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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

2019; Elsevier BV; Volume: 9; Linguagem: Inglês

10.1016/j.eclinm.2019.03.007

2589-5370

Alessandro Gronchi, Nadia Hindi, Josefina Cruz, Jean-Yves Blay, Antonio López‐Pousa, Antoîne Italiano, Rosa Álvarez, Antonio Gutiérrez, Inmaculada del Rincón, Claudia Sangalli, Jose Luis Pérez Aguiar, Jesús Romero, Carlo Morosi, Marie Pierre Sunyach, Roberta Sanfilippo, Cleofé Romagosa, Dominique Ranchère‐Vince, Angelo Paolo Dei Tos, Paolo G. Casali, Javier Martín‐Broto,

Cardiac tumors and thrombi

BackgroundMyxoid 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.MethodsPatients 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.FindingsFrom 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).InterpretationT 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.FundingThis study was partially supported by Pharmamar.