Eribulin improved overall survival compared with dacarbazine in patients with advanced soft-tissue sarcoma, a study published in the journal The Lancet Oncology has shown.1
Because a non-randomized, phase 2 trial demonstrated activity and tolerability of eribulin in advanced or metastatic soft-tissue sarcoma, researchers sought to compare overall survival in patients who received eribulin with that in patients who received dacarbazine in a phase 3 study.
For the international, open-label study, researchers enrolled 452 patients 18 years or older with intermediate-grate or high-grade advanced liposarcoma or leiomyosarcoma who had received at least 2 prior systemic therapies, including an anthracycline, for advanced disease.
Participants were randomly assigned 1:1 to receive eribulin mesylate 1.4 mg/m2 intravenously on days 1 and 8, or dacarbazine 850 – 1200 mg/m2 intravenously on day 1, every 21 days until disease progression.
Results showed that median overall survival was 13.5 months (95% CI, 10.9 – 15.6) with eribulin vs 11.5 months (95% CI, 9.6 – 13.0) with dacarbazine (HR, 0.77; 95% CI, 0.62 – 0.95; P = .0169).
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In regard to safety, treatment-related adverse events occurred in 99% of patients who received eribulin compared with 97% of those who received dacarbazine. Grade 3 or higher adverse events were more frequently reported in the eribulin group than the dacarbazine group, and 1 death in the eribulin arm was considered treatment-related.
In January 2016, the U.S. Food and Drug Administration approved eribulin for the treatment of patients with unresectable or metastatic liposarcoma who have received a prior anthracycline-containing regimen.
- Schöffski P, Chawla S, Maki RG, et al. Eribulin versus dacarbazine in previously treated patients with advanced liposarcoma or leiomyosarcoma: a randomised, open-label, multicentre, phase 3 trial [published online ahead of print February 10, 20016]. Lancet. doi: 10.1016/S0140-6736(15)01283-0.