2026-07-22T09:50:42Zhttps://repisalud.isciii.es/rest/oai/requestoai: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
Repisalud
author
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
2024-09-10T13:10:42Z
2024-09-10T13:10:42Z
2019
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
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.
eng
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.
research article