RT Journal Article
T1 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.
A1 Gronchi, Alessandro
A1 Hindi, Nadia
A1 Cruz, Josefina
A1 Blay, Jean-Yves
A1 Lopez-Pousa, Antonio
A1 Italiano, Antoine
A1 Alvarez, Rosa
A1 Gutierrez, Antonio
A1 Rincón, Inmaculada
A1 Sangalli, Claudia
A1 Pérez Aguiar, Jose Luis
A1 Romero, Jesús
A1 Morosi, Carlo
A1 Sunyach, Marie Pierre
A1 Sanfilippo, Roberta
A1 Romagosa, Cleofe
A1 Ranchere-Vince, Dominique
A1 Dei Tos, Angelo P
A1 Casali, Paolo G
A1 Martin-Broto, Javier
K1 Chemotherapy
K1 Myxoid Liposarcoma
K1 Neoadjuvant
K1 Prognosis
K1 Radiotherapy
K1 Sarcoma
K1 Survival
K1 Trabectedin
AB 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.
YR 2019
FD 2019-03-11
LK https://hdl.handle.net/10668/27241
UL https://hdl.handle.net/10668/27241
LA en
DS RISalud
RD Apr 17, 2025