The Royal Marsden Hospital, Sarcoma Unit , Fulham Road, London, SW3 6JJ , UK
Expert Opin Drug Saf. 2013 Nov;12(6):905-11. doi: 10.1517/14740338.2013.829037. Epub 2013 Aug 12.
Trabectedin gained the approval by the European Medicines Agency (EMA) in 2007 for the treatment of patients affected by soft-tissue sarcomas (STS). Its safety and activity profiles have been assessed in many clinical trials as well as in standard clinical practice for > 10 years.
This article extensively reviews the most common and specific adverse events associated with trabectedin. Moreover, we compare these toxicity data with other drugs active in STS such as doxorubicin and ifosfamide. Also, we provide a comprehensive view of the special mechanism of action of this drug and its clinical applications. Additionally, we discuss the current role of trabectedin in the treatment of STS and give a future perspective with the review of ongoing clinical trials and potential new indications.
Trabectedin is, in general, a well-tolerated drug with a favorable toxicity profile. The majority of its side effects are mild and easily manageable. Specific adverse events such as liver toxicity and rhabdomyolysis do not usually have a significant clinical impact. Overall, trabectedin is a safe and active treatment option in STS.
2007 年，盐酸多柔比星脂质体注射液（商品名：多美素）获得欧洲药品管理局（EMA）批准，用于治疗软组织肉瘤（STS）患者。在超过 10 年的时间里，它的安全性和疗效已在许多临床试验和标准临床实践中得到评估。
本文广泛回顾了与盐酸多柔比星脂质体注射液相关的最常见和特定的不良反应。此外，我们还将这些毒性数据与其他在 STS 中具有活性的药物（如多柔比星和异环磷酰胺）进行了比较。我们还全面介绍了这种药物的特殊作用机制及其临床应用。此外，我们还讨论了盐酸多柔比星脂质体注射液在 STS 治疗中的当前作用，并通过对正在进行的临床试验和潜在新适应症的回顾，展望了未来。
盐酸多柔比星脂质体注射液总体上是一种耐受性良好的药物，具有良好的毒性特征。其大多数副作用为轻度且易于处理。特定的不良反应，如肝毒性和横纹肌溶解症，通常不会产生重大的临床影响。总的来说，盐酸多柔比星脂质体注射液是 STS 安全有效的治疗选择。
