Complete pathological response following levonorgestrel intrauterine device in clinically stage 1 endometrial adenocarcinoma: Results of a randomized clinical trial

PurposeIntrauterine levonorgestrel (LNG-IUD) is used to treat patients with endometrial adenocarcinoma (EAC) and hyperplasia atypia (EHA) but limited evidence available on its effectiveness. The study determined the extent which LNG-IUD or without metformin (M) weight loss (WL) achieves a pathological complete response (pCR) in EAC EHA.Patients methodsThis phase II randomized controlled clinical trial enrolled histologically confirmed, clinically stage 1 FIGO grade EHA; body mass index > 30 kg/m2; depth of myometrial invasion less than 50% MRI; serum CA125 ? U/mL. All received were observation (OBS), M (500 mg orally twice daily), WL (pooled analysis). primary outcome measure was proportion developing pCR (defined as absence any EHA) after 6 months.ResultsFrom December 2012 October 2019, 165 154 completed 6-months follow up. Women had mean age 53 years, BMI 48 kg/m2. Ninety-six diagnosed (58%) 69 EHA (42%). Thirty-five participants OBS, 36 47 (10 withdrawn). After months rate 61% (95% CI 42% 77%) for 67% 48% 82%) 57% 41% 72%) M. Across three treatment groups, 82% 43% EAC, respectively.ConclusionComplete rates at encouraging across groups.Trial registrationU.S. National Library Medicine, NCT01686126.