Title :

IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma.

Author(s) :

Stathis, A. [Auteur]
Pirosa, M. C. [Auteur]
Orsucci, L. [Auteur]
Feugier, Pierre [Auteur]
Centre Hospitalier Régional Universitaire de Nancy [CHRU Nancy]
Tani, M. [Auteur]
Ghesquières, Hervé [Auteur]
Hospices Civils de Lyon [HCL]
Musuraca, G. [Auteur]
Rossi, F. G. [Auteur]
Merli, F. [Auteur]
Guièze, Romain [Auteur]
CHU Estaing [Clermont-Ferrand]
Gyan, Emmanuel [Auteur]
Centre d’Investigation Clinique [Tours] CIC 1415 [CIC]
Gini, G. [Auteur]
Marino, D. [Auteur]
Gressin, Remy [Auteur]
Institute for Advanced Biosciences / Institut pour l'Avancée des Biosciences (Grenoble) [IAB]
Morschhauser, Franck [Auteur]
Groupe de Recherche sur les formes Injectables et les Technologies Associées (GRITA) - ULR 7365
Cavallo, F. [Auteur]
Palombi, F. [Auteur]
Conconi, A. [Auteur]
Tessoulin, Benoit [Auteur]
Université de Nantes [UN]
Tilly, Hervé [Auteur]
Centre de Lutte Contre le Cancer Henri Becquerel Normandie Rouen [CLCC Henri Becquerel]
Zanni, M. [Auteur]
Cabras, M. G. [Auteur]
Capochiani, E. [Auteur]
Califano, C. [Auteur]
Celli, M. [Auteur]
Pulsoni, A. [Auteur]
Angrilli, F. [Auteur]
Occhini, U. [Auteur]
Casasnovas, René-Olivier [Auteur]
Lipides - Nutrition - Cancer [Dijon - U1231] [LNC]
Cartron, Guillaume [Auteur]
CHU Montpellier = Montpellier University Hospital
Devizzi, L. [Auteur]
Haioun, Corinne [Auteur]
Hôpital Henri Mondor
Liberati, A. M. [Auteur]
Houot, Roch [Auteur]
Centre Hospitalier Universitaire de Rennes [CHU Rennes] = Rennes University Hospital [Pontchaillou]
Merli, M. [Auteur]
Pietrantuono, G. [Auteur]
Re, F. [Auteur]
Spina, M. [Auteur]
Landi, F. [Auteur]
Cavalli, F. [Auteur]
Bertoni, F. [Auteur]
Rossi, D. [Auteur]
Ielmini, N. [Auteur]
Borgo, E. [Auteur]
Luminari, S. [Auteur]
Zucca, E. [Auteur]
Thieblemont, Catherine [Auteur]
Université Paris Diderot - Paris 7 [UPD7]

Journal title :

Haematologica

Abbreviated title :

Haematologica

Publication date :

2024-02-22

ISSN :

1592-8721

HAL domain(s) :

Sciences du Vivant [q-bio]

English abstract : [en]

The IELSG38 trial was conducted to investigate the effects of subcutaneous (SC) rituximab on the complete remission (CR) rate and the benefits of SC maintenance in patients with extranodal marginal zone lymphoma (MZL) who ...
Show more >The IELSG38 trial was conducted to investigate the effects of subcutaneous (SC) rituximab on the complete remission (CR) rate and the benefits of SC maintenance in patients with extranodal marginal zone lymphoma (MZL) who received frontline treatment with chlorambucil plus rituximab. Study treatment comprised an induction phase with chlorambucil 6 mg/m2/day orally on weeks 1-6, 9-10, 13-14, 17-18, and 21-22, and rituximab 375 mg/m2 intravenously on day 1 of weeks 1-4, and 1400 mg SC on weeks 9, 13, 17, and 21. Then, a maintenance phase followed with rituximab administered at 1400 mg SC every two months for two years. Of the 112 patients enrolled, 109 were evaluated for efficacy. The CR rates increased from 52% at the end of the induction phase to 70% upon completion of the maintenance phase. With a median follow-up of 5.8 years, the 5-year event-free, progression-free, and overall survival rates were 87% (95% CI, 78-92), 84% (95% CI, 75-89), and 93% (95% CI, 86-96), respectively. The most common grade ≥3 toxicities were neutropenia (33%) and lymphocytopenia (16%). Six patients experienced treatment-related serious adverse events, including fever of unknown origin, sepsis, pneumonia, respiratory failure, severe cerebellar ataxia, and fatal acute myeloid leukemia. The trial showed that subcutaneous rituximab did not improve the complete remission rate at the conclusion of the induction phase, which was the main endpoint. Nevertheless, SC maintenance might have facilitated long-term disease control, potentially contributing to enhanced event-free and progression-free survival.Show less >

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 :

2024-05-15T21:08:08Z
2024-06-07T09:09:51Z
2024-06-07T09:12:35Z