Trabectedin Superior to Dacarbazine for Previously Treated Liposarcoma, Leiomyosarcoma

Trabectedin demonstrated superior disease control compared with conventional dacarbazine in patients with advanced liposarcoma and leiomyosarcoma following failure of prior chemotherapy, a new study published online ahead of print in the Journal of Clinical Oncology has shown.¹

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.

Reference

1. Demetri GD, von Mehren M, Jones RL, et al. Efficacy and safety of trabectedin or dacarbazine for metastatic liposarcoma or leiomyosarcoma after failure of conventional chemotherapy: results of a phase III randomized multicenter clinical trial [published online ahead of print September 14, 2015]. J Clin Oncol. doi: 10.1200/JCO.2015.62.4734.