Compared with best supportive care, trabectedin significantly improves progression-free survival among patients with pretreated advanced soft tissue sarcoma, according to a study presented at the European Society for Medical Oncology (ESMO) 2016 Congress.1
Although trabectedin has demonstrated single-agent activity among patients with pretreated advanced soft tissue sarcoma, it has never been compared with best supportive care in a randomized trial of patients with soft tissue sarcoma of multiple histologies, with the exception of translocation-related sarcomas. For the present study researchers assessed the efficacy, safety, and quality of life of trabectedin versus best supportive care as second- or later-line therapy in this patient population.
For the phase 3 study, investigators enrolled 103 French patients with advanced soft tissue sarcoma who progressed after at least 1 anthracycline-containing regimen and had received fewer than 3 previous lines of chemotherapy. Of those, 58.3% had liposarcoma or leiomyosarcoma.
Participants were randomly assigned 1:1 to receive trabectedin via 24-hour continuous intravenous infusion every 3 weeks or best supportive care until disease progression or unacceptable toxicity.
After 88 progression events, results showed that median progression-free survival was 1.4 months with best supportive care compared with 3.0 months with trabectedin, corresponding to a 60% reduction in the risk of progression for trabectedin (hazard ratio [HR], 0.40; 95% CI, 0.26-0.63; P < .0001).
Among those with liposarcoma and leiomyosarcoma, median progression-free survival was 5.8 months and 1.4 months in the trabectedin and best supportive care arms, respectively (HR, 0.33; 95% CI, 0.17-0.62; P = .0003).
Among patients without those histologies, median progression-free survival was 2.6 months in the trabectedin group and 1.3 months in the best supportive care arm (HR, 0.49; 95% CI, 0.26-0.94; P = .03).
- Le Cesne A, Blay J, Cupissol D, et al. Results of a prospective randomized phase III T-SAR trial comparing trabectedin vs best supportive care (BSC) in patients with pretreated advanced soft tissue sarcoma (ASTS). Paper presented at: European Society for Medical Oncology (ESMO) 2016 Congress; October 7-11, 2016; Copenhagen, Denmark.