@article{Rule_Barreto_Briones_Carella_Casasnovas_Pocock_Wendtner_Zaja_Robson_MacGregor_Tschopp_Nick_Dreyling_2022, place={Pavia, Italy}, title={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}, volume={107}, url={https://haematologica.org/article/view/haematol.2020.274803}, DOI={10.3324/haematol.2020.274803}, abstractNote={<p>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).</p&gt;}, number={2}, journal={Haematologica}, author={Rule, Simon and Barreto, Wolney Gois and Briones, Javier and Carella, Angelo M. and Casasnovas, Olivier and Pocock, Chris and Wendtner, Clemens-Martin and Zaja, Francesco and Robson, Susan and MacGregor, Lachlan and Tschopp, Roger R. and Nick, Sonja and Dreyling, Martin}, year={2022}, month={Feb.}, pages={500-509} }