Evidence map›Paper›PMID 27654262›Full record

Trial reportInternational journal of gynecological cancer : official journal of the International Gynecological Cancer Society2016

Long-Term Oncologic and Reproductive Outcomes in Young Women With Early Endometrial Cancer Conservatively Treated: A Prospective Study and Literature Update.

Giuseppe Laurelli, Francesca Falcone, Maria Stella Gallo, Felice Scala, Simona Losito, Vincenza Granata, Marco Cascella, Stefano Greggi

Registry-linked trialAbstract readClinical Trial
PubMed Publisher
In one paragraph

Trial report in International journal of gynecological cancer : official journal of the International Gynecological Cancer Society, 2016. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT07462663 (SHAPE-ENDO), which is not on this map. Cited by 37 papers, 7 of them syntheses that pooled it.

0numbers the graph read from it
0cells of the map it votes in
37citing papers in PubMed, 7 pooled it
3.7field-weighted citation impact, top 7% 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.

NCT07462663 phase4not yet recruitingstarted 2027, after this paper: background citation

SHAPE-ENDO (Strategic Hormonal Approach & Prehabilitation in Endometrial Cancer): An Open-Label, Pilot Randomized Clinical Trial Comparing Standard Immediate Surgery Versus a Multimodal Metabolic Optimization and Prehabilitation Strategy Before Surgery in Patients With Atypical Endometrial Hyperplasia or Low-Risk Endometrioid Endometrial Cancer and BMI ≥40 kg/m²

Ran2027Enrolled80Registered outcomes34Posted comparisons0ConditionsAtypical Endometrial Hyperplasia, Atypical Endometrial Hyperplasia and Endometrial Carcinoma Stage I, BMI>40, Endometrial CancerArmsDietetic-Nutritional intervention, Endometrial Biopsy With or Without Hysteroscopy, GLP-1 receptor agonist, Levonorgestrel IUD (Lng-IUD), Oral Progestins
Open the trial in the graph
3 · Its place in the literature

Who cites it

37 citing papers in PubMed, 7 syntheses or guidelines pooled it, 61 citations in OpenAlex.

  1. Pooled it
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  16. Fertility preservation in gynecologic cancer patients.Revista brasileira de ginecologia e obstetricia : revista da Federacao Brasileira das Sociedades de Ginecologia e Obstetricia · 2023
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  19. Immunotherapy Assessment: A New Paradigm for Radiologists.Diagnostics (Basel, Switzerland) · 2023
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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

8 authors at 1 institution in 1 country.

Giuseppe Laurelli*Gynecologic Oncology Surgery, Istituto Nazionale Tumori "Fondazione G. Pascale"-IRCCS; †Department of Woman, Child, and General and Specialized Surgery, Seconda Università degli Studi di Napoli; and ‡Surgical Pathology Unit, §Radiology Unit, and ‖Department of Anesthesia, Endoscopy and Cardiology, Istituto Nazionale Tumori "Fondazione G. Pascale"-IRCCS, Naples, Italy.
Francesca Falcone
Maria Stella Gallo
Felice Scala
Simona Losito
Vincenza Granata
Marco Cascella
Stefano Greggi
Istituto Nazionale Tumori IRCCS "Fondazione G. Pascale" · IT

Funding

No grant is acknowledged in the PubMed record.

6 · The paper itself

Abstract

objectiveThis study aimed to analyze the long-term oncologic and reproductive outcomes in endometrial cancer (EC) in young patients conservatively treated by combined hysteroscopic resection (HR) and levonorgestrel intrauterine device (LNG-IUD).

methodsTwenty-one patients (age ≤ 40 years; Stage IA, G1-2 endometrioid EC), wishing to preserve their fertility, were enrolled into this prospective study. The HR was used to resect (1) the tumor lesion, (2) the endometrium adjacent to the tumor, and (3) the myometrium underlying the tumor. Hormonal therapy consisted of LNG-IUD (52 mg) for at least 6 months.

resultsThe median follow-up time is 85 months (range, 30-114). After 3 months from the progestin start date, 18 patients (85.7%) showed a complete regression (CR), 2 (9.5%) showed persistent disease, whereas 1 patient (4.8%) presented with progressive disease and underwent definitive surgery (Stage IA, G3 endometrioid). At 6 months, 1 of the 2 persistences underwent definitive surgery (Stage IA, G1 endometrioid), whereas the other was successfully re-treated. Two recurrences (10.5%) were observed, both involving the endometrium and synchronous ovarian cancer (OC) (atypical hyperplasia and Stage IIB G1 endometrioid OC; Stage IA endometrioid G1 EC, and Stage IA G1 endometrioid OC). The median duration of complete response was 85 months (range, 8-117). Sixty-three percent of complete responders attempted to conceive with 92% and 83% pregnancy and live birth rates, respectively. To date, all patients are alive and have no evidence of disease.

conclusionsAfter a long follow-up, combined HR and LNG-IUD would seem to improve the efficacy of progestin alone. High pregnancy and live birth rates were observed in women attempting to conceive. This approach is still experimental and should be offered only in the framework of scientific protocols conducted in cancer centers.

Indexed as

FertilityOrgan Sparing TreatmentsPregnancyAdultEndometrial NeoplasmsFemaleHumansHysteroscopyIntrauterine Devices, MedicatedLevonorgestrelProspective StudiesLevonorgestrel

Identifiers

PMID27654262
OpenAlexW2521094682

What OpenQuestion holds

Textmetadata
Read underepoch 390

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.