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.
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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, ENDOIUD group
Аннотация
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.