Gronchi, AlessandroHindi, NadiaCruz, JosefinaBlay, Jean-YvesLopez-Pousa, AntonioItaliano, AntoineAlvarez, RosaGutierrez, AntonioRincón, InmaculadaSangalli, ClaudiaPérez Aguiar, Jose LuisRomero, JesúsMorosi, CarloSunyach, Marie PierreSanfilippo, RobertaRomagosa, CleofeRanchere-Vince, DominiqueDei Tos, Angelo PCasali, Paolo GMartin-Broto, Javier2025-01-072025-01-072019-03-11https://hdl.handle.net/10668/27241Myxoid 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. 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. 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). 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. This study was partially supported by Pharmamar.enAttribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/ChemotherapyMyxoid LiposarcomaNeoadjuvantPrognosisRadiotherapySarcomaSurvivalTrabectedinresearch article31143880open access10.1016/j.eclinm.2019.03.0072589-5370PMC6510725http://www.thelancet.com/article/S2589537019300434/pdfhttps://pmc.ncbi.nlm.nih.gov/articles/PMC6510725/pdf