title: Trabectedin for sarcomas in daily clinical practice: analysis of 45 patients treated in a French institution.
abstract: BACKGROUND
  The active clinical research programme of trabectedin continues to improve knowledge on the therapeutic activity and toxicity of the drug in the treatment of soft tissue sarcomas (STS). In contrast, limited number of data is available on its use outside of clinical trials.
  
  
  METHODS
  We retrospectively analysed efficacy and safety of trabectedin when given in daily practice to patients with advanced/recurrent STS. Outcomes were compared with previously published works including clinical and retrospective studies.
  
  
  RESULTS
  Forty-five patients received trabectedin between January 2005 and May 2014. Sarcomas were histologically heterogeneous in our cohort (37.9% of other types of sarcomas than L-sarcomas). Our patients had poor baseline health status (ECOG ≥ 2 [17.8%]) and had received multiple previous lines of chemotherapy. Patients received a median of five cycles of treatment (1-22). The objective response rate was statistically superior in our study (37.8%) compared to the other works. However, median PFS was similar. Trabectedin-related serious adverse events (AEs) induced hospitalizations and treatment discontinuation in 22 and 15% of patients.
  
  
  CONCLUSIONS
  This analysis confirms the efficacy of trabectedin in clinical practice (with a third of patients experiencing prolonged disease control) and highlighted the importance of its administration as early line therapy to allow the best management of serious AEs.
authors.affiliation: a Department of Pharmacy , Hôpital Tenon (Hôpitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France.|b Faculty of Pharmacy , Université Paris Descartes (Paris 5) , Paris , France.
authors.forename: Johanne
authors.initials: J
authors.lastname: Daupin
authors.affiliation: b Faculty of Pharmacy , Université Paris Descartes (Paris 5) , Paris , France.
authors.forename: Pascal
authors.initials: P
authors.lastname: Paubel
authors.affiliation: a Department of Pharmacy , Hôpital Tenon (Hôpitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France.
authors.forename: Julie
authors.initials: J
authors.lastname: Fillon
authors.affiliation: a Department of Pharmacy , Hôpital Tenon (Hôpitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France.
authors.forename: Isabelle
authors.initials: I
authors.lastname: Debrix
authors.affiliation: c Department of Medical Oncology and Cellular Therapy , APREC (Alliance Pour la Recherche En Cancérologie), Hôpital Tenon (Hôpitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France.
authors.forename: Daniele G
authors.initials: DG
authors.lastname: Soares
authors.affiliation: c Department of Medical Oncology and Cellular Therapy , APREC (Alliance Pour la Recherche En Cancérologie), Hôpital Tenon (Hôpitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France.|d Institut Universitaire de Cancérologie (IUC) , Sorbonne Universités, Université Pierre et Marie Curie (UPMC Univ Paris 06) , Paris , France.
authors.forename: Jean-Pierre
authors.initials: JP
authors.lastname: Lotz
mesh_terms: D018906:Antineoplastic Agents, Alkylating / Q000627:therapeutic use*; D004149:Dioxoles / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D018572:Disease-Free Survival; D005602:France; D006801:Humans; D012189:Retrospective Studies; D012509:Sarcoma / Q000175:diagnosis / Q000188:drug therapy*; D044005:Tetrahydroisoquinolines / Q000008:administration & dosage / Q000009:adverse effects / Q000627:therapeutic use*; D000077606:Trabectedin
chemical_list: D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin
keywords: Clinical practice; Efficacy; Safety; Soft tissue sarcomas; Trabectedin