Long-Term Follow-Up of Rituximab Maintenance in Young Patients With Mantle-Cell Lymphoma Included in the LYMA Trial: A LYSA Study
In: ISSN: 0732-183X, 2023
academicJournal
Zugriff:
International audience ; 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.
| Titel: |
Long-Term Follow-Up of Rituximab Maintenance in Young Patients With Mantle-Cell Lymphoma Included in the LYMA Trial: A LYSA Study
|
|---|---|
| Autor/in / Beteiligte Person: | Sarkozy, Clémentine ; Thieblemont, Catherine ; Oberic, Lucie ; Moreau, Anne ; Bouabdallah, Krimo ; Damaj, Gandhi ; Gastinne, Thomas ; Tessoulin, Benoit ; Ribrag, Vincent ; Casasnovas, Olivier ; Haioun, Corinne ; Houot, Roch ; Jardin, Fabrice ; van den Neste, Eric ; Cheminant, Morgane ; Morschhauser, Franck ; Callanan, Mary ; Safar, Violaine ; Gressin, Remy ; Hermine, Olivier ; Le Gouill, Steven ; Laboratoire d'Imagerie Translationnelle en Oncologie (LITO ) ; Institut Curie Paris -Institut National de la Santé et de la Recherche Médicale (INSERM) ; Service d'Hématologie Institut Curie ; Institut Curie Paris ; Service d'Hémato-oncologie CHU Saint-Louis ; Groupe Hospitalier Saint Louis - Lariboisière - Fernand Widal Paris ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP) ; Service Hématologie - IUCT-Oncopole CHU Toulouse ; Pôle Biologie CHU Toulouse ; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Centre Hospitalier Universitaire de Toulouse (CHU Toulouse)-Pôle IUCT CHU Toulouse ; Centre Hospitalier Universitaire de Toulouse (CHU Toulouse) ; Service d'Anatomopathologie Nantes ; Centre Hospitalier Universitaire de Nantes = Nantes University Hospital (CHU Nantes) ; Service d'hématologie CHU Bordeaux ; CHU Bordeaux-Hôpital Haut-Lévêque CHU Bordeaux ; Bordeaux, CHU ; Service d'hématologie biologique CHU Caen ; Caen, CHU ; Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN)-Normandie Université (NU)-Tumorothèque de Caen Basse-Normandie (TCBN) ; Service d'Hématologie CHU Nantes ; Institut Gustave Roussy (IGR) ; Service d'hématologie biologique CHU de Dijon ; Centre Hospitalier Universitaire de Dijon - Hôpital François Mitterrand (CHU Dijon) ; Hôpital Henri Mondor ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Hôpital Henri Mondor-Université Paris-Est Créteil Val-de-Marne - Paris 12 (UPEC UP12) ; Service d’Hématologie Clinique Rennes ; Centre Hospitalier Universitaire de Rennes CHU Rennes = Rennes University Hospital Ponchaillou ; Cancer and Brain Genomics (CBG) ; Université de Rouen Normandie (UNIROUEN) ; Normandie Université (NU)-Normandie Université (NU)-Institute for Research and Innovation in Biomedicine (IRIB) ; Normandie Université (NU)-Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Université de Rouen Normandie (UNIROUEN) ; Normandie Université (NU)-Institut National de la Santé et de la Recherche Médicale (INSERM)-Centre National de la Recherche Scientifique (CNRS)-Institut National de la Santé et de la Recherche Médicale (INSERM) ; Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen (CLCC Henri Becquerel) ; Cliniques Universitaires Saint-Luc Bruxelles ; Service d'hématologie CHU Necker ; Hôpital Necker - Enfants Malades AP-HP ; Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Assistance publique - Hôpitaux de Paris (AP-HP) (AP-HP)-Centre National de la Recherche Scientifique (CNRS) ; Service d'Hématologie CHU Huriez Lille ; Hôpital Claude Huriez Lille ; Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille)-Centre Hospitalier Régional Universitaire CHU Lille (CHRU Lille) ; Service d’Hématologie Centre Hospitalier Lyon Sud -, HCL ; Centre Hospitalier Lyon Sud CHU - HCL (CHLS) ; Hospices Civils de Lyon (HCL)-Hospices Civils de Lyon (HCL) ; Université de Versailles Saint-Quentin-en-Yvelines (UVSQ) |
| Link: | |
| Zeitschrift: | ISSN: 0732-183X, 2023 |
| Veröffentlichung: | HAL CCSD ; American Society of Clinical Oncology, 2023 |
| Medientyp: | academicJournal |
| DOI: | 10.1200/JCO.23.01586 |
| Schlagwort: |
|
| Sonstiges: |
|