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

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...

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Published inHaematologica (Roma) Vol. 107; no. 2; pp. 500 - 509
Main Authors Rule, Simon, Barreto, Wolney Gois, Briones, Javier, Carella, Angelo M, Casasnovas, Olivier, Pocock, Chris, Wendtner, Clemens-Martin, Zaja, Francesco, Robson, Susan, MacGregor, Lachlan, Tschopp, Roger R, Nick, Sonja, Dreyling, Martin
Format Journal Article
LanguageEnglish
Published Italy Fondazione Ferrata Storti 01.02.2022
Ferrata Storti Foundation
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Summary: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 maintenance 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 needed 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).
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Disclosures
SR declares a consultation or advisory role for Janssen, AstraZeneca, F. Hoffmann-La Roche Ltd, Sunesis, Pharmacyclics, Celgene, Celltrion, Kite; speakers bureau for Janssen; and research funding from Janssen. WGB declares no conflict of interest. JB declares honoraria from F. Hoffmann-La Roche Ltd, Takeda, Celgene, Novartis, and Gilead; consultation or advisory role for Takeda, Janssen, Celgene, and Gilead; research funding from F. Hoffmann-La Roche Ltd; and travel and/or accommodation expenses from F. Hoffmann La-Roche Ltd, Takeda, Celgene, Janssen, and Gilead. AMC does not declare any conflict of interest. OC declares honoraria from F. Hoffmann-La Roche Ltd, Takeda, BMS, Merck, Gilead, and Janssen; consultation or advisory role for F. Hoffmann-La Roche Ltd, Takeda, BMS, Merck, Gilead, and Janssen; research funding from F. Hoffmann-La Roche Ltd, Takeda, Gilead, and AbbVie; and travel and/or accommodation expenses from F. Hoffmann-La Roche Ltd, Takeda, and Janssen. CP declares honoraria from Janssen and Gilead; consultancy or advisory role for Takeda and Celgene and travel and/or accommodation expenses from Gilead. C-MW declares honoraria from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; consultation or advisory role for F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; research funding from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie; and travel and/or accommodation expenses from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, and AbbVie. FZ declares honoraria from F. Hoffmann-La Roche Ltd, Janssen-Cilag, Gilead, Celgene, AbbVie, Takeda, and Novartis; consultation or advisory role for Sandoz, F. Hoffmann-La Roche Ltd, Janssen- Cilag, Gilead, Celgene, AbbVie, Takeda, and Novartis; research funding from Celgene and Novartis; and travel and/or accommodation expenses from F. Hoffmann-La Roche Ltd, Celgene, AbbVie, Takeda, and Novartis. SR is employed by F. Hoffmann- La Roche Ltd. LMacG, RRT, and SN are employed by F. Hoffmann-La Roche Ltd. MD declares honoraria from Bayer, Celgene, Gilead, Janssen, and F. Hoffmann-La Roche Ltd; consultation or advisory role for Acerta, Bayer, Celgene, Gilead, Janssen, Novartis, F. Hoffmann La Roche Ltd, and Sandoz; and research funding from Celgene, Janssen, Mundipharma, and F. Hoffmann-La Roche Ltd.
Contributions
SR, WGB, JB, AMC, OC, CP, C-MW, FZ and MD were involved in accrual and treatment of patients. SR analyzed data. All authors were involved in interpreting the data, critically reviewing the manuscript, approved the manuscript for submission and agree to be accountable for the accuracy and integrity of the study.
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ISSN:0390-6078
1592-8721
DOI:10.3324/haematol.2020.274803