13 years of trabectedin, 5 years of Yondelis®: what have we learnt?

Trabectedin (Yondelis (R) [PharmaMar S.A., Madrid, Spain]) is one of the most promising agents tested in the last two decades in patients with anthracycline/ifosfamide-resistant sarcomas and is the first agent highlighting the notion of prolonged tumor control in advanced soft tissue sarcoma. Indeed, the unusual pattern of tumor response to trabectedin has raised queries about the appropriateness of conventional radiological evaluation of efficacy according to Response Evaluation Criteria in Solid Tumors and has prompted the search for new end points for Phase II studies. The safety profile of trabectedin is unique and much more favorable than that of doxorubicin and ifosfamide especially as regards neutropenia and alopecia. Its efficacy in translocation-related sarcomas suggests a targeted approach to tumor control in these sarcoma subtypes. With numerous Phase II and III studies of trabectedin underway, it appears certain that the current standard-of-care paradigm in advanced soft tissue sarcoma is set for change.