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

•In adults with STS, trabectedin significantly prolonged PFS as compared to BSC.•Overall, 13.7% achieved a partial response in the arm, while no objective was observed BSC arm.•Benefits were across most of analyzed subgroups, but particularly patients liposarcoma/leiomyosarcoma.•QoL questionnaire evidenced statistical difference between arms for any domain or time point.•Trabectedin has superior disease control recurrent STS multiple histologies. BackgroundThe French Sarcoma Group assessed efficacy, safety, and quality life (QoL) versus best supportive care (BSC) advanced soft tissue sarcoma (STS).Patients methodsThis randomized, multicenter, open-label, phase III study included who progressed after 1-3 prior treatment lines. Patients randomized (1 : 1) receive 1.5 mg/m2 every 3 weeks BSC, stratified into L-STS (liposarcoma/leiomyosarcoma) non-L-STS groups (other histotypes). from arm allowed cross over at progression. The primary efficacy endpoint progression-free survival (PFS) confirmed by blinded central review intention-to-treat population.ResultsBetween 26 January 2015 5 November 2015, 103 heavily pre-treated (60.2% L-STS) 16 centers allocated (n = 52) 51). Median 3.1 months [95% confidence interval (CI) 1.8-5.9 months] (0.9-2.6 months) (hazard ratio 0.39, 95% CI 0.24-0.64, P < 0.001) benefits almost all (5.1 1.4 months, 0.0001). Seven (13.7%) (all response, responses (P 0.004). common grade 3/4 adverse events neutropenia (44.2% patients), leukopenia (34.6%), transaminase increase (32.7%). Health-related 30-item core European Organization Research Treatment Cancer Quality-of-Life Questionnaire differences point. After progression, 91.8% crossed trabectedin.ConclusionTrabectedin demonstrates without impairing QoL histologies, greater impact L-STS. (STS). This population. Between trabectedin. Trabectedin