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

Giuseppe Badalamenti, Laura Milesi, Alberto Righi, Emanuela Palmerini, Libero Ciuffreda, Antonella Brunello, Maria Abbondanza Pantaleo, Roberta Sanfilippo, Irene Quattrini, Antonio Pizzolorusso, Fabio Gelsomino, Alessandro Comandone, Elisabetta Setola, Elisa Carretta, Francesca Zanelli, Tommaso De Pas, Angela Buonadonna, Federica Grosso, Bruno Vincenzi, Antonella RomaniniEmanuela Marchesi, Toni Ibrahim, Giovanni Grignani, Piero Picci, Vittorio Ferrari, Stefano Ferrari, Virginia Ferraresi

Risultato della ricerca: Articlepeer review

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).
Lingua originaleEnglish
pagine (da-a)1-15
Numero di pagine15
RivistaCancers
Volume13
Stato di pubblicazionePublished - 2021

All Science Journal Classification (ASJC) codes

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  • ???subjectarea.asjc.1300.1306???

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