Fax +41 61 306 12 34 E-Mail karger@karger.ch www.karger.com Original Article Gynecol Obstet Invest 2010;69:203–211 DOI: 10.1159/000270901 Treatment of Endometriosis with Transvaginal Ultrasound-Guided Drainage and Recombinant Interleukin-2 Left in the Cysts: A Third Clinical Trial Pedro Acién Irene Velasco Maribel Acién Francisco Quereda Service of Obstetrics and Gynecology, San Juan University Hospital, and Department/Division of Gynecology, School of Medicine, Miguel Hernandez University, Campus of San Juan, Alicante, Spain years, these numbers were 55 and 82%, respectively. Con- clusions: Treatment of endometriomas with transvaginal US-guided drainage and rIL-2 left in the cysts, without using endometrial suppressive therapy with GnRH analogues as done in previous studies, has low efficacy. Recurrences are even more frequent after the use of two rIL-2 doses. Copyright © 2009 S. Karger AG, Basel Introduction Endometriosis is an enigmatic disease that is likely due, among other causes, to immunological deregulation [1, 2] and/or neuroendocrine-immune disequilibrium [3]. It has been suggested that curing moderate–severe cases of endometriosis may involve enhancing the cyto- toxic activity of macrophages and NK cells with immu- nomodulators, such as interferons or interleukin-2 [4, 5]. Additionally, this method could be accompanied by a temporary suppression of endometrial (ovarian) activity (with GnRH analogues) or surgical reduction. D’Hooghe [6] suggested immunomodulators and aromatase inhibi- tors as the next generation of treatment for endometrio- sis. On the other hand, some reports [7, 8] have proposed ultrasound (US)-guided aspiration of ovarian endome- Key Words Endometriomas  Drainage  GnRH analogues  Immunomodulators  Recombinant interleukin-2  Treatment Abstract Background: To analyze the therapeutic results of recombi- nant interleukin-2 (rIL-2) left in the cysts after transvaginal ultrasound (US)-guided drainage of endometriomas as an alternative to surgery. Methods: Prospective and random- ized clinical trial. A total of 25 consecutive patients were in- cluded. Two transvaginal US-guided punctures were per- formed, and 3 million IU of rIL-2 were left in the aspirated cysts once (group I) or both (group II) times according to ran- domization. Main Outcome Measures: Clinical results, pre- vented surgeries, and recurrences. Results: Results were moderate or good in only 16% of subjects at 3 months and in 33% of subjects at 6 months after treatment in group I; these numbers were 66 and 33%, respectively, in group II. Differences were not statistically significant. However, the evolution of symptoms, endometriomas, and CA-125 re- vealed the low efficacy of rIL-2 left intracyst as well as a poor control of the clinical manifestations. After 1 year, 20% (group I) and 73% (group II) of patients had to be operated; after 2 Received: January 12, 2009 Accepted after revision: October 27, 2009 Published online: December 24, 2009 Prof. Pedro Acién, MD, FRCOG Departamento/División de Ginecología, Facultad de Medicina Universidad Miguel Hernández, Campus de San Juan Apartado de Correos 18, ES–03550 San Juan de Alicante (Spain) Tel. +34 965 919 524, Fax +34 965 919 550, E-Mail acien @ umh.es © 2009 S. Karger AG, Basel 0378–7346/10/0693–0203$26.00/0 Accessible online at: www.karger.com/goi