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

Cancers

Antonella Romanini¹  Angela Buonadonna²  Irene Quattrini³  Emanuela Palmerini³  Stefano Ferrari³  Elisa Carretta³  Roberta Sanfilippo⁴  Fabio Gelsomino⁵  Elisabetta Setola⁶  Alberto Righi⁶  Giuseppe Badalamenti⁷  Laura Milesi⁸  Francesca Zanelli⁹  Vittorio Ferrari^1,10  Giovanni Grignani^1,11  MariaAbbondanza Pantaleo^1,12  Virginia Ferraresi^1,13  Antonio Pizzolorusso^1,14  Emanuela Marchesi^1,15  Piero Picci^1,16  Libero Ciuffreda^1,17  Bruno Vincenzi^1,18  Federica Grosso^1,19  Antonella Brunello^2,20  Toni Ibrahim^2,21  Alessandro Comandone^2,22  TommasoDe Pas^2,23 

[1] Azienda Ospedaliero-Universitaria Pisana, Via Filippo Mazzei 16, 56124 Pisa, Italy;Centro di Riferimento Oncologico di Aviano (CRO Aviano), IRCCS, Via Franco Gallini 2, 33081 Aviano, Italy;Chemotherapy Unit, IRCCS Istituto Ortopedico Rizzoli, 1 Via Pupilli, 40136 Bologna, Italy;Department of Cancer Medicine, Fondazione IRCCS Istituto Nazionale dei Tumori, Via Giacomo Venezian, 1, 20133 Milano, Italy;Department of Oncology and Hematology, University Hospital of Modena, Via del Pozzo 71, 41124 Modena, Italy;Department of Pathology, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy;Department of Surgical, Oncological and Oral Sciences, Section of Medical Oncology, University of Palermo, Piazza Marina 61, 90133 Palermo, Italy;Depatement of Oncology, ASST. Papa Giovanni XXIII Hospital, Piazza OMS, 1, 24127 Bergamo, Italy;Dipartimento Oncologico e Tecnologie Avanzate, Arcispedale Santa Maria Nuova IRCCS Reggio Emilia, Viale Risorgimento 80, 42123 Reggio Emilia, Italy;Dipartimento di Specialità Medico-Chirurgiche, Scienze Radiologiche e Sanità Pubblica, Oncologia Medica, Università degli Studi di Brescia, ASST Spedali Civili, Piazzale Spedali Civili 1, 25123 Brescia, Italy;Division of Medical Oncology, Candiolo Cancer Institute, FPO-IRCCS, Strada Provinciale 142, Candiolo, 10060 Torino, Italy;Division of Oncology, IRCSS Azienda Ospedaliero-Universitaria di Bologna, Via Albertoni 15, 40138 Bologna, Italy;IRCCS Regina Elena National Cancer Institute-Division of Medical Oncology 1-Via Elio Chianesi 53, 00144 Rome, Italy;Istituto Nazionale Tumori IRCCS “Fondazione G. Pascale”, Via Mariano Semmola 53, 80131 Naples, Italy;Italian Sarcoma Group Clinical Trial Unit, IRCCS Istituto Ortopedico Rizzoli, Via Pupilli 1, 40136 Bologna, Italy;Laboratory of Oncologic Research, IRCCS Istituto Ortopedico Rizzoli, Via di Barbiano 1/10, 40136 Bologna, Italy;Medical Oncology Unit, Azienda Ospedaliero Universitaria San Giovanni Battista, Molinette, Via Santena 5, 10126 Torino, Italy;Medical Oncology, University Campus Bio-Medico, Via Alvaro del Portillo 200, 00128 Rome, Italy;Mesothelioma and Rare Cancer Unit, Azienda Ospedaliera SS. Antonio e Biagio General Hospital, Via Venezia, 16, 15121 Alessandria, Italy;Oncology 1 Unit, Istituto Oncologico Veneto IOV–IRCCS, Via Gattamelata 64, 35128 Padova, Italy;Osteoncology and Rare Tumors Center, IRCCS Istituto Romagnolo per lo Studio dei Tumori (IRST) “Dino Amadori”, Via Piero Maroncelli 40, 47014 Meldola, Italy;SC Oncologia ASL Città di Torino, Ospedale San Giovanni Bosco Torino, Piazza del Donatore di Sangu, 3, 10154 Torino, Italy;Unit of Medical Oncology Sarcomas, Thymomas and Rare Tumors, European Institute of Oncology, IRCCS, Via Ripamonti 435, 20121 Milano, Italy;

关键词: trabectedin;    soft tissue sarcoma;    real-life;    observational;   

DOI  :  10.3390/cancers13051053

来源: DOAJ

【 摘 要 】

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).

【 授权许可】

Unknown