Trabectedin (T) has demonstrated single-agent activity in patients (pts) with pretreated ASTS and was approved in 2007 in Europe in this indication. With the exception of a study in translocation-related sarcomas (Kawai, 2015), T was never compared to BSC in a randomized study in pts with all sarcoma histotypes. The efficacy, safety and quality of life of T vs BSC as second or later treatment line were evaluated in pts with ASTS in a multicenter French Sarcoma Group (FSG) trial.
The study included adult pts ≥18 years of age with histologically proven ASTS who progressed after at least one anthracycline-containing regimen (
Between January and November 2015 a total of 103 pts were enrolled by 16 FSG centers. 52 and 51 pts were randomized in the trabectedin and BSC arm, respectively. Pts with L-STS and non L-STS represented 58.3% and 41.7% of pts, respectively. On March 2016, after 88 PD, the median PFS after randomization were 1.4 months (m) in the BSC arm and 3.0 m in the trabectedin arm (HR: 0.40, 95% IC: 0.26-0.63, p
This study met its first endpoint as a preplanned PFS analysis showed a significant improvement in median PFS with trabectedin over BSC in pts with pretreated ASTS of multiple histologies.
Clinical trial identification
Legal entity responsible for the study
Gustave Roussy Institute
A. Le Cesne: Honoraria from Novartis, Pfizer, Pharmamar, Lilly. J-Y. Blay: Honoraria from Roche, Novartis, Pfizer, Lilly, Bayer, Pharmamar. I.L. Ray-Coquard: Honoraria from Roche, Novartis, Pharmamar, Merck. All other authors have declared no conflicts of interest.