Results of a Prospective Randomized Phase III T-SAR Trial Comparing Trabectedin (T) vs Best Supportive Care (BSC) in Patients with Padvanced Soft Tissue Sarcoma (ASTS): A French Sarcoma Group (FSG) Trial.Presented Monday, June 4, 2018 .
Authors:
Axel Le Cesne, Jean-Yves Blay, Didier Cupissol, Antoine Italiano, Corinne Delcambre, Nicolas Penel, Nicolas Isambert, Christine Chevreau, Emmanuelle Bompas, Francois Bertucci, Loic Chaigneau, Sophie Piperno-Neumann, Sébastien Salas, Maria Rios, Cecile Guillemet, Jacques Olivier Bay, Isabelle Laure Ray-Coquard, Leila Haddag, Olivier Mir, Stéphanie Foulon; Gustave Roussy Cancer Campus,... View More
Abstract Disclosures
Background:
With the exception of a study in translocation-related STS (Kawai, 2015), T has never been compared to BSC in a study including patients (pts) with all sarcoma histotypes. The efficacy, safety and quality of life of T vs BSC as second or later treatment line were evaluated in pts with ASTS in a multicenter FSG trial.
Methods:
The study enrolled pts ≥18 years of age with histologically proven ASTS who progressed after at least 1 anthracycline-containing regimen (≤3 previous chemotherapy (CT) lines), stratified by L-STS (lipo-leiomyosarcoma) and non L-STS and with a WHO performance status score 0-1. Pts were randomized 1:1 to receive either T (1.5 mg/m2 24h every 3 weeks) or BSC until disease progression (PD), unacceptable toxicity, or patient’s request. Pts allocated to BSC could cross over to T at PD. The primary endpoint was progression-free survival (PFS).
Results:
Between January to November 2015, 103 pts (median 65 yrs (range 22-84), grade 3 ASTS in 57% of cases, median number of 1 prior CT lines) were enrolled by 16 FSG centers, 52 in the T arm and 51 the BSC arm. Pts with L-STS and non L-STS represented 60% and 40% of pts, respectively. Two pts refused to be allocated in the BSC arm and received other CT. The objective response rate (ORR) in the T arm was 11.8%, all observed in the L-STS group (ORR: 18.8% in L-STS). 23% of pts in the T arm received more than 9 cycles of T. The median PFS were 1.5 months (m) in the BSC arm and 3.1m in the T arm (HR: 0.39, p < 0.0001). In the L-STS cohort, the median PFS were 1.4m and 5.1m in the BSC and T arm (HR: 0.29, p < 0.0001), respectively, whereas in the non L-STS group they were 1.5m and1.8 m (p = 0.16). A cross-over was performed in 92% of pts included in the BSC arm. By After a median follow-up of 25.7 months, the differences on OS were not statistically significant between the two arms, 13.6 m vs 10.8 m in the T and BSC arms respectively (p = 0.86).
Conclusions:
This study met its first endpoint as a preplanned PFS analysis showed a significant improvement in median PFS with T over BSC in pts with pretreated ASTS of multiple histologies. L-STS pts benefit the most from T therapy in terms of prolonged tumor control.