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GIUSEPPE BADALAMENTI

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

  • Autori: Palmerini E.; Sanfilippo R.; Grignani G.; Buonadonna A.; Romanini A.; Badalamenti G.; Ferraresi V.; Vincenzi B.; Comandone A.; Pizzolorusso A.; Brunello A.; Gelsomino F.; De Pas T.; Ibrahim T.; Grosso F.; Zanelli F.; Pantaleo M.A.; Milesi L.; Ciuffreda L.; Ferrari V.; Marchesi E.; Quattrini I.; Righi A.; Setola E.; Carretta E.; Picci P.; Ferrari S.
  • Anno di pubblicazione: 2021
  • Tipologia: Articolo in rivista
  • OA Link: http://hdl.handle.net/10447/519765

Abstract

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).