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Results of a prospective randomized phase III T-SAR trial comparing trabectedin vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS)

Date

08 Oct 2016

Session

Sarcoma

Presenters

Axel Le Cesne

Citation

Annals of Oncology (2016) 27 (6): 483-492. 10.1093/annonc/mdw388

Authors

A. Le Cesne1, J. Blay2, D. Cupissol3, A. Italiano4, C. Delcambre5, N. Penel6, N. Isambert7, C. Chevreau8, E. Bompas9, F. Bertucci10, L. Chaigneau11, S. Piperno-Neumann12, S. Salas13, M. Rios14, C. Guillemet15, J. Bay16, I.L. Ray-Coquard17, O. Mir1, L. Haddag1, S. Foulon1

Author affiliations

  • 1 Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 2 University Claude Bernard Lyon I, Centre Léon Bérard, 69008 - Lyon/FR
  • 3 Medicine, Clinique Val d'Aurelle, Montpellier/FR
  • 4 Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 5 Medicine, Centre Francois Baclesse, Caen/FR
  • 6 Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 7 Medicine, Centre Georges-François Leclerc (Dijon), Dijon/FR
  • 8 Oncology, Centre Claudius-Regaud, Toulouse/FR
  • 9 Department Of Medical Oncology, Institut de cancérologie de l'Ouest - René Gauducheau, 44805 - Saint-Herblain/FR
  • 10 Oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 11 Medicine, CHU Besançon, Hôpital Jean Minjoz, Besançon/FR
  • 12 Medicine, Institut Curie, Paris/FR
  • 13 Medicine, CHU La Timone Adultes, Marseille/FR
  • 14 Medecine, Institut de Cancérologie de Lorraine, Nancy/FR
  • 15 Medecine, Centre Henri Becquerel, Rouen/FR
  • 16 Medecine, CHU Estaing, Clermont-Ferrand/FR
  • 17 Département D'oncologie Médicale Adulte, Centre Léon Bérard, 69008 - Lyon/FR
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Resources

Background

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.

Methods

The study included adult pts ≥18 years of age with histologically proven ASTS who progressed after at least one anthracycline-containing regimen (

Results

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 

Conclusions

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

2014-003176-23

Legal entity responsible for the study

Gustave Roussy Institute

Funding

Pharmamar

Disclosure

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.

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