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AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma

(2019) JOURNAL OF CLINICAL ONCOLOGY. 37(14). p.1188-1199
Author
Organization
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.
Keywords
RECURRENT FOLLICULAR LYMPHOMA, MONOCLONAL-ANTIBODY THERAPY, NATURAL-KILLER-CELL, OPEN-LABEL, TRIAL, BENDAMUSTINE, MULTICENTER, MAINTENANCE, GUIDELINES, SURVIVAL

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MLA
Leonard, John P et al. “AUGMENT : a Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.” JOURNAL OF CLINICAL ONCOLOGY 37.14 (2019): 1188–1199. Print.
APA
Leonard, J. P., Trneny, M., Izutsu, K., Fowler, N. H., Hong, X., Zhu, J., Zhang, H., et al. (2019). AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. JOURNAL OF CLINICAL ONCOLOGY, 37(14), 1188–1199.
Chicago author-date
Leonard, John P, Marek Trneny, Koji Izutsu, Nathan H Fowler, Xiaonan Hong, Jun Zhu, Huilai Zhang, et al. 2019. “AUGMENT : a Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.” Journal of Clinical Oncology 37 (14): 1188–1199.
Chicago author-date (all authors)
Leonard, John P, Marek Trneny, Koji Izutsu, Nathan H Fowler, Xiaonan Hong, Jun Zhu, Huilai Zhang, Fritz Offner, Adriana Scheliga, Grzegorz S Nowakowski, Antonio Pinto, Francesca Re, Laura Maria Fogliatto, Phillip Scheinberg, Ian W Flinn, Claudia Moreira, Jose Cabecadas, David Liu, Stacey Kalambakas, Pierre Fustier, Chengqing Wu, John G Gribben, Maria Calaminici, Christiane Copie-Bergman, Armando Lopez-Guillermo, Owen O’Connor, Michael Williams, Stefan Suciu, Benjamin Levine, and Julie Kern. 2019. “AUGMENT : a Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.” Journal of Clinical Oncology 37 (14): 1188–1199.
Vancouver
1.
Leonard JP, Trneny M, Izutsu K, Fowler NH, Hong X, Zhu J, et al. AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma. JOURNAL OF CLINICAL ONCOLOGY. 2019;37(14):1188–99.
IEEE
[1]
J. P. Leonard et al., “AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma,” JOURNAL OF CLINICAL ONCOLOGY, vol. 37, no. 14, pp. 1188–1199, 2019.
@article{8618776,
  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.},
  author       = {Leonard, John P and Trneny, Marek and Izutsu, Koji and Fowler, Nathan H and Hong, Xiaonan and Zhu, Jun and Zhang, Huilai and Offner, Fritz and Scheliga, Adriana and Nowakowski, Grzegorz S and Pinto, Antonio and Re, Francesca and Fogliatto, Laura Maria and Scheinberg, Phillip and Flinn, Ian W and Moreira, Claudia and Cabecadas, Jose and Liu, David and Kalambakas, Stacey and Fustier, Pierre and Wu, Chengqing and Gribben, John G and Calaminici, Maria and Copie-Bergman, Christiane and Lopez-Guillermo, Armando and O'Connor, Owen and Williams, Michael and Suciu, Stefan and Levine, Benjamin and Kern, Julie},
  issn         = {0732-183X},
  journal      = {JOURNAL OF CLINICAL ONCOLOGY},
  keywords     = {RECURRENT FOLLICULAR LYMPHOMA,MONOCLONAL-ANTIBODY THERAPY,NATURAL-KILLER-CELL,OPEN-LABEL,TRIAL,BENDAMUSTINE,MULTICENTER,MAINTENANCE,GUIDELINES,SURVIVAL},
  language     = {eng},
  number       = {14},
  pages        = {1188--1199},
  title        = {AUGMENT : a phase III study of lenalidomide plus rituximab versus placebo plus rituximab in relapsed or refractory indolent lymphoma},
  url          = {http://dx.doi.org/10.1200/JCO.19.00010},
  volume       = {37},
  year         = {2019},
}

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