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
dc.contributor.author | Rule, Simon | |
dc.contributor.author | Barreto, WG | |
dc.contributor.author | Briones, J | |
dc.contributor.author | Carella, AM | |
dc.contributor.author | Casasnovas, O | |
dc.contributor.author | Pocock, C | |
dc.contributor.author | Wendtner, C-M | |
dc.contributor.author | Zaja, F | |
dc.contributor.author | Robson, S | |
dc.contributor.author | MacGregor, L | |
dc.contributor.author | Tschopp, RR | |
dc.contributor.author | Nick, S | |
dc.contributor.author | Dreyling, M | |
dc.date.accessioned | 2022-03-08T10:33:47Z | |
dc.date.available | 2022-03-08T10:33:47Z | |
dc.date.issued | 2021-06-17 | |
dc.identifier.issn | 0390-6078 | |
dc.identifier.issn | 1592-8721 | |
dc.identifier.uri | http://hdl.handle.net/10026.1/18911 | |
dc.description.abstract |
<jats: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).</jats:p> | |
dc.format.extent | 500-509 | |
dc.format.medium | Electronic | |
dc.language | eng | |
dc.language.iso | en | |
dc.publisher | Ferrata Storti Foundation (Haematologica) | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Humans | |
dc.subject | Lymphoma, Non-Hodgkin | |
dc.subject | Progression-Free Survival | |
dc.subject | Rituximab | |
dc.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 | |
dc.type | journal-article | |
dc.type | Journal Article | |
dc.type | Randomized Controlled Trial | |
plymouth.author-url | https://www.webofscience.com/api/gateway?GWVersion=2&SrcApp=PARTNER_APP&SrcAuth=LinksAMR&KeyUT=WOS:000751895900019&DestLinkType=FullRecord&DestApp=ALL_WOS&UsrCustomerID=11bb513d99f797142bcfeffcc58ea008 | |
plymouth.issue | 2 | |
plymouth.volume | 107 | |
plymouth.publication-status | Published online | |
plymouth.journal | Haematologica | |
dc.identifier.doi | 10.3324/haematol.2020.274803 | |
plymouth.organisational-group | /Plymouth | |
plymouth.organisational-group | /Plymouth/Faculty of Health | |
plymouth.organisational-group | /Plymouth/Faculty of Health/Peninsula Medical School | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/REF 2021 Researchers by UoA/UoA01 Clinical Medicine/UoA01 Clinical Medicine | |
plymouth.organisational-group | /Plymouth/Research Groups | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED) | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CBR | |
plymouth.organisational-group | /Plymouth/Research Groups/Institute of Translational and Stratified Medicine (ITSMED)/CCT&PS | |
plymouth.organisational-group | /Plymouth/Users by role | |
plymouth.organisational-group | /Plymouth/Users by role/Academics | |
dc.publisher.place | Italy | |
dcterms.dateAccepted | 2021-05-03 | |
dc.rights.embargodate | 2022-3-9 | |
dc.identifier.eissn | 1592-8721 | |
dc.rights.embargoperiod | Not known | |
rioxxterms.versionofrecord | 10.3324/haematol.2020.274803 | |
rioxxterms.licenseref.uri | http://www.rioxx.net/licenses/all-rights-reserved | |
rioxxterms.licenseref.startdate | 2021-06-17 | |
rioxxterms.type | Journal Article/Review |