PMID- 30181173 OWN - NLM STAT- MEDLINE DCOM- 20190729 LR - 20240207 IS - 1528-0020 (Electronic) IS - 0006-4971 (Print) IS - 0006-4971 (Linking) VI - 132 IP - 19 DP - 2018 Nov 8 TI - Five-year follow-up of lenalidomide plus rituximab as initial treatment of mantle cell lymphoma. PG - 2016-2025 LID - 10.1182/blood-2018-07-859769 [doi] AB - We report 5-year follow-up of a multicenter phase 2 study of lenalidomide plus rituximab (LR) as initial treatment of mantle cell lymphoma (MCL). The regimen includes induction and maintenance with the LR doublet. Treatment was continuous until progression, with optional discontinuation after 3 years. The median age of the 38 participants was 65 years, with MCL international prognostic index scores balanced among low, intermediate, and high risk (34%, 34%, and 32%, respectively). Twenty-seven (75%) of the 36 evaluable patients completed >/=3 years of study treatment. At a median follow-up of 64 months (range, 21-78), the 3-year progression-free survival (PFS) and overall survival (OS) were 80% and 90%, respectively, with 5-year estimated PFS and OS of 64% and 77%, respectively. During maintenance, hematologic adverse events (AEs) included asymptomatic grade 3 or 4 cytopenias (42% neutropenia, 5% thrombocytopenia, 3% anemia) and mostly grade 1 or 2 infections managed in the outpatient setting (45% upper respiratory infection, 21% urinary tract infection, 13% sinusitis, 11% cellulitis, 8% pneumonia). Nonhematologic AEs, such as constitutional and inflammatory symptoms, occurred at reduced frequency and intensity compared with induction. A peripheral blood minimal residual disease (MRD) assay (clonoSEQ) showed MRD-negative complete remission in 8 of 10 subjects who had completed >/=3 years of treatment and with available samples for analysis. With longer follow-up, LR continues to demonstrate durable responses and manageable safety as initial induction and maintenance therapy for MCL (ClinicalTrials.gov NCT01472562). CI - (c) 2018 by The American Society of Hematology. FAU - Ruan, Jia AU - Ruan J AD - Division of Hematology and Medical Oncology. FAU - Martin, Peter AU - Martin P AD - Division of Hematology and Medical Oncology. FAU - Christos, Paul AU - Christos P AD - Division of Biostatistics and Epidemiology, and. FAU - Cerchietti, Leandro AU - Cerchietti L AD - Division of Hematology and Medical Oncology. FAU - Tam, Wayne AU - Tam W AD - Department of Pathology and Laboratory Medicine, Meyer Cancer Center, Weill Cornell Medicine and New York Presbyterian Hospital, New York, NY. FAU - Shah, Bijal AU - Shah B AD - Moffitt Cancer Center, Tampa, FL. FAU - Schuster, Stephen J AU - Schuster SJ AD - University of Pennsylvania Abramson Cancer Center, Philadelphia, PA; and. FAU - Rodriguez, Amelyn AU - Rodriguez A AD - Division of Hematology and Medical Oncology. FAU - Hyman, David AU - Hyman D AD - Division of Hematology and Medical Oncology. FAU - Calvo-Vidal, Maria Nieves AU - Calvo-Vidal MN AD - Division of Hematology and Medical Oncology. FAU - Smith, Sonali M AU - Smith SM AD - University of Chicago Medical Center, Chicago, IL. FAU - Svoboda, Jakub AU - Svoboda J AD - Moffitt Cancer Center, Tampa, FL. FAU - Furman, Richard R AU - Furman RR AD - Division of Hematology and Medical Oncology. FAU - Coleman, Morton AU - Coleman M AD - Division of Hematology and Medical Oncology. FAU - Leonard, John P AU - Leonard JP AD - Division of Hematology and Medical Oncology. LA - eng SI - ClinicalTrials.gov/NCT01472562 GR - UL1 TR002384/TR/NCATS NIH HHS/United States PT - Clinical Trial PT - Journal Article PT - Research Support, N.I.H., Extramural PT - Research Support, Non-U.S. Gov't DEP - 20180904 PL - United States TA - Blood JT - Blood JID - 7603509 RN - 0 (Angiogenesis Inhibitors) RN - 0 (Antineoplastic Agents, Immunological) RN - 4F4X42SYQ6 (Rituximab) RN - F0P408N6V4 (Lenalidomide) CIN - Blood. 2018 Nov 8;132(19):2001-2002. PMID: 30409891 MH - Adult MH - Aged MH - Aged, 80 and over MH - Angiogenesis Inhibitors/adverse effects/*therapeutic use MH - Antineoplastic Agents, Immunological/adverse effects/*therapeutic use MH - Antineoplastic Combined Chemotherapy Protocols/adverse effects/*therapeutic use MH - Female MH - Follow-Up Studies MH - Humans MH - Lenalidomide/adverse effects/*therapeutic use MH - Lymphoma, Mantle-Cell/*drug therapy MH - Male MH - Middle Aged MH - Neutropenia/chemically induced MH - Rituximab/adverse effects/*therapeutic use MH - Survival Analysis MH - Thrombocytopenia/chemically induced MH - Treatment Outcome PMC - PMC6634960 COIS- Conflict-of-interest disclosure: J.R. has received research support, acted as a consultant for, and served on the advisory board of Celgene. P.M. has received research support and served as a consultant for Celgene. R.R.F. has received research support from Celgene. J.P.L. has received research support and/or served as a consultant for Genentech and Celgene. S.M.S. has served as a consultant for Genentech and Celgene, as well as participated on a Data Safety Monitoring Board for Genentech. J.S. has received research support from Celgene. The remaining authors declare no competing financial interest. EDAT- 2018/09/06 06:00 MHDA- 2019/07/30 06:00 PMCR- 2019/03/08 CRDT- 2018/09/06 06:00 PHST- 2018/07/20 00:00 [received] PHST- 2018/08/24 00:00 [accepted] PHST- 2018/09/06 06:00 [pubmed] PHST- 2019/07/30 06:00 [medline] PHST- 2018/09/06 06:00 [entrez] PHST- 2019/03/08 00:00 [pmc-release] AID - S0006-4971(20)43024-1 [pii] AID - 2018/859769 [pii] AID - 10.1182/blood-2018-07-859769 [doi] PST - ppublish SO - Blood. 2018 Nov 8;132(19):2016-2025. doi: 10.1182/blood-2018-07-859769. Epub 2018 Sep 4.