The combination of ombrabulin and cisplatin significantly improved progression-free survival, but did not demonstrate a sufficient clinical benefit in patients with advanced soft-tissue sarcomas to support its therapeutic use, a new study published online early in the journal The Lancet Oncology has shown.
For this international, double-blind, placebo-controlled phase III trial, researchers sough to assess the efficacy and safety of ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas who had previously received treatment with an anthracycline and ifosfamide.
Researchers enrolled 355 patients and randomly assigned them to receive cisplatin 75mg/m2 IV plus either ombrabulin 25mg/m2 IV or placebo every 3 weeks.
Results showed that median progression-free survival was 1.54 months (95% CI: 1.45-2.69) in the ombrabulin group compared with 1.41 months (95% CI: 1.38-1.58) in the placebo group (HR = 0.76; 95% CI: 0.59-0.98; P = 0.0302).
In regard to safety, grade 3-4 neutropenia and thrombocytopenia were more common the ombrabulin group. A total of 18 patients in the ombrabulin group died as a result of adverse events versus 10 patients in the placebo group.
- Blay J-Y, Papai Z, Tolcher AW, et al. Ombrabulin plus cisplatin versus placebo plus cisplatin in patients with advanced soft-tissue sarcomas after failure of anthracycline and ifosfamide chemotherapy: a randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2015. [Epub ahead of print]. doi: 10.1016/S1470-2045(15)70102-6.