Trabectedin: novel insights in the treatment of advanced sarcoma.

Soft tissue sarcomas are a heterogenous group of malignancies with relatively high mortality rates. The outlook for these patients has been poor, with only a few drugs showing measurable activity. Trabectedin is a new alkylating agent with significant activity in sarcomas, but particularly in liposarcomas and leiomyosarcomas, both as a single agent or in combination with other drugs. Phase I and II studies of trabectedin have shown measurable benefit. Currently there are several Phase III trials which have completed accrual to better study its use as a single agent or in combination therapy, although outcomes have not yet been reported. Trabectedin (Yondelis) is approved for the treatment of sarcomas by the EMEA, but is not yet approved by the FDA, pending the results of the currently maturing phase III trials.