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
| Autor: | C. Delcambre, C. Guillemet, Raissa Kapso, A. Fraslin, Sophie Piperno-Neumann, Sébastien Salas, L. Haddag, Loic Chaigneau, N. Bouvet, Emmanuelle Bompas, Antoine Italiano, François Bertucci, Julia Bonastre, Maria Rios, Jacques-Olivier Bay, Stéphanie Foulon, Didier Cupissol, Christine Chevreau, Nicolas Penel, Olivier Mir, N. Isambert, A. Le Cesne, J.-Y. Blay, I.L. Ray-Coquard |
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| Rok vydání: | 2021 |
| Předmět: |
Adult
0301 basic medicine Leiomyosarcoma medicine.medical_specialty Population Dioxoles Disease-Free Survival law.invention 03 medical and health sciences 0302 clinical medicine Randomized controlled trial Quality of life law Tetrahydroisoquinolines Internal medicine medicine Humans education Antineoplastic Agents Alkylating Trabectedin education.field_of_study business.industry Soft tissue sarcoma Sarcoma Hematology medicine.disease Confidence interval 030104 developmental biology Oncology 030220 oncology & carcinogenesis Quality of Life business medicine.drug |
| Zdroj: | Annals of Oncology. 32:1034-1044 |
| ISSN: | 0923-7534 |
| DOI: | 10.1016/j.annonc.2021.04.014 |
| Popis: | The French Sarcoma Group assessed the efficacy, safety, and quality of life (QoL) of trabectedin versus best supportive care (BSC) in patients with advanced soft tissue sarcoma (STS).This randomized, multicenter, open-label, phase III study included adults with STS who progressed after 1-3 prior treatment lines. Patients were randomized (1 : 1) to receive trabectedin 1.5 mg/mBetween 26 January 2015 and 5 November 2015, 103 heavily pre-treated patients (60.2% with L-STS) from 16 French centers were allocated to receive trabectedin (n = 52) or BSC (n = 51). Median PFS was 3.1 months [95% confidence interval (CI) 1.8-5.9 months] in the trabectedin arm versus 1.5 months (0.9-2.6 months) in the BSC arm (hazard ratio = 0.39, 95% CI 0.24-0.64, P0.001) with benefits observed across almost all analyzed subgroups, but particularly in patients with L-STS (5.1 versus 1.4 months, P = 0.0001). Seven patients (13.7%) in the trabectedin arm (all with L-STS) achieved a partial response, while no objective responses were observed in the BSC arm (P = 0.004). The most common grade 3/4 adverse events were neutropenia (44.2% of patients), leukopenia (34.6%), and transaminase increase (32.7%). Health-related 30-item core European Organization for the Research and Treatment of Cancer Quality-of-Life Questionnaire evidenced no statistical differences between the arms for any domain and at any time point. After progression, 91.8% of patients crossed over from BSC to trabectedin.Trabectedin demonstrates superior disease control to BSC without impairing QoL in patients with recurrent STS of multiple histologies, with greater impact in patients with L-STS. |
| Databáze: | OpenAIRE |
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