For the study, researchers enrolled 518 patients and randomly assigned them 2:1 to receive trabectedin or dacarbazine intravenously every 3 weeks.
Results showed that median progression-free survival was 4.2 months with trabectedin and 1.5 months with dacarbazine (HR = 0.55; P +0.001). Subgroup analyses demonstrated benefit in all patient subgroups.
An interim analysis showed a median overall survival of 12.4 months 12.9 months for the trabectedin group and dacarbazine group, respectively (HR = 0.87; P=0.37).
In regard to safety, the most common grade 3 to 4 adverse events in the trabectedin arm were myelosuppression and transient elevation of transaminases.
This is the first phase 3 trial to compare trabectedin with dacarbazine in patients with advanced liposarcoma or leiomyosarcoma after prior therapy with an anthracycline and least 1 additional systemic regimen. The findings support the activity of trabectedin for patients with these malignancies.