1396O - Results of a prospective randomized phase III T-SAR trial comparing trabectedin vs best supportive care (BSC) in patients with pretreated advanced...

Date 08 October 2016
Event ESMO 2016 Congress
Session Sarcoma
Topics Cytotoxic agents
Soft Tissue Sarcomas
Therapy
Biological therapy
Presenter 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
  • 1Medicine, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 2University Claude Bernard Lyon I, Centre Léon Bérard, 69008 - Lyon/FR
  • 3Medicine, Clinique Val d'Aurelle, Montpellier/FR
  • 4Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 5Medicine, Centre Francois Baclesse, Caen/FR
  • 6Medical Oncology, Centre Oscar Lambret, Lille/FR
  • 7Medicine, Centre Georges-François Leclerc (Dijon), Dijon/FR
  • 8Oncology, Centre Claudius-Regaud, Toulouse/FR
  • 9Department Of Medical Oncology, Institut de cancérologie de l'Ouest - René Gauducheau, 44805 - Saint-Herblain/FR
  • 10Oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 11Medicine, CHU Besançon, Hôpital Jean Minjoz, Besançon/FR
  • 12Medicine, Institut Curie, Paris/FR
  • 13Medicine, CHU La Timone Adultes, Marseille/FR
  • 14Medecine, Institut de Cancérologie de Lorraine, Nancy/FR
  • 15Medecine, Centre Henri Becquerel, Rouen/FR
  • 16Medecine, CHU Estaing, Clermont-Ferrand/FR
  • 17Département D'oncologie Médicale Adulte, Centre Léon Bérard, 69008 - Lyon/FR

Abstract

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.