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7 Effect of megestrol acetate plus metformin as fertility-sparing treatment for patients with atypical endometrial hyperplasia and well-differentiated endometrial cancer. A randomized controlled trial
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  1. B Yang1,
  2. G Yierfulati1,
  3. J Guan2 and
  4. X Chen1
  1. 1Shanghai ObandGyn Hospital of Fudan University, Gynecology, Shanghai, China
  2. 2Charite Medical University, Gynecology, Berlin, Germany

Abstract

Objectives The clinical remission (CR) rate of Megestrol acetate (MA) as fertility-sparing treatment was still not optimal. This study was to access whether MA plus metformin could lead to better CR rate for patients with atypical endometrial hyperplasia (AEH) and well-differentiated endometrial cancer (EC).

Methods This was a randomized, single-center, open-label and controlled trial (July 2013-December 2017). Patients were randomized to receive MA (160mg, orally, daily) or MA (160mg, orally, daily) plus metformin (500mg, orally, three times a day), then underwent hysteroscopy every 3–4 months. The primary efficacy parameter was the CR rates at 16th and 30th weeks of treatment (16w-CR rate and 30w-CR rate); the secondary efficacy parameter was rates of recurrence, pregnancy and live-birth.

Results Totally 150 patients received MA (n=74, 62 AEH and 12 EC) or MA/metformin (n=76, 61 AEH and 15 EC). The 16w-CR rates were 34.3% (23/67) and 20.7% (12/58) in MA/metformin- and MA-treated women (p=0.091). However, among 102 AEH patients, MA/metformin yielded significantly higher CR rate (39.6%, 21/53) than MA alone (20.4%,10/49, p=0.032, OR 0.347, 95%CI 0.132–0.914). Regarding 30w-CR rate, it was slightly higher in MA/metformin group than control (69.2% vs 57.4%, p=0.167). Nevertheless, the mean treatment time in MA/metformin group was 4 weeks shorter (27 vs 31 weeks). Particularly, the mean weight gain by MA/metformin (2.5kg) was twice lower than MA alone (5.0kg, p=0.014). No intra-group difference was found in rates of recurrence, pregnancy or live birth.

Conclusions MA/metformin may lead to a higher CR rate, shorter treatment time and less weight gain compared with MA alone.

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