Safety evaluation of trabectedin in treatment of soft-tissue sarcomas.

INTRODUCTION: 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. AREAS COVERED: 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. EXPERT OPINION: 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.