Phase 3 study of trabectedin versus best supportive care for pre-treated soft tissue sarcoma

The multicenter phase 3 T-SAR study in France evaluated addition of trabectedin to best supportive care for advanced soft tissue sarcoma. Partial response was seen in 13.7% of patients in the trabectedin arm versus 0 patients in the BSC arm. The median progression-free survival was 3.1 months in the trabectedin arm versus 1.5 months in the BSC arm (HR 0.39; p<0.001) among all patients, and 5.1 months versus 1.4 months (p=0.0001) among patients with lipo/leiomyosarcoma. There were no significant HRQOL differences between arms.