Safety and efficacy of trabectedin when administered in the inpatient versus outpatient setting: Clinical considerations for outpatient administration of trabectedin.

ABSTRACT:

Background

The results of the randomized, phase 3 ET743-SAR-3007 trial demonstrated that trabectedin had a significantly longer progression-free survival (PFS) compared with dacarbazine in patients with advanced leiomyosarcoma/liposarcoma after the failure of prior chemotherapy. Patients randomized to trabectedin received a 24-hour intravenous infusion either in an inpatient or outpatient setting. Herein, the authors reported the safety, efficacy, and patient-reported outcomes based on first infusion site of care.

Methods

Patients were randomized 2:1 to trabectedin (at a dose of 1.5 mg/m² ) or dacarbazine (1 g/m² over 20-120 minutes) with overall survival (OS) as the primary endpoint and PFS, time to disease progression, objective response rate, duratio

SUBMITTER: Jones RL 

PROVIDER: S-EPMC6916570 | biostudies-literature | 2019 Dec

REPOSITORIES: biostudies-literature