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Research Article

Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing Breast Cancer

Victor G. Vogel, Joseph P. Costantino, D. Lawrence Wickerham, Walter M. Cronin, Reena S. Cecchini, James N. Atkins, Therese B. Bevers, Louis Fehrenbacher, Eduardo R. Pajon, James L. Wade III, André Robidoux, Richard G. Margolese, Joan James, Carolyn D. Runowicz, Patricia A. Ganz, Steven E. Reis, Worta McCaskill-Stevens, Leslie G. Ford, V. Craig Jordan and Norman Wolmark
Victor G. Vogel
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Joseph P. Costantino
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D. Lawrence Wickerham
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Walter M. Cronin
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Reena S. Cecchini
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James N. Atkins
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Therese B. Bevers
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Louis Fehrenbacher
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Eduardo R. Pajon
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James L. Wade III
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André Robidoux
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Richard G. Margolese
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Joan James
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Carolyn D. Runowicz
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Patricia A. Ganz
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Steven E. Reis
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Worta McCaskill-Stevens
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Leslie G. Ford
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V. Craig Jordan
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Norman Wolmark
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DOI: 10.1158/1940-6207.CAPR-10-0076 Published June 2010
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  • Fig. 1.
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    Fig. 1.

    Cumulative incidences of invasive and noninvasive breast cancer.

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    Fig. 2.

    Cumulative incidences of invasive uterine cancer and thromboembolic events.

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  • Table 1.

    Characteristics at entry to the NSABP STAR Trial (P-2) for women included in the STAR-update analyses

    Participant characteristicsTamoxifenRaloxifene
    No.%No.%
    Age (years)
        ≤498849.18789.0
        50–594,85649.94,85549.8
        60–693,13732.23,17432.5
        ≥708598.88478.7
    Race/ethnicity
        White9,10593.59,11593.4
        African-American2332.42432.5
        Hispanic1922.01932.0
        Other2062.12032.1
    No. 1° relatives with breast cancer
        02,83829.12,79128.6
        15,04651.85,13552.6
        21,53215.71,56116.0
        ≥33203.32672.7
    History of hysterectomy
        No4,73948.74,71748.4
        Yes4,99751.35,03751.6
    History of lobular carcinoma in situ
        No8,84490.88,86590.9
        Yes8929.28899.1
    History of breast atypical hyperplasia
        No7,54577.57,51377.0
        Yes2,19122.52,24123.0
    5-year predicted breast cancer risk (%)*
        ≤2.001,05510.81,10211.3
        2.01-3.002,99330.72,89329.7
        3.01-5.003,04231.23,08631.6
        ≥5.012,64627.22,67327.4
    Total9,736100.09,754100.0

    Abbreviation: NSABP STAR, National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene.

    • ↵*Determined by the Gail model.

  • Table 2.

    Annual rates of invasive breast cancer—NSABP STAR Trial (P-2)

    Participant characteristic at baselineNumber of eventsRate per 1000RR*RR (95% CI)
    TamoxifenRaloxifeneTamoxifenRaloxifeneDifference†
    Age at entry (years)
        ≤4910151.842.80−0.961.530.64–3.80
        50-591251554.095.03−0.941.230.97–1.57
        ≥601121404.475.48−1.011.220.95–1.58
    History of lobular carcinoma in situ
        No1972533.544.50−0.961.271.05–1.54
        Yes50579.1410.34−1.201.130.76–1.69
    History of atypical hyperplasia
        No1872183.904.52−0.621.160.95–1.42
        Yes60924.586.79−2.211.481.06–2.09
    5-year predicted breast cancer risk (%)
        ≤3.0061812.393.21−0.821.340.95–1.90
        3.01-5.0084914.434.63−0.201.050.77–1.42
        ≥5.011021386.138.17−2.041.331.02–1.74
    No. 10 relatives with breast cancer
        0821054.776.17−1.401.290.96–1.75
        11121353.514.10−0.591.170.90–1.51
        ≥253704.445.96−1.521.340.93–1.96
    Total2473104.045.02−0.981.241.05–1.47

    Abbreviations: CI, confidence interval; NSABP STAR, National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene; RR, risk ratio.

    • ↵*Risk ratio for women in the raloxifene group compared to women in the tamoxifen group.

    • ↵†Rate in the tamoxifen group minus rate in the raloxifene group.

  • Table 3.

    Annual rates of noninvasive breast cancer and uterine disease/hysterectomy—NSABP STAR Trial (P-2)

    Disease/uterine event typeEvents, nRate per 1,000RR*RR (95% CI)
    TamoxifenRaloxifeneTamoxifenRaloxifeneDifference†
    Noninvasive breast cancer
        DCIS70861.151.40−0.251.220.88–1.69
        LCIS33340.540.55−0.011.020.61–1.70
        Mixed8170.130.28−0.152.110.86–5.64
        Total1111371.832.23−0.401.220.95–1.59
    Uterine disease and hysterectomy‡
    Invasive Cancer65372.251.231.020.550.36–0.83
    Hyperplasia§126254.400.843.560.190.12–0.29
        Without atypia§104213.630.702.930.190.11–0.31
        With atypia§2240.770.130.640.170.04–0.51
    Hysterectomy during follow-up34916212.085.416.670.450.37–0.54

    Abbreviations: CI, confidence interval; DCIS, ductal carcinoma in situ; LCIS, lobular carcinoma in situ; NSABP STAR, National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene; RR, risk ratio.

    • ↵*Risk ratio for women in the raloxifene group compared with women in the tamoxifen group.

    • ↵†Rate in the tamoxifen group minus rate in the raloxifene group.

    • ↵‡Women at risk were those with an intact uterus at entry (see Table 1).

    • ↵§Among women not diagnosed with uterine cancer.

  • Table 4.

    Annual rates of site-specific invasive cancer cases other than breast and uterine cancer—NSABP STAR Trial (P-2)

    Site of cancerEvents, nRate per 1000RR*RR (95% CI)
    TamoxifenRaloxifeneTamoxifenRaloxifeneDifference†
    Adrenal gland0100.02−0.02——
    Bone/cartilage/connective tissue340.050.06−0.011.320.22–8.98
    Buccal cavity and pharynx460.060.10−0.041.480.35–7.13
    Cervix300.0500.05——
    Colorectal48450.780.720.060.930.60 to 1.42
    Esophagus200.0300.03——
    Eye110.020.0200.990.01–77.48
    Gallbladder520.080.030.050.390.04–2.41
    Kidney14210.230.34−0.111.480.72–3.15
    Larynx0100.02−0.02——
    Leukemia/other lymph/hemato60530.970.850.120.870.59–1.28
    Liver720.110.030.080.280.03–1.48
    Lung, trachea, bronchus57640.921.02−0.101.110.76–1.61
    Nasal/middle ear/sinuses110.020.0200.990.01–77.48
    Nervous system9100.150.16−0.011.100.40–3.05
    Other gyn220.030.0300.990.07–13.62
    Ovary21340.500.79−0.291.580.89–2.86
    Pancreas12110.190.180.010.900.36–2.24
    Retroperitoneum740.110.060.050.560.12–2.22
    Skin25240.400.380.020.950.52–1.73
    Small intestine0200.03−0.03——
    Spleen0200.03−0.03——
    Stomach510.080.020.060.200.004–1.76
    Thyroid gland18320.290.51−0.221.760.96–3.32
    Urinary bladder15120.240.190.050.790.34–1.81
    Site unspecified/unspecified nature15190.240.30−0.061.250.60–2.64
    Secondary/uncertain450.060.08−0.021.230.27–6.22

    Abbreviations: CI, confidence interval; gyn, gynecologic; hemato, hematopoietic; lymph, lymphatic; NSABP STAR, National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene; RR, risk ratio.

    • ↵*Risk ratio for women in the raloxifene group compared with women in the tamoxifen group.

    • ↵†Rate in the tamoxifen group minus rate in the raloxifene group.

  • Table 5.

    Rates of thromboembolic events, cataracts, and cataracts surgery—NSABP STAR Trial (P-2)

    Type of eventEvents, nRate per 1,000RR*RR (95% CI)
    TamoxifenRaloxifeneTamoxifenRaloxifeneDifference†
    Thromboembolic events2021543.302.470.830.750.60–0.93
        Pulmonary embolism84681.361.090.270.800.57–1.11
        Deep-vein thrombosis118861.931.380.550.720.54–0.95
    Cataracts and Cataract Surgery
    Developed cataracts during follow-up‡73960314.5811.692.890.800.72–0.89
    Developed cataracts and had cataract surgery‡57546211.188.852.330.790.70–0.90

    Abbreviations: CI, confidence interval; NSABP STAR, National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene; RR, risk ratio.

    • ↵*Risk ratio for women in the raloxifene group compared to women in the tamoxifen group.

    • ↵†Rate in the tamoxifen group minus rate in the raloxifene group.

    • ↵‡Women at risk were those with no prior history of cataracts at entry (8,341 and 8,336 tamoxifen and raloxifene participants, respectively).

  • Table 6.

    Distribution of Deaths - NSABP STAR Trial (P-2)

    Cause of deathDeaths, n
    TamoxifenRaloxifene
    Cancer10186
        Bladder13
        Bone, articular cartilage and connective tissue11
        Brain64
        Breast114
        Colon43
        Endocrine gland01
        Gallbladder21
        Kidney11
        Liver71
        Lung2528
        Lymphatic/hematopoietic1211
        Oral21
        Ovary87
        Pancreas75
        Peritoneum20
        Skin20
        Spleen01
        Stomach21
        Thyroid10
        Uterus22
        Other, uncertain, and unspecified sites511
    Circulatory/vascular disease4242
        Aortic12
        Atherosclerosis01
        Cerebrovascular disease, unspecified10
        Hypertensive disease14
        Ischemic heart disease138
        Other heart disease914
        Peripheral vascular disease, unspecified01
        Polyarteritis nodosa01
        Pulmonary embolism32
        Primary pulmonary hypertension10
        Stroke139
    Other9374
        Accident, auto34
        Accident, fire10
        Alcohol dependence syndrome11
        Asphyxiation and strangulation10
        Complications of surgery01
        Dementia01
        Diabetes13
        Disorders of metabolism10
        Emphysema10
        Injury, intracranial22
        Injury, other10
        Interferon toxicity01
        Intestinal infectious disease01
        Other conditions of the blood02
        Other conditions of the brain/neurological system73
        Other diseases of the digestive system76
        Other Diseases of the urinary system21
        Other respiratory disease137
        Pneumonia24
        Poisoning20
        Septicemia43
        Skin infections01
        Symptoms, signs, and ill-defined conditions23
        Unknown4230
    Total deaths (rate per 1,000)236 (3.81)202 (3.22)
        Risk ratio (95% CI)0.70–1.02)

    Abbreviations: CI, confidence interval; NSABP STAR, National Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene.

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      Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing Breast Cancer
      Victor G. Vogel, Joseph P. Costantino, D. Lawrence Wickerham, Walter M. Cronin, Reena S. Cecchini, James N. Atkins, Therese B. Bevers, Louis Fehrenbacher, Eduardo R. Pajon, James L. Wade III, André Robidoux, Richard G. Margolese, Joan James, Carolyn D. Runowicz, Patricia A. Ganz, Steven E. Reis, Worta McCaskill-Stevens, Leslie G. Ford, V. Craig Jordan and Norman Wolmark for the National Surgical Adjuvant Breast and Bowel Project
      Cancer Prev Res June 1 2010 (3) (6) 696-706; DOI: 10.1158/1940-6207.CAPR-10-0076

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      Update of the National Surgical Adjuvant Breast and Bowel Project Study of Tamoxifen and Raloxifene (STAR) P-2 Trial: Preventing Breast Cancer
      Victor G. Vogel, Joseph P. Costantino, D. Lawrence Wickerham, Walter M. Cronin, Reena S. Cecchini, James N. Atkins, Therese B. Bevers, Louis Fehrenbacher, Eduardo R. Pajon, James L. Wade III, André Robidoux, Richard G. Margolese, Joan James, Carolyn D. Runowicz, Patricia A. Ganz, Steven E. Reis, Worta McCaskill-Stevens, Leslie G. Ford, V. Craig Jordan and Norman Wolmark for the National Surgical Adjuvant Breast and Bowel Project
      Cancer Prev Res June 1 2010 (3) (6) 696-706; DOI: 10.1158/1940-6207.CAPR-10-0076
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