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- Title
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.
- Authors
Yang, B‐Y; Gulinazi, Y; Du, Y; Ning, C‐C; Cheng, Y‐L; Shan, W‐W; Luo, X‐Z; Zhang, H‐W; Zhu, Q; Ma, F‐H; Liu, J; Sun, L; Yu, M; Guan, J; Chen, X‐J; Yang, B-Y; Ning, C-C; Cheng, Y-L; Shan, W-W; Luo, X-Z
- Abstract
<bold>Objective: </bold>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).<bold>Design: </bold>A randomised, single-centre, open-label, controlled trial conducted between October 2013 and December 2017.<bold>Setting: </bold>Shanghai OBGYN Hospital of Fudan University, China.<bold>Population: </bold>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).<bold>Methods: </bold>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).<bold>Main Outcomes and Measures: </bold>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.<bold>Results: </bold>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.<bold>Conclusion: </bold>As a fertility-sparing treatment, metformin plus MA was associated with a higher early CR rate compared with MA alone in AEH patients.<bold>Tweetable Abstract: </bold>For AEH patients, metformin plus MA might be a better fertility-sparing treatment to achieve a higher early CR rate compared with MA alone.
- Subjects
CHINA; ENDOMETRIAL hyperplasia; FUDAN University (Shanghai, China); ENDOMETRIAL cancer; METFORMIN; ACETATES; UNIVERSITY hospitals; ANTINEOPLASTIC agents; COMBINATION drug therapy; COMPARATIVE studies; RESEARCH methodology; MEDICAL cooperation; SYNTHETIC progestagens; RESEARCH; UTERINE diseases; ENDOMETRIAL tumors; EVALUATION research; RANDOMIZED controlled trials; TREATMENT effectiveness; FERTILITY preservation; DISEASE complications
- Publication
BJOG: An International Journal of Obstetrics & Gynaecology, 2020, Vol 127, Issue 7, p848
- ISSN
1470-0328
- Publication type
journal article
- DOI
10.1111/1471-0528.16108