Identifier to cite or link to this item: http://hdl.handle.net/20.500.13003/17422
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.
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AuthorGronchi, Alessandro; Hindi, Nadia; Cruz, Josefina; Blay, Jean-Yves; Lopez-Pousa, Antonio; Italiano, Antoine; Alvarez, Rosa; Gutierrez, Antonio ; Rincon, Inmaculada; Sangalli, Claudia; Perez Aguiar, Jose Luis; Romero, Jesus; Morosi, Carlo; Sunyach, Marie Pierre; Sanfilippo, Roberta; Romagosa, Cleofe; Ranchere-Vince, Dominique; Dei Tos, Angelo Paolo; Casali, Paolo G; Martin-Broto, Javier
Document typeresearch article
CitationGronchi 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.
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.
This item appears in following Docusalut collectionsHospital Universitario Son Espases - HUSE > Comunicación científica
Instituto de Investigación Sanitaria Islas Baleares - IDISBA > Comunicación científica