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
Gronchi, Alessandro (Fondazione IRCCS Istituto Nazionale dei Tumori)
Hindi, Nadia (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Cruz, Josefina (University Hospital Canarias)
Blay, Jean-Yves (Center Leon Berard (Lyon))
López Pousa, Antonio (Institut d'Investigació Biomèdica Sant Pau)
Italiano, Antoine (Institute Bergonie - Bourdeaux)
Alvarez, Rosa (Hospital General Universitario Gregorio Marañón)
Gutierrez, Antonio (Hospital Universitari Son Espases (Palma de Mallorca, Balears))
Rincón, Inmaculada (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Sangalli, Claudia (Fondazione IRCCS Istituto Nazionale dei Tumori)
Pérez Aguiar, José Luis (Hospital Universitario Canarias)
Romero, Jesús (Hospital Universitario Puerta de Hierro Majadahonda (Madrid))
Morosi, Carlo (Fondazione IRCCS Istituto Nazionale dei Tumori)
Sunyach, Marie Pierre (Center Leon Berard)
Sanfilippo, Roberta (Fondazione IRCCS Istituto Nazionale dei Tumori)
Romagosa, Cleofe (Hospital Universitari Vall d'Hebron)
Ranchere-Vince, Dominique (Center Leon Berard)
Dei Tos, Angelo (University of Padova)
Casali, Paolo G. (University of Milan)
Martin-Broto, Javier (Hospital Universitario Virgen del Rocío (Sevilla, Andalusia))
Universitat Autònoma de Barcelona

Date:	2019
Abstract:	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. 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.
Rights:	Aquest document està subjecte a una llicència d'ús Creative Commons. Es permet la reproducció total o parcial, la distribució, i la comunicació pública de l'obra, sempre que no sigui amb finalitats comercials, i sempre que es reconegui l'autoria de l'obra original. No es permet la creació d'obres derivades.
Language:	Anglès
Document:	Article ; recerca ; Versió publicada
Subject:	Chemotherapy ; Myxoid Liposarcoma ; Neoadjuvant ; Prognosis ; Radiotherapy ; Sarcoma ; Survival ; Trabectedin
Published in:	EClinicalMedicine, Vol. 9 (march 2019) , p. 35-43, ISSN 2589-5370

DOI: 10.1016/j.eclinm.2019.03.007
PMID: 31143880

9 p, 1.5 MB

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Research literature > UAB research groups literature > Research Centres and Groups (research output) > Health sciences and biosciences > Institut de Recerca Sant Pau
Articles > Research articles
Articles > Published articles