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


METHODS
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.


CONCLUSIONS
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.
The Royal Marsden Hospital, Sarcoma Unit , Fulham Road, London, SW3 6JJ , UK Juan.Martin@rmh.nhs.uk.
Juan
J
Martin-Liberal
Ian
I
Judson
D018906:Antineoplastic Agents, Alkylating / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D056486:Chemical and Drug Induced Liver Injury / Q000209:etiology; D002986:Clinical Trials as Topic; D004149:Dioxoles / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D006801:Humans; D012206:Rhabdomyolysis / Q000139:chemically induced; D012509:Sarcoma / Q000188:drug therapy* / Q000473:pathology; D044005:Tetrahydroisoquinolines / Q000009:adverse effects* / Q000494:pharmacology / Q000627:therapeutic use; D000077606:Trabectedin; D016896:Treatment Outcome
D018906:Antineoplastic Agents, Alkylating; D004149:Dioxoles; D044005:Tetrahydroisoquinolines; D000077606:Trabectedin