TY - JOUR
T1 - A phase II trial of lenalidomide plus rituximab in previously untreated follicular non-Hodgkin's lymphoma (NHL)
T2 - CALGB 50803 (Alliance)
AU - Martin, Peter
AU - Jung, S. H.
AU - Pitcher, B.
AU - Bartlett, N. L.
AU - Blum, K. A.
AU - Shea, T.
AU - Hsi, E. D.
AU - Ruan, J.
AU - Smith, S. E.
AU - Leonard, J. P.
AU - Cheson, B. D.
N1 - Funding Information:
PM is a consultant for Roche-Genentech and Celgene. NLB received research funding from Roche-Genentech and Celgene. JR received research funding and consultant for Celgene. JPL is a consultant for Roche-Genentech and Celgene. BDC: Advisory Board for Celgene, Advisory board and research support for Roche-Genentech. All remaining authors have declared no conflicts of interest.
Funding Information:
Research reported in this publication was supported by the National Cancer Institute of the National Institutes of Health under Award Numbers U10CA180821 and U10CA180882 (to the Alliance for Clinical Trials in Oncology), U10CA007968, U10CA077597, U10CA180833, U10CA180850, and U10CA180838. Also supported in part by an independent investigator award from Celgene. The content is solely the responsibility of the authors and does not necessarily represent the official views of the National Institutes of Health. The following institutional networks participated in this study: Dana-Farber/Partners CancerCare LAPS, Boston, MA, Harold Burstein, 5U10CA180867. Delaware/Christiana Care NCI Community Oncology Research Program, Newark, DE, Gregory Masters, 5UG1CA189819. Duke University - Duke Cancer Institute LAPS, Durham, NC, Jeffrey Crawford, 5U10CA180857. Florida Hospital Orlando, Orlando, FL, Carlos Alemany. Heartland Cancer Research NCORP, Decatur, IL, James Wade, 5UG1CA189830. MedStar Georgetown University Hospital, Washington, DC, Chaitra Ujjani. Ohio State University Comprehensive Cancer Center LAPS, Columbus, OH, Clara Bloomfield, 5U10CA180850. Southeast Clinical Oncology Research (SCOR) Consortium NCORP, Winston-Salem, NC, James Atkins, 5UG1CA189858. State University of New York Upstate Medical University, Syracuse, NY, Stephen Graziano. UNC Lineberger Comprehensive Cancer Center LAPS, Chapel Hill, NC, Thomas Shea, 5U10CA180838. University of Chicago Comprehensive Cancer Center LAPS, Chicago, IL, Hedy Kindler, 5U10CA180836. University of Nebraska Medical Center, Omaha, NE, Apar Ganti. University of Vermont College of Medicine, Burlington, VT, Claire Verschraegen. VCU Massey Cancer Center Minority Underserved NCORP, Richmond, VA, Steven Grossman, UG1CA189869. Wake Forest University Health Sciences, Winston-Salem, NC, Heidi Klepin. Washington University - Siteman Cancer Center LAPS, Saint Louis, MO, Nancy Bartlett, U10CA180833. Weill Medical College of Cornell University, New York, NY, Scott Tagawa.
Publisher Copyright:
© The Author 2017. Published by Oxford University Press on behalf of the European Society for Medical Oncology. All rights reserved.
PY - 2017/11
Y1 - 2017/11
N2 - Background: This multicenter, phase II trial tested the tolerability and efficacy of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma (FL). Patients and methods: Patients with grade 1-3a FL, stage 3-4 or bulky stage 2, FL international prognostic index (FLIPI) 0-2, and no prior therapy were eligible to receive rituximab 375 mg/m2 weekly during cycle 1 and day 1 of cycles 4, 6, 8, and 10, plus lenalidomide 20-25mg on days 1-21 for twelve 28-day cycles. The primary objectives were to evaluate response rates [complete (CR) and overall] and time to progression. Secondary objectives included toxicity, response according to polymorphisms in FcgR2A and FcgR3A, and changes in circulating pro-angiogenic cells. Results: From October 2010 to September 2011, 66 patients were enrolled. Median age was 53 years, 34 were female, 15 had bulky disease, 21 were FLIPI 0-1, 43 FLIPI 2, and 2 FLIPI 3. One patient withdrew before receiving treatment. Fifty-one patients completed 12 cycles of lenalidomide. Reasons for discontinuation included withdrawal (n = 6), adverse events (n = 6), progression (n = 2). Grade 3-4 hematologic toxicity included neutropenia (21%), lymphopenia (9%), and thrombocytopenia (2%), infection (11%), and rash (8%). Grade 1-2 toxicity included fatigue (78%), diarrhea (37%), rash (32%), and febrile neutropenia in one patient. The overall response rate was 95%; the CR rate was 72% (95% confidence interval, 60% to 83%). With a median follow-up of 5 years, the 2- and 5-year progression-free survival were 86% and 70%, respectively, and the 5-year overall survival was 100%. There was no association between CR rate or PFS and FLIPI, histological grade, bulky disease, FcgR2A/FcgR3A polymorphism, or change in circulating endothelial cell/hematopoietic progenitor cell. Conclusion: Lenalidomide plus rituximab was associated with low rates of grade 3-4 toxicity, yielded a CR rate and PFS similar to chemotherapy-based treatment and may represent a reasonable alternative to immunochemotherapy in previously untreated FL. ClinicalTrials.gov Identifier: NCT01145495.
AB - Background: This multicenter, phase II trial tested the tolerability and efficacy of lenalidomide plus rituximab in patients with previously untreated follicular lymphoma (FL). Patients and methods: Patients with grade 1-3a FL, stage 3-4 or bulky stage 2, FL international prognostic index (FLIPI) 0-2, and no prior therapy were eligible to receive rituximab 375 mg/m2 weekly during cycle 1 and day 1 of cycles 4, 6, 8, and 10, plus lenalidomide 20-25mg on days 1-21 for twelve 28-day cycles. The primary objectives were to evaluate response rates [complete (CR) and overall] and time to progression. Secondary objectives included toxicity, response according to polymorphisms in FcgR2A and FcgR3A, and changes in circulating pro-angiogenic cells. Results: From October 2010 to September 2011, 66 patients were enrolled. Median age was 53 years, 34 were female, 15 had bulky disease, 21 were FLIPI 0-1, 43 FLIPI 2, and 2 FLIPI 3. One patient withdrew before receiving treatment. Fifty-one patients completed 12 cycles of lenalidomide. Reasons for discontinuation included withdrawal (n = 6), adverse events (n = 6), progression (n = 2). Grade 3-4 hematologic toxicity included neutropenia (21%), lymphopenia (9%), and thrombocytopenia (2%), infection (11%), and rash (8%). Grade 1-2 toxicity included fatigue (78%), diarrhea (37%), rash (32%), and febrile neutropenia in one patient. The overall response rate was 95%; the CR rate was 72% (95% confidence interval, 60% to 83%). With a median follow-up of 5 years, the 2- and 5-year progression-free survival were 86% and 70%, respectively, and the 5-year overall survival was 100%. There was no association between CR rate or PFS and FLIPI, histological grade, bulky disease, FcgR2A/FcgR3A polymorphism, or change in circulating endothelial cell/hematopoietic progenitor cell. Conclusion: Lenalidomide plus rituximab was associated with low rates of grade 3-4 toxicity, yielded a CR rate and PFS similar to chemotherapy-based treatment and may represent a reasonable alternative to immunochemotherapy in previously untreated FL. ClinicalTrials.gov Identifier: NCT01145495.
KW - Follicular lymphoma
KW - Lenalidomide
KW - Rituximab
UR - http://www.scopus.com/inward/record.url?scp=85034115082&partnerID=8YFLogxK
U2 - 10.1093/annonc/mdx496
DO - 10.1093/annonc/mdx496
M3 - Article
C2 - 28945884
AN - SCOPUS:85034115082
SN - 0923-7534
VL - 28
SP - 2806
EP - 2812
JO - Annals of Oncology
JF - Annals of Oncology
IS - 11
ER -