A single-arm multicentre phase II trial of doxorubicin in combination with trabectedin in the first-line treatment for leiomyosarcoma with long-term follow-up and impact of cytoreductive surgery.

ABSTRACT:

Background

Uterine leiomyosarcomas (U-LMSs) and soft tissue leiomyosarcomas (ST-LMSs) are rare tumours with poor prognosis when locally advanced or metastatic, and with moderate chemosensitivity. In 2015 we reported very encouraging results of the LMS-02 study (NCT02131480) with manageable toxicity. Herein, we report the updated and long-term results of progression-free survival (PFS) and overall survival (OS).

Patients and methods

Patients received 60 mg/m² intravenous doxorubicin followed by trabectedin 1.1 mg/m² as a 3-h infusion on day 1 and pegfilgrastim on day 2, every 3 weeks, up to six cycles. Surgery for residual disease was permitted. Patients were stratified into U-LMS and ST-LMS groups.

Results

One-hundred and eight patients were enro

SUBMITTER: Pautier P 

PROVIDER: S-EPMC8446791 | biostudies-literature | 2021 Aug

REPOSITORIES: biostudies-literature