94555 20230914083303.0 doi 10.1016/j.gore.2020.100594 sideral 118625 ART-2020-118625 eng Rubio, M.J. Efficacy and safety of trabectedin in metastatic uterine leiomyosarcoma: A retrospective multicenter study of the Spanish ovarian cancer research group (GEICO) 2020 Access copy available to the general public Unrestricted Objective: We assessed trabectedin in patients with advanced uterine leiomyosarcoma (uLMS) in real-life clinical practice given according to the marketing authorization. Methods: Thirty-six women from 11 tertiary hospitals across Spain who received trabectedin after anthracycline-containing regimen/s were retrospectively analyzed. The primary endpoint was progression-free survival (PFS). Results: Median PFS and overall survival (OS) since starting trabectedin treatment were 5.4 (95%CI: 3.5–7.3) and 18.5 months (95%CI: 11.5–25.6), respectively. Median OS was significantly higher (P = 0.028) in patients receiving trabectedin in = 2nd line (25.3 months) than in = 3rd (15.1 months) and with ECOG performance status = 1 at trabectedin start (19.8 months) than ECOG 2–3 (6.0 months, P = 0.013). When calculating OS since diagnosis, patients had longer OS with localized disease at diagnosis (87.4 months) vs. locally advanced (30.0 months) or metastatic (44.0 months, P = 0.041); and patients who received adjuvant therapy (87.4 months) compared with those who did not (30.0 months, P = 0.003), especially when receiving radiochemotherapy (106.7 months, P = 0.027). One patient (2.8%) had a complete response (CR) and nine patients (25.0%) achieved a partial response (PR) for an objective response rate of 27.8% with median response duration of 11 months (range: 4–93). Eighteen patients (50.0%) had disease stabilization for a disease control rate (DCR) of 77.8%. More patients receiving trabectedin in 1st-line of advanced disease achieved CR (16.7%) and PR (50.0%) than those in = 2nd line/s (0.0% and 20.0%), whereas the DCR was similar across treatment lines. Reversible neutropenia was the most common grade 3/4 laboratory abnormality (19.4%). Conclusions: Trabectedin confers clinical benefit in patients with recurrent/metastatic uLMS, given after failure to an anthracycline-based regimen being comparable to those reported in clinical trials and with a manageable safety profile. info:eu-repo/semantics/openAccess by-nc-nd http://creativecommons.org/licenses/by-nc-nd/3.0/es/ 0.557 2020 Oncology 2020 Q3 Obstetrics and Gynecology 2020 Q3 info:eu-repo/semantics/article info:eu-repo/semantics/publishedVersion Lecumberri, M.J. Varela, S. Alarcón, J. Ortega, M.E. Universidad de Zaragoza Gaba, L. Espinós, J. Calzas, J. Barretina, P. Ruiz, I. Marquina, G. Santaballa, A. 1007 610 Universidad de Zaragoza Dpto. Medicina, Psiqu. y Derm. Area Medicina 33, 100594 (2020), 1-6 Gynecologic Oncology Reports 2352-5789 478919 http://zaguan.unizar.es/record/94555/files/texto_completo.pdf Versión publicada 66152 http://zaguan.unizar.es/record/94555/files/texto_completo.jpg?subformat=icon icon Versión publicada oai:zaguan.unizar.es:94555 articulos driver 2023-09-13-10:54:33 ARTICLE