Yondelis Reduce el Riesgo de la Progresíón de la Enfermedad en un 45 % versus el Tratamiento con Dacarbazine en Pacientes con Sarcomas .Jason M. Broderick @jasoncology /// Published Online: Wednesday, June 3, 2015 .
George D. Demetri, MD
Trabectedin reduced the risk of disease progression by 45% versus dacarbazine in patients with advanced soft tissue sarcoma, according to results from the phase III ET743-SAR-3007 trial presented at the 2015 ASCO Annual Meeting. There was also a slight survival trend with trabectedin, but the results were not significant.
“Trabectedin is confirmed as an important treatment option for relapsed/refractory patients with advanced leiomyosarcoma and liposarcoma,” lead author George D. Demetri, MD, said when presenting the results. “There was a clinically relevant improvement in progression-free survival observed with trabectedin that is superior to the active comparator, dacarbazine,” added Demetri, who is director of the Center for Sarcoma and Bone Oncology at the Dana-Farber Cancer Institute.
Based on the data from the trial, the FDA previously granted trabectedin a priority review designation as a treatment for patients with advanced soft tissue sarcoma, including liposarcoma and leiomyosarcoma subtypes, who have previously received chemotherapy that included an anthracycline.
A Final Approval decision is expected from the FDA by early August.
The open-label, multicenter, phase III SAR-3007 trial compared trabectedin with dacarbazine in 518 patients with liposarcoma and leiomyosarcoma who previously received an anthracycline-containing regimen followed by at least one additional line of chemotherapy. The protocol required patients to have an ECOG performance status of 0 or 1. The study was conducted at 85 sites in four different countries, but Demetri noted that 94% of the patients were enrolled in the United States.
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