OBJECTIVE: This study aimed to clarify the role of levonorgestrel-releasing intra-uterine device as a stand-alone therapy in managing patients with endometrial atypical hyperplasia/endometrial cancer who are not suitable for surgery, through the evaluation of cause-specific survival and the control of vaginal bleeding. METHODS: This is a retrospective, multi-center study conducted in 9 referral gynecologic centers in Italy. Data regarding the clinical and oncological outcomes of patients with endometrial atypical hyperplasia/endometrial cancer (International Federation of Gynecology and Obstetrics Stage I) were analyzed. Patients were judged unsuitable for surgery due to an American Society of Anesthesiologists score ≥3 and the presence of multiple severe co-morbidities and, therefore, triaged to receive levonorgestrel-releasing intra-uterine device alone. RESULTS: A total of 78 women were enrolled. Fifteen patients (19.2%) had a diagnosis of endometrial atypical hyperplasia, whereas the other 63 (80.8%) had endometrial cancer. The baseline hemoglobin levels averaged 11.6 (range; 6-16), increasing to 12.1 (range; 7.8-14.9) during follow-up after levonorgestrel-releasing intra-uterine device insertion (p = .003). No patient experienced any side effects, and bleeding control was rated as excellent in most patients. Median disease-free survival was 43 months (range; 5-120) and median overall survival was 45 months (range; 5-120). CONCLUSIONS: Levonorgestrel-releasing intra-uterine device alone is a safe and effective approach, showing no side effects, and a promising oncological outcome in women with early-stage endometrial atypical hyperplasia/endometrial cancer unfit for surgery. Future prospective studies are required to clarify how to select patient candidates for this therapy and how to predict response to levonorgestrel-releasing intra-uterine device.
Levonorgestrel-releasing intra-uterine device alone for managing early-stage endometrial cancer and endometrial hyperplasia with atypia in patients unfit for surgery: the ENDOIUD study / Petrillo, Marco; Degano, Matilde; Arcieri, Martina; Bogani, Giorgio; Legge, Francesco; Catena, Ursula; Cucinella, Giuseppe; Raimondo, Diego; Capozzi, Vito Andrea; Dinoi, Giorgia; La Fera, Eleonora; Bruni, Simone; Ceppi, Lorenzo; Lucidi, Alessandro; D'Antonio, Francesco; D'Angelo, Emanuela; Dessole, Francesco; Virdis, Giuseppe; Casadio, Paolo; Iodice, Raffaella; Di Donna, Mariano Catello; Berretta, Roberto; Raspagliesi, Francesco; Fanfani, Francesco; Chiantera, Vito; Seracchioli, Renato; Driul, Lorenza; Restaino, Stefano; Capobianco, Giampiero; Vizzielli, Giuseppe. - In: INTERNATIONAL JOURNAL OF GYNECOLOGICAL CANCER. - ISSN 1048-891X. - 36:1(2026), p. 102785. [10.1016/j.ijgc.2025.102785]
Levonorgestrel-releasing intra-uterine device alone for managing early-stage endometrial cancer and endometrial hyperplasia with atypia in patients unfit for surgery: the ENDOIUD study
Petrillo, MarcoWriting – Original Draft Preparation
;Dessole, Francesco;Virdis, Giuseppe;Chiantera, Vito;Capobianco, Giampiero;
2026-01-01
Abstract
OBJECTIVE: This study aimed to clarify the role of levonorgestrel-releasing intra-uterine device as a stand-alone therapy in managing patients with endometrial atypical hyperplasia/endometrial cancer who are not suitable for surgery, through the evaluation of cause-specific survival and the control of vaginal bleeding. METHODS: This is a retrospective, multi-center study conducted in 9 referral gynecologic centers in Italy. Data regarding the clinical and oncological outcomes of patients with endometrial atypical hyperplasia/endometrial cancer (International Federation of Gynecology and Obstetrics Stage I) were analyzed. Patients were judged unsuitable for surgery due to an American Society of Anesthesiologists score ≥3 and the presence of multiple severe co-morbidities and, therefore, triaged to receive levonorgestrel-releasing intra-uterine device alone. RESULTS: A total of 78 women were enrolled. Fifteen patients (19.2%) had a diagnosis of endometrial atypical hyperplasia, whereas the other 63 (80.8%) had endometrial cancer. The baseline hemoglobin levels averaged 11.6 (range; 6-16), increasing to 12.1 (range; 7.8-14.9) during follow-up after levonorgestrel-releasing intra-uterine device insertion (p = .003). No patient experienced any side effects, and bleeding control was rated as excellent in most patients. Median disease-free survival was 43 months (range; 5-120) and median overall survival was 45 months (range; 5-120). CONCLUSIONS: Levonorgestrel-releasing intra-uterine device alone is a safe and effective approach, showing no side effects, and a promising oncological outcome in women with early-stage endometrial atypical hyperplasia/endometrial cancer unfit for surgery. Future prospective studies are required to clarify how to select patient candidates for this therapy and how to predict response to levonorgestrel-releasing intra-uterine device.I documenti in IRIS sono protetti da copyright e tutti i diritti sono riservati, salvo diversa indicazione.
