Evidence map›Paper›PMID 30740964›Full record

Trial reportJournal of gynecologic oncology2019

Six months response rate of combined oral medroxyprogesterone/levonorgestrel-intrauterine system for early-stage endometrial cancer in young women: a Korean Gynecologic-Oncology Group Study.

Mi Kyoung Kim, Seok Ju Seong, Soon Beom Kang, Duk Soo Bae, Jae Weon Kim, Joo Hyun Nam, Myong Cheol Lim, Taek Sang Lee, Sunghoon Kim, Jiheum Paek

Registry-linked trialOpen access · diamondAbstract readClinical Trial, Phase IIMulticenter Study
PubMed Full text at PMC Publisher
In one paragraph

Trial report in Journal of gynecologic oncology, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT01594879 (Treatment With Medroxyprogesterone Acetate), which is not on this map. Cited by 32 papers, 4 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
32citing papers in PubMed, 4 pooled it
6.4field-weighted citation impact, top 3% 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.

NCT01594879 phase2unknown statusnot on this map

Treatment With Medroxyprogesterone Acetate(MPA) Plus Levonorgestrel-releasing Intrauterine System(LNG-IUS) in Young Women With Early Stage Endometrial Cancer: Multicenter Study: Korean Gynecologic Oncology Group Study (KGOG2009)

TypeinterventionalSponsorKorean Gynecologic Oncology GroupRan2012 to 2014Enrolled39ConditionsEndometrial CancerArmsMIrena(LNG-IUS), oral MPA
3 · Its place in the literature

Who cites it

32 citing papers in PubMed, 4 syntheses or guidelines pooled it, 51 citations in OpenAlex.

  1. Pooled it
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  4. ESGO/ESTRO/ESP Guidelines for the management of patients with endometrial carcinoma.Virchows Archiv : an international journal of pathology · 2021
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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

10 authors at 9 institutions in 2 countries.

Mi Kyoung KimDepartment of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea.
Seok Ju SeongDepartment of Obstetrics and Gynecology, CHA Gangnam Medical Center, CHA University, Seoul, Korea. sjseongcheil@naver.com.
Soon Beom KangDepartment of Obstetrics and Gynecology, Konkuk University School of Medicine, Seoul, Korea.
Duk Soo BaeDepartment of Obstetrics and Gynecology, Samsung Medical Center, Sungkyunkwan University School of Medicine, Seoul, Korea.
Jae Weon KimDepartment of Obstetrics and Gynecology, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea.
Joo Hyun NamDepartment of Obstetrics and Gynecology, University of Ulsan College of Medicine, Asan Medical Center, Seoul, Korea.
Myong Cheol LimCancer Healthcare Research Branch, Center for Uterine Cancer and Center for Clinical Trials, Research Institute and Hospital, and Department of Cancer Control and Population Health, Graduate School of Cancer Science and Policy, National Cancer Center, Goyang, Korea.
Taek Sang LeeDepartment of Obstetrics and Gynecology, Seoul Metropolitan Government-Seoul National University Boramae Medical Center, Seoul National University College of Medicine, Seoul, Korea.
Sunghoon KimDepartment of Obstetrics and Gynecology, Yonsei University College of Medicine, Seoul, Korea.
Jiheum PaekDepartment of Obstetrics and Gynecology, Ajou University School of Medicine, Suwon, Korea.
CHA University · KRAjou University · KRKonkuk University · KRNational Cancer Center · USSamsung Medical Center · KRSeoul Metropolitan Government · KRSeoul National University Hospital · KRUlsan College · KRYonsei University · KR

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveTo evaluate the efficacy of combined oral medroxyprogesterone acetate (MPA)/levonorgestrel-intrauterine system (LNG-IUS) treatment and to compare the diagnostic accuracy of endometrial aspiration biopsy with dilatation & curettage (D&C) in young women with early-stage endometrial cancer (EC) who wished to preserve their fertility.

methodsA prospective phase II multicenter study was conducted from January 2012 to January 2017. Patients with grade 1 endometrioid adenocarcinoma confined to the endometrium were treated with combined oral MPA (500 mg/day)/LNG-IUS. At 3 and 6 months of treatment, the histologic change of the endometrial tissue was assessed. The regression rate at 6 months treatment and the consistency of the histologic results between the aspiration biopsy and the D&C were evaluated.

resultsForty-four patients were enrolled. Nine voluntarily withdrew and 35 patients completed the protocol treatment. The complete regression (CR) rate at 6 months was 37.1% (13/35). Partial response was shown in 25.7% of cases (9/35). There were no cases of progressive disease and no treatment-related complications. A comparison of the pathologic results from aspiration biopsy and D&C was carried out for 33 cases. Fifteen cases were diagnosed as "EC" by D&C. Among these, only 8 were diagnosed with EC from aspiration biopsy, yielding a diagnostic concordance of 53.3% (κ=0.55).

conclusionCombined oral MPA/LNG-IUS treatment for EC showed 37.1% of CR rate at 6 months. Considering the short treatment periods, CR rate may be much higher if the treatment continued to 9 or 12 months. So, this treatment is still a viable treatment option for young women of early-stage EC. Endometrial aspiration biopsy with the LNG-IUS in place is less accurate than D&C for follow-up evaluation of patients undergoing this treatment.

trial registrationClinicalTrials.gov Identifier: NCT01594879.

Indexed as

Biopsy, NeedleDilatation and CurettageIntrauterine Devices, MedicatedAdministration, OralAdultAntineoplastic Agents, HormonalCarcinoma, EndometrioidEndometrial NeoplasmsEndometriumFemaleFertility PreservationHumansLevonorgestrelMedroxyprogesterone AcetateProspective StudiesAntineoplastic Agents, HormonalLevonorgestrelMedroxyprogesterone AcetateEndometrial NeoplasmsFertility PreservationMirenaProgestin

Identifiers

PMID30740964
PMCPMC6393640
OpenAlexW2911197585

What OpenQuestion holds

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LicenceCC BY-NC
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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.