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oai:repisalud.isciii.es:20.500.12105/228332024-09-10T13:10:42Zcom_20.500.12105_15322com_20.500.12105_2051col_20.500.12105_16958col_20.500.12105_16967

00925njm 22002777a 4500 dc Gronchi, Alessandro author Hindi, Nadia author Cruz, Josefina author Blay, Jean-Yves author Lopez-Pousa, Antonio author Italiano, Antoine author Alvarez, Rosa author Gutierrez, Antonio author Rincon, Inmaculada author Sangalli, Claudia author Perez Aguiar, Jose Luis author Romero, Jesus author Morosi, Carlo author Sunyach, Marie Pierre author Sanfilippo, Roberta author Romagosa, Cleofe author Ranchere-Vince, Dominique author Dei Tos, Angelo Paolo author Casali, Paolo G author Martin-Broto, Javier author 2019 Background: Myxoid liposarcoma (ML) exhibits a special sensitivity to trabectedin (T) and radiation therapy (RT). Preclinical data suggest a synergistic effect. We aimed to study safety, feasibility and activity of the administration of pre-operative concurrent T and RT in patients affected by localized resectable ML.Methods: Patients received 3?cycles (C) of T in combination with RT (45?Gy) in 25 fractions (1.8?Gy/fraction). Dose Levels for T were: -1 (1.1?mg/m2), 0 (1.3?mg/m2) and 1 (1.5?mg/m2). Primary endpoint was safety; antitumor activity was assessed by RECIST and Choi criteria. This study is registered at ClinicalTrials.gov, number NCT02275286. The phase 1 part of the study is complete and phase 2 is ongoing.Findings: From February 2015 to May 2016, 14 patients (M/F 7/7), median age 36?years (range 24-70) and median tumor size 12.5?cm (range 7-17?cm), were enrolled. One dose limiting toxicity (G3 transaminitis) occurred at Level 0 and one (sepsis due to catheter infection) at Level 1. All patients completed RT. Five patients achieved PR (36%), 8 SD (57%), 1 distant PD (7%) by RECIST, while 12 achieved PR (86%), 1 SD (7%) and 1 distant PD (7%) by Choi criteria. Twelve patients underwent surgery. Median viable residual tumor was 5% (0-60).Interpretation: T in combination with RT showed a favorable safety profile and antitumor activity in localized ML. T dose of 1.5?mg/m2 is the recommended dose for the phase 2 study, which is ongoing.Funding: This study was partially supported by Pharmamar. Gronchi A, Hindi N, Cruz J, Blay JY, Lopez-Pousa A, Italiano A, et al. Trabectedin and RAdiotherapy in Soft Tissue Sarcoma (TRASTS): Results of a Phase I Study in Myxoid Liposarcoma from Spanish (GEIS), Italian (ISG), French (FSG) Sarcoma Groups.. EClinicalMedicine. 2019;9:35-43. 10.1016/j.eclinm.2019.03.007 2589-5370 Eclinicalmedicine http://hdl.handle.net/20.500.13003/17422 31143880 L2001676280 2-s2.0-85064457164 https://hdl.handle.net/20.500.12105/22833 Chemotherapy Myxoid Liposarcoma Neoadjuvant Prognosis Radiotherapy Sarcoma Survival Trabectedin Trabectedin and RAdiotherapy in Soft Tissue Sarcoma (TRASTS): Results of a Phase I Study in Myxoid Liposarcoma from Spanish (GEIS), Italian (ISG), French (FSG) Sarcoma Groups.