PMID- 27535294 OWN - NLM STAT- MEDLINE DCOM- 20170308 LR - 20181202 IS - 1973-9478 (Electronic) IS - 1120-009X (Linking) VI - 28 IP - 6 DP - 2016 Dec TI - Trabectedin for sarcomas in daily clinical practice: analysis of 45 patients treated in a French institution. PG - 494-499 AB - INTRODUCTION: 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. PATIENTS AND 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. CONCLUSION: 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. FAU - Daupin, Johanne AU - Daupin J AD - a Department of Pharmacy , Hopital Tenon (Hopitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France. AD - b Faculty of Pharmacy , Universite Paris Descartes (Paris 5) , Paris , France. FAU - Paubel, Pascal AU - Paubel P AD - b Faculty of Pharmacy , Universite Paris Descartes (Paris 5) , Paris , France. FAU - Fillon, Julie AU - Fillon J AD - a Department of Pharmacy , Hopital Tenon (Hopitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France. FAU - Debrix, Isabelle AU - Debrix I AD - a Department of Pharmacy , Hopital Tenon (Hopitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France. FAU - Soares, Daniele G AU - Soares DG AD - c Department of Medical Oncology and Cellular Therapy , APREC (Alliance Pour la Recherche En Cancerologie), Hopital Tenon (Hopitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France. FAU - Lotz, Jean-Pierre AU - Lotz JP AD - c Department of Medical Oncology and Cellular Therapy , APREC (Alliance Pour la Recherche En Cancerologie), Hopital Tenon (Hopitaux Universitaires de l'Est-Parisien, AP-HP) , Paris , France. AD - d Institut Universitaire de Cancerologie (IUC) , Sorbonne Universites, Universite Pierre et Marie Curie (UPMC Univ Paris 06) , Paris , France. LA - eng PT - Journal Article DEP - 20160818 PL - England TA - J Chemother JT - Journal of chemotherapy (Florence, Italy) JID - 8907348 RN - 0 (Antineoplastic Agents, Alkylating) RN - 0 (Dioxoles) RN - 0 (Tetrahydroisoquinolines) RN - ID0YZQ2TCP (Trabectedin) SB - IM MH - Antineoplastic Agents, Alkylating/*therapeutic use MH - Dioxoles/administration & dosage/adverse effects/*therapeutic use MH - Disease-Free Survival MH - France MH - Humans MH - Retrospective Studies MH - Sarcoma/diagnosis/*drug therapy MH - Tetrahydroisoquinolines/administration & dosage/adverse effects/*therapeutic use MH - Trabectedin OTO - NOTNLM OT - Clinical practice OT - Efficacy OT - Safety OT - Soft tissue sarcomas OT - Trabectedin EDAT- 2016/08/19 06:00 MHDA- 2017/03/09 06:00 CRDT- 2016/08/19 06:00 PHST- 2016/08/19 06:00 [pubmed] PHST- 2017/03/09 06:00 [medline] PHST- 2016/08/19 06:00 [entrez] AID - 10.1080/1120009X.2016.1218179 [doi] PST - ppublish SO - J Chemother. 2016 Dec;28(6):494-499. doi: 10.1080/1120009X.2016.1218179. Epub 2016 Aug 18.