Trabectedin use in soft‐tissue sarcoma patients in a real‐world setting: Data from an Italian national drug‐access registry. Issue 4 (13th October 2022)

• Record Type: Journal Article
• Authors: Vincenzi, Bruno; Napolitano, Andrea; Comandone, Alessandro; Sanfilippo, Roberta; Celant, Simone; Olimpieri, Pier P.; Di Segni, Susanna; Russo, Pierluigi; Casali, Paolo G.
• Is Part Of: International journal of cancer. Volume 152:Issue 4(2023)
• Page Start: 761
• Page End: 768
• Publication Date: 2022-10-13
• Subjects: AIFA -- Italy -- registry -- sarcoma -- trabectedin; Cancer -- Periodicals; Cancer -- Prevention -- Periodicals; 616.994
• DOI: 10.1002/ijc.34309
• Languages: English
• ISSNs: 0020-7136

Abstract

Abstract: Trabectedin is a marine‐derived anticancer drug approved for the treatment of patients with advanced soft‐tissue sarcomas (STS). Here, we aimed to analyze its use in a large cohort of STS patients treated in Italy in a real‐world setting. Data on STS patients treated with trabectedin in Italy were prospectively collected from January 2013 to December 2019 by the national drug regulator, the Italian Medicines Agency (AIFA). Time‐to‐off‐treatment (TToT) was defined as the time between the initial prescription of trabectedin and the date of treatment discontinuation for any cause. The impact of the different baseline covariates, including the initial prescribed dose of trabectedin, on TToT was evaluated using an accelerated failure time (AFT) models with log‐logistic distribution. In total, we analyzed data from 2633 sarcoma patients and 14 950 individual cycles of trabectedin. The median number of cycles of trabectedin received per patient was 3 (interquartile range 2‐7). The labeled 1.5 mg/sqm dose was used in 27.3% of all first prescriptions. Overall, the median TToT was 93 days. In the final AFT model, the variables significantly associated to longer TToT were female gender (+13% increase in TToT); ECOG performance status 0 (+50%); histological diagnosis of leiomyosarcoma (+22%), well‐differentiated/dedifferentiated liposarcoma (+72%) or myxoid liposarcoma (+61%); receiving treatment in a high‐volume center (+23%). In this large real‐world cohort of STS patients treated with trabectedin, our findings support the use of trabectedin in STS patients, in particular in leiomyosarcoma and liposarcoma patients, and highlight the role of treatment center volume in their management. Abstract : What's new? The anticancer drug trabectedin, originally isolated from a marine species, is used for the treatment of advanced pretreated soft‐tissue sarcoma (STS). Here, to support evidence from randomized clinical trials, the authors evaluated real‐world use of trabectedin in STS patients treated between 2013 and 2019 in Italy. Analyses show that patients treated at high‐volume centers underwent trabectedin therapy for a significantly longer time compared to patients treated at low‐volume centers. The drug was notably effective in patients with leiomyosarcoma or liposarcoma. The findings highlight the utility of trabectedin for STS and the influence of treatment center volume on STS patient management.