Evidence map›Paper›PMID 32805208›Full record

Trial reportAmerican journal of obstetrics and gynecology2021

Prospective phase II trial of levonorgestrel intrauterine device: nonsurgical approach for complex atypical hyperplasia and early-stage endometrial cancer.

Shannon N Westin, Bryan Fellman, Charlotte C Sun, Russell R Broaddus, Misty L Woodall, Navdeep Pal, Diana L Urbauer, Lois M Ramondetta, Kathleen M Schmeler, Pamela T Soliman and 9 more

Open access · greenAbstract readClinical Trial, Phase II
PubMed Full text at PMC Publisher
In one paragraph

Trial report in American journal of obstetrics and gynecology, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. 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
6.6field-weighted citation impact, top 2% 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, 110 citations in OpenAlex.

  1. Pooled it
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  10. Endometrial cancer therapy in 2026.Current opinion in obstetrics & gynecology · 2026
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4 · The record

Corrections and comments

PubMed lists nothing against this paper. Absence here is not a guarantee, only a check that was made.

5 · Who and what money

Authors and funding

19 authors at 3 institutions in 1 country.

Shannon N WestinDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX. Electronic address: swestin@mdanderson.org.
Bryan FellmanBiostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Charlotte C SunDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Russell R BroaddusDepartment of Pathology and Laboratory Medicine, The University of Texas MD Anderson Cancer Center, Houston, TX; Department of Pathology and Laboratory Medicine, University of North Carolina School of Medicine, Chapel Hill, NC.
Misty L WoodallDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Navdeep PalDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Diana L UrbauerBiostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Lois M RamondettaDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Kathleen M SchmelerDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Pamela T SolimanDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Nicole D FlemingDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Jennifer K BurzawaDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Alpa M NickDivision of Gynecologic Oncology, Tennessee Oncology, Nashville, TN.
Andrea M MilbourneDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Ying YuanBiostatistics, The University of Texas MD Anderson Cancer Center, Houston, TX.
Karen H LuDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Diane C BodurkaDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Robert L ColemanDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
Melinda S YatesDepartments of Gynecologic Oncology, The University of Texas MD Anderson Cancer Center, Houston, TX.
The University of Texas MD Anderson Cancer Center · USTennessee Oncology · USUniversity of North Carolina at Chapel Hill · US

Funding

Protocol Review and Monitoring SystemP30CA016672 · UNIVERSITY OF TX MD ANDERSON CAN CTR · 1985 to 2025
$57.3M
MD Anderson Cancer Ctr. Gynecology SPORE: Uterine CancerP50CA098258 · UNIVERSITY OF TEXAS MD ANDERSON CAN CTR · 2003 to 2005
$5.9M
Paul Calabresi Clinical Oncology AwardK12CA088084 · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2000 to 2025
$4.1M
Training of Academic Gynecologic OncologistsT32CA101642 · UNIVERSITY OF TX MD ANDERSON CAN CTR · 2005 to 2025
$710k
NCI NIH HHS K12 CA088084NCI NIH HHS L30 CA189102NCI NIH HHS P30 CA016672NCI NIH HHS P50 CA098258NCI NIH HHS T32 CA101642
6 · The paper itself

Abstract

backgroundThe incidence of complex atypical hyperplasia and early-stage endometrioid endometrial cancer is increasing, in part owing to the epidemic of obesity, which is a risk factor tightly linked to the development of endometrial hyperplasia and cancer. The standard upfront treatment for complex atypical hyperplasia and early-stage endometrial cancer is hysterectomy. However, nonsurgical treatment of early-stage endometrial neoplasia may be necessary owing to medical comorbidities precluding surgery or desired future fertility.

objectiveThis study aimed to evaluate the efficacy of the levonorgestrel intrauterine device to treat complex atypical hyperplasia and grade 1 endometrioid endometrial carcinoma. STUDY

designA single-institution, single-arm, phase II study of the levonorgestrel intrauterine device (52 mg levonorgestrel, Mirena) was conducted in patients with complex atypical hyperplasia or grade 1 endometrioid endometrial cancer. The primary endpoint was pathologic response rate at 12 months, including complete or partial response. Quality of life and toxicity were assessed. Molecular analyses for proliferation markers, hormone-regulated genes, and wingless-related integration site pathway activation were performed at baseline and 3 months.

resultsA total of 57 patients were treated (21 endometrial cancer, 36 complex atypical hyperplasia). The median age was 48.0 years, and the median body mass index was 45.5 kg/m

conclusionThe levonorgestrel intrauterine device has a substantial activity in complex atypical hyperplasia and grade 1 endometrioid endometrial cancer, with a modest proportion demonstrating upfront progesterone resistance. Potential biomarkers were identified that may correlate with resistance to therapy; further exploration is warranted.

Indexed as

Intrauterine Devices, MedicatedAdaptor Proteins, Signal TransducingAdultAgedAged, 80 and overAldehyde Dehydrogenase 1 FamilyBiomarkersBiomarkers, TumorBody Mass IndexCarcinoma, EndometrioidContraceptive Agents, HormonalEndometrial HyperplasiaEndometrial NeoplasmsFemaleGene ExpressionHumansAdaptor Proteins, Signal TransducingAldehyde Dehydrogenase 1 FamilyALDH1A2 protein, humanBiomarkersBiomarkers, TumorContraceptive Agents, HormonalDKK3 protein, humanFzd8 protein, humanIntercellular Signaling Peptides and ProteinsKi-67 AntigenLevonorgestrelMembrane ProteinsMKI67 protein, humanReceptors, Cell SurfaceRetinal DehydrogenaseSecreted Frizzled-Related ProteinsSFRP1 protein, humancomplex atypical hyperplasiaconservativeendometrial cancerendometrial hyperplasia intrauterine devicepredictive biomarkersprogesterone

Identifiers

PMID32805208
PMCPMC7855308
OpenAlexW3049224817

What Socratic holds

Textmetadata
LicenceTDM
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 Socratic graph.