1. 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
- Author
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Simon Rule, Sonja Nick, Chris Pocock, Javier Briones, Clemens-Martin Wendtner, Lachlan MacGregor, Roger R Tschopp, Susan Robson, Martin Dreyling, Olivier Casasnovas, Angelo Michele Carella, Francesco Zaja, Wolney Barreto, Rule, Simon, Barreto, Wolney Goi, Briones, Javier, Carella, Angelo M, Casasnovas, Olivier, Pocock, Chri, Wendtner, Clemens-Martin, Zaja, Francesco, Robson, Susan, Macgregor, Lachlan, Tschopp, Roger R, Nick, Sonja, and Dreyling, Martin
- Subjects
Oncology ,medicine.medical_specialty ,medicine.medical_treatment ,Population ,lymphoma ,03 medical and health sciences ,0302 clinical medicine ,Refractory ,immune system diseases ,hemic and lymphatic diseases ,Internal medicine ,Antineoplastic Combined Chemotherapy Protocols ,Indolent Non-Hodgkin Lymphoma ,Clinical endpoint ,Rituximab ,subcutaneous administration ,Humans ,Medicine ,education ,Chemotherapy ,education.field_of_study ,business.industry ,Lymphoma, Non-Hodgkin ,Hazard ratio ,Hematology ,medicine.disease ,Progression-Free Survival ,Lymphoma ,business ,030215 immunology ,medicine.drug - 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 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).
- Published
- 2022