Lenalidomide plus Rituximab as Initial Treatment for Mantle-Cell Lymphoma
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BACKGROUND: Mantle-cell lymphoma is generally incurable. Initial treatment is not standardized but usually includes cytotoxic chemotherapy. Lenalidomide, an immunomodulatory compound, and rituximab, an anti-CD20 antibody, are active in patients with recurrent mantle-cell lymphoma. We evaluated lenalidomide plus rituximab as a first-line therapy. METHODS: We conducted a single-group, multicenter, phase 2 study with induction and maintenance phases. During the induction phase, lenalidomide was administered at a dose of 20 mg daily on days 1 through 21 of every 28-day cycle for 12 cycles; the dose was escalated to 25 mg daily after the first cycle if no dose-limiting adverse events occurred during the first cycle and was reduced to 15 mg daily during the maintenance phase. Rituximab was administered once weekly for the first 4 weeks and then once every other cycle until disease progression. The primary end point was the overall response rate. Secondary end points included outcomes related to safety, survival, and quality of life. RESULTS: A total of 38 participants were enrolled at four centers from July 2011 through April 2014. The median age was 65 years. On the basis of the Mantle Cell Lymphoma International Prognostic Index scores, the proportions of participants with low-risk, intermediate-risk, and high-risk disease at baseline were similar (34%, 34%, and 32%, respectively). The most common grade 3 or 4 adverse events were neutropenia (in 50% of the patients), rash (in 29%), thrombocytopenia (in 13%), an inflammatory syndrome ("tumor flare") (in 11%), anemia (in 11%), serum sickness (in 8%), and fatigue (in 8%). At the median follow-up of 30 months (through February 2015), the overall response rate among the participants who could be evaluated was 92% (95% confidence interval [CI], 78 to 98), and the complete response rate was 64% (95% CI, 46 to 79); median progression-free survival had not been reached. The 2-year progression-free survival was estimated to be 85% (95% CI, 67 to 94), and the 2-year overall survival 97% (95% CI, 79 to 99). A response to treatment was associated with improvement in quality of life. CONCLUSIONS: Combination biologic therapy consisting of lenalidomide plus rituximab was active as initial therapy for mantle-cell lymphoma. (Funded by Celgene and Weill Cornell Medical College; ClinicalTrials.gov number, NCT01472562.).
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Lenalidomide monotherapy triples PFS when used as a maintenance regimen following standard second-line chemotherapy (median PFS 33.9 months versus 9.2 months with placebo; HR 0.40, 95% CI 0.29-0.55; P<0.0001).
“lenalidomide monotherapy triples PFS when used as a maintenance regimen following standard second-line chemotherapy (median PFS 33.9 months versus 9.2 months with placebo; HR 0.40, 95% CI 0.29–0.55; P <0.0001)79.”
From Cancer therapies based on targeted protein degradation — lessons learned with lenalidomide (2021) · cites this paper as [79]
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- Authors
- Ruan, J., Martin, P., Shah, B., Schuster, S. J., Smith, S. M., Furman, R. R., Christos, P., Rodriguez, A., Svoboda, J., Lewis, J., Katz, O., Coleman, M., & Leonard, J. P.
- Affiliations
- NewYork–Presbyterian Hospital (US)
- Moffitt Cancer Center (US)
- Abramson Cancer Center (US)
- University of Chicago Medical Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-11-05
- Volume
- 373
- Issue
- 19
- Pages
- 1835-1844
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- PMC
- PMC4710541
- OpenAlex
- W2184668473
- Cited by
- 236
- References
- 31
- Citations by year
- 2026: 2 · 2025: 10 · 2024: 12 · 2023: 9 · 2022: 21 · 2021: 19 · 2020: 41 · 2019: 28 · 2018: 30 · 2017: 33 · 2016: 30 · 2012: 1
- FWCI
- 24.62
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- PubMed Central (acceptedVersion)
- Funders
- Celgene
- National Institutes of Health (KL2TR000458, UL1TR000457)
- Weill Cornell Medical College (UL1 TR000457‐06)
- National Center for Advancing Translational Sciences
- Topics
- Health Sciences › Medicine › Pathology and Forensic Medicine › Lymphoma Diagnosis and Treatment
- Health Sciences › Medicine › Hematology › Multiple Myeloma Research and Treatments
- Health Sciences › Medicine › Oncology › Viral-associated cancers and disorders
- Keywords
- mantle cell lymphoma, lenalidomide, rituximab, first-line therapy, immunomodulators, anti-CD20 monoclonal antibody, overall response rate, progression-free survival, overall survival, adverse events, neutropenia, tumor flare, maintenance therapy, quality of life
- MeSH terms
- Rituximab, Lenalidomide, Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols, Exanthema, Female, Follow-Up Studies, Humans, Male, Middle Aged, Neutropenia, Quality of Life, Thalidomide, Survival Analysis, Lymphoma, Mantle-Cell, Intention to Treat Analysis, Antibodies, Monoclonal, Murine-Derived, Maintenance Chemotherapy, Induction Chemotherapy
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