University Campus Bio-Medico, Rome, Italy.
Royal Marsden NHS Foundation Trust, London, UK.
Int J Cancer. 2023 Feb 15;152(4):761-768. doi: 10.1002/ijc.34309. Epub 2022 Oct 13.
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.
曲贝替定是一种海洋来源的抗癌药物，已被批准用于治疗晚期软组织肉瘤（STS）患者。在这里，我们旨在分析其在意大利真实环境中治疗的大量 STS 患者中的应用。意大利药品监管机构意大利药品管理局（AIFA）从 2013 年 1 月至 2019 年 12 月前瞻性收集了在意大利接受曲贝替定治疗的 STS 患者的数据。停药时间（TToT）定义为从曲贝替定首次处方到因任何原因停止治疗的时间。使用具有对数逻辑分布的加速失效时间（AFT）模型评估包括曲贝替定初始规定剂量在内的不同基线协变量对 TToT 的影响。总共分析了 2633 名肉瘤患者和 14950 个曲贝替定个体周期的数据。每位患者接受的曲贝替定治疗周期中位数为 3 个（四分位距 2-7）。标签剂量 1.5mg/sqm 用于所有首次处方的 27.3%。总体而言，TToT 的中位数为 93 天。在最终的 AFT 模型中，与较长 TToT 显著相关的变量包括女性性别（TToT 增加 13%）；ECOG 表现状态 0（+50%）；组织学诊断为平滑肌肉瘤（+22%）、高分化/去分化脂肪肉瘤（+72%）或黏液样脂肪肉瘤（+61%）；在高容量中心接受治疗（+23%）。在接受曲贝替定治疗的 STS 患者的这一大规模真实世界队列中，我们的发现支持在 STS 患者中使用曲贝替定，特别是在平滑肌肉瘤和脂肪肉瘤患者中，并强调了治疗中心数量在其管理中的作用。
