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

Anastasios Stathis; Maria Cristina Pirosa; Lorella Orsucci; Pierre Feugier; Monica Tani; Hervé Ghesquières; Gerardo Musuraca; Francesca Gaia Rossi; Francesco Merli; Romain Guièze; Emmanuel Gyan; Guido Gini; Dario Marino; Remy Gressin; Franck Morschhauser; Federica Cavallo; Francesca Palombi; Annarita Conconi; Benoît Tessoulin; Hervé Tilly; Manuela Zanni; Maria Giuseppina Cabras; Enrico Capochiani; Catello Califano; Melania Celli; Alessandro Pulsoni; Francesco Angrilli; Ubaldo Occhini; René-Olivier Casasnovas; Guillaume Cartron; Liliana Devizzi; Corinne Haioun; Anna Marina Liberati; Roch Houot; Michele Merli; Giuseppe Pietrantuono; Francesca Re; Michele Spina; Francesco Landi; Franco Cavalli; Francesco Bertoni; Davide Rossi; Nicoletta Ielmini; Elena Borgo; Stefano Luminari; Emanuele Zucca; Catherine Thieblemont

doi:10.3324/haematol.2023.283918

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

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

Anastasios Stathis, Maria Cristina Pirosa, Lorella Orsucci, Pierre Feugier, Monica Tani, Hervé Ghesquières, Gerardo Musuraca, Francesca Gaia Rossi, Francesco Merli, Romain Guièze, …

Haematologica (Roma), Vol.109(8), pp.2564-2573

01/08/2024

DOI: https://doi.org/10.3324/haematol.2023.283918

PMID: 38385243

Résumé

Adult

Aged

Aged, 80 and over

Antineoplastic Combined Chemotherapy Protocols - adverse effects

Antineoplastic Combined Chemotherapy Protocols - therapeutic use

Chlorambucil - administration & dosage

Chlorambucil - therapeutic use

Female

Humans

Injections, Subcutaneous

Lymphoma, B-Cell, Marginal Zone - drug therapy

Lymphoma, B-Cell, Marginal Zone - mortality

Maintenance Chemotherapy

Male

Middle Aged

Remission Induction

Rituximab - administration & dosage

Rituximab - therapeutic use

Treatment Outcome

The IELSG38 trial was conducted to investigate the effects of subcutaneous (SC) rituximab on the complete remission (CR) rate and the benefits of SC rituximab maintenance in patients with extranodal marginal zone lymphoma (MZL) who received front-line treatment with chlorambucil plus rituximab. Study treatment was an induction phase with oral chlorambucil 6 mg/m2/day on weeks 1-6, 9-10, 13-14, 17-18, and 21-22, and intravenous rituximab 375 mg/m2 on day 1 of weeks 1-4, and 1,400 mg SC on weeks 9, 13, 17, and 21. Then, a maintenance phase followed with rituximab administered at 1,400 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 SC rituximab did not improve the CR rate at the conclusion of the induction phase, which was the main endpoint. Nevertheless, SC rituximab maintenance might have facilitated long-term disease control, potentially contributing to enhanced event-free and progression-free survival.

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Titre: IELSG38: phase II trial of front-line chlorambucil plus subcutaneous rituximab induction and maintenance in mucosa-associated lymphoid tissue lymphoma
Créateurs - sans rôle: Anastasios Stathis
Maria Cristina Pirosa
Lorella Orsucci - S.C. Ematologia, AOU Città della Salute e della Scienza di Torino, Turin
Pierre Feugier - Centre Hospitalier Régional et Universitaire de Nancy
Monica Tani - U.O. Ematologia, Dipartimento Oncologia e Ematologia, Ospedale Santa Maria delle Croci, Ravenna
Hervé Ghesquières - Hospices Civils de Lyon
Gerardo Musuraca - Hematology Unit, IRCCS Istituto Scientifico Romagnolo per lo Studio dei Tumori (IRST) "Dino Amadori", Meldola
Francesca Gaia Rossi - Hematology-BMT Center, Fondazione IRCCS Ca' Granda Ospedale Maggiore Policlinico, University of Milan, Milano
Francesco Merli - AUSL-IRCCS of Reggio Emilia, Reggio Emilia
Romain Guièze - Laboratoire d'hématologie
Emmanuel Gyan - Centre Hospitalier Universitaire de Tours
Guido Gini - Hematology, Department of Clinical and Molecular Sciences, Marche Polytechnic University, Ancona
Dario Marino - Oncology 1 Unit, Istituto Oncologico Veneto IOV-IRCCS, Padova
Remy Gressin - Institute for Advanced Biosciences, INSERM U1209/CNRS UMR 5309/Grenoble Alpes University, Grenoble
Franck Morschhauser - Université de Lille
Federica Cavallo - Division of Hematology, Department of Molecular Biotechnologies and Health Sciences, University of Torino/AOU Città della Salute e della Scienza di Torino, Turin
Francesca Palombi - Hematology and Stem Cell Transplant Unit, IRCCS. National Cancer Institute, Istituto Regina Elena, Rome Italy
Annarita Conconi - Division of Hematology, Ospedale degli Infermi, Biella
Benoît Tessoulin - Hématologie Clinique, CHU de Nantes, INSERM CRCINA Nantes-Angers, NeXT Université de Nantes, Nantes
Hervé Tilly - Centre Henri Becquerel
Manuela Zanni - Hematology Unit, Antonio e Biagio e Cesare Arrigo Hospital, Alessandria
Maria Giuseppina Cabras - Ospedale Oncologico, Ematologia e CTMO, Cagliari
Enrico Capochiani - Hematology Unit, Azienda USL Toscana NordOvest, Center for Translational Medicine, Livorno
Catello Califano - Hematology Unit, P.O. A. Tortora, Pagani
Melania Celli - Hematology Unit, Ospedale degli Infermi, Rimini
Alessandro Pulsoni - Department of Translational and Precision Medicine, Sapienza University, Rome
Francesco Angrilli - Unità Operativa Semplice Dipartimentale Centro Diagnosi e Terapia Linfomi, Presidio Ospedaliero, Pescara
Ubaldo Occhini - Unità Operativa di Ematologia, Ospedale San Donato, AUSL Toscana Sud-Est, Arezzo
René-Olivier Casasnovas - Department of Hematology, University Hospital F Mitterrand and INSERM 1231, Dijon
Guillaume Cartron - Institut de Génétique Moléculaire de Montpellier
Liliana Devizzi - Hematology Unit, Fondazione IRCCS, Istituto Nazionale dei Tumori, Milan
Corinne Haioun - Assistance Publique – Hôpitaux de Paris
Anna Marina Liberati - SC Oncoematologia, Azienda Ospedaliera Santa Maria, Università degli studi di Perugia, Terni
Roch Houot - Department of Clinical Hematology, University Hospital of Rennes, Rennes
Michele Merli - Division of Hematology, University Hospital Ospedale di Circolo e Fondazione Macchi ASST Sette Laghi, University of Insubria, Varese
Giuseppe Pietrantuono - Hematology Unit, Centro di Riferimento Oncologico della Basilicata IRCCS Rionero in Vulture
Francesca Re - Hematology and BMT Center, Azienda Ospedaliera Universitaria, Parma
Michele Spina - Division of Medical Oncology, Centro di Riferimento Oncologico IRCCS, Aviano
Francesco Landi - Oncology Institute of Southern Switzerland, EOC, Bellinzona
Franco Cavalli - Institute of Oncology Research, Bellinzona
Francesco Bertoni
Davide Rossi
Nicoletta Ielmini - Institute of Oncology Research, Bellinzona
Elena Borgo - FIL, Fondazione Italiana Linfomi ONLUS, Alessandria
Stefano Luminari
Emanuele Zucca
Catherine Thieblemont - Hôpital Saint-Louis
Détails de publication: Haematologica (Roma), Vol.109(8), pp.2564-2573
Identifiants: 99139788309311
Unité académique: Institut de Génétique Moléculaire de Montpellier - IGMM
Langue: English
Type de ressource: Journal article