Associate Director, Research Strategy Bayer U.S. LLC Brandon, FL, United States
Introduction: Use of 52 mg levonorgestrel-releasing intrauterine system (LNG-IUS) Mirena as treatment for non-atypical endometrial hyperplasia (NAEH), atypical endometrial hyperplasia (AEH) (or endometrial intraepithelial neoplasia [EIN]), and early-stage endometrial cancer (EC) is considered off-label and investigational in the United States. However, there is evidence of the beneficial health outcomes associated with LNG-IUS treatment for these conditions. Methods: The literature was reviewed for studies of LNG-IUS in EH and EC (as of May 2022). Eighty publications were categorized into 4 levels of evidence. Level 1 and 2 studies reported clear outcomes definitions and aligned with the 2014 World Health Organization (WHO) EH classification criteria or were defined as International Federation of Gynecology and Obstetrics (FIGO) grade 1 stage 1/1A EC; these studies were assessed in random-effects meta-analyses. Results: Thirty-seven publications were identified as Level 1 and 2. Complete response (CR) rates were high; 86% (95%CI: 78.5%-91.6%) of patients with NAEH, 82% (95%CI: 69.4%-89.8%) of patients with AEH, and 51% (95%CI: 16.3%-84.9%) of patients with EC achieved CR at 12 months. Mirena was associated with significantly greater odds of CR at 12 months compared to oral progestins in NAEH and AEH populations with ORs ranging from 2.16 (95%CI: 1.38-3.36) to 3.57 (95%CI: 2.00-6.37). There were no comparative data available for EC. In addition, the safety profile appears consistent with that of approved LNG-IUS indications. Conclusion/Implications: LNG-IUS may be an effective non-surgical treatment option for patients with NAEH, AEH, and EC. Greater availability of LNG-IUS treatment could provide meaningful benefit to these patients.
Disclosure(s):
Kristina Rosa Cruz Bolling, PhD: Bayer Pharmaceuticals: Employee (Ongoing); Bayer U.S. LLC: Employee (Ongoing)