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

• Published in: Blood Vol. 132; no. 19; pp. 2016 - 2025
• Main Authors: Ruan, Jia, Martin, Peter, Christos, Paul, Cerchietti, Leandro, Tam, Wayne, Shah, Bijal, Schuster, Stephen J., Rodriguez, Amelyn, Hyman, David, Calvo-Vidal, Maria Nieves, Smith, Sonali M., Svoboda, Jakub, Furman, Richard R., Coleman, Morton, Leonard, John P.
• Format: Journal Article
• Language: English
• Published: United States Elsevier Inc 08.11.2018; American Society of Hematology
• Subjects: Adult; Aged; Aged, 80 and over; Angiogenesis Inhibitors - adverse effects; Angiogenesis Inhibitors - therapeutic use; Antineoplastic Agents, Immunological - adverse effects; Antineoplastic Agents, Immunological - therapeutic use; Antineoplastic Combined Chemotherapy Protocols - adverse effects; Antineoplastic Combined Chemotherapy Protocols - therapeutic use; Clinical Trials and Observations; Female; Follow-Up Studies; Humans; Lenalidomide - adverse effects; Lenalidomide - therapeutic use; Lymphoma, Mantle-Cell - drug therapy; Male; Middle Aged; Neutropenia - chemically induced; Rituximab - adverse effects; Rituximab - therapeutic use; Survival Analysis; Thrombocytopenia - chemically induced; Treatment Outcome
• ISSN: 0006-4971; 1528-0020; 1528-0020
• DOI: 10.1182/blood-2018-07-859769

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). •Lenalidomide plus rituximab as induction and maintenance therapy for MCL can achieve durable MRD-negative complete remissions.•Chronic therapy–associated adverse events are generally nonaccumulative and remain manageable. [Display omitted]