Evidence map›Paper›PMID 20959578›Full record

Trial reportJAMA2010

Estrogen plus progestin and breast cancer incidence and mortality in postmenopausal women.

Rowan T Chlebowski, Garnet L Anderson, Margery Gass, Dorothy S Lane, Aaron K Aragaki, Lewis H Kuller, JoAnn E Manson, Marcia L Stefanick, Judith Ockene, Gloria E Sarto and 10 more

Registry-linked trialAbstract readMulticenter StudyRandomized Controlled Trial
In one paragraph

Trial report in JAMA, 2010. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT00000611 (Women's Health Initiative), which is not on this map. Cited by 214 papers, 9 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
214citing papers in PubMed, 9 pooled it
34.7field-weighted citation impact, top 1% of its field
1 · What the graph read from it

What it found

Each row is one number read from the abstract, on the scale the paper reported it, with its interval. Left of the dashed line favours the treatment, right favours the comparator. Under each row is the sentence it came from. New to these charts? A ten-minute tutorial.

The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.

2 · The registry

The trial behind it

Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.

NCT00000611 phase3completednot on this map

Women's Health Initiative (WHI)

TypeinterventionalSponsorNational Heart, Lung, and Blood Institute (NHLBI)ConditionsBone Diseases, Breast Neoplasms, Cardiovascular Diseases, Colonic NeoplasmsArmshormone replacement therapy, estrogens, progestins, estrogen replacement therapy, diet, fat-restricted
3 · Its place in the literature

Who cites it

214 citing papers in PubMed, 9 syntheses or guidelines pooled it, 564 citations in OpenAlex.

  1. Pooled it
  2. Pooled it
  3. Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017
    Guideline
  4. Long-term hormone therapy for perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2017
    Pooled it
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  9. Guideline
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154 more citing papers are in PubMed but not listed here.

4 · The record

Corrections and comments

5 · Who and what money

Authors and funding

20 authors at 16 institutions in 1 country.

Rowan T ChlebowskiLos Angeles Biomedical Research Institute at Harbor-UCLA Medical Center, 1124 W Carson St, Torrance, CA 90502, USA. rchlebowski@gmail.com
Garnet L Anderson
Margery Gass
Dorothy S Lane
Aaron K Aragaki
Lewis H Kuller
JoAnn E Manson
Marcia L Stefanick
Judith Ockene
Gloria E Sarto
Karen C Johnson
Jean Wactawski-Wende
Peter M Ravdin
Robert Schenken
Susan L Hendrix
Aleksandar Rajkovic
Thomas E Rohan
Shagufta Yasmeen
Ross L Prentice
WHI Investigators
Fred Hutch Cancer Center · USThe University of Texas Health Science Center at San Antonio · USBaylor College of Medicine · USHarvard University Press · USStanford University · USStony Brook University · USUniversity at Buffalo, State University of New York · USUniversity of California, Davis · USUniversity of California, Los Angeles · USUniversity of Cincinnati · USUniversity of Massachusetts Chan Medical School · USUniversity of Pittsburgh · USUniversity of Tennessee Health Science Center · USUniversity of Wisconsin–Madison · USWayne State University · USYeshiva University · US

Funding

CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042119 · WH · YESHIVA UNIVERSITY · PI WASSERTHEIL-SMOLLER, SYLVIA · 1994 to 2001
$2.2M
VANGUARD CENTER FOR WOMEN'S HEALTH INITIATIVEN01WH032101 · WH · UNIVERSITY OF MINNESOTA TWIN CITIES · PI GRIMM, RICHARD H · 1993 to 2000
$1.7M
VANGUARD CENTER FOR WOMEN'S HEALTH INITIATIVEN01WH032111 · WH · EMORY UNIVERSITY · PI WATTS, NELSON · 1993 to 2001
$1.6M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042123 · WH · MEDSTAR RESEARCH INSTITUTE · PI HOWARD, BARBARA V · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042109 · WH · STANFORD UNIVERSITY · PI STEFANICK, MARCIA L · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042114 · WH · KAISER FOUNDATION RESEARCH INSTITUTE · PI RITENBAUGH, CHERYL K · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042108 · WH · GEORGE WASHINGTON UNIVERSITY · PI HSIA, JUDITH · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042124 · WH · RUSH UNIVERSITY MEDICAL CENTER · PI BLACK, HENRY R · 1994 to 2000
$1.4M
CLIN CTR CLIN TRIAL/OBSERVATIONAL STUDY OF WHIN01WH042131 · WH · UNIVERSITY OF MIAMI SCHOOL OF MEDICINE · PI O'SULLIVAN, MARY J · 1994 to 2000
$1.3M
WOMENS HEALTH INITIATIVE-N01WH22110N01WH022110 · WH · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ROSS, PRENTICE · 1992 to 2006
$1.2M
VANGUARD CENTER FOR WOMEN'S HEALTH INITIATIVEN01WH032105 · WH · UNIVERSITY OF ALABAMA AT BIRMINGHAM · PI OBERMAN, ALBERT · 1993 to 2000
$1.2M
VANGUARD CENTER FOR WOMEN'S HEALTH INITIATIVEN01WH032119 · WH · MEMORIAL HOSPITAL OF RHODE ISLAND · PI ASSAF, ANNLOUISE R. · 1993 to 2000
$1.2M
NHLBI NIH HHS N01 WH032105NHLBI NIH HHS N01 WH032118NHLBI NIH HHS N01 WH042107WHI NIH HHS N01 WH022110WHI NIH HHS N01 WH024152WHI NIH HHS N01 WH032100WHI NIH HHS N01 WH032108WHI NIH HHS N01 WH032111WHI NIH HHS N01 WH032115WHI NIH HHS N01 WH032119WHI NIH HHS N01 WH032122WHI NIH HHS N01 WH042129WHI NIH HHS N01 WH044221WHI NIH HHS N01WH32101WHI NIH HHS N01WH32102WHI NIH HHS N01WH32106WHI NIH HHS N01WH32109WHI NIH HHS N01WH32112WHI NIH HHS N01WH32113WHI NIH HHS N01WH42108WHI NIH HHS N01WH42109WHI NIH HHS N01WH42110WHI NIH HHS N01WH42111WHI NIH HHS N01WH42112WHI NIH HHS N01WH42113WHI NIH HHS N01WH42114WHI NIH HHS N01WH42115WHI NIH HHS N01WH42116WHI NIH HHS N01WH42117WHI NIH HHS N01WH42118WHI NIH HHS N01WH42119WHI NIH HHS N01WH42120WHI NIH HHS N01WH42121WHI NIH HHS N01WH42122WHI NIH HHS N01WH42123WHI NIH HHS N01WH42124WHI NIH HHS N01WH42125WHI NIH HHS N01WH42126WHI NIH HHS N01WH42130WHI NIH HHS N01WH42131WHI NIH HHS N01WH42132
6 · The paper itself

Abstract

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

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

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

main outcome measuresInvasive breast cancer incidence and breast cancer mortality.

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

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

trial registrationclinicaltrials.gov Identifier: NCT00000611.

Indexed as

PostmenopauseAgedBreast NeoplasmsDrug CombinationsEstrogens, Conjugated (USP)FemaleFollow-Up StudiesHormone Replacement TherapyHumansIncidenceLymphatic MetastasisMedroxyprogesterone AcetateMiddle AgedNeoplasm InvasivenessNeoplasm StagingPrognosisDrug CombinationsEstrogens, Conjugated (USP)Medroxyprogesterone AcetatePrempro

Identifiers

PMID20959578
PMCPMC5142300
OpenAlexW2139272277

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Registered trials

Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.