| Sumario: | Background: Levonorgestrel-releasing intrauterine systems (LNG-IUS) are considered off-label and investigational in the United States for treating non-atypical endometrial hyperplasia (NAEH), atypical endometrial hyperplasia (AEH), and early-stage endometrial cancer (EC), though evidence suggests potential benefit. Objectives: To summarize the available evidence regarding the use of LNG-IUS, with or without other therapies, for the treatment of NAEH, AEH, and early-stage (FIGO I/IA) EC. Design: Systematic literature review and meta-analyses. Data sources: MEDLINE, Embase, Cochrane Central Register of Controlled Trials (CENTRAL), and Cochrane Database of Systematic Reviews (CDSR) were searched from database inception through May 2022. Methods: Data from studies reporting complete outcome definitions and study populations that were aligned with the 2014 World Health Organization (WHO) endometrial hyperplasia classification criteria or were defined as FIGO grade 1 stage I/IA EC were extracted and assessed in random-effects meta-analyses. A risk of bias assessment was completed using recommended study-design-specific tools. Results: 1085 unique records were reviewed; 80 publications were included, with data from 30 assessed in meta-analyses: NAEH, n = 14; AEH, n = 21; EC, n = 5. Complete response (CR) rates at 12 months were high: 86.3% (95% confidence interval (CI): 78.50%–91.55%; n = 342) of patients with NAEH, 83.9% (95% CI: 71.95%–91.34%; n = 196) of patients with AEH, and 51.1% (95% CI: 16.30%–84.90%; n = 20) of patients with EC. LNG-IUS was associated with significantly greater odds of CR at 12 months compared to oral progestins in NAEH and AEH populations, with odds ratios ranging from 2.16 (95% CI: 1.38–3.36) to 4.56 (95% CI: 2.57–8.09). No comparative data were available for EC. Safety information was consistent with that of approved LNG-IUS indications. Risk of bias varied across study designs. Conclusion: The findings suggest that NAEH, AEH, and early-stage (FIGO I/IA) EC can be effectively treated with LNG-IUS, with the evidence being strongest for NAEH and weakest for EC. Greater availability of LNG-IUS treatment could provide meaningful benefit to these patients. Trial registration: Not applicable. Plain language summary: Hormonal intrauterine system (IUS) treatment for thickened uterine lining and early uterine cancer: a comprehensive review This comprehensive review of published scientific studies looked at whether a type of hormonal device called a levonorgestrel-releasing intrauterine system (LNG-IUS) is effective and safe for treating abnormally thickened uterine lining and early uterine cancer. The specific uterine conditions of interest included non-atypical endometrial hyperplasia (NAEH), atypical endometrial hyperplasia (AEH), and early-stage endometrial cancer (EC). Researchers reviewed studies published up to May 2022 and identified 80 relevant articles, focusing on 30 of them for detailed analysis. A high percentage of patients had positive outcomes. In 86.3% of patients with NAEH, 83.9% of patients with AEH, and 51.1% of patients with EC, there was no evidence of disease after 12 months of treatment. The LNG-IUS was found to be more effective than oral hormone medications for treating NAEH and AEH. However, there was not enough information available to make direct comparisons for patients with EC. The safety of LNG-IUS treatment was similar to what has already been established for its approved uses. Overall, the published literature suggests that LNG-IUS is an effective treatment option for NAEH, AEH, and EC, with the strongest evidence for NAEH and the weakest evidence for EC. Greater access to this treatment could offer significant benefits to patients with these uterine conditions.
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