Titre :

Final Results of the IELSG-19 Randomized Trial of Mucosa-Associated Lymphoid Tissue Lymphoma: Improved Event-Free and Progression-Free Survival With Rituximab Plus Chlorambucil Versus Either Chlorambucil or Rituximab Monotherapy

Auteur(s) :

Zucca, Emanuele [Auteur]
Conconi, Annarita [Auteur]
Martinelli, Giovanni [Auteur]
Bouabdallah, Reda [Auteur]
Tucci, Alessandra [Auteur]
Vitolo, Umberto [Auteur]
Martelli, Maurizio [Auteur]
Pettengell, Ruth [Auteur]
Salles, Gilles [Auteur]
Sebban, Catherine [Auteur]
Guillermo Armando, Lopez [Auteur]
Pinotti, Graziella [Auteur]
Devizzi, Liliana [Auteur]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées - ULR 7365 [GRITA]
Tilly, Herve [Auteur]
Torri, Valter [Auteur]
Hohaus, Stefan [Auteur]
Ferreri Andres J, M [Auteur]
Zachee, Pierre [Auteur]
Bosly, Andre [Auteur]
Haioun, Corinne [Auteur]
Stelitano, Caterina [Auteur]
Bellei, Monica [Auteur]
Ponzoni, Maurilio [Auteur]
Copie-Bergman, Christiane [Auteur]
Jack, Andrew [Auteur]
Campo, Elias [Auteur]
Mazzucchelli, Luca [Auteur]
Cavalli, Franco [Auteur]
Johnson, Peter [Auteur]
Thieblemont, Catherine [Auteur]

Titre de la revue :

Journal of clinical oncology

Nom court de la revue :

J. Clin. Oncol.

Numéro :

35

Pagination :

1905-+

Date de publication :

2017

Discipline(s) HAL :

Sciences du Vivant [q-bio]

Résumé en anglais : [en]

Purpose There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such ...
Lire la suite >Purpose There is no consensus on the optimal systemic treatment of patients with extranodal marginal zone lymphoma of mucosa-associated lymphoid tissue. The IELSG-19 phase III study, to our knowledge, was the first such study to address the question of first-line treatment in a randomized trial. Patients and Methods Eligible patients were initially randomly assigned (1:1 ratio) to receive either chlorambucil monotherapy (6 mg/m2/d orally on weeks 1 to 6, 9 to 10, 13 to 14, 17 to 18, and 21 to 22) or a combination of chlorambucil (same schedule as above) and rituximab (375 mg/m2 intravenously on day 1 of weeks 1, 2, 3, 4, 9, 13, 17, and 21). After the planned enrollment of 252 patients, the protocol was amended to continue with a three-arm design (1:1:6 ratio), with a new arm that included rituximab alone (same schedule as the combination arm) and with a final sample size of 454 patients. The main end point was event-free survival (EFS). Analysis of chlorambucil versus the combination arm was performed and reported separately before any analysis of the third arm. Results At a median follow-up of 7.4 years, addition of rituximab to chlorambucil led to significantly better EFS (hazard ratio, 0.54; 95% CI, 0.38 to 0.77). EFS at 5 years was 51% (95% CI, 42 to 60) with chlorambucil alone, 50% (95% CI, 42 to 59) with rituximab alone, and 68% (95% CI, 60 to 76) with the combination ( P = .0009). Progression-free survival was also significantly better with the combination ( P = .0119). Five-year overall survival was approximately 90% in each arm. All treatments were well tolerated. No unexpected toxicities were recorded. Conclusion Rituximab in combination with chlorambucil demonstrated superior efficacy in mucosa-associated lymphoid tissue lymphoma; however, improvements in EFS and progression-free survival did not translate into longer overall survival.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 :

2019-02-26T17:07:12Z