Trabectedin for patients with advanced soft tissue sarcoma: A non-interventional, retrospective, multicenter study of the italian sarcoma group

E. Palmerini, R. Sanfilippo, G. Grignani, A. Buonadonna, A. Romanini, G. Badalamenti, V. Ferraresi, B. Vincenzi, A. Comandone, A. Pizzolorusso, A. Brunello, F. Gelsomino, T. De Pas, T. Ibrahim, F. Grosso, F. Zanelli, M.A. Pantaleo, L. Milesi, L. Ciuffreda, V. FerrariE. Marchesi, I. Quattrini, A. Righi, E. Setola, E. Carretta, P. Picci, S. Ferrari

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The Italian Sarcoma Group performed this retrospective analysis of patients with advanced soft tissue sarcoma, pretreated with ≥1 anthracycline-based treatment, and treated with trabectedin every three weeks. Primary endpoint was to describe real-life use of trabectedin across Italy. Secondary endpoints included objective response rate (ORR) and safety. Overall, 512 patients from 20 Italian centers were evaluated. Leiomyosarcoma (37.7%)/liposarcoma (30.3%) were the most prevalent histological types (abbreviated as L-sarcoma). Patients received a median of four trabectedin cycles (range: 1–40), mostly as a second-line treatment (~60% of patients). The ORR was 13.7% superior (p < 0.0001) in patients with L-sarcoma compared with patients with non-L-sarcoma (16.6% vs. 9.0%). Median progression-free survival (PFS) was 5.1 months, whereas median overall survival (OS) was 21.6 months. Significantly better PFS and OS were observed in patients with L-sarcoma, those with objective responses and/or disease stabilization, treated in an early line and treated with reduced dose. Bone marrow toxicity (61.4%) and transaminase increases (21.9%) were the most common grade 3/4 adverse events. The results of this real-life study suggest that trabectedin is an active treatment, which is mostly given as a second-line treatment to patients with a good performance status and high-grade, metastatic L-sarcoma (clinical trial information: NCT02793050). © 2021 by the authors. Licensee MDPI, Basel, Switzerland.
Original languageEnglish
Pages (from-to)1-15
Number of pages15
Issue number5
Publication statusPublished - 2021


  • Observational
  • Real-life
  • Soft tissue sarcoma
  • Trabectedin
  • dacarbazine
  • docetaxel
  • doxorubicin
  • gemcitabine
  • ifosfamide
  • pazopanib
  • trabectedin
  • adult
  • advanced cancer
  • aged
  • Article
  • bone marrow toxicity
  • cancer combination chemotherapy
  • cancer survival
  • clinical effectiveness
  • controlled study
  • dose response
  • drug dose reduction
  • drug efficacy
  • drug safety
  • female
  • follow up
  • human
  • hypertransaminasemia
  • leiomyosarcoma
  • liposarcoma
  • major clinical study
  • male
  • monotherapy
  • multicenter study (topic)
  • observational study
  • progression free survival
  • recommended drug dose
  • retrospective study
  • soft tissue sarcoma
  • survival time
  • treatment duration
  • treatment outcome
  • treatment planning


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