Titre :

Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma.

Auteur(s) :

Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Fowler, Nathan [Auteur]
Feugier, Pierre [Auteur]
Bouabdallah, Reda [Auteur]
Tilly, Herve [Auteur]
Palomba M, Lia [Auteur]
Fruchart, Christophe [Auteur]
Libby Edward, N [Auteur]
Casasnovas, Rene-Olivier [Auteur]
Flinn, Ian [Auteur]
Haioun, Corinne [Auteur]
Maisonneuve, Herve [Auteur]
Ysebaert, Loic [Auteur]
Bartlett Nancy, L [Auteur]
Bouabdallah, Kamal [Auteur]
Brice, Pauline [Auteur]
Ribrag, Vincent [Auteur]
Daguindau, Nicolas [Auteur]
Le Gouill, Steven [Auteur]
Pica Gian, M [Auteur]
Martin Garcia-Sancho, Alejandro [Auteur]
Lopez-Guillermo, Armando [Auteur]
Larouche, Jean-Francois [Auteur]
Ando, Kiyoshi [Auteur]
Gomes Da Silva, Maria [Auteur]
Andre, Marc [Auteur]
Zachee, Pierre [Auteur]
Sehn Laurie, H [Auteur]
Tobinai, Kensei [Auteur]
Cartron, Guillaume [Auteur]
Liu, David [Auteur]
Wang, Jianming [Auteur]
Xerri, Luc [Auteur]
Salles, Gilles [Auteur]

Titre de la revue :

The New England journal of medicine

Nom court de la revue :

N. Engl. J. Med.

Numéro :

379

Pagination :

934-947

Date de publication :

2018

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

BACKGROUND: Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy ...
Lire la suite >BACKGROUND: Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma. METHODS: We conducted this multicenter, international, phase 3 superiority trial to evaluate rituximab plus lenalidomide, as compared with rituximab plus chemotherapy, in patients with previously untreated follicular lymphoma. Patients were randomly assigned to receive one of the two regimens, followed by maintenance monotherapy with rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses). Treatment with rituximab plus chemotherapy consisted of the investigator's choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primary end points were complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival. RESULTS: A total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab-lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab-chemotherapy group (P=0.13). The interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab-chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrile neutropenia of any grade (2% vs. 7%), and a higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%). CONCLUSIONS: Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy). The safety profile differed in the two groups. (Funded by Celgene; RELEVANCE ClinicalTrials.gov numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).Lire moins >

Langue :

Anglais

Audience :

Internationale

Vulgarisation :

Non

Établissement(s) :

Université de Lille
CHU Lille

Collections :

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

Équipe(s) de recherche :

Innovation/évaluation des médicaments injectables

Date de dépôt :

2019-02-26T17:06:51Z