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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
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
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: 3115 Gapstur JAMA 1999; 281: 2021

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

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

descriptive characteristics in whi participants
Descriptive Characteristics in WHI Participants

Age Age at menarche Relatives with breast ca (n)

Ethnicity Term pregnancies (n) Benign breast disease

Education Age at first birth Prior estrogen (E) alone use

Gail Risk Children breastfed (n) Prior E + progestin (P) use

BMI Oral Contraceptive use NSAID use

Alcohol Use % Energy from fat Physical Activity

None of these characteristics differed significantly between treatment groups

descriptive characteristics by treatment group
Descriptive Characteristics By Treatment Group

“Current” users required three month washout

slide5

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
breast cancers by category and treatment group
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

slide7

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

sensitivity analysis of adherent participants invasive breast cancers by group
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

breast cancers annualized percentage by age
Breast Cancers (Annualized Percentage) by Age

P-value tests interactions of E+P and age

breast cancer annualized percentage by bmi
Breast Cancer (Annualized Percentage) by BMI

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

breast cancers annualized percentage by prior menopausal hormone therapy mht use
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

breast cancer characteristics by group
Breast Cancer Characteristics by Group

1 P value tests association with treatment groups

Similar histology and grade on E+P and placebo

slide14

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

breast cancer characteristics by group15
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

year 1 mammogram findings by group
Year 1 Mammogram Findings by Group

1 p < .0001 comparing E+P versus placebo

Increased abnormal mammograms after 1 year on E+P

summary mammogram findings by group and time
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

abnormal mammograms associated with short duration e p use
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

slide19
Recent Results from the UK Million Women Study

National Health Service Breast Cancer Screening Program

Inform Interpretation of WHI Results

million women study
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.

slide21
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 never Lancet 2003; 362; 419-27.

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

relative risk of breast cancer in the million women study by e p duration
Relative Risk of Breast Cancer in the Million Women Study By E+P Duration

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

conclusions
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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