Title :

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

Author(s) :

Le Cesne, A. [Auteur]
Département de médecine oncologique [Gustave Roussy]
Blay, J. Y. [Auteur]
Université Claude Bernard Lyon 1 [UCBL]
Cupissol, D. [Auteur]
UNICANCER - Institut régional du Cancer Montpellier Val d'Aurelle [ICM]
Italiano, A. [Auteur]
Institut Bergonié [Bordeaux]
Delcambre, C. [Auteur]
Centre Régional de Lutte contre le Cancer François Baclesse [Caen] [UNICANCER/CRLC]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Isambert, N. [Auteur]
Centre Régional de Lutte contre le cancer Georges-François Leclerc [Dijon] [UNICANCER/CRLCC-CGFL]
Chevreau, C. [Auteur]
Institut Universitaire du Cancer de Toulouse - Oncopole [IUCT Oncopole - UMR 1037]
Bompas, E. [Auteur]
Institut de Cancérologie de l'Ouest [Angers/Nantes] [UNICANCER/ICO]
Bertucci, F. [Auteur]
Institut Paoli-Calmettes [IPC]
Chaigneau, L. [Auteur]
Service d'Oncologie Médicale [CHRU Besançon]
Piperno-Neumann, S. [Auteur]
Institut Curie [Paris]
Salas, S. [Auteur]
Hôpital de la Timone [CHU - APHM] [TIMONE]
Rios, M. [Auteur]
Institut de Cancérologie de Lorraine - Alexis Vautrin [Nancy] [UNICANCER/ICL]
Guillemet, C. [Auteur]
Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen [CLCC Henri Becquerel]
Bay, J. O. [Auteur]
Centre Jean Perrin [Clermont-Ferrand] [UNICANCER/CJP]
Ray-Coquard, I. [Auteur]
Département cancer environnement (Centre Léon Bérard - Lyon)
Haddag, L. [Auteur]
Bonastre, J. [Auteur]
Oncostat [U1018 (Équipe 2)]
Kapso, R. [Auteur]
Oncostat [U1018 (Équipe 2)]
Fraslin, A. [Auteur]
Oncostat [U1018 (Équipe 2)]
Bouvet, N. [Auteur]
Mir, O. [Auteur]
Foulon, S. [Auteur]
Oncostat [U1018 (Équipe 2)]

Journal title :

Annals of Oncology

Abbreviated title :

Ann Oncol

Volume number :

32

Pages :

p. 1034-1044

Publication date :

2021-08

ISSN :

1569-8041

English keyword(s) :

soft tissue sarcoma
randomized trial
trabectedin

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Highlights • In adults with STS, trabectedin significantly prolonged PFS as compared to BSC. • Overall, 13.7% achieved a partial response in the trabectedin arm, while no objective response was observed ...
Show more >Highlights • In adults with STS, trabectedin significantly prolonged PFS as compared to BSC. • Overall, 13.7% achieved a partial response in the trabectedin arm, while no objective response was observed in the BSC arm. • Benefits were observed across most of analyzed subgroups, but particularly in patients with liposarcoma/leiomyosarcoma. • QoL questionnaire evidenced no statistical difference between the arms for any domain or time point. • Trabectedin has superior disease control to BSC in patients with recurrent STS of multiple histologies. Background 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). Patients and methods 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/m2 every 3 weeks or BSC, stratified into L-STS (liposarcoma/leiomyosarcoma) and non-L-STS groups (other histotypes). Patients from the BSC arm were allowed to cross over to trabectedin at progression. The primary efficacy endpoint was progression-free survival (PFS) confirmed by blinded central review and analyzed in the intention-to-treat population. Results Between 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, P < 0.001) 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. Conclusion 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.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694

Submission date :

2023-11-15T06:47:28Z
2024-03-27T09:49:34Z