| dc.creator |
Rule, S |
|
| dc.creator |
Barreto, WG |
|
| dc.creator |
Briones, J |
|
| dc.creator |
Carella, AM |
|
| dc.creator |
Casasnovas, O |
|
| dc.creator |
Pocock, C |
|
| dc.creator |
Wendtner, C-M |
|
| dc.creator |
Zaja, F |
|
| dc.creator |
Robson, S |
|
| dc.creator |
MacGregor, L |
|
| dc.creator |
Tschopp, RR |
|
| dc.creator |
Nick, S |
|
| dc.creator |
Dreyling, M |
|
| dc.date |
2022-03-08T10:33:47Z |
|
| dc.date |
2022-03-08T10:33:47Z |
|
| dc.date |
2021-06-17 |
|
| dc.date.accessioned |
2022-05-26T21:09:41Z |
|
| dc.date.available |
2022-05-26T21:09:41Z |
|
| dc.identifier |
0390-6078 |
|
| dc.identifier |
http://hdl.handle.net/10026.1/18911 |
|
| dc.identifier |
10.3324/haematol.2020.274803 |
|
| dc.identifier |
1592-8721 |
|
| dc.identifier.uri |
http://localhost:8080/xmlui/handle/CUHPOERS/228963 |
|
| dc.description |
<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 |
500 - 509 |
|
| dc.language |
en |
|
| dc.publisher |
Ferrata Storti Foundation (Haematologica) |
|
| dc.relation |
ISSN:0390-6078 |
|
| dc.relation |
E-ISSN:1592-8721 |
|
| dc.rights |
2022-03-09 |
|
| dc.rights |
Not known |
|
| 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 |
|