Metformin plus megestrol acetate compared with megestrol acetate alone as fertility-sparing treatment in patients with atypical endometrial hyperplasia and well-differentiated endometrial cancer: a randomised controlled trial.
Adolescent
Adult
Antineoplastic Agents, Hormonal
/ administration & dosage
China
Drug Therapy, Combination
Endometrial Hyperplasia
/ complications
Endometrial Neoplasms
/ complications
Female
Fertility Preservation
/ methods
Humans
Megestrol Acetate
/ administration & dosage
Metformin
/ administration & dosage
Middle Aged
Treatment Outcome
Young Adult
Atypical endometrial hyperplasia
endometrioid endometrial cancer
fertility-sparing
megestrol acetate
metformin
Journal
BJOG : an international journal of obstetrics and gynaecology
ISSN: 1471-0528
Titre abrégé: BJOG
Pays: England
ID NLM: 100935741
Informations de publication
Date de publication:
06 2020
06 2020
Historique:
accepted:
13
01
2020
pubmed:
22
1
2020
medline:
24
6
2020
entrez:
22
1
2020
Statut:
ppublish
Résumé
To assess the efficacy of metformin in megestrol acetate (MA)-based fertility-sparing treatment for patients with atypical endometrial hyperplasia (AEH) and endometrioid endometrial cancer (EEC). A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017. Shanghai OBGYN Hospital of Fudan University, China. A total of 150 patients (18-45 years old) with primary AEH or well-differentiated EEC were randomised into an MA group (n = 74) and an MA plus metformin group (n = 76). Patients with AEH or EEC were firstly stratified, then randomised to receive MA (160 mg orally, daily) or MA (160 mg orally, daily) plus metformin (500 mg orally, three times a day). The primary efficacy parameter was the cumulate complete response (CR) rate within 16 weeks of treatment (16w-CR rate); the secondary efficacy parameters were 30w-CR rate and adverse events. The 16w-CR rate was higher in the metformin plus MA group than in the MA-only group (34.3 versus 20.7%, odds ratio [OR] 2.0, 95% confidence interval [CI] 0.89-4.51, P = 0.09) but the difference was more significant in 102 AEH patients (39.6 versus 20.4%, OR 2.56, 95% CI 1.06-6.21, P = 0.04). This effect of metformin was also significant in non-obese (51.4 versus 24.3%, OR 3.28, 95% CI 1.22-8.84, P = 0.02) and insulin-sensitive (54.8 versus 28.6%, OR 3.04, 95% CI 1.03-8.97, P = 0.04) subgroups of AEH women. No significant result was found in secondary endpoints. As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients. For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.
Identifiants
pubmed: 31961463
doi: 10.1111/1471-0528.16108
doi:
Substances chimiques
Antineoplastic Agents, Hormonal
0
Metformin
9100L32L2N
Megestrol Acetate
TJ2M0FR8ES
Types de publication
Journal Article
Randomized Controlled Trial
Langues
eng
Sous-ensembles de citation
IM
Pagination
848-857Subventions
Organisme : Municipal Human Resources Development Program for Outstanding Leaders in Medical Disciplines in Shanghai
ID : 2017BR035
Pays : International
Organisme : National Key Technology R&D Programme of China
ID : 2019YFC1005200
Pays : International
Organisme : National Key Technology R&D Programme of China
ID : 2019YFC1005204
Pays : International
Organisme : National Natural Science Foundation of China
ID : 81671417
Pays : International
Organisme : National Natural Science Foundation of China
ID : 81370688
Pays : International
Organisme : Shanghai Medical Centre of Key Programmes for Female Reproductive Diseases
ID : 2017ZZ010616
Pays : International
Organisme : Shanghai Science and Technology Development medical guide project
ID : 17411961000
Pays : International
Organisme : Shanghai Science and Technology Development medical guide project
ID : 134119a4500
Pays : International
Organisme : Shanghai Science and Technology Development medical guide project
ID : 19411960400
Pays : International
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 Royal College of Obstetricians and Gynaecologists.
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