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 Anti-Cancer Agents & Biologic Therapy
Soft Tissue Sarcomas
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.