Title :

Long-Term Follow-Up of Rituximab Maintenance in Young Patients With Mantle-Cell Lymphoma Included in the LYMA Trial: A LYSA Study.

Author(s) :

Sarkozy, C. [Auteur]
Thieblemont, C. [Auteur]
Oberic, L. [Auteur]
Moreau, A. [Auteur]
Bouabdallah, K. [Auteur]
Damaj, G. [Auteur]
Gastinne, T. [Auteur]
Tessoulin, B. [Auteur]
Ribrag, V. [Auteur]
Casasnovas, O. [Auteur]
Haioun, C. [Auteur]
Houot, R. [Auteur]
Jardin, F. [Auteur]
Van Den Neste, E. [Auteur]
Cheminant, M. [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Callanan, M. [Auteur]
Safar, V. [Auteur]
Gressin, R. [Auteur]
Hermine, O. [Auteur]
Le Gouill, S. [Auteur]

Journal title :

Journal of Clinical Oncology

Abbreviated title :

J Clin Oncol

Volume number :

42

Publication date :

2024-03-01

ISSN :

1527-7755

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not ...
Show more >Clinical trials frequently include multiple end points that mature at different times. The initial report, typically based on the primary end point, may be published when key planned coprimary or secondary analyses are not yet available. Clinical trial updates provide an opportunity to disseminate additional results from studies, published in JCO or elsewhere, for which the primary end point has already been reported. The LYMA trial demonstrated the benefit of rituximab maintenance (RM) in first-line young patients with mantle-cell lymphoma. In this prolonged follow-up of 7.5 years (95% CI, 7.4 to 7.7) from inclusion, the median progression-free survival (PFS) and overall survival (OS) for the full population were not reached (NR) with a 7-year PFS of 55.5% (95% CI, 49.5 to 61) and OS of 69.5% (95% CI, 63.8 to 74.5). The EFS remained statistically superior in favor of RM (median NR v 5.8 years, P < .0001; HR, 0.39 [95% CI, 0.52 to 0.6] and 7-year estimate, 76.2% versus 46% for RM and observation, respectively). Similarly, RM prolonged PFS (estimated PFS at 7 years, 78.5% v 47.4% and HR, 0.36 [95% CI, 0.23 to 0.56] for RM and observation, respectively, P < .0001). The 7-year OS estimate was 83.2% versus 72.2%, respectively (P = .088, HR, 0.63 [95% CI, 0.37 to 1.08]). Cause of death was not significantly distinct between the two groups, with lymphoma being the leading cause with a very low rate of infection-related death. Overall, the PFS benefit of RM after autologous stem cell transplantation remains after 7-year follow-up, and RM was not associated with an increase in infection-related mortality, making this strategy a safe standard of care with long-term follow-up.Show less >

Language :

Anglais

Audience :

Internationale

Popular science :

Non

Administrative institution(s) :

Université de Lille
CHU Lille

Collections :

• Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365

Submission date :

2024-01-03T01:16:02Z
2024-06-10T14:03:00Z