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PR001/#476  Gonadotropin-releasing hormone agonist (GnRH-a) plus letrozole in young women with early endometrial cancer: a prospective randomized controlled trial
  1. Yu Xue1,
  2. Youting Dong1 and
  3. Xiaojun Chen2
  1. 1Obstetrics and Gynecology Hospital of Fudan University, Shanghai, China
  2. 2Tenth People’s Hospital Affiliated To Tongji University, Shanghai, China

Abstract

Introduction It was aimed to compare gonadotropin-releasing hormone Agonist (GnRH-a) plus letrozole versus megestrol acetate (MA) on fertility-preserving treatment in young women with early endometrial cancer (EEC).

Methods This was a single-center phase II study with a prospective, randomized, controlled trial (NCT05247268) conducted between March 2022 and October 2023 at the Obstetrics and Gynecology Hospital of Fudan University. A total of 42 patients with primary EEC were randomly assigned (1:1) to the GnRH-a plus letrozole (Gn+Le, N=21) or MA (N=21) groups, where the patients received intramuscular injection of GnRH-a (3.75 mg every 4 weeks) combined with oral letrozole (2.5 mg daily), or oral MA (160 mg daily), respectively. The primary endpoint was the complete response (CR) rate at 16 weeks of treatment. The secondary endpoints were CR rate at 28 weeks of treatment, adverse events, recurrence rate, and pregnancy outcomes.

Results The 16-week CR rate was 63.2% (12/19) in the Gn+Le group and 36.8% (7/19) in the MA group, with median time to CR of 13.1 weeks (95% confidence interval [CI] 11.4-14.8 weeks) and 27.0 weeks (95% CI 11.5-42.5 weeks), respectively. One patient in the Gn+Le group experienced recurrence after CR, while no recurrence occurred in the MA group. Side effect of weight gain was more likely to observed in the MA group, while back pain was more likely to observed in the Gn+Le group.

Conclusion/Implications GnRH-a combined with letrozole might be a standard treatment regimen for fertility-preserving treatment in patients with primary EEC. Further studies including sufficient sample-size are needed to validate the finding.

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