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J Clin Oncol. 2019 May 10;37(14):1188-1199. doi: 10.1200/JCO.19.00010. Epub 2019 Mar 21.

AUGMENT: A Phase III Study of Lenalidomide Plus Rituximab Versus Placebo Plus Rituximab in Relapsed or Refractory Indolent Lymphoma.

Author information

1
1 Weill Cornell Medicine and New York Presbyterian Hospital, New York, NY.
2
2 Charles University, General Hospital, Prague, Czech Republic.
3
3 National Cancer Center Hospital, Tokyo, Japan.
4
4 The University of Texas MD Anderson Cancer Center, Houston, TX.
5
5 Fudan University Shanghai Cancer Center, Shanghai, People's Republic of China.
6
6 Peking University Cancer Hospital and Institute, Beijing, People's Republic of China.
7
7 Tianjin Medical University Cancer Institute and Hospital, Tianjin, People's Republic of China.
8
8 Ghent University Hospital, Gent, Belgium.
9
9 Instituto Nacional de Câncer, Rio de Janeiro, Brazil.
10
10 Mayo Clinic, Rochester, MN.
11
11 Istituto Nazionale Tumori IRCCS - Fondazione Pascale, Naples, Italy.
12
12 Azienda Ospedaliero Universitaria di Parma, Parma, Italy.
13
13 Hospital de Clínicas de Porto Alegre, Porto Alegre, Brazil.
14
14 Hospital A Beneficência Portuguesa de São Paulo, São Paulo, Brazil.
15
15 Sarah Cannon Research Institute, Nashville, TN.
16
16 Instituto Português de Oncologia do Porto Francisco Gentil Epe, Porto, Portugal.
17
17 Instituto Português de Oncologia de Lisboa Francisco Gentil, Lisbon, Portugal.
18
18 Celgene Corporation, Summit, NJ.
19
19 Celgene International, Boudry, Switzerland.
20
20 Barts Cancer Institute, London, United Kingdom.

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.

PMID:
30897038
DOI:
10.1200/JCO.19.00010

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