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

Autor: 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
Jazyk: angličtina
Rok vydání: 2024
Předmět:
Zdroj: Haematologica, Vol 999, Iss 1 (2024)
Druh dokumentu: article
ISSN: 0390-6078
1592-8721
DOI: 10.3324/haematol.2023.283918
Popis: 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.
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