 Percent Tamoxifen Raloxifene

19 P-2 STAR Nodal Status of Invasive Cancers NegativePositive Percent Tamoxifen Raloxifene

20 TAMRaloxifene Av Ann Rate per 1000 P-2 STAR Average Annual Rate And Number Of Non-invasive (In Situ) Cancers 57* 80 * # of events Relative risk = % Confidence Interval: 0.98 to 2.00

21 P-2 STAR Cumulative Incidence of Non-Invasive Breast Cancer Cumulative Incidence (per 1000) Time Since Randomization (months) At Risk by Year# ofRate/1000 Treatment036Eventsat 6 yrs.P-value Tamoxifen Raloxifene

22 Average Annual Rate of Non-Invasive Breast Cancer by Treatment Group Tumor Type # of Events Rate per 1000 Risk Ratio RR 95% Confidence Interval TAMRALTAMRAL DCIS LCIS Mixed Total

23 LCIS 1789 AH 4426 Av Ann Rate per P-2 STAR Average Annual Rate and Number of Invasive Breast Cancers by History of Atypical Hyperplasia and Lobular Carcinoma in Situ Tamoxifen Raloxifene

24 TAMRaloxifene Av Ann Rate per 1000 P-2 STAR Average Annual Rate and Number of Uterine Cancers 36* 23 * # of events RR = 0.62, 95% CI: 0.35 to 1.08

25 P-2 STAR Cumulative Incidence of Uterine Cancer Cumulative Incidence (per 1000) Time Since Randomization (months) At Risk by Year# ofRate/1000 Treatment036Eventsat 6 yrs.P-value Tamoxifen Raloxifene

26 TAMRAL Hyperplasia8414 with Atypia121 w/o Atypia7213 P-2 STAR Endometrial Hyperplasia

27 # of Hysterectomies for Non-Cancer Reasons TAMRAL

28 P-2 STAR Cumulative Incidence of Thromboembolic Events Cumulative Incidence (per 1000) Time Since Randomization (months) At Risk by Year# ofRate/1000 Treatment036Eventsat 6 yrs.RR Tamoxifen Raloxifene P-value=

29 TAMRaloxifene Av Ann Rate per 1000 P-2 STAR Average Annual Rate and Number of Strokes 53* 51 * # of events

30 P-2 STAR Number of Ischemic Heart Disease Events Type of eventTamoxifen#Raloxifene#RiskRatio(RR) RR 95% ConfidenceInterval Myocardial infarction Severe Angina Acute ischemic syndrome

31 P-2 STAR Number of Osteoporotic Fractures by Site and Treatment Group Type of event Tamoxifen#Raloxifene#RiskRatio(RR) RR 95% ConfidenceInterval Hip Spine Radius (Colles’) Total

32 TAMRaloxifene Av ann rate per 1000 P-2 STAR Average Annual Rates of Cataracts 394* 313 RR = 0.79; 95% CI 0.68 – 0.92

33 P-2 STAR Summary Raloxifene is as effective as tamoxifen in the prevention of primary invasive breast cancer Raloxifene is less effective than tamoxifen in the prevention of non-invasive breast cancer (LCIS & DCIS) Compared to tamoxifen, raloxifene use results in: –Fewer thromboembolic events –Fewer endometrial cancers and –Fewer cataracts

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