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3D" 3D" Vol. 304 No. 15, = October 20,=20 2010 3D" 3D"
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CLINICIAN'S=20 CORNER
Estrogen Plus=20 Progestin and Breast Cancer Incidence and Mortality in=20 Postmenopausal Women

Rowan=20 T. Chlebowski, MD, PhD; Garnet L. Anderson, = PhD;=20 Margery Gass, MD; Dorothy S. Lane, = MD;=20 Aaron K. Aragaki, MS; Lewis H. Kuller, = MD;=20 JoAnn E. Manson, MD, DrPH; Marcia L. = Stefanick,=20 PhD; Judith Ockene, MD; Gloria E. = Sarto,=20 MD; Karen C. Johnson, MD, MPH; = Jean=20 Wactawski-Wende, PhD; Peter M. Ravdin, MD, = PhD;=20 Robert Schenken, MD; Susan L. Hendrix, = DO;=20 Aleksandar Rajkovic, MD, PhD; Thomas E. = Rohan,=20 PhD; Shagufta Yasmeen, MD; Ross L. = Prentice, PhD; for the WHI Investigators=20

JAMA. 2010;304(15):1684-1692.=20 doi:10.1001/jama.2010.1500

ABSTRACT=20
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Context  In=20 the Women's Health Initiative randomized, = placebo-controlled=20 trial of estrogen plus progestin, after a mean=20 intervention time of 5.6 (SD, 1.3) years (range, = 3.7-8.6=20 years) and a mean follow-up of 7.9 (SD, 1.4) = years,=20 breast cancer incidence was increased among women = who=20 received combined hormone therapy. Breast cancer=20 mortality among participants in the trial has not = been=20 previously reported.

Objective  To determine the effects of = therapy with=20 estrogen plus progestin on cumulative breast = cancer=20 incidence and mortality after a total mean = follow-up of=20 11.0 (SD, 2.7) years, through August 14, = 2009.=20

Design, Setting, and Participants  A total of = 16 608 postmenopausal women aged 50 to 79 = years with=20 no prior hysterectomy from 40 US clinical centers = were=20 randomly assigned to receive combined conjugated = equine=20 estrogens, 0.625 mg/d, plus medroxyprogesterone = acetate,=20 2.5 mg/d, or placebo pill. After the original trial=20 completion date (March 31, 2005), reconsent was = required=20 for continued follow-up for breast cancer = incidence and=20 was obtained from 12 788 (83%) of the = surviving=20 participants.

Main Outcome Measures  Invasive breast cancer = incidence and breast cancer mortality. =

Results  In intention-to-treat analyses = including all=20 randomized participants and censoring those not=20 consenting to additional follow-up on March 31, = 2005,=20 estrogen plus progestin was associated with more = invasive=20 breast cancers compared with placebo (385 cases = [0.42%=20 per year] vs 293 cases [0.34% per year]; hazard = ratio=20 [HR], 1.25; 95% confidence interval [CI], 1.07-1.46;=20 P =3D .004). Breast cancers in = the=20 estrogen-plus-progestin group were similar in = histology=20 and grade to breast cancers in the placebo group = but were=20 more likely to be node-positive (81 [23.7%] vs 43 = [16.2%],=20 respectively; HR, 1.78; 95% CI, 1.23-2.58;=20 P =3D .03). There were more = deaths=20 directly attributed to breast cancer (25 deaths = [0.03%=20 per year] vs 12 deaths [0.01% per year]; HR, = 1.96; 95%=20 CI, 1.00-4.04; P =3D .049) as well as = more=20 deaths from all causes occurring after a breast cancer = diagnosis (51 deaths [0.05% per year] vs 31 = deaths [0.03%=20 per year]; HR, 1.57; 95% CI, 1.01-2.48;=20 P =3D .045) among women who = received=20 estrogen plus progestin compared with women in the=20 placebo group.

Conclusions  Estrogen plus progestin was = associated=20 with greater breast cancer incidence, and the = cancers are=20 more commonly node-positive. Breast cancer = mortality also=20 appears to be increased with combined use of = estrogen=20 plus progestin.

Trial Registration  clinicaltrials.gov = Identifier: NCT00000611 =



INTRODUCTION=20
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The Women's Health Initiative (WHI) randomized = trial=20 evaluating estrogen plus progestin compared with placebo in=20 postmenopausal women was stopped after a mean of 5.6 (SD, = 1.3) years=20 when health risks exceeded benefits for combined hormone=20 therapy,1=20 including an increased risk of invasive breast=20 cancers1-2=20 and delayed breast cancer diagnoses resulting in = more=20 advanced-stage cancers.2-3=20 Assessment of breast cancer outcomes after a = mean=20 follow-up of 7.9 (SD, 1.4) years revealed that the increased = risk of=20 breast cancer associated with combined hormone therapy = declined soon=20 after discontinuation of hormones.4=20 Nonetheless, questions of clinical relevance = remain,=20 including the cumulative, long-term effect of = estrogen=20 plus progestin on breast cancer incidence and = whether=20 breast cancer mortality is increased by combined = hormone=20 therapy use.

Most5-7=20 but not all8-9=20 observational studies have suggested that breast = cancers=20 associated with combined postmenopausal hormone = therapy=20 have favorable characteristics,5-7=20 less advanced stage,5,=20 10<= /SUP>=20 and less mortality risk.7,=20 10-= 11<= /SUP>=20 Because the influence of estrogen plus progestin = on=20 breast cancer mortality has not been addressed in = a=20 randomized trial setting, we report updated = information=20 on breast cancer incidence and, for the first time,=20 information on breast cancer mortality related to = combined=20 hormone therapy use in the WHI trial.


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The WHI=20 trial of estrogen plus progestin has been previously=20 described1,=20 12-= 13<= /SUP>=20 and used a study design approved by the institutional=20 review boards at the participating clinical = centers.12,= =20 14<= /SUP>=20 Briefly, women were eligible if they were aged 50 = to 79=20 years, were postmenopausal, and provided written = informed=20 consent. Excluded were women with prior = hysterectomy,=20 prior breast cancer, or conditions precluding = 3-year=20 survival. Women using postmenopausal hormones were = eligible=20 after a 3-month washout period. Baseline mammograms = and=20 clinical breast examinations with results not = suggestive=20 of cancer were required. Information on = demographic=20 characteristics, medical history, lifestyle, and = breast=20 cancer risk factors were collected with = standardized=20 self-report instruments. Medication use was = assessed by=20 interviewer-administered questionnaire. Time since=20 menopause was defined as the interval from onset of=20 menopause to first hormone therapy or placebo = use.15<= /SUP>=20 Adherence to study medication was assessed by = dispensing=20 history and serial pill counts by weighing = returned=20 pills.

Participants were randomized to receive conjugated equine = estrogens, 0.625 mg/d, and medroxyprogesterone = acetate,=20 2.5 mg/d, in a single tablet (Prempro; Wyeth = Ayerst,=20 Collegeville, Pennsylvania) or an = identical-appearing=20 placebo pill. Randomization by permuted-block = algorithm,=20 stratified by clinical center and age group,14<= /SUP>=20 was determined at the WHI Clinical Coordinating = Center=20 and implemented at local clinical centers using a = bar-code dispensing procedure for staff and = participant=20 blinding. Participants were contacted at 6-month=20 intervals to collect clinical outcome information = and=20 attended annual clinic visits. Yearly mammograms and = clinical=20 breast examinations were required during the = intervention=20 phase, and study drugs were withheld until = completion and=20 clearance of abnormal findings. After the active=20 intervention ended, annual mammograms and breast=20 examinations were encouraged and information on = their=20 frequency was collected annually.

The total study population included 16 608 women = with=20 initial randomization beginning on November 15, = 1993. The=20 study intervention phase ended on July 7, 2002, = after net=20 harm for combined hormone therapy use was=20 identified1=20 and participants were instructed to stop taking = their=20 assigned study medication. In the postintervention = phase=20 beginning on July 8, 2002, clinical visits and = follow-up=20 continued per protocol through March 31, 2005, the=20 original trial completion date. In the study = extension=20 phase beginning April 1, 2005, through August 14, = 2009,=20 subsequent follow-up for additional breast cancer = incidence results required reconsent (which was = obtained=20 from 12 788 [83%] of 15 408 surviving=20 participants).

Breast cancers were verified by centrally trained, = locally=20 based physician adjudicators after medical record = and=20 pathology report review.16<= /SUP>=20 Final adjudication and coding of histology, hormone=20 receptor status (positive or negative), and ERBB2=20 (HER2) status (overexpression or not) based = on=20 pathology report review was performed at the WHI = Clinical=20 Coordinating Center using the Surveillance, = Epidemiology,=20 and End Results coding system.17<= /SUP>=20 Attribution of cause of death was based on medical = record=20 review by physician adjudicators, blinded to=20 randomization allocation at the local clinical = centers,=20 with central final adjudication.16<= /SUP>=20 The National Death Index was cross-checked with all = clinical=20 trial participants at 2- to 3-year intervals. =

Prior reports of breast cancer cases include 349 cases=20 identified during the intervention phase with = mean=20 follow-up of 5.6 (SD, 1.3) years (median, 5.6 = years;=20 range, 4.6-8.6 years)2=20 and 488 cases identified through the original = trial=20 completion date with mean follow-up of 7.9 (SD, = 1.4)=20 years.4=20 The current report, based on a preplanned = analysis of=20 breast cancer incidence and associated mortality, = includes 678 cases identified through August 14, = 2009,=20 with a mean follow-up of 11.0 (SD, 2.7) years.

For the WHI estrogen and progestin clinical trial, a = target=20 sample size of 15 125 participants was calculated = primarily based on coronary heart disease = considerations.=20 As a result, power to detect a 15% increase in = breast=20 cancer was 55% after 9 years and 87% after 14 = years of=20 follow-up.12<= /SUP>=20

Comparisons of breast cancer characteristics were based = on=20 Fisher exact tests and t tests. Age at = menopause=20 was defined as previously described,15<= /SUP>=20 largely by age at last menstrual bleeding, bilateral=20 oophorectomy date, or date postmenopausal hormone = therapy=20 was initiated.

Results for invasive breast cancer incidence and deaths = from=20 breast cancer were assessed with time-to-event methods = based on the intention-to-treat principle. = Analyses=20 included all 16 608 randomized participants. = Annualized percentages were calculated by = dividing the=20 total number of events by total follow-up time in = years.=20 Hazard ratios (HRs) were estimated from Cox regression=20 models stratified by baseline 5-year age groups and=20 randomization status in the WHI dietary = modification=20 trial. No distinction was made between the = intervention=20 phase and the postintervention phase. In both = phases, the=20 breast cancer risk for use of estrogen plus = progestin was=20 greater than 1 and was approximately equal. The = summary=20 (Cox model) HRs represent the mean over the entire = study=20 period. In addition, the null hypothesis tests for = breast=20 cancer incidence and mortality do not assume=20 proportionality. Event times were defined = relative to the=20 date of randomization, with censoring defined by = end of=20 follow-up, loss to follow-up, or death from = causes other=20 than breast cancer. Kaplan-Meier curves describe=20 cumulative breast cancer hazard ratios over time. = Competing risk curves were also computed and were = nearly=20 identical to the Kaplan-Meier estimates.

For breast cancer incidence analyses, women who did not=20 consent to active follow-up after March 31, 2005, = were=20 censored as of that date. The original consent = permitted=20 continued follow-up for vital status. Analyses = for deaths=20 due to breast cancer among women who did not = reconsent=20 were censored on December 31, 2005, early in the=20 reconsent period, because mortality data in this = group=20 may be incomplete at more recent times. Additional = mortality=20 analyses censored women not reconsenting on March 31,=20 2005.

To examine the potential effect of censoring women who = did=20 not reconsent to follow-up after March 31, 2005, = several=20 secondary analyses were performed, including = comparison=20 of reconsent rates by baseline characteristics = and=20 randomization assignment and adjusted HR analyses = using=20 both inverse probability weighting and multiple=20 imputation. The inverse probability weighting analyses=20 developed a logistic regression model for reconsenting = using baseline factors and randomization = assignment. For=20 the multiple imputation method, invasive breast = cancer=20 events or censoring times were imputed for the = 2620=20 eligible participants who did not reconsent (1333 = in the=20 intervention and 1287 in the placebo groups) = beginning on=20 March 31, 2005. Cox regression models were then = fit for=20 each of 25 imputed data sets and the resulting = regression=20 parameter estimates were averaged. Adherence = sensitivity=20 analyses for breast cancer mortality were conducted by = censoring follow-up 6 months after a participant = became=20 nonadherent (defined as using <80% of study = pills or=20 starting nonprotocol hormone therapy). Six = subgroups of=20 clinical interest were identified post hoc and = examined=20 for breast cancer HR variation. Less than 1 = subgroup=20 would be expected to be positive by chance alone. =

All analyses were conducted using SAS software, version = 9.1=20 (SAS Institute Inc, Cary, North Carolina). All = statistical=20 tests were 2-sided and P <.05 was = considered=20 statistically significant.


RESULTS=20
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The flow of=20 participants through the study is outlined in Figure=20 1. Baseline characteristics for the initially randomized = 16 608 participants have been previously = published=20 (eTable= =20 1).1-2=20 Participant characteristics in the 2 = randomization groups=20 were closely comparable in both the initial and=20 reconsenting populations (eTable= =20 2 and eTable= =20 3). Those reconsenting were slightly younger and = more=20 likely to be white compared with those not = reconsenting.=20 During the active intervention, study drugs were = stopped=20 at some time by 42% in the combined hormone group = and 38%=20 in the placebo group.1=20



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Figure=20 1. Flow of Study Participants

The intervention phase ran from = November 15,=20 1993, to July 7, 2002. The = postintervention phase=20 began on July 8, 2002, the day after = participants=20 were instructed to stop study medication = use=20 (conjugated equine estrogens plus=20 medroxyprogesterone acetate or placebo) = and=20 continued through the original trial = completion=20 date (March 31, 2005). The extension phase = began=20 on April 1, 2005, and includes follow-up = for=20 participants who reconsented (83% of those = eligible) through August 14, 2009. =


Mammography frequency was comparable in the 2 = randomization=20 groups during the original trial period through March = 31,=20 2005 (annualized percentage, 80% for hormone vs = 80% for=20 placebo). In the reconsenting population of = 15 408=20 women in the extension phase, the percentages of = women=20 with 1 or more mammograms were also comparable in = the 2=20 groups (86% for hormone vs 86% placebo).

Mean follow-up in the intervention plus postintervention=20 periods was 11.0 (SD, 2.7) years, with a range of = 0.1 to=20 15.3 years, representing a total of 170 166=20 person-years of follow-up.

In intention-to-treat analysis, estrogen plus progestin=20 compared with placebo increased the incidence of = invasive=20 breast cancer (385 cases [0.42% per year] vs 293 = cases=20 [0.34% per year], respectively; HR, 1.25; 95% = confidence=20 interval [CI], 1.07-1.46; P =3D .004). = Figure=20 2 also shows quintiles of duration of study = intervention=20 based on time of participant entry into study and=20 cessation of study intervention.



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Figure=20 2. Incidence of Invasive Breast Cancer = in the=20 WHI Clinical Trial

Intention-to-treat Kaplan-Meier = cumulative=20 hazard curves for incidence of invasive = breast=20 cancer by study group and time since=20 randomization. The hazard ratio (HR), 95%=20 confidence interval (CI), and P = value are=20 from Cox regression models, stratified by = 5-year=20 age intervals and randomization assignment = in the=20 Women's Health Initiative (WHI) dietary=20 modification trial. All women stopped the=20 intervention by 8.6 years. Quintiles of = duration=20 of follow-up are indicated by the dotted = lines. =


A significantly larger fraction of breast cancers = presented=20 with positive lymph nodes in the combined hormone = therapy=20 group compared with the placebo group (81 [23.7%] = vs 43=20 [16.2%], respectively; HR, 1.78; 95% CI, = 1.23-2.58;=20 P =3D .03). There was no = evidence of a=20 differential effect of combined hormone therapy = on=20 receptor-positive vs receptor-negative tumors. Somewhat = more=20 tumors overexpressed ERBB2 (HER2) and were=20 triple-negative in the hormone therapy group = compared=20 with the placebo group (Table).<= SUP>=20 However, because determination of ERBB2 (HER2) = status=20 was not routinely obtained in community medical = practices=20 until 1998, it was not uncommon for information = on=20 ERBB2 (HER2) status to be missing. =


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Table.=20 Characteristics of Invasive Breast Cancers = by=20 Study Group =


In subgroup analyses, no significant interactions were=20 observed among combined hormone therapy use and = breast=20 cancer incidence with age, body mass index, and = Gail risk=20 score (Figure=20 3). For women entering the study with no = prior use of=20 estrogen plus progestin, the HR for breast cancer = incidence was 1.16 (95% CI, 0.98-1.37) compared = with an=20 HR of 1.85 (95% CI, 1.25-2.80) for women with = prior=20 combined hormone therapy use = (P =3D .03=20 for interaction). The HR for breast cancer incidence = among=20 women with 1 year or less of prior combined = hormone=20 therapy use was 2.16 (95% CI, 1.15-4.24) (Figure=20 3). Women who first used hormone therapy = closer to=20 menopause (<5 years) were at somewhat greater = risk of=20 developing breast cancer in the combined hormone = therapy=20 group, but the interaction term was not significant=20 (P =3D .08).



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Figure=20 3. Invasive Breast Cancer Incidence by = Baseline Characteristics and Study Group

Hazard ratios (HRs; estrogen plus = progestin vs=20 placebo) with 95% confidence intervals = (CIs) are=20 from Cox regression models stratified by = age and=20 randomization assignment in the dietary=20 modification trial. For subgroup analyses, = HRs are=20 allowed to vary by subgroup, and Cox = regression=20 models are stratified by age, = randomization=20 assignment in the Women's Health = Initiative=20 dietary modification trial, and subgroup. = P=20 values are from Cox regression models for = a=20 1-degree-of-freedom test for trend. = Current use=20 refers to those reporting estrogen plus = progestin=20 use at time of initial evaluation. A = 3-month=20 washout was required before study entry. = The=20 time-since-menopause variable was defined = as the=20 interval from the onset of menopause until = first=20 menopausal hormone therapy use or first = study=20 medication use (estrogen plus progestin or = placebo). =
aEvents in=20 both subsets of the estrogen plus = progestin group=20 are compared with all events in the = placebo group. =


More women died of breast cancer in the combined hormone=20 therapy group compared with the placebo group (25 = deaths=20 [0.03% per year] vs 12 deaths [0.01% per year]; = HR, 1.96;=20 95% CI, 1.00-4.04; P =3D .049) = (Figure=20 4A), representing 2.6 vs 1.3 deaths per = 10 000=20 women per year, respectively. Censoring of follow-up = time=20 on March 31, 2005, for women not reconsenting did not = alter=20 the results for death due to breast cancer (HR, 1.96; = 95%=20 CI, 1.01-4.05; P =3D .048). = Consideration=20 of all-cause mortality after breast cancer = diagnosis=20 provided similar results; among women in the = combined=20 hormone therapy group, there were 51 deaths = [0.05% per=20 year] compared with 31 deaths [0.03% per year] among=20 women in the placebo group; HR, 1.57; 95% CI, = 1.01-2.48;=20 P =3D .045) (Figure=20 4B), representing 5.3 vs 3.4 deaths per 10 000 = women per year, respectively.



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Figure=20 4. Deaths After Breast Cancer in the = WHI=20 Clinical Trial

Kaplan-Meier cumulative hazard curves = for (A)=20 mortality directly attributed to breast = cancer, by=20 study group and time since randomization = and (B)=20 mortality due to all causes following a = breast=20 cancer diagnosis, by study group and time = in the=20 trial. Hazard ratios (HRs), 95% confidence = intervals (CIs), and P values are = from Cox=20 regression models, stratified by 5-year = age=20 intervals and randomization assignment in = the=20 Women's Health Initiative (WHI) dietary=20 modification trial. All women stopped the=20 intervention by 8.6 years. =


Sensitivity analyses also suggested an adverse effect of=20 combined hormone therapy compared with placebo on = breast=20 cancer mortality when follow-up time for each = woman was=20 censored at nonadherence (14 vs 5 deaths, = respectively;=20 HR, 2.96; 95% CI, 1.00-8.77; = P =3D .053).=20 Inverse probability weighting and multiple = imputation=20 analyses to address potential imbalance associated = with=20 reconsent supported the primary analyses, suggesting an = increase in deaths due to breast cancer with estrogen = plus=20 progestin (inverse probability weighting summary = HR,=20 2.22; 95% CI, 1.07-4.59; multiple imputation = summary HR,=20 2.12; 95% CI, 1.02-4.40).


COMMENT=20
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 =95 Top
 =95 Introduction
 =95 Methods=
 =95 Results=
 =95 Comment
 =95 Author=20 information
 =95 References
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In=20 the WHI randomized, placebo-controlled trial, conjugated = equine=20 estrogen plus medroxyprogesterone acetate increased invasive = breast=20 cancer incidence, and the cancers were more commonly=20 node-positive. There were more deaths = attributed to=20 breast cancer (2.6 vs 1.3 per 10 000 women per year) = and more=20 deaths due to all causes following a diagnosis of breast = cancer (5.3=20 vs 3.4 per 10 000 women per year) in the combined = hormone=20 therapy group vs the placebo group.

With some exceptions,8-9=20 the preponderance of observational studies have=20 associated combined hormone therapy use with an = increase=20 in breast cancers that have favorable = characteristics,7=20 lower stage,5,=20 10<= /SUP>=20 and longer survival compared with breast cancers=20 diagnosed in nonusers of hormone therapy.7,=20 10<= /SUP>=20 However, in the WHI randomized trial, combined = hormone=20 therapy increased breast cancer risk and = interfered with=20 breast cancer detection, leading to cancers being = diagnosed at more advanced stages.2-3=20 Now, with longer follow-up results available, there = remains=20 a cumulative, statistically significant increase in = breast=20 cancers in the combined hormone therapy group, = and the=20 cancers more commonly had lymph node involvement. = The=20 observed adverse influence on breast cancer = mortality of=20 combined hormone therapy can reasonably be = explained by=20 the influence on breast cancer incidence and = stage.=20

The discrepancy between the current randomized clinical=20 trial findings and observational studies with = respect to=20 breast cancer mortality likely are related to = potential=20 confounding in observational analyses. = Observational=20 studies that begin analyses at breast cancer = diagnosis=20 and adjust for stage7,=20 18<= /SUP>=20 potentially adjust away unfavorable consequences = of=20 estrogen-plus-progestin use. Postmenopausal = hormone=20 therapy users have mammograms at more regular = intervals=20 than nonusers,19-= 20<= /SUP>=20 likely because of breast cancer concerns. Studies = that=20 are unable to control for mammography can be = confounded=20 by differences between screening-detected and=20 non=96screening-detected breast cancers. Screening more = commonly identifies slow-growing, favorable-grade, = hormone=20 receptor=96positive breast cancers, and diagnosis = is made=20 at an earlier stage.21-= 23<= /SUP>=20 Our findings are consistent with the observational = Million=20 Women Study, in which all women had mammograms and = breast=20 cancer mortality analyses began at cohort entry = rather=20 than at the time of breast cancer diagnosis. In = the=20 Million Women Study, combined hormone therapy use = was=20 associated with higher breast cancer mortality = (HR, 1.22;=20 95% CI, 1.00-1.48; P =3D .05).10<= /SUP>=20

Following the initial report of results from the WHI=20 trial,1=20 a substantial decrease in breast cancer incidence = occurred=20 in the United States, which was attributed24-= 25<= /SUP>=20 to the marked decrease in postmenopausal hormone = therapy=20 use that occurred after publication of the trial=20 results.26<= /SUP>=20 The adverse influence of estrogen plus progestin = on=20 breast cancer mortality suggests that a future = reduction=20 in breast cancer mortality in the United States may = be=20 anticipated as well.

Accurate determination of cause of death after a breast=20 cancer diagnosis is problematic given the = potential=20 interaction between common comorbidities and = cancer=20 treatments.27<= /SUP>=20 Thus, the actual mortality risk related to breast = cancer=20 likely lies somewhere between the medical record=20 attributed risk and consideration of all = mortality=20 following breast cancer diagnoses.

The relative influence of combined hormone therapy on = both=20 the breast cancer mortality reported herein and = lung=20 cancer mortality28<= /SUP>=20 was greater than its influence on cancer incidence. Reproductive hormones,29-= 30<= /SUP>=20 especially progestin,31-= 32<= /SUP>=20 are potent stimulators of angiogenesis. Because = increased=20 angiogenesis increases both lung33<= /SUP>=20 and breast cancer metastases,34<= /SUP>=20 these findings suggest that angiogenesis = stimulation by=20 combined hormone therapy may facilitate growth = and=20 metastatic spread of already-established = cancers.=20 Unless the mortality risks of lung cancer and breast=20 cancer can be mitigated, use of combined hormone=20 therapy=97other than short-term therapy in women = with=20 climacteric symptoms not ameliorated by other=20 therapies=97seems unwarranted.

The WHI trial results evaluating estrogen plus progestin=20 have been generally accepted by health regulatory = agencies. However, some clinicians continue to = question=20 the applicability of the results to current = clinical=20 practice,35-= 36<= /SUP>=20 emphasizing potential differences in coronary = heart=20 disease risk when hormone therapy is begun = shortly after=20 menopause.15,= =20 37<= /SUP>=20 However, both prior analyses38<= /SUP>=20 and the current analysis reflecting longer follow-up = of=20 the study participants suggest a somewhat greater = adverse=20 hormonal effect on breast cancer incidence among women = randomized closer to menopause, with similar = findings=20 seen in the French E3N observational = cohort.39<= /SUP>=20 Additionally, current analyses support our prior=20 suggestion that durations of use only slightly longer=20 than those in the trial are associated with increases = in=20 breast cancer risk.40<= /SUP>=20 Given these findings and the effect of combined = hormone=20 therapy to delay breast cancer diagnosis,2-3=20 from a breast cancer perspective, a safe interval = for=20 combined hormone therapy use cannot be reliably=20 defined.

Strengths of this study include the randomized, = double-blind=20 design, a large and ethnically diverse study = population,=20 serial assessment of mammography and clinical = breast=20 examinations, central adjudication of breast = cancers, and=20 the long follow-up period. The lack of breast = cancer=20 therapy information and the modest number of = deaths in=20 women diagnosed as having breast cancer are = limitations,=20 as is the difficulty in attributing cause of = death in=20 breast cancer patients. For the breast cancer = mortality=20 analyses, the wide CIs with lower limits close to = 1.0=20 imply some caution in interpretation. The relatively = modest=20 duration of study estrogen-plus-progestin use was = limited=20 by the net adverse effect of combined hormone = therapy on=20 clinical outcomes.

Some might consider a study limitation to be the = necessity=20 of reconsent for follow-up of disease incidence = beyond=20 the original trial completion date. The fact that = 17% of=20 women did not reconsent may have influenced = estimation of=20 the effect of combined hormone therapy on breast = cancer.=20 However, in both the original randomized group = and in the=20 reconsenting group, baseline characteristics were = comparable in the hormone therapy and placebo groups. = In=20 addition, inverse probability weighting and multiple=20 imputation analyses to address this concern = resulted in=20 similar findings regarding use of estrogen plus = progestin=20 and deaths due to breast cancer.

In conclusion, use of estrogen plus progestin increases = the=20 incidence of breast cancer, and the cancers are more=20 commonly node-positive. Mortality data analyses = suggest=20 that breast cancer mortality may also be = increased.=20


AUTHOR=20 INFORMATION
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 =95 Introduction
 =95 Methods=
 =95 Results=
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Corresponding=20 Author: Rowan T. Chlebowski, MD, PhD, Los Angeles=20 Biomedical Research Institute at Harbor-UCLA Medical=20 Center, 1124 W Carson St, Torrance, CA 90502 = (rchlebowski{at}gmail.com ).

Author Contributions: Dr Chlebowski had full = access to all=20 of the data in the study and takes responsibility = for the=20 integrity of the data and the accuracy of the = data=20 analysis.

Study concept and design: Chlebowski, Manson,=20 Wactawski-Wende, Hendrix, Prentice.

Acquisition of data: Chlebowski, Gass, Lane, = Kuller,=20 Manson, Stefanick, Ockene, Sarto, Johnson,=20 Wactawski-Wende, Hendrix, Yasmeen.

Analysis and interpretation of data: Chlebowski, = Anderson,=20 Aragaki, Manson, Johnson, Wactawski-Wende, = Ravdin,=20 Schenken, Hendrix, Rajkovic, Rohan, = Prentice.

Drafting of the manuscript: Chlebowski, Aragaki,=20 Prentice.

Critical revision of the manuscript for important=20 intellectual content: Chlebowski, Anderson, = Gass,=20 Lane, Aragaki, Kuller, Manson, Stefanick, Ockene, = Sarto,=20 Johnson, Wactawski-Wende, Ravdin, Schenken, = Hendrix,=20 Rajkovic, Rohan, Prentice.

Statistical analysis: Aragaki, Yasmeen, = Prentice.=20

Obtained funding: Lane, Kuller, Manson, Stefanick, = Ockene,=20 Wactawski-Wende, Hendrix, Prentice.

Administrative, technical, or material support:=20 Chlebowski, Anderson, Kuller, Manson, Stefanick, = Johnson,=20 Wactawski-Wende, Schenken, Hendrix, = Prentice.

Study supervision: Chlebowski, Anderson, Ockene, = Johnson,=20 Hendrix, Rajkovic.

Financial Disclosures: Dr Chlebowski reports that = he has=20 received consulting fees from AstraZeneca, = Novartis, and=20 Pfizer, lecture fees from AstraZeneca and = Novartis, and=20 grant funding from Amgen. Dr Gass reports that = she has=20 received funding for multisite clinical trials = from=20 Procter & Gamble and Wyeth Laboratories and=20 consulting fees from Upsher-Smith Laboratories, Wyeth=20 Pharmaceuticals, and Procter & Gamble. Dr = Hendrix=20 reports that she has received consulting fees = from=20 Meditrina Pharmaceuticals Inc, lecture fees from = Merck,=20 and grant funding from Boehringer Ingelheim and = Organon.=20 Dr Rohan reports that he has received consulting = fees=20 from legal firms regarding hormone therapy issues. No = other=20 financial disclosures were reported.

WHI Investigators: Program Office: National = Heart,=20 Lung, and Blood Institute, Bethesda, MD = (Elizabeth Nabel,=20 Jacques Rossouw, Shari Ludlam, Joan McGowan, = Nancy=20 Geller, Leslie Ford). Clinical Coordinating=20 Center: Fred Hutchinson Cancer Research Center,=20 Seattle, WA (Ross Prentice, Garnet Anderson, Andrea=20 LaCroix, Ruth Patterson, Anne McTiernan, Barbara=20 Cochrane, Julie Hunt, Lesley Tinker, Charles = Kooperberg,=20 Martin McIntosh, C. Y. Wang, Chu Chen, Deborah = Bowen,=20 Alan Kristal, Janet Stanford, Nicole Urban, Noel = Weiss,=20 Emily White); Medical Research Laboratories, = Highland=20 Heights, KY (Evan Stein, Peter Laskarzewski); San = Francisco=20 Coordinating Center, San Francisco, CA (Steven R.=20 Cummings, Michael Nevitt, Lisa Palermo); = University of=20 Minnesota, Minneapolis (Lisa Harnack); Fisher=20 BioServices, Rockville, MD (Frank Cammarata, = Steve=20 Lindenfelser); University of Washington, Seattle (Bruce = Psaty, Susan Heckbert). Clinical Centers: = Albert=20 Einstein College of Medicine, Bronx, NY (Sylvia=20 Wassertheil-Smoller, William Frishman, Judith=20 Wylie-Rosett, David Barad, Ruth Freeman); Baylor = College=20 of Medicine, Houston, TX (Aleksandar Rajkovic, Jennifer = Hays, Ronald Young, Haleh Sangi-Haghpeykar); Brigham = and=20 Women's Hospital, Harvard Medical School, Boston, = MA=20 (JoAnn E. Manson, Kathryn M. Rexrode, Brian = Walsh, J.=20 Michael Gaziano, Maria Bueche); Brown University, = Providence, RI (Charles B. Eaton, Michele Cyr, = Gretchen=20 Sloane); Emory University, Atlanta, GA (Lawrence=20 Phillips, Vicki Butler, Vivian Porter); Fred = Hutchinson=20 Cancer Research Center, Seattle, WA (Shirley A. = A.=20 Beresford, Vicky M. Taylor, Nancy F. Woods, = Maureen=20 Henderson, Robyn Andersen); George Washington = University,=20 Washington, DC (Lisa Martin, Judith Hsia, Nancy = Gaba,=20 Richard Katz); Los Angeles Biomedical Research = Institute=20 at Harbor-UCLA Research and Education Institute, = Torrance,=20 CA (Rowan Chlebowski, Robert Detrano, Anita Nelson,=20 Michele Geller); Kaiser Permanente Center for = Health=20 Research, Portland, OR (Yvonne Michael, Evelyn = Whitlock,=20 Victor Stevens, Njeri Karanja); Kaiser Permanente = Division of Research, Oakland, CA (Bette Caan, = Stephen=20 Sidney, Geri Bailey Jane Hirata); Medical College of=20 Wisconsin, Milwaukee (Jane Morley Kotchen, Vanessa=20 Barnabei, Theodore A. Kotchen, Mary Ann C. = Gilligan, Joan=20 Neuner); MedStar Research Institute/Howard = University,=20 Washington, DC (Barbara V. Howard, Lucile = Adams-Campbell,=20 Lawrence Lessin, Cheryl Iglesia, Linda K Mickel); = Northwestern University, Chicago/Evanston, IL = (Linda Van=20 Horn, Philip Greenland, Janardan Khandekar, Kiang = Liu,=20 Carol Rosenberg); Rush University Medical Center, = Chicago,=20 IL (Henry Black, Lynda Powell, Ellen Mason, Martha=20 Gulati); Stanford Prevention Research Center, = Stanford,=20 CA (Marcia L. Stefanick, Mark A. Hlatky, Bertha = Chen,=20 Randall S. Stafford, Sally Mackey); State = University of=20 New York at Stony Brook (Dorothy Lane, Iris = Granek,=20 William Lawson, Catherine Messina, Gabriel San = Roman);=20 Ohio State University, Columbus (Rebecca Jackson, = Randall=20 Harris, Electra Paskett, W. Jerry Mysiw, Michael = Blumenfeld);=20 University of Alabama at Birmingham (Cora E. Lewis, = Albert=20 Oberman, James M. Shikany, Monika Safford); = University of=20 Arizona, Tucson/Phoenix (Cynthia A. Thomson, = Tamsen=20 Bassford, Cheryl Ritenbaugh, Zhao Chen, Marcia = Ko);=20 University at Buffalo, Buffalo, NY (Jean = Wactawski-Wende,=20 Maurizio Trevisan, Ellen Smit, Susan Graham, June = Chang);=20 University of California at Davis, Sacramento = (John=20 Robbins, S. Yasmeen); University of California at = Irvine=20 (F. Allan Hubbell, Gail Frank, Nathan Wong, Nancy = Greep,=20 Bradley Monk); University of California at Los = Angeles=20 (Lauren Nathan, David Heber, Robert Elashoff, = Simin Liu);=20 University of California at San Diego, LaJolla/Chula=20 Vista (Robert D. Langer, Michael H. Criqui, Gregory T. = Talavera, Cedric F. Garland, Matthew A. Allison); = University of Cincinnati, Cincinnati, OH (Margery = Gass,=20 Nelson Watts); University of Florida,=20 Gainesville/Jacksonville (Marian Limacher, Michael = Perri,=20 Andrew Kaunitz, R. Stan Williams, Yvonne = Brinson);=20 University of Hawaii, Honolulu (J. David Curb, = Helen=20 Petrovitch, Beatriz Rodriguez, Kamal Masaki, = Patricia=20 Blanchette); University of Iowa, Iowa = City/Davenport=20 (Robert Wallace, James Torner, Susan Johnson, = Linda=20 Snetselaar, Jennifer Robinson); University of=20 Massachusetts/Fallon Clinic, Worcester (Judith = Ockene,=20 Milagros Rosal, Ira Ockene, Robert Yood, Patricia = Aronson); University of Medicine and Dentistry of = New=20 Jersey, Newark (Norman Lasser, Baljinder Singh, Vera=20 Lasser, John Kostis, Peter McGovern); University of = Miami,=20 Miami, FL (Mary Jo O=92Sullivan, Linda Parker, = JoNell=20 Potter, Diann Fernandez, Pat Caralis); University = of=20 Minnesota, Minneapolis (Karen L. Margolis, = Richard H.=20 Grimm, Mary F. Perron, Cynthia Bjerk, Sarah = Kempainen);=20 University of Nevada, Reno (Robert Brunner, = William=20 Graettinger, Vicki Oujevolk, Michael Bloch); = University=20 of North Carolina, Chapel Hill (Gerardo Heiss, Pamela=20 Haines, David Ontjes, Carla Sueta, Ellen Wells);=20 University of Pittsburgh, Pittsburgh, PA (Lewis = Kuller,=20 Jane Cauley, N. Carole Milas); University of = Tennessee=20 Health Science Center, Memphis (Karen C. Johnson, = Suzanne=20 Satterfield, Rongling Li, Stephanie Connelly, = Fran=20 Tylavsky); University of Texas Health Science = Center, San=20 Antonio (Robert Brzyski, Robert Schenken); = University of=20 Wisconsin, Madison (Gloria E. Sarto, Douglas Laube,=20 Patrick McBride, Julie Mares, Barbara Loevinger); Wake = Forest University School of Medicine, = Winston-Salem, NC=20 (Mara Vitolins, Greg Burke, Robin Crouse, Scott=20 Washburn); Wayne State University School of=20 Medicine/Hutzel Hospital, Detroit, MI (Michael Simon).=20 Women's Health Initiative Memory Study: Wake = Forest=20 University School of Medicine, Winston-Salem, NC = (Sally=20 Shumaker, Stephen Rapp, Claudine Legault, Mark = Espeland,=20 Laura Coker). Former Principal Investigators = and=20 Project Officers: Baylor College of Medicine, = Houston, TX (Jennifer Hays, John Foreyt); Brown=20 University, Providence, RI (Annlouise R. Assaf); Emory = University, Atlanta, GA (Dallas Hall); George = Washington=20 University, Washington, DC (Valery Miller); = Kaiser=20 Permanente Center for Health Research, Portland, = OR=20 (Barbara Valanis); Kaiser Permanente Division of=20 Research, Oakland, CA (Robert Hiatt); National Cancer=20 Institute, Bethesda, MD (Carolyn Clifford3D{dagger});=20 National Heart, Lung, and Blood Institute, = Bethesda, MD=20 (Linda Pottern); University of California at = Irvine=20 (Frank Meyskens Jr); University of California at Los=20 Angeles (Howard Judd3D{dagger}=20); = University of=20 Cincinnati, Cincinnati, OH (James Liu, Nelson = Watts);=20 University of Miami, Miami, FL (Marianna Baum);=20 University of Minnesota, Minneapolis (Richard = Grimm);=20 University of Nevada, Reno (Sandra Daugherty3D{dagger});=20 University of North Carolina, Chapel Hill (David = Sheps,=20 Barbara Hulka); University of Tennessee Health = Science=20 Center, Memphis (William Applegate); University = of=20 Wisconsin, Madison (Catherine Allen3D{dagger}=20); Wake = Forest=20 University School of Medicine, Winston-Salem, NC = (Denise=20 Bonds).

3D{dagger}=20Deceased.

Funding/Support: The WHI program is funded by the = National=20 Heart, Lung, and Blood Institute, National = Institutes of=20 Health, US Department of Health and Human = Services,=20 through contracts N01WH22110, 24152, 32100-2, = 32105-6,=20 32108-9, 32111-13, 32115, 32118-32119, 32122, = 42107-26,=20 42129-32, and 44221.

Role of the Sponsor: The study sponsor had input = into the=20 design and conduct of the study and participated = in the=20 report review but did not participate in = preparation of=20 the manuscript.

Additional Contributions: We acknowledge the = dedicated=20 efforts of the investigators and staff at the WHI = clinical centers, the WHI Clinical Coordinating = Center,=20 and the National Heart, Lung, and Blood Institute = program=20 office (listing available at http://www.whi.org/). We = recognize=20 the WHI participants for their extraordinary = commitment=20 to the WHI program.

Author=20 Affiliations: Los Angeles Biomedical Research Institute = at=20 Harbor-UCLA Medical Center, Torrance, California (Dr = Chlebowski);=20 Fred Hutchinson Cancer Research Center, Seattle, Washington = (Drs=20 Anderson and Prentice and Mr Aragaki); University of = Cincinnati,=20 Cincinnati, Ohio (Dr Gass); State University of New York at = Stony=20 Brook (Dr Lane); University of Pittsburgh, Pittsburgh, = Pennsylvania=20 (Dr Kuller); Brigham and Women's Hospital, Harvard Medical = School,=20 Boston, Massachusetts (Dr Manson); Stanford Prevention = Research=20 Center, Stanford, California (Dr Stefanick); University of=20 Massachusetts/ Fallon Clinic, Worcester (Dr Ockene); = University of=20 Wisconsin, Madison (Dr Sarto); University of Tennessee = Health=20 Science Center, Memphis (Dr Johnson); University at Buffalo, = Buffalo, New York (Dr Wactawski-Wende); Cancer Therapy and = Research=20 Center (Dr Ravdin) and University of Texas Health Science = Center (Dr=20 Schenken), San Antonio; Wayne State School of Medicine and = Hurtzel=20 Hosptial, Detroit, Michigan (Dr Hendrix); Baylor College of=20 Medicine, Houston, Texas (Dr Rajkovic); Albert Einstein = College of=20 Medicine, New York, New York (Dr Rohan); and University of=20 California at Davis, Sacramento (Dr Yasmeen).


REFERENCES=20
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 =95 Top
 =95 Introduction
 =95 Methods=
 =95 Results=
 =95 Comment=
 =95 Author=20 information
 =95 References
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1. = Rossouw JE, Anderson GL, Prentice RL; et al, Writing Group = for the=20 Women's Health Initiative Investigators. Risks and benefits = of=20 estrogen plus progestin in healthy postmenopausal women: = principal=20 results from the Women's Health Initiative randomized = controlled=20 trial. JAMA. 2002;288(3):321-333. FREE FULL=20 TEXT
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RELATED=20 ARTICLE=20
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Postmenopausal Hormone Therapy and Breast Cancer: = An=20 Uncertain Trade-off
Peter B. Bach =
JAMA.=20 2010;304(15):1719-1720.
EXTRACT= =20 | FULL=20 TEXT  =20


THIS ARTICLE HAS = BEEN CITED=20 BY OTHER ARTICLES=20
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Postmenopausal=20 Hormone Therapy and Breast Cancer: An Uncertain=20 Trade-off
Bach
JAMA=20 2010;304:1719-1720.
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