Efficacy and safety of trabectedin or dacarbazine in patients with advanced uterine leiomyosarcoma after failure of anthracycline-based chemotherapy: Subgroup analysis of a phase 3, randomized clinical trial.

ABSTRACT:

Objective

Trabectedin demonstrated significantly improved disease control in leiomyosarcoma and liposarcoma patients in a global phase 3 trial (NCT01343277). A post hoc analysis was conducted to assess the efficacy and safety of trabectedin or dacarbazine in women with uterine leiomyosarcoma (uLMS), the largest subgroup of enrolled patients (40%).

Methods

Of 577 patients randomized 2:1 to receive trabectedin 1.5mg/m² by 24-hour IV infusion or dacarbazine 1g/m² by 20-120-minute IV infusion once every three weeks, 232 had uLMS (trabectedin: 144; dacarbazine: 88). The primary endpoint was overall survival (OS); secondary endpoints were progression-free survival (PFS), objective response rate (ORR), clinical benefit rate (CBR: complete responses+partial res

SUBMITTER: Hensley ML 

PROVIDER: S-EPMC5783302 | biostudies-literature | 2017 Sep

REPOSITORIES: biostudies-literature