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
| Autor: | Jean-Yves Blay, Claudia Sangalli, Angelo Paolo Dei Tos, Alessandro Gronchi, Cleofe Romagosa, Rosa Alvarez, Jesus G. Romero, Nadia Hindi, Marie Pierre Sunyach, Josefina Cruz, Javier Martin-Broto, Roberta Sanfilippo, Antoine Italiano, Inmaculada Rincón, Antonio Lopez-Pousa, Carlo Morosi, Antonio Gutierrez, Jose Luis Pérez Aguiar, Paolo G. Casali, Dominique Ranchère-Vince |
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| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
medicine.medical_specialty
Survival medicine.medical_treatment Phases of clinical research Myxoid Liposarcoma 01 natural sciences Gastroenterology 03 medical and health sciences 0302 clinical medicine Internal medicine medicine Clinical endpoint Chemotherapy 030212 general & internal medicine 0101 mathematics Trabectedin Myxoid liposarcoma Radiotherapy business.industry Soft tissue sarcoma 010102 general mathematics Sarcoma General Medicine medicine.disease Prognosis Radiation therapy Neoadjuvant business Research Paper medicine.drug |
| Zdroj: | EClinicalMedicine |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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