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Rituximab plus Lenalidomide in Advanced Untreated Follicular Lymphoma
Open accessAbstract
BACKGROUND: Rituximab plus chemotherapy has been shown to be effective in patients with advanced-stage, previously untreated follicular lymphoma; nevertheless, most patients will have a relapse. Combination immunotherapy with lenalidomide and rituximab is an immunomodulatory regimen that has shown promising activity in patients with indolent B-cell non-Hodgkin's lymphoma. METHODS: We conducted this multicenter, international, phase 3 superiority trial to evaluate rituximab plus lenalidomide, as compared with rituximab plus chemotherapy, in patients with previously untreated follicular lymphoma. Patients were randomly assigned to receive one of the two regimens, followed by maintenance monotherapy with rituximab. Treatment with rituximab plus lenalidomide consisted of 18 cycles of the two drugs, followed by rituximab maintenance therapy every 8 weeks for 12 cycles (six additional doses). Treatment with rituximab plus chemotherapy consisted of the investigator's choice of one of three rituximab-based regimens, followed by maintenance monotherapy with rituximab every 8 weeks for 12 cycles. The primary end points were complete response (confirmed or unconfirmed) at 120 weeks and progression-free survival. RESULTS: A total of 1030 patients were randomly assigned to receive rituximab plus lenalidomide (513 patients) or rituximab plus chemotherapy (517 patients). The rate of confirmed or unconfirmed complete response at 120 weeks was similar in the two groups: 48% (95% confidence interval [CI], 44 to 53) in the rituximab-lenalidomide group and 53% (95% CI, 49 to 57) in the rituximab-chemotherapy group (P=0.13). The interim 3-year rate of progression-free survival was 77% (95% CI, 72 to 80) and 78% (95% CI, 74 to 82), respectively. A higher percentage of patients in the rituximab-chemotherapy group had grade 3 or 4 neutropenia (32% vs. 50%) and febrile neutropenia of any grade (2% vs. 7%), and a higher percentage of patients in the rituximab-lenalidomide group had grade 3 or 4 cutaneous reactions (7% vs. 1%). CONCLUSIONS: Among patients with previously untreated follicular lymphoma, efficacy results were similar with rituximab plus lenalidomide and rituximab plus chemotherapy (with both regimens followed by rituximab maintenance therapy). The safety profile differed in the two groups. (Funded by Celgene; RELEVANCE ClinicalTrials.gov numbers, NCT01476787 and NCT01650701 , and EudraCT number, 2011-002792-42 .).
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Metadata
- Authors
- Morschhauser, F., Fowler, N. H., Feugier, P., Bouabdallah, R., Tilly, H., Palomba, M. L., Fruchart, C., Libby, E. N., Casasnovas, R.-O., Flinn, I. W., Haioun, C., Maisonneuve, H., Ysebaert, L., Bartlett, N. L., Bouabdallah, K., Brice, P., Ribrag, V., Daguindau, N., Le Gouill, S., Pica, G. M., Martin Garcia-Sancho, A., López-Guillermo, A., Larouche, J.-F., Ando, K., Gomes da Silva, M., André, M., Zachée, P., Sehn, L. H., Tobinai, K., Cartron, G., Liu, D., Wang, J., Xerri, L., & Salles, G. A.
- Affiliations
- Centre National de la Recherche Scientifique (FR)
- From Université Lille, Centre Hospitalier Universitaire (CHU), Groupe de Recherche sur les formes Injectables et les Technologies Associées, Lille (F.M.), CHU Régional de Nancy, Service d’Hématologie, Vandoeuvre lès Nancy (P.F.), Institut Paoli-Calmettes (R.B.) and Department of Pathology, Institut Paoli-Calmettes, Centre de Recherche en Cancerologie de Marseille, INSERM, Centre National de la Recherche Scientifique, Aix-Marseille Université (L.X.), Marseille, Centre Henri Becquerel, Unité 1245 and...
- ORCID
- Morschhauser, Franck
- Fowler, Nathan H.
- Feugier, Pierre
- Tilly, Hervé
- Palomba, M. Lia
- Fruchart, Christophe
- Flinn, Ian W.
- Bartlett, Nancy L.
- Bouabdallah, Kamal
- Brice, Pauline
- Ribrag, Vincent
- Larouche, Jean-François
- Ando, Kiyoshi
- André, Marc
- Zachée, Pierre
- Sehn, Laurie H.
- Tobinai, Kensei
- Cartron, Guillaume
- Wang, Jianming
- Xerri, Luc
- Salles, Gilles A.
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2018-09-06
- Volume
- 379
- Issue
- 10
- Pages
- 934-947
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC11003525
- OpenAlex
- W2891543930
- Cited by
- 373
- References
- 30
- Citations by year
- 2026: 17 · 2025: 52 · 2024: 38 · 2023: 37 · 2022: 52 · 2021: 62 · 2020: 58 · 2019: 51 · 2018: 5
- FWCI
- 33.44
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Digital Commons@Becker (Washington University School of Medicine) (submittedVersion)
- HAL (submittedVersion)
- Archivio istituzionale della ricerca (Alma Mater Studiorum Università di Bologna) (submittedVersion)
- DIAL (Catholic University of Leuven) (submittedVersion)
- Funders
- Celgene
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Hematology › Chronic Lymphocytic Leukemia Research
- Health Sciences › Medicine › Oncology › Viral-associated cancers and disorders
- Keywords
- follicular lymphoma, rituximab, lenalidomide, previously untreated lymphoma, rituximab plus chemotherapy, maintenance therapy, complete response, progression-free survival, neutropenia, skin reactions, immunomodulatory therapy, B-cell non-Hodgkin lymphoma, safety and tolerability
- MeSH terms
- Rituximab, Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Female, Humans, Lymphoma, Follicular, Male, Middle Aged, Neutropenia, Skin Diseases, Thalidomide, Survival Rate, Disease-Free Survival, Intention to Treat Analysis
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