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Poster display

2368 - Update of the T-DIS randomized phase II trial: Trabectedin rechallenge versus continuation in patients (pts) with advanced soft tissue sarcoma (ASTS)


10 Oct 2016


Poster display


Nuria Kotecki


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


N. Kotecki1, A. Le Cesne2, E. Tresch-Bruneel3, O. Mir4, C. Chevreau5, F. Bertucci6, C. Delcambre7, E. Saada-Bouzid8, S. Piperno-Neumann9, J. Bay10, I.L. Ray-Coquard11, T. Ryckewaert1, N. Isambert12, A. Italiano13, S. Clisant14, J. Blay15, N. Penel1

Author affiliations

  • 1 Medical Oncology, Centre Oscar Lambret, 59020 - Lille/FR
  • 2 Medical Oncology, Institut de Cancérologie Gustave Roussy, 94805 - Villejuif/FR
  • 3 Clinical Research And Methodological Platform, Centre Oscar Lambret, 59020 - Lille/FR
  • 4 Department Of Medical Oncology, Institut Gustave Roussy, 94805 - Villejuif/FR
  • 5 Oncology, Centre Claudius-Regaud, Toulouse/FR
  • 6 Oncologie Médicale, Institute Paoli Calmettes, 13274 - Marseille/FR
  • 7 Medicine, Centre Francois Baclesse, Caen/FR
  • 8 Medical Oncology, Centre Antoine Lacassagne, Nice/FR
  • 9 Medicine, Institut Curie, Paris/FR
  • 10 Oncohematology, CHU Estaing, Clermont-Ferrand/FR
  • 11 Département D'oncologie Médicale Adulte, Centre Léon Bérard, 69008 - Lyon/FR
  • 12 Medicine, Centre Georges-François Leclerc (Dijon), Dijon/FR
  • 13 Medical Oncology, Institute Bergonié, 33076 - Bordeaux/FR
  • 14 Clinical Research Unit, Centre Oscar Lambret, 59020 - Lille/FR
  • 15 University Claude Bernard Lyon I, Centre Léon Bérard, 69008 - Lyon/FR


Abstract 2368


Trabectedin (T) maintenance beyond 6 cycles (cy) of treatment in responding pts with ASTS is associated with improved progression-free survival (PFS) vs T discontinuation (Le Cesne, Lancet Oncol 2015). The impact of T rechallenge after progressive disease (PD) was prospectively analyzed by the French Sarcoma Group in the national randomized phase II trial (T-DIS; NCT01303094).


After the initial 6 cy of T (1.5 mg/m2 as 24-h infusion every 3 weeks) pts free of PD were randomly assigned either to continuous treatment with T (C arm; immediate 7th cy) or therapy interruption (I arm). Pts allocated to the I arm could restart T in case of PD (7th cy at the time of PD). Here we report updated outcomes in both arms obtained either from randomization or from the 7th cy date.


From 2/2011 to 3/2013, 178 pretreated pts have been enrolled. Median age and performance status were 57 years (range 19-82) and 1 (range 0-3), respectively. Most pts had leiomyosarcoma (30.0%), liposarcoma (18.0%) or synovial sarcoma (12.0%). 53/178 (29.7%) non progressive patients were eligible for randomization after 6 cy of T, 27 and 26 non progressive pts were randomized to C and I arms, respectively. T has been restarted in 22/26 progressive pts in I arm whereas 25 out of 27 pts of the C arm immediately continued T. Median number of cy after randomization was similar in both arms (5 vs 6 cy, p = 0.96). From the date of randomization the median PFS was 5.3 vs 3.5 months (p = 0.019) in the C and I arm, respectively, and 6-month PFS was 48.2 vs 19.2%. From the date of the 7th cy comparable median PFS (4.2 vs 4.8 months, p = 0.88) and 6-m rates of PFS (45.8% vs 34.7%) were observed in C and I arm, respectively. From the 7th cycle, a favorable trend in longer median OS was observed in C arm (26.0 vs 14.9 months), which did not reach the level of significance (log-rank test p = 0.14) due to the small sample size. Grade ≥3 toxicity rates were not significantly different between the two arms (36.0% vs 38.1%) after T rechallenge (p = 0.88).


Though T remains an active agent at rechallenge, we do not recommend trabectedin discontinuation in pts experiencing stable disease or partial response since interruption of T resulted in a rapid PD in most pts.

Clinical trial identification

EudraCT NCT01303094

Legal entity responsible for the study

Centre Oscar Lambret


Centre Oscar Lambret


All authors have declared no conflicts of interest.

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