Trabectedin for Patients with Advanced Soft Tissue Sarcoma: A Non-Interventional, Retrospective, Multicenter Study of the Italian Sarcoma Group

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

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).

Keywords: observational; real-life; soft tissue sarcoma; trabectedin.

Conflict of interest statement

The authors declare no conflict of interest. The funders had no role in the design of the study; in the collection, analyses, or interpretation of data; in the writing of the manuscript, or in the decision to publish the results.

Figures

Figure 1
Figure 1
Overall response rate by histology as per RECIST v.1.1. UPS, Undifferentiated pleomorphic sarcoma.
Figure 2
Figure 2
Kaplan–Meier plots of progression-free survival and univariate analyses.
Figure 3
Figure 3
Kaplan–Meier plots of overall survival and univariate analyses.

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