Efficacy and safety assessment of prolonged maintenance with subcutaneous rituximab in patients with relapsed or refractory indolent non-Hodgkin lymphoma: results of the phase Ill MabCute study
Por:
Rule, S, Barreto, WG, Briones, J, Carella, AM, Casasnovas, O, Pocock, C, Wendtner, CM, Zaja, F, Robson, S, MacGregor, L, Tschopp, RR, Nick, S, Dreyling, M
Publicada:
1 feb 2022
Resumen:
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.
Filiaciones:
Rule, S:
Derriford Hosp, Plymouth, Devon, England
Plymouth Univ Med Sch, Plymouth, Devon, England
Barreto, WG:
Univ Sao Paulo, Hemoctr Ribeirao Preto, Sao Paulo, Brazil
Briones, J:
Hosp Santa Creu & Sant Pau, Barcelona, Spain
Carella, AM:
IRCCS AOU San Martino IST, Genoa, Italy
Casasnovas, O:
Ctr Hosp Univ Francois Mitterand, Dijon, France
Pocock, C:
Kent & Canterbury Hosp, Canterbury, Kent, England
Wendtner, CM:
Ludwig Maximilians Univ Munchen, Acad Teaching Hosp, Munich Clin Schwabing, Munich, Germany
Zaja, F:
Univ Trieste, DSM, Trieste, Italy
Robson, S:
F Hoffmann La Roche Ltd, Basel, Switzerland
MacGregor, L:
F Hoffmann La Roche Ltd, Basel, Switzerland
Tschopp, RR:
F Hoffmann La Roche Ltd, Basel, Switzerland
Nick, S:
F Hoffmann La Roche Ltd, Basel, Switzerland
Dreyling, M:
Klinikum Univ Munchen, Munich, Germany
gold, Green Published
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