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Ferrata Storti Foundation
Haematologica 2022 Volume 107(2):500-509
Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase III MabCute study
Simon Rule,1 Wolney Gois Barreto,2 Javier Briones,3 Angelo M. Carella,4 Olivier
Casasnovas,5 Chris Pocock,6 Clemens-Martin Wendtner,7 Francesco Zaja,8
Susan Robson,9 Lachlan MacGregor,9 Roger R. Tschopp,9 Sonja Nick9 and
10 Martin Dreyling
1Derriford Hospital and Plymouth University Medical School, Plymouth, UK; 2Hemocentro Ribeirão Preto, University of São Paulo, São Paulo, Brazil; 3Hospital de la Santa Creu i Sant Pau, Barcelona, Spain; 4IRCCS AOU San Martino-IST, Genova, Italy; 5Centre Hospitalier Universitaire François Mitterand, Dijon, France; 6Kent & Canterbury Hospital, Canterbury, UK; 7Munich Clinic Schwabing, Academic Teaching Hospital, Ludwig- Maximilians University, Munich, Germany; 8DSM, University of Trieste, Trieste, Italy;
9F. Hoffmann-La Roche Ltd, Basel, Switzerland and 10Klinikum der Universität München, Munich, Germany
ABSTRACT
Rituximab plus chemotherapy induction followed by rituximab maintenance for up to 2 years confers a long-term benefit in terms of progression-free survival in patients with indolent non-Hodgkin lymphoma. It is not known whether further prolonged maintenance with rituximab provides additional benefit. The phase III MabCute study enrolled 692 patients with relapsed or refractory indolent non-Hodgkin lymphoma. Patients who responded to induction with rituximab plus chemotherapy and were still responding after up to 2 years’ initial main- tenance with subcutaneous rituximab were randomized to extended maintenance with subcutaneous rituximab (n=138) or observation only (n=138). The primary endpoint of investigator-assessed progression-free survival in the randomized population was un-addressed by the end of study because of an insufficient number of events (129 events were need- ed for 80% power at 5% significance if approximately 330 patients were randomized). In total, there were 46 progression-free survival events, 19 and 27 in the rituximab and observation arms, respectively (P=0.410 by stratified log-rank test; hazard ratio 0.76 [95% confidence interval: 0.37– 1.53]). The median progression-free survival was not reached in either randomized arm. There were no new safety signals; however, adverse events were seen slightly more frequently with rituximab than with observation during extended maintenance. Maintenance for up to 2 years with rituximab after response to initial induction therefore remains the standard of care in patients with relapsed or refractory indolent non- Hodgkin lymphoma. (Clinicaltrials.gov identifier: NCT01461928)
Introduction
Non-Hodgkin lymphoma (NHL) accounts for approximately 85% of lymphomas.1 Indolent forms include follicular lymphoma (FL), Waldenström macroglobulinemia/ lymphoplasmacytic lymphoma and marginal zone lymphoma. Of these, FL is the most common,1,2 accounting for 5/100,000 cases in Western Europe.3 Indolent NHL usually develops slowly (and may not need immediate treatment), follows a relaps- ing-remitting course, and is often incurable.1
Chemoimmunotherapy based on the human/murine chimeric anti-CD20 mono- clonal antibody rituximab is standard treatment for a range of B-cell malignancies, including indolent and aggressive forms of NHL.3-7 Intravenously administered ritux-
Non-Hodgkin Lymphoma
Correspondence:
MARTIN DREYLING
martin.dreyling@med.uni-muenchen.de
Received: November 10, 2020. Accepted: May 3, 2021. Pre-published: June 17, 2021.
https://doi.org/10.3324/haematol.2020.274803 ©2022 Ferrata Storti Foundation
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