Comprehensive Cancer Center - Musculoskeletal Tumors, General Hospital of Vienna, Medical University of Vienna, Vienna, Austria.
Anticancer Drugs. 2013 Aug;24(7):725-30. doi: 10.1097/CAD.0b013e3283629b9b.
The aim of this study was to retrospectively evaluate the efficacy and safety of trabectedin treatment in patients with metastatic soft tissue sarcoma (STS) in the routine clinical setting. Further, the type and frequency of systemic treatments before commencing treatment with trabectedin and after its discontinuation, as well as the frequency of pulmonary metastasectomies, were analyzed. The current analysis includes retrospective data from consecutive STS patients treated with trabectedin at the Department of Medicine I, Division of Oncology, Medical University of Vienna, between January 2008 and December 2012. Patients were analyzed for median progression-free survival, overall survival (OS), and therapy-related toxicity. Data of 60 STS patients were included in the present analysis. In total, 198 cycles of trabectedin were administered, whereas the median number of cycles administered per patient was two (range 1-25). The median progression-free survival was 2.2 months and the median OS (mOS) was 11.8 months. mOS calculated from the first time point of detection of metastatic disease was 35.8 months. The 18 patients (30%) who underwent pulmonary metastasectomy had an mOS of 50.2 months. Further, trabectedin had a manageable toxicity profile comparable to data reported in previous phase II trials. Our findings support the use of trabectedin as an active and feasible therapeutic option among advanced, metastatic, and refractory STS patients. The good safety profile and lack of cumulative toxicity allow prolonged administration in highly pretreated patients. As visible from the present data, a considerable percentage of patients with advanced/metastatic STS benefit from sequential lines of drug therapy as well as pulmonary metastasectomy.
本研究旨在回顾性评估在常规临床环境中，转移性软组织肉瘤（STS）患者接受 trabectedin 治疗的疗效和安全性。此外，还分析了开始 trabectedin 治疗前和停止治疗后的全身治疗类型和频率，以及肺转移切除术的频率。本分析包括维也纳医科大学医学系肿瘤学分部 2008 年 1 月至 2012 年 12 月连续接受 trabectedin 治疗的 STS 患者的回顾性数据。对患者的中位无进展生存期（PFS）、总生存期（OS）和治疗相关毒性进行了分析。本分析共纳入 60 例 STS 患者。共给予 trabectedin198 个周期，而每位患者接受的中位数为 2 个周期（范围 1-25）。中位 PFS 为 2.2 个月，中位 OS（mOS）为 11.8 个月。从转移性疾病首次检测到的时间点计算 mOS 为 35.8 个月。接受肺转移切除术的 18 例患者（30%）mOS 为 50.2 个月。此外，trabectedin 的毒性谱可管理，与之前的 II 期试验报告的数据相当。我们的研究结果支持 trabectedin 作为晚期、转移性和难治性 STS 患者的一种有效且可行的治疗选择。良好的安全性和无累积毒性允许在高度预处理的患者中延长给药。从目前的数据可以看出，相当一部分晚期/转移性 STS 患者受益于序贯药物治疗和肺转移切除术。
