Impact of trabectedin interruption and ...
Type de document :
Article dans une revue scientifique: Article original
PMID :
URL permanente :
Titre :
Impact of trabectedin interruption and subsequent rechallenge on progression in patients with advanced soft tissue sarcoma long-term follow-up of the t-dis trial
Auteur(s) :
Kotecki, Nuria [Auteur]
Le Cesne, Axel [Auteur]
Tresch-Bruneel, Emmanuelle [Auteur]
Ray-Coquard, Isabelle [Auteur]
Chevreau, Christine [Auteur]
Bertucci, François [Auteur]
Bogart, Emilie [Auteur]
Mir, Olivier [Auteur]
Pautier, Patricia [Auteur]
Decoupigny, Emilie [Auteur]
Clisant-Delaine, Stephanie [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Blay, Jean-Yves [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Le Cesne, Axel [Auteur]
Tresch-Bruneel, Emmanuelle [Auteur]
Ray-Coquard, Isabelle [Auteur]
Chevreau, Christine [Auteur]
Bertucci, François [Auteur]
Bogart, Emilie [Auteur]
Mir, Olivier [Auteur]
Pautier, Patricia [Auteur]
Decoupigny, Emilie [Auteur]
Clisant-Delaine, Stephanie [Auteur]
Centre Régional de Lutte contre le Cancer Oscar Lambret [Lille] [UNICANCER/Lille]
Blay, Jean-Yves [Auteur]
Penel, Nicolas [Auteur]
METRICS : Evaluation des technologies de santé et des pratiques médicales - ULR 2694
Titre de la revue :
American journal of clinical oncology
Nom court de la revue :
Am. J. Clin. Oncol.-Cancer Clin. Trials
Numéro :
41
Pagination :
1094-1100
Éditeur :
Wolters Kluwer
Date de publication :
2018-11-01
ISSN :
0277-3732
Mot(s)-clé(s) en anglais :
continuation
trabectedin
sarcoma
rechallenge
Q-TWIST
trabectedin
sarcoma
rechallenge
Q-TWIST
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
OBJECTIVE: To assess the impact of trabectedin rechallenge.
METHODS: In the T-DIS trial (NCT0130309), after the 6 initial cycles of trabectedin, patients who were free from progressive disease (PD) were randomly assigned ...
Lire la suite >OBJECTIVE: To assess the impact of trabectedin rechallenge. METHODS: In the T-DIS trial (NCT0130309), after the 6 initial cycles of trabectedin, patients who were free from progressive disease (PD) were randomly assigned either to continuous treatment with trabectedin (C arm) or therapy interruption (I arm). Patients randomized in the interruption arm were allowed to restart trabectedin in case of PD. Herein we report an update of the impact of trabectedin discontinuation after subsequent rechallenge. RESULTS: From February 2011 to March 2013, 27 and 26 nonprogressive patients were randomized to C and I arm, respectively. Twenty-two of 26 patients in I arm and 25 of 27 patients in C arm received 7 cycles and more. After randomization, the median number of cycles was similar in both arms (C arm: 5 cycles [range, 1 to 34]; I arm: 6 cycles [range, 1 to 48], P=0.96). After a median follow-up from randomization of 35.3 months, continuous treatment with trabectedin was associated with a significant improvement in progression-free survival compared with the rechallenge arm (5.3 vs. 3.5 mo, P=0.019). The observed difference in median overall survival from the seventh cycle did not meet the level of significance (26.0 vs. 14.9 mo, P=0.14). The safety profile was similar in both arms. Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance. CONCLUSIONS: We have demonstrated that trabectedin retains its activity when patients are rechallenged on progression after a treatment break.Lire moins >
Lire la suite >OBJECTIVE: To assess the impact of trabectedin rechallenge. METHODS: In the T-DIS trial (NCT0130309), after the 6 initial cycles of trabectedin, patients who were free from progressive disease (PD) were randomly assigned either to continuous treatment with trabectedin (C arm) or therapy interruption (I arm). Patients randomized in the interruption arm were allowed to restart trabectedin in case of PD. Herein we report an update of the impact of trabectedin discontinuation after subsequent rechallenge. RESULTS: From February 2011 to March 2013, 27 and 26 nonprogressive patients were randomized to C and I arm, respectively. Twenty-two of 26 patients in I arm and 25 of 27 patients in C arm received 7 cycles and more. After randomization, the median number of cycles was similar in both arms (C arm: 5 cycles [range, 1 to 34]; I arm: 6 cycles [range, 1 to 48], P=0.96). After a median follow-up from randomization of 35.3 months, continuous treatment with trabectedin was associated with a significant improvement in progression-free survival compared with the rechallenge arm (5.3 vs. 3.5 mo, P=0.019). The observed difference in median overall survival from the seventh cycle did not meet the level of significance (26.0 vs. 14.9 mo, P=0.14). The safety profile was similar in both arms. Mean time spent without symptoms and toxicity (Q-TWIST) was higher in the C arm, but the difference did not reach the level of significance. CONCLUSIONS: We have demonstrated that trabectedin retains its activity when patients are rechallenged on progression after a treatment break.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
CHU Lille
Université de Lille
Université de Lille
Date de dépôt :
2019-12-09T18:19:47Z
2024-03-06T08:19:15Z
2024-03-06T08:19:15Z