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.

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 local...

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Autores: Gronchi, 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
Tipo de recurso: artículo
Fecha de publicación:2019
País:España
Institución:Instituto de Salud Carlos III (ISCIII)
Repositorio:Repisalud
Idioma:inglés
OAI Identifier:oai:repisalud.isciii.es:20.500.12105/22833
Acceso en línea:https://hdl.handle.net/20.500.12105/22833
Access Level:acceso abierto
Palabra clave:Chemotherapy
Myxoid Liposarcoma
Neoadjuvant
Prognosis
Radiotherapy
Sarcoma
Survival
Trabectedin
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spelling 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, AlessandroHindi, NadiaCruz, JosefinaBlay, Jean-YvesLopez-Pousa, AntonioItaliano, AntoineAlvarez, RosaGutierrez, AntonioRincon, InmaculadaSangalli, ClaudiaPerez Aguiar, Jose LuisRomero, JesusMorosi, CarloSunyach, Marie PierreSanfilippo, RobertaRomagosa, CleofeRanchere-Vince, DominiqueDei Tos, Angelo PaoloCasali, Paolo GMartin-Broto, JavierChemotherapyMyxoid LiposarcomaNeoadjuvantPrognosisRadiotherapySarcomaSurvivalTrabectedinBackground: 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.20242024-09-1020192019-01-0120192019-01-01research articlehttp://purl.org/coar/resource_type/c_2df8fbb1info:eu-repo/semantics/articlehttps://hdl.handle.net/20.500.12105/22833reponame:Repisaludinstname:Instituto de Salud Carlos III (ISCIII)Inglésengopen accesshttp://purl.org/coar/access_right/c_abf2Attribution-NonCommercial-NoDerivatives 4.0 Internationalhttp://creativecommons.org/licenses/by-nc-nd/4.0/info:eu-repo/semantics/openAccessoai:repisalud.isciii.es:20.500.12105/228332026-06-12T12:43:37Z
dc.title.none.fl_str_mv 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.
title 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.
spellingShingle 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
Chemotherapy
Myxoid Liposarcoma
Neoadjuvant
Prognosis
Radiotherapy
Sarcoma
Survival
Trabectedin
title_short 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.
title_full 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.
title_fullStr 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.
title_full_unstemmed 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.
title_sort 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.
dc.creator.none.fl_str_mv Gronchi, 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
author Gronchi, Alessandro
author_facet Gronchi, 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
author_role author
author2 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
author2_role author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
author
dc.contributor.none.fl_str_mv
dc.subject.none.fl_str_mv Chemotherapy
Myxoid Liposarcoma
Neoadjuvant
Prognosis
Radiotherapy
Sarcoma
Survival
Trabectedin
topic Chemotherapy
Myxoid Liposarcoma
Neoadjuvant
Prognosis
Radiotherapy
Sarcoma
Survival
Trabectedin
description 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.
publishDate 2019
dc.date.none.fl_str_mv 2019
2019-01-01
2019
2019-01-01
2024
2024-09-10
dc.type.none.fl_str_mv research article
http://purl.org/coar/resource_type/c_2df8fbb1
dc.type.openaire.fl_str_mv info:eu-repo/semantics/article
format article
dc.identifier.none.fl_str_mv https://hdl.handle.net/20.500.12105/22833
url https://hdl.handle.net/20.500.12105/22833
dc.language.none.fl_str_mv Inglés
eng
language_invalid_str_mv Inglés
language eng
dc.rights.none.fl_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
dc.rights.openaire.fl_str_mv info:eu-repo/semantics/openAccess
rights_invalid_str_mv open access
http://purl.org/coar/access_right/c_abf2
Attribution-NonCommercial-NoDerivatives 4.0 International
http://creativecommons.org/licenses/by-nc-nd/4.0/
eu_rights_str_mv openAccess
dc.source.none.fl_str_mv reponame:Repisalud
instname:Instituto de Salud Carlos III (ISCIII)
instname_str Instituto de Salud Carlos III (ISCIII)
reponame_str Repisalud
collection Repisalud
repository.name.fl_str_mv
repository.mail.fl_str_mv
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score 15,811543

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