AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma
PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab. METHODS A phase III, multicenter, r...
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| creator | Leonard, John P Trneny, Marek Izutsu, Koji Fowler, Nathan H Hong, Xiaonan Zhu, Jun Zhang, Huilai Offner, Fritz Scheliga, Adriana Nowakowski, Grzegorz S Pinto, Antonio Re, Francesca Fogliatto, Laura Maria Scheinberg, Phillip Flinn, Ian W Moreira, Claudia Cabecadas, Jose Liu, David Kalambakas, Stacey Fustier, Pierre Wu, Chengqing Gribben, John G Calaminici, Maria Copie-Bergman, Christiane Lopez-Guillermo, Armando O'Connor, Owen Williams, Michael Suciu, Stefan Levine, Benjamin Kern, Julie |
| description | PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.
METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.
RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.
CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile. |
| format | Article |
| fullrecord | <record><control><sourceid>ghent</sourceid><recordid>TN_cdi_ghent_librecat_oai_archive_ugent_be_8618776</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>oai_archive_ugent_be_8618776</sourcerecordid><originalsourceid>FETCH-ghent_librecat_oai_archive_ugent_be_86187763</originalsourceid><addsrcrecordid>eNqdjDFvwjAUhD1QCSj8h_cHIiUESMSGUCgZ6AQSm_USvxAjB1u2g5q9P7xG6sTIdKf77m7EJnGWLqIkTy9jNnXuFsfJMk9XE_a7PX8di-8TbADBtOgIyrIE53sxgG5A0R2VFLqTgsCo3oGVvv-RHVbwIOtCYBTWVOlXKu9gSaFxJEDb4BuLtdd2CETo8OtBDZ1pdYcz9tGgcjT_10-22Ben3SG6tqHGlaws1ei5RsnR1q18EO-vT1QRz9dJnmXr9K3RH0IGXmw</addsrcrecordid><sourcetype>Institutional Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype></control><display><type>article</type><title>AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma</title><source>Ghent University Academic Bibliography</source><source>American Society of Clinical Oncology Online Journals</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>Alma/SFX Local Collection</source><creator>Leonard, John P ; Trneny, Marek ; Izutsu, Koji ; Fowler, Nathan H ; Hong, Xiaonan ; Zhu, Jun ; Zhang, Huilai ; Offner, Fritz ; Scheliga, Adriana ; Nowakowski, Grzegorz S ; Pinto, Antonio ; Re, Francesca ; Fogliatto, Laura Maria ; Scheinberg, Phillip ; Flinn, Ian W ; Moreira, Claudia ; Cabecadas, Jose ; Liu, David ; Kalambakas, Stacey ; Fustier, Pierre ; Wu, Chengqing ; Gribben, John G ; Calaminici, Maria ; Copie-Bergman, Christiane ; Lopez-Guillermo, Armando ; O'Connor, Owen ; Williams, Michael ; Suciu, Stefan ; Levine, Benjamin ; Kern, Julie</creator><creatorcontrib>Leonard, John P ; Trneny, Marek ; Izutsu, Koji ; Fowler, Nathan H ; Hong, Xiaonan ; Zhu, Jun ; Zhang, Huilai ; Offner, Fritz ; Scheliga, Adriana ; Nowakowski, Grzegorz S ; Pinto, Antonio ; Re, Francesca ; Fogliatto, Laura Maria ; Scheinberg, Phillip ; Flinn, Ian W ; Moreira, Claudia ; Cabecadas, Jose ; Liu, David ; Kalambakas, Stacey ; Fustier, Pierre ; Wu, Chengqing ; Gribben, John G ; Calaminici, Maria ; Copie-Bergman, Christiane ; Lopez-Guillermo, Armando ; O'Connor, Owen ; Williams, Michael ; Suciu, Stefan ; Levine, Benjamin ; Kern, Julie</creatorcontrib><description>PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.
METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.
RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.
CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.</description><identifier>ISSN: 0732-183X</identifier><identifier>ISSN: 1527-7755</identifier><language>eng</language><subject>BENDAMUSTINE ; GUIDELINES ; MAINTENANCE ; Medicine and Health Sciences ; MONOCLONAL-ANTIBODY THERAPY ; MULTICENTER ; NATURAL-KILLER-CELL ; OPEN-LABEL ; RECURRENT FOLLICULAR LYMPHOMA ; SURVIVAL ; TRIAL</subject><creationdate>2019</creationdate><rights>No license (in copyright) info:eu-repo/semantics/openAccess</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,315,776,780,4010,27837</link.rule.ids></links><search><creatorcontrib>Leonard, John P</creatorcontrib><creatorcontrib>Trneny, Marek</creatorcontrib><creatorcontrib>Izutsu, Koji</creatorcontrib><creatorcontrib>Fowler, Nathan H</creatorcontrib><creatorcontrib>Hong, Xiaonan</creatorcontrib><creatorcontrib>Zhu, Jun</creatorcontrib><creatorcontrib>Zhang, Huilai</creatorcontrib><creatorcontrib>Offner, Fritz</creatorcontrib><creatorcontrib>Scheliga, Adriana</creatorcontrib><creatorcontrib>Nowakowski, Grzegorz S</creatorcontrib><creatorcontrib>Pinto, Antonio</creatorcontrib><creatorcontrib>Re, Francesca</creatorcontrib><creatorcontrib>Fogliatto, Laura Maria</creatorcontrib><creatorcontrib>Scheinberg, Phillip</creatorcontrib><creatorcontrib>Flinn, Ian W</creatorcontrib><creatorcontrib>Moreira, Claudia</creatorcontrib><creatorcontrib>Cabecadas, Jose</creatorcontrib><creatorcontrib>Liu, David</creatorcontrib><creatorcontrib>Kalambakas, Stacey</creatorcontrib><creatorcontrib>Fustier, Pierre</creatorcontrib><creatorcontrib>Wu, Chengqing</creatorcontrib><creatorcontrib>Gribben, John G</creatorcontrib><creatorcontrib>Calaminici, Maria</creatorcontrib><creatorcontrib>Copie-Bergman, Christiane</creatorcontrib><creatorcontrib>Lopez-Guillermo, Armando</creatorcontrib><creatorcontrib>O'Connor, Owen</creatorcontrib><creatorcontrib>Williams, Michael</creatorcontrib><creatorcontrib>Suciu, Stefan</creatorcontrib><creatorcontrib>Levine, Benjamin</creatorcontrib><creatorcontrib>Kern, Julie</creatorcontrib><title>AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma</title><description>PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.
METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.
RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.
CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.</description><subject>BENDAMUSTINE</subject><subject>GUIDELINES</subject><subject>MAINTENANCE</subject><subject>Medicine and Health Sciences</subject><subject>MONOCLONAL-ANTIBODY THERAPY</subject><subject>MULTICENTER</subject><subject>NATURAL-KILLER-CELL</subject><subject>OPEN-LABEL</subject><subject>RECURRENT FOLLICULAR LYMPHOMA</subject><subject>SURVIVAL</subject><subject>TRIAL</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>ADGLB</sourceid><recordid>eNqdjDFvwjAUhD1QCSj8h_cHIiUESMSGUCgZ6AQSm_USvxAjB1u2g5q9P7xG6sTIdKf77m7EJnGWLqIkTy9jNnXuFsfJMk9XE_a7PX8di-8TbADBtOgIyrIE53sxgG5A0R2VFLqTgsCo3oGVvv-RHVbwIOtCYBTWVOlXKu9gSaFxJEDb4BuLtdd2CETo8OtBDZ1pdYcz9tGgcjT_10-22Ben3SG6tqHGlaws1ei5RsnR1q18EO-vT1QRz9dJnmXr9K3RH0IGXmw</recordid><startdate>2019</startdate><enddate>2019</enddate><creator>Leonard, John P</creator><creator>Trneny, Marek</creator><creator>Izutsu, Koji</creator><creator>Fowler, Nathan H</creator><creator>Hong, Xiaonan</creator><creator>Zhu, Jun</creator><creator>Zhang, Huilai</creator><creator>Offner, Fritz</creator><creator>Scheliga, Adriana</creator><creator>Nowakowski, Grzegorz S</creator><creator>Pinto, Antonio</creator><creator>Re, Francesca</creator><creator>Fogliatto, Laura Maria</creator><creator>Scheinberg, Phillip</creator><creator>Flinn, Ian W</creator><creator>Moreira, Claudia</creator><creator>Cabecadas, Jose</creator><creator>Liu, David</creator><creator>Kalambakas, Stacey</creator><creator>Fustier, Pierre</creator><creator>Wu, Chengqing</creator><creator>Gribben, John G</creator><creator>Calaminici, Maria</creator><creator>Copie-Bergman, Christiane</creator><creator>Lopez-Guillermo, Armando</creator><creator>O'Connor, Owen</creator><creator>Williams, Michael</creator><creator>Suciu, Stefan</creator><creator>Levine, Benjamin</creator><creator>Kern, Julie</creator><scope>ADGLB</scope></search><sort><creationdate>2019</creationdate><title>AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma</title><author>Leonard, John P ; Trneny, Marek ; Izutsu, Koji ; Fowler, Nathan H ; Hong, Xiaonan ; Zhu, Jun ; Zhang, Huilai ; Offner, Fritz ; Scheliga, Adriana ; Nowakowski, Grzegorz S ; Pinto, Antonio ; Re, Francesca ; Fogliatto, Laura Maria ; Scheinberg, Phillip ; Flinn, Ian W ; Moreira, Claudia ; Cabecadas, Jose ; Liu, David ; Kalambakas, Stacey ; Fustier, Pierre ; Wu, Chengqing ; Gribben, John G ; Calaminici, Maria ; Copie-Bergman, Christiane ; Lopez-Guillermo, Armando ; O'Connor, Owen ; Williams, Michael ; Suciu, Stefan ; Levine, Benjamin ; Kern, Julie</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-ghent_librecat_oai_archive_ugent_be_86187763</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>BENDAMUSTINE</topic><topic>GUIDELINES</topic><topic>MAINTENANCE</topic><topic>Medicine and Health Sciences</topic><topic>MONOCLONAL-ANTIBODY THERAPY</topic><topic>MULTICENTER</topic><topic>NATURAL-KILLER-CELL</topic><topic>OPEN-LABEL</topic><topic>RECURRENT FOLLICULAR LYMPHOMA</topic><topic>SURVIVAL</topic><topic>TRIAL</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Leonard, John P</creatorcontrib><creatorcontrib>Trneny, Marek</creatorcontrib><creatorcontrib>Izutsu, Koji</creatorcontrib><creatorcontrib>Fowler, Nathan H</creatorcontrib><creatorcontrib>Hong, Xiaonan</creatorcontrib><creatorcontrib>Zhu, Jun</creatorcontrib><creatorcontrib>Zhang, Huilai</creatorcontrib><creatorcontrib>Offner, Fritz</creatorcontrib><creatorcontrib>Scheliga, Adriana</creatorcontrib><creatorcontrib>Nowakowski, Grzegorz S</creatorcontrib><creatorcontrib>Pinto, Antonio</creatorcontrib><creatorcontrib>Re, Francesca</creatorcontrib><creatorcontrib>Fogliatto, Laura Maria</creatorcontrib><creatorcontrib>Scheinberg, Phillip</creatorcontrib><creatorcontrib>Flinn, Ian W</creatorcontrib><creatorcontrib>Moreira, Claudia</creatorcontrib><creatorcontrib>Cabecadas, Jose</creatorcontrib><creatorcontrib>Liu, David</creatorcontrib><creatorcontrib>Kalambakas, Stacey</creatorcontrib><creatorcontrib>Fustier, Pierre</creatorcontrib><creatorcontrib>Wu, Chengqing</creatorcontrib><creatorcontrib>Gribben, John G</creatorcontrib><creatorcontrib>Calaminici, Maria</creatorcontrib><creatorcontrib>Copie-Bergman, Christiane</creatorcontrib><creatorcontrib>Lopez-Guillermo, Armando</creatorcontrib><creatorcontrib>O'Connor, Owen</creatorcontrib><creatorcontrib>Williams, Michael</creatorcontrib><creatorcontrib>Suciu, Stefan</creatorcontrib><creatorcontrib>Levine, Benjamin</creatorcontrib><creatorcontrib>Kern, Julie</creatorcontrib><collection>Ghent University Academic Bibliography</collection></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Leonard, John P</au><au>Trneny, Marek</au><au>Izutsu, Koji</au><au>Fowler, Nathan H</au><au>Hong, Xiaonan</au><au>Zhu, Jun</au><au>Zhang, Huilai</au><au>Offner, Fritz</au><au>Scheliga, Adriana</au><au>Nowakowski, Grzegorz S</au><au>Pinto, Antonio</au><au>Re, Francesca</au><au>Fogliatto, Laura Maria</au><au>Scheinberg, Phillip</au><au>Flinn, Ian W</au><au>Moreira, Claudia</au><au>Cabecadas, Jose</au><au>Liu, David</au><au>Kalambakas, Stacey</au><au>Fustier, Pierre</au><au>Wu, Chengqing</au><au>Gribben, John G</au><au>Calaminici, Maria</au><au>Copie-Bergman, Christiane</au><au>Lopez-Guillermo, Armando</au><au>O'Connor, Owen</au><au>Williams, Michael</au><au>Suciu, Stefan</au><au>Levine, Benjamin</au><au>Kern, Julie</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma</atitle><date>2019</date><risdate>2019</risdate><issn>0732-183X</issn><issn>1527-7755</issn><abstract>PURPOSE Patients with indolent non-Hodgkin lymphoma typically respond well to first-line immunochemotherapy. At relapse, single-agent rituximab is commonly administered. Data suggest the immunomodulatory agent lenalidomide could increase the activity of rituximab.
METHODS A phase III, multicenter, randomized trial of lenalidomide plus rituximab versus placebo plus rituximab was conducted in patients with relapsed and/or refractory follicular or marginal zone lymphoma. Patients received lenalidomide or placebo for 12 cycles plus rituximab once per week for 4 weeks in cycle 1 and day 1 of cycles 2 through 5. The primary end point was progression-free survival per independent radiology review.
RESULTS A total of 358 patients were randomly assigned to lenalidomide plus rituximab (n = 178) or placebo plus rituximab (n = 180). Infections (63% v 49%), neutropenia (58% v 23%), and cutaneous reactions (32% v 12%) were more common with lenalidomide plus rituximab. Grade 3 or 4 neutropenia (50% v 13%) and leukopenia (7% v 2%) were higher with lenalidomide plus rituximab; no other grade 3 or 4 adverse event differed by 5% or more between groups. Progression-free survival was significantly improved for lenalidomide plus rituximab versus placebo plus rituximab, with a hazard ratio of 0.46 (95% CI, 0.34 to 0.62; P < .001) and median duration of 39.4 months (95% CI, 22.9 months to not reached) versus 14.1 months (95% CI, 11.4 to 16.7 months), respectively.
CONCLUSION Lenalidomide improved efficacy of rituximab in patients with recurrent indolent lymphoma, with an acceptable safety profile.</abstract><oa>free_for_read</oa></addata></record> |
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| source | Ghent University Academic Bibliography; American Society of Clinical Oncology Online Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | BENDAMUSTINE GUIDELINES MAINTENANCE Medicine and Health Sciences MONOCLONAL-ANTIBODY THERAPY MULTICENTER NATURAL-KILLER-CELL OPEN-LABEL RECURRENT FOLLICULAR LYMPHOMA SURVIVAL TRIAL |
| title | AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma |
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