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).
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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.
- 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.