Five-year follow-up of lenalidomide plus rituximab as initial treatment of mantle cell lymphoma

Abstract

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).

Mantle cell lymphoma: 2019 update on the diagnosis, pathogenesis, prognostication, and management

“…Promising overall survival results were obtained from adding bortezomib to the R‐CHOP regimen compared to R‐CHOP alone in a randomized study, but an increase in hematologic toxicity was noted . Recently, a 5 year follow up study on the lenalidomide with rituximab combination was reported. It included induction and maintenance with lenalidomide and rituximab in 38 elderly patients, and the majority (75%) completed >3 years of treatment.…”

How to manage lymphoid malignancies during novel 2019 coronavirus (CoVid-19) outbreak: a Brazilian task force recommendation

“…20 Lenalidomide-based oral regimens for initial treatment of unfit patients with MCL can also be considered, if available. 21 In the relapsed setting, oral medications should be preferred, including ibrutinib 22 and lenalidomide, 23 if not HTCT 3120 1-8 Please cite this article in press as: Perini…”

Phase 1–2 study of vorinostat (SAHA), cladribine and rituximab (SCR) in relapsed B‐cell non‐Hodgkin lymphoma and previously untreated mantle cell lymphoma

“…However, the response rates and PFS seen with the SCR regimen compare favourably with other less intensive induction regimens. For example, the CR rate with SCR was higher than that seen in prospective studies using BR (40%), R‐cladribine (52%), R‐CHOP (34–42%), and VR‐CAP (rituximab, cyclophosphamide, doxorubicin and prednisone plus bortezomib; 53%) (Kluin‐Nelemans et al , ; Robak et al , ; Chen et al , ; Le Gouill et al , ; Visco et al , ; Chang et al , ; Ruan et al , ; Tam et al , ). Furthermore, although MRD testing was only available for 14 responding patients, all were MRD‐negative after induction.…”