Efficacy and safety of crizotinib in ...
Type de document :
Article dans une revue scientifique: Article original
PMID :
URL permanente :
Titre :
Efficacy and safety of crizotinib in ALK-positive systemic anaplastic large-cell lymphoma in children, adolescents, and adult patients: results of the French AcSé-crizotinib trial.
Auteur(s) :
Brugières, L. [Auteur]
Cozic, N. [Auteur]
Houot, R. [Auteur]
Rigaud, C. [Auteur]
Sibon, D. [Auteur]
Arfi-Rouche, J. [Auteur]
Bories, P. [Auteur]
Cottereau, A. S. [Auteur]
Delmer, A. [Auteur]
Ducassou, S. [Auteur]
Garnier, N. [Auteur]
Lamant, L. [Auteur]
Leruste, A. [Auteur]
Millot, F. [Auteur]
Moalla, S. [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Nolla, M. [Auteur]
Pagnier, A. [Auteur]
Reguerre, Y. [Auteur]
Renaud, L. [Auteur]
Schmitt, A. [Auteur]
Simonin, M. [Auteur]
Verschuur, A. [Auteur]
Hoog Labouret, N. [Auteur]
Mahier Ait Oukhatar, C. [Auteur]
Vassal, G. [Auteur]
Cozic, N. [Auteur]
Houot, R. [Auteur]
Rigaud, C. [Auteur]
Sibon, D. [Auteur]
Arfi-Rouche, J. [Auteur]
Bories, P. [Auteur]
Cottereau, A. S. [Auteur]
Delmer, A. [Auteur]
Ducassou, S. [Auteur]
Garnier, N. [Auteur]
Lamant, L. [Auteur]
Leruste, A. [Auteur]
Millot, F. [Auteur]
Moalla, S. [Auteur]
Morschhauser, Franck [Auteur]

Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Nolla, M. [Auteur]
Pagnier, A. [Auteur]
Reguerre, Y. [Auteur]
Renaud, L. [Auteur]
Schmitt, A. [Auteur]
Simonin, M. [Auteur]
Verschuur, A. [Auteur]
Hoog Labouret, N. [Auteur]
Mahier Ait Oukhatar, C. [Auteur]
Vassal, G. [Auteur]
Titre de la revue :
European Journal of Cancer
Nom court de la revue :
Eur J Cancer
Numéro :
191
Pagination :
112984
Date de publication :
2023-09
ISSN :
1879-0852
Mot(s)-clé(s) en anglais :
ALK inhibitors
Crizotinib
Anaplastic large-cell lymphoma ALK plus
Crizotinib
Anaplastic large-cell lymphoma ALK plus
Discipline(s) HAL :
Sciences du Vivant [q-bio]
Résumé en anglais : [en]
Background
The French phase II AcSé-crizotinib trial aimed to evaluate the safety and efficacy of crizotinib in patients with ALK, ROS1, and MET-driven malignancies, including ALK-positive anaplastic large-cell lymphoma ...
Lire la suite >Background The French phase II AcSé-crizotinib trial aimed to evaluate the safety and efficacy of crizotinib in patients with ALK, ROS1, and MET-driven malignancies, including ALK-positive anaplastic large-cell lymphoma (ALK+ ALCL). Methods ALK+ ALCL patients 12 months or older with measurable disease and no standard care options available received crizotinib twice daily at 165 mg/m2 in children and adolescents and 250 mg in adults. The primary end-point was the response rate at 8 weeks. Results Twenty-eight patients were enroled between February 2014 and March 2018. Three patients who were not treated were excluded from the analysis. The median age was 19 years. The median previous line of chemotherapy was two. In the 24 patients with an evaluable response, the response rate at 8 weeks was 67% (95% CI: 47–82%). All patients discontinued crizotinib after a median treatment duration of 3.7 months: eight for progression, two for adverse events (AEs) related to prior treatments, and 15 by choice, including six for allogeneic stem-cell transplantation. The median follow-up was 45 months. Nine patients experienced an event: eight relapses (seven after crizotinib discontinuation and one after dose reduction), and one died in complete remission. The median duration of response was 43.3 months (95% CI: 8.3–not reached). The 3-year progression-free and overall survival rates were 40% (95% CI: 23–59%) and 63% (95% CI: 43–79%). Grade 3 or 4 treatment-related AEs occurred in 32% of patients. Conclusion Crizotinib shows efficacy and an acceptable safety profile in ALK+ ALCL relapsed/refractory patients. However, a large proportion of patients experience a relapse after crizotinib discontinuation. Future studies will assess if prolonged ALK inhibitor exposure has curative potential without consolidation.Lire moins >
Lire la suite >Background The French phase II AcSé-crizotinib trial aimed to evaluate the safety and efficacy of crizotinib in patients with ALK, ROS1, and MET-driven malignancies, including ALK-positive anaplastic large-cell lymphoma (ALK+ ALCL). Methods ALK+ ALCL patients 12 months or older with measurable disease and no standard care options available received crizotinib twice daily at 165 mg/m2 in children and adolescents and 250 mg in adults. The primary end-point was the response rate at 8 weeks. Results Twenty-eight patients were enroled between February 2014 and March 2018. Three patients who were not treated were excluded from the analysis. The median age was 19 years. The median previous line of chemotherapy was two. In the 24 patients with an evaluable response, the response rate at 8 weeks was 67% (95% CI: 47–82%). All patients discontinued crizotinib after a median treatment duration of 3.7 months: eight for progression, two for adverse events (AEs) related to prior treatments, and 15 by choice, including six for allogeneic stem-cell transplantation. The median follow-up was 45 months. Nine patients experienced an event: eight relapses (seven after crizotinib discontinuation and one after dose reduction), and one died in complete remission. The median duration of response was 43.3 months (95% CI: 8.3–not reached). The 3-year progression-free and overall survival rates were 40% (95% CI: 23–59%) and 63% (95% CI: 43–79%). Grade 3 or 4 treatment-related AEs occurred in 32% of patients. Conclusion Crizotinib shows efficacy and an acceptable safety profile in ALK+ ALCL relapsed/refractory patients. However, a large proportion of patients experience a relapse after crizotinib discontinuation. Future studies will assess if prolonged ALK inhibitor exposure has curative potential without consolidation.Lire moins >
Langue :
Anglais
Audience :
Internationale
Vulgarisation :
Non
Établissement(s) :
Université de Lille
CHU Lille
CHU Lille
Collections :
Date de dépôt :
2023-10-20T05:39:52Z
2024-06-07T11:44:53Z
2024-06-07T11:44:53Z
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