Evidence map›Paper›PMID 23008295›Full record

Trial reportJournal of clinical oncology : official journal of the American Society of Clinical Oncology2012

Estrogen plus progestin and colorectal cancer incidence and mortality.

Michael S Simon, Rowan T Chlebowski, Jean Wactawski-Wende, Karen C Johnson, Andrew Muskovitz, Ikuko Kato, Alicia Young, F Allan Hubbell, Ross L Prentice

Erratum issuedAbstract readRandomized Controlled Trial
In one paragraph

Trial report in Journal of clinical oncology : official journal of the American Society of Clinical Oncology, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. An erratum has been issued. Cited by 60 papers, 5 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
60citing papers in PubMed, 5 pooled it
3.6field-weighted citation impact, top 6% 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.

Neither the registry nor the abstract names a trial number. If this is a trial report, that itself is worth knowing.

3 · Its place in the literature

Who cites it

60 citing papers in PubMed, 5 syntheses or guidelines pooled it, 116 citations in OpenAlex.

  1. Pooled it
  2. Survivorship, Version 2.2017, NCCN Clinical Practice Guidelines in Oncology.Journal of the National Comprehensive Cancer Network : JNCCN · 2017
    Guideline
  3. Long-term hormone therapy for perimenopausal and postmenopausal women.The Cochrane database of systematic reviews · 2017
    Pooled it
  4. Pooled it
  5. Pooled it
  6. Estrogen Plus Progestin and Colorectal Cancer: Long-Term Findings From the Women's Health Initiative Randomized Clinical Trial.Journal of clinical oncology : official journal of the American Society of Clinical Oncology · 2024
    Trial
  7. Article
  8. Then and Now: What We Have Learned From the WHI.The Journal of clinical endocrinology and metabolism · 2026
    Review
  9. Article
  10. Article
  11. Article
  12. Article
  13. Review
  14. Article
  15. Article
  16. Article
  17. Review
  18. Article
  19. Article
  20. Article
4 · The record

Corrections and comments

  • Erratum issued
5 · Who and what money

Authors and funding

9 authors at 1 institution in 1 country.

Michael S SimonKarmanos Cancer Institute, Wayne State University, Hudson Webber Cancer Research Building, 4221 HWCRC, 4100 John R, Detroit, MI 48201, USA. simonm@karmanos.org
Rowan T Chlebowski
Jean Wactawski-Wende
Karen C Johnson
Andrew Muskovitz
Ikuko Kato
Alicia Young
F Allan Hubbell
Ross L Prentice
University at Buffalo, State University of New York · US

Funding

Tumor Biology and Microenvironment (Program 1)P30CA022453 · NCI · WAYNE STATE UNIVERSITY · PI PAUL M STEMMER · 1985 to 2026
$68.4M
UCLA Clinical and Translational Science InstituteUL1TR000124 · NCATS · UNIVERSITY OF CALIFORNIA LOS ANGELES · PI DUBINETT, STEVEN M. · 2012 to 2015
$57.0M
WOMENS HEALTH INITIATIVE-N01WH22110N01WH022110 · WH · FRED HUTCHINSON CANCER RESEARCH CENTER · PI ROSS, PRENTICE · 1992 to 2006
$1.2M
NCATS NIH HHS UL1 TR000124NCI NIH HHS P30 CA022453NCI NIH HHS P30CA022453WHI NIH HHS N01 WH022110
6 · The paper itself

Abstract

purposeDuring the intervention phase in the Women's Health Initiative (WHI) clinical trial, use of estrogen plus progestin reduced the colorectal cancer diagnosis rate, but the cancers were found at a substantially higher stage. To assess the clinical relevance of the findings, analyses of the influence of combined hormone therapy on colorectal cancer incidence and colorectal cancer mortality were conducted after extended follow-up. PATIENTS AND

methodsThe WHI study was a randomized, double-blind, placebo-controlled clinical trial involving 16,608 postmenopausal women with an intact uterus who were randomly assigned to daily 0.625 mg conjugated equine estrogen plus 2.5 mg medroxyprogesterone acetate (n = 8,506) or matching placebo (n = 8,102). Colorectal cancer diagnosis rates and colorectal cancer mortality were assessed.

resultsAfter a mean of 5.6 years (standard deviation [SD], 1.03 years) of intervention and 11.6 years (SD, 3.1 years) of total follow-up, fewer colorectal cancers were diagnosed in the combined hormone therapy group compared with the placebo group (diagnoses/year, 0.12% v 0.16%; hazard ratio [HR], 0.72; 95% CI, 0.56 to 0.94; P = .014). Bowel screening examinations were comparable between groups throughout. Cancers in the combined hormone therapy group more commonly had positive lymph nodes (50.5% v 28.6%; P < .001) and were at higher stage (regional or distant, 68.8% v 51.4%; P = .003). Although not statistically significant, there was a higher number of colorectal cancer deaths in the combined hormone therapy group (37 v 27 deaths; 0.04% v 0.03%; HR, 1.29; 95% CI, 0.78 to 2.11; P = .320).

conclusionThe findings, suggestive of diagnostic delay, do not support a clinically meaningful benefit for combined hormone therapy on colorectal cancer.

Indexed as

Estrogen Replacement TherapyAdultAgedColorectal NeoplasmsDelayed DiagnosisDouble-Blind MethodEstrogens, Conjugated (USP)FemaleFollow-Up StudiesHumansIncidenceKaplan-Meier EstimateMedroxyprogesterone AcetateMiddle AgedNeoplasm StagingOdds RatioEstrogens, Conjugated (USP)Medroxyprogesterone AcetateProgestins

Identifiers

PMID23008295
PMCPMC3488271
OpenAlexW2039129359

What OpenQuestion holds

Textmetadata
Read underepoch 390

Registered trials

None linked

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.