Efficacy and Safety of Trabectedin in Patients With Advanced or Metastatic Liposarcoma or Leiomyosarcoma After Failure of Prior Anthracyclines and Ifosfamide: Results of a Randomized Phase II Study of Two Different Schedules

Abstract

Prior studies showed clinical benefit with trabectedin in patients with sarcomas after failure of standard chemotherapy. This trial documents superior disease control with the q3 weeks 24-hour trabectedin regimen in liposarcomas and leiomyosarcomas, although the qwk 3-hour regimen also demonstrated activity relative to historical comparisons. Trabectedin may now be considered an important new option to control advanced sarcomas in patients after failure of available standard-of-care therapies.

Pazopanib for metastatic soft-tissue sarcoma (PALETTE): a randomised, double-blind, placebo-controlled phase 3 trial

“…5 The only truly new treatment approved for sarcoma failing standard therapy is trabectedin (approved by the European Medicines Agency in 2007). 6,7 Gemcitabine with dacarbazine or docetaxel [8][9][10] and paclitaxel for angiosarcoma 11 seem to improve progression-free and overall survival in non-randomised and adaptively randomised trials.…”

Trabectedin in patients with pre-treated advanced soft tissue sarcoma: a retrospective single center analysis

“…Generally, trabectedin has shown slightly better efficacy in leiomyosarcoma and liposarcoma subtypes compared to other STS subtypes [12,21]. Trabectedin has shown notable efficacy in myxoid liposarcomas [11,12].…”

“…The only randomized phase II trial with trabectedin in pretreated advanced liposarcomas and leiomyosarcomas has confirmed efficacy of 24-hour infusion every 3 weeks regimen for superior disease control as compared to historical control with median overall survival approaching 14 months (in the context of expected 6-month survival range) [21].…”

Prolonged response to trabectedin in a patient with carcinosarcoma of the ovary refractory to adjuvant platinum-taxane

“…This case is not the first that describes a patient with carcinosarcoma of the ovary minimally responding to chemotherapy used for epithelial carcinomas but reaching a complete response after receiving chemotherapy used for sarcomas [7] .…”