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Breast Cancer in the Women’s Health Initiative Trial of Estrogen Plus Progestin. For the WHI Investigators Rowan T Chlebowski, MD., Ph.D. Menopausal Hormone Therapy and Breast Cancer (Background).

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Breast Cancer in the Women’s Health Initiative Trial of Estrogen Plus Progestin

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Breast cancer in the women s health initiative trial of estrogen plus progestin l.jpg

Breast Cancer in the Women’s Health Initiative Trial of Estrogen Plus Progestin

For the WHI Investigators

Rowan T Chlebowski, MD., Ph.D.


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Menopausal Hormone Therapy and Breast Cancer (Background)

Preponderance of observational studies suggest long duration estrogen plus progestin increases breast cancers which have:

- Low stage and favorable prognosis

- Receptor positive preponderance

- More lobular histology

Holli J Clin Oncol 1998; 16: 3115Gapstur JAMA 1999; 281: 2021

Delgado Maturitas 2001; 38: 147Lower Breast Cancer Res Treat 1999; 58: 205

Chen, JAMA 287: 734, 2002Coldity Am JEpid 147 (5): 645, 1998


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Descriptive Characteristics in WHI Participants

AgeAge at menarcheRelatives with breast ca (n)

EthnicityTerm pregnancies (n)Benign breast disease

EducationAge at first birthPrior estrogen (E) alone use

Gail RiskChildren breastfed (n) Prior E + progestin (P) use

BMIOral Contraceptive useNSAID use

Alcohol Use% Energy from fatPhysical Activity

None of these characteristics differed significantly between treatment groups


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Descriptive Characteristics By Treatment Group

“Current” users required three month washout


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WHI Estrogen+Progestin TrialBreast Safety

  • Baseline mammogram and clinical breast exams required for eligibility

  • Annual mammograms and clinical breast exams required when on study

  • Study medications withheld if safety procedures not performed


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Breast Cancers by Category and Treatment Group

1 Hazard ratios (HR) from unweighted Cox proportional hazards regression models

2 P values from weighted Cox proportional hazards regression models


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Invasive Breast Cancer By Group

Hazard ratios (HR) from unweighted Cox proportional hazards regressions models

Z Statistics and p values from weighted Cox proportional hazards regression models


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Sensitivity Analysis of Adherent Participants Invasive Breast Cancers by Group

Participants were censored 6 months after becoming non-adherent (taking < 80% study meds or taking non-protocol hormones)

Hazard ratios (HR) from unweighted Cox proportional hazards regressions models

Z Statistics and p values form weighted Cox proportional hazards regression models


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Breast Cancers (Annualized Percentage) by Age

P-value tests interactions of E+P and age


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Breast Cancer (Annualized Percentage) by BMI

P-value tests for interaction of E+P with BMI


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Breast Cancers (Annualized Percentage) by Prior Menopausal Hormone Therapy (MHT) Use

More breast cancers on E+P in both groups

Non-significant trend, no interaction

Ever users at somewhat lower risk

Cumulative exposure versus selection bias

1 P value tests for interaction with E+P and prior MHT


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Breast Cancer Incidence by Prior MHT Use and Randomization Assignment


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Breast Cancer Characteristics by Group

1 P value tests association with treatment groups

Similar histology and grade on E+P and placebo


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1 The first P value tests association with treatment groups

2 P-value for “missing” rows test the association of % missing with treatment group

Both receptor positive and negative breast cancers greater on E+P


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Breast Cancer Characteristics by Group

1 mean (SD) for tumor with known tumor size

2 P-values from weighted Cox proportional hazards models

More advanced stage on E+P


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Year 1 Mammogram Findings by Group

1 p < .0001 comparing E+P versus placebo

Increased abnormal mammograms after 1 year on E+P


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SummaryMammogram Findings by Group and Time

1 % of women due for visit with mammogram in study period who had mammogram

2 % of women with any category of abnormal mammogram

3 p < 0.0001 E+P versus placebo


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Abnormal Mammograms: Associated with Short Duration E+P Use

4 % absolute increase in abnormal mammograms after one year on E+P

10% absolute increase in abnormal mammograms after about 5 years on E+P


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Recent Results from the UK Million Women Study

National Health Service Breast Cancer Screening Program

Inform Interpretation of WHI Results


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Million Women Study

  • NHSBSP in the UK invites women 50-69 for mammography screening q 3 years by letters

  • A questionnaire regarding HT use was added to the screening invitation letter

  • HT use data was linked to NHS central registries for breast cancer and death outcomes

  • 1,084,110 women flagged

  • 9,364 incident invasive breast cancers seen

Lancet 2003; 362: 419-27.


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Relative Risk of Fatal Breast Cancer by HT Use at Baseline in the Million Women Study Based on 517 deaths after 4.1 years

* P = 0.05 for current versus neverLancet 2003; 362; 419-27.

HT associated with increased breast cancer mortality in “short term” users


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Relative Risk of Breast Cancer in the Million Women Study By E+P Duration

E+P associated with increased breast cancers in < 1 year


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Relative Risk of Breast Cancer in the Million Women Study By Hormone Type


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Conclusions

Combined E+P use increases breast Ca,

diagnosed at more advanced stage and

increases abnormal mammograms

These results suggest: Use of E+P may

stimulate breast cancer growth and hinder

breast cancer diagnosis


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