Five-year follow-up of lenalidomide plus rituximab as initial treatment for mantle cell lymphoma
Mené sur 38 patients atteints d'un lymphome à cellules du manteau (âge médian : 65 ans), cet essai de phase II évalue l'efficacité, du point de vue de la survie sans progression et de la survie globale à 3 ans, et de la survie estimée à 5 ans, et la toxicité d'un traitement initial (induction et entretien) à base de lénalidomide et rituximab (durée médiane de suivi : 64 mois)
We report 5-year follow-up of a multicenter phase 2 study of lenalidomide plus rituximab (LR) as initial treatment for MCL. The regimen includes both 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, with Mantle cell lymphoma international prognostic index (MIPI) scores balanced between low-, intermediate-, and high-risk (34%, 34%, and 32% respectively). Twenty-seven (75%) of the 36 evaluable patients completed at least 3 years of study treatment. At a median follow-up of 64 months (range, 21 to 78 months), the 3-yr PFS and OS were 80% and 90%, respectively, with 5-yr estimated PFS and OS at 64% and 77%, respectively. During maintenance, hematologic AEs included asymptomatic grade 3-4 cytopenias (42% neutropenia, 5% thrombocytopenia, 3% anemia), and mostly grade 1-2 infections managed in outpatient setting (45% URI, 21% UTI, 13% sinusitis, 11% cellulitis and 8% pneumonia). Non-hematologic AEs, such as constitutional and inflammatory symptoms, occurred in reduced frequency and intensity compared to induction. Peripheral blood MRD assay (ClonoSEQTM) showed MRD negative CR in 8 out of 10 subjects who have completed at least 3-year 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).