Trabectedin in patients with advanced soft tissue sarcoma: a retrospective national analysis of the French Sarcoma Group

Eur J Cancer. 2015 Apr;51(6):742-50. doi: 10.1016/j.ejca.2015.01.006. Epub 2015 Feb 23.


Aim: The French Sarcoma Group performed this retrospective analysis of the 'RetrospectYon' database with data of patients with recurrent advanced soft tissue sarcoma (STS) treated with trabectedin 1.5 mg/m(2) as a 24-h infusion every three weeks.

Methods: Patients who achieved non-progressive disease after six initial cycles could receive long-term trabectedin treatment until disease progression.

Results: Overall, 885 patients from 25 French centres were included. Patients received a median of four trabectedin cycles (range: 1-28). The objective response rate was 17% (six complete/127 partial responses) and 50% (n = 403) of patients had stable disease for a disease control rate of 67%. After a median follow-up of 22.0 months, median progression-free survival (PFS) and overall survival (OS) were 4.4 and 12.2 months, respectively. After six cycles, 227/304 patients with non-progressive disease received trabectedin until disease progression and obtained a significantly superior median PFS (11.7 versus 7.6 months, P<0.003) and OS (24.9 versus 16.9 months, P < 0.001) compared with those who stopped trabectedin treatment. Deaths and unscheduled hospitalisation attributed to drug-related events occurred in 0.5% and 9.4% of patients, respectively.

Conclusion: The results of this real-life study demonstrate that treatment with trabectedin of patients with STS yielded comparable or improved efficacy outcomes versus those observed in clinical trials. A long-term treatment with trabectedin given until disease progression is associated with significantly improved PFS and OS.

Keywords: Advanced; Metastasis; RetrospectYon; Sarcoma; Trabectedin.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • Antineoplastic Agents, Alkylating / therapeutic use*
  • Child
  • Dioxoles / therapeutic use*
  • Disease-Free Survival
  • Female
  • France
  • Humans
  • Male
  • Middle Aged
  • Retrospective Studies
  • Sarcoma / drug therapy*
  • Tetrahydroisoquinolines / therapeutic use*
  • Trabectedin
  • Treatment Outcome
  • Young Adult


  • Antineoplastic Agents, Alkylating
  • Dioxoles
  • Tetrahydroisoquinolines
  • Trabectedin