Trabectedin has superior disease control over best supportive care in recurrent STS
In patients with recurrent soft-tissue sarcoma (STS), trabectedin demonstrated better disease control than best supportive care (BSC) without hurting quality of life, according to a study.
In this randomized, multicenter, open-label, phase 3 study, 103 adult patients with STS who progressed after 1-3 prior lines of treatment were randomized to receive trabectedin 1.5 mg/m2 every 3 weeks (n =52) or BSC (n =51). Patients were stratiﬁed into lipo/leiomyosarcoma (L-STS) and other histotypes (non-L-STS groups). The primary efficacy endpoint was progression-free survival (PFS).
A total of 60.2% of patients had L-STS. Median PFS was 3.1 months and 1.5 months in the trabectedin arm and BSC arm, respectively. Benefits were observed across most subgroups, especially in patients with L-STS (5.1 vs 1.4 months). A partial response was achieved in 7 patients (13.7%) with L-STS in the trabectedin arm. No objective responses were observed in the BSC arm.
The most common grade 3/4 adverse events were neutropenia, leukopenia, and transaminases increase.
After progression, 91.8% of patients in the BSC arm crossed over to trabectedin.
Le Cesne A, Blay JY, Cupissol D; French Sarcoma Group, et al. A randomized phase III trial comparing trabectedin to best supportive care in patients with pre-treated soft tissue sarcoma: T-SAR, a French Sarcoma Group trial. Ann Oncol. 2021;S0923-7534(21)01171-6. DOI: 10.1016/j.annonc.2021.04.014.