作者
Javier Martin-Broto, Nadia Hindi, Antonio Lopez-Pousa, Javier Peinado-Serrano, Rosa Alvarez, Ana Alvarez-Gonzalez, Antoine Italiano, Paul Sargos, Josefina Cruz-Jurado, Josep Isern-Verdum, Maria Carmen Dolado, Inmaculada Rincon-Pérez, Paloma Sanchez-Bustos, Antonio Gutierrez, Cleofe Romagosa, Carlo Morosi, Giovanni Grignani, Marco Gatti, Pablo Luna, Ignacio Alastuey, Andres Redondo, Belen Belinchon, Jordi Martinez-Serra, Marie-Pierre Sunyach, Jean-Michel Coindre, Angelo P Dei Tos, Jesus Romero, Alessandro Gronchi, Jean-Yves Blay, David S Moura
发表日期
2020/4/1
期刊
JAMA oncology
卷号
6
期号
4
页码范围
535-541
出版商
American Medical Association
简介
Importance
Active therapeutic combinations, such as trabectedin and radiotherapy, offer potentially higher dimensional response in second-line treatment of advanced soft-tissue sarcomas. Dimensional response can be relevant both for symptom relief and for survival.
Objective
To assess the combined use of trabectedin and radiotherapy in treating patients with progressing metastatic soft-tissue sarcomas.
Design, Setting, and Participants
Phase 1 of this nonrandomized clinical trial followed the classic 3 + 3 design, with planned radiotherapy at a fixed dose of 30 Gy (3 Gy/d for 10 days) and infusion of trabectedin at 1.3 mg/m2as the starting dose, 1.5 mg/m2as dose level +1, and 1.1 mg/m2as dose level –1. Phase 2 followed the Simon optimal 2-stage design. Allowing for type I and II errors of 10%, treatment success was defined as an overall response rate of 35%. This study was conducted in 9 sarcoma referral …
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J Martin-Broto, N Hindi, A Lopez-Pousa… - JAMA oncology, 2020