%0 Journal Article
%A Gronchi, Alessandro
%A Hindi, Nadia
%A Cruz, Josefina
%A Blay, Jean-Yves
%A Lopez-Pousa, Antonio
%A Italiano, Antoine
%A Alvarez, Rosa
%A Gutierrez, Antonio
%A Rincón, Inmaculada
%A Sangalli, Claudia
%A Pérez Aguiar, Jose Luis
%A Romero, Jesús
%A Morosi, Carlo
%A Sunyach, Marie Pierre
%A Sanfilippo, Roberta
%A Romagosa, Cleofe
%A Ranchere-Vince, Dominique
%A Dei Tos, Angelo P
%A Casali, Paolo G
%A Martin-Broto, Javier
%T 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.
%D 2019
%U https://hdl.handle.net/10668/27241
%X 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.
%K Chemotherapy
%K Myxoid Liposarcoma
%K Neoadjuvant
%K Prognosis
%K Radiotherapy
%K Sarcoma
%K Survival
%K Trabectedin
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