Patients with advanced-stage leiomyosarcoma, a type of soft-tissue sarcoma that occurs predominantly in uterine locations, typically receive doxorubicin and have a median overall survival (OS) of ~20 months. Now, data from a randomized phase III trial demonstrate that adding trabectedin to doxorubicin significantly improves OS.

A total of 150 patients with previously untreated locally advanced or metastatic leiomyosarcoma were randomly assigned (1:1) to receive doxorubicin plus trabectedin (up to 6 cycles) followed by maintenance trabectedin, or doxorubicin (up to 6 cycles). Post-treatment surgical resection of residual disease was permitted for all patients. Progression-free survival (PFS) was the primary end point.