Lenalidomide in Transfusion-Dependent IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes and Isolated Del(5q): Results of a European Post-Authorization Safety Surveillance Study
Poloni A, Raaschou-Jensen K, Mohedo F, Paolini S, Oliva E, Buccisano F, Vasconcelos A, Kim I, Makwana A, Bernasconi D, Rosettani B, Prebet T, Santini V. Lenalidomide in Transfusion-Dependent IPSS Low- or Intermediate-1-Risk Myelodysplastic Syndromes and Isolated Del(5q): Results of a European Post-Authorization Safety Surveillance Study. Clinical Lymphoma Myeloma & Leukemia 2024 DOI: 10.1016/j.clml.2024.10.007.Peer-Reviewed Original ResearchInternational Prognostic Scoring SystemDose of lenalidomideMyelodysplastic syndromeIsolated del(5qAcute myeloid leukemiaBenefit-risk profileSafety populationTransfusion-dependentOverall survivalCumulative incidenceCumulative incidence of acute myeloid leukemiaGrade 3/4 treatment-emergent adverse eventsNon-interventional post-authorization safety studyInternational Prognostic Scoring System low-Intermediate-1-risk myelodysplastic syndromeIncidence of acute myeloid leukemiaLower-risk myelodysplastic syndromesTreatment-emergent adverse eventsEffects of lenalidomidePrognostic Scoring SystemKaplan-Meier analysisPost-authorization safety studyRoutine careClinical trial dataSafety surveillance studyLuspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial
Della Porta M, Garcia-Manero G, Santini V, Zeidan A, Komrokji R, Shortt J, Valcárcel D, Jonasova A, Dimicoli-Salazar S, Tiong I, Lin C, Li J, Zhang J, Pilot R, Kreitz S, Pozharskaya V, Keeperman K, Rose S, Prebet T, Lai Y, Degulys A, Paolini S, Cluzeau T, Fenaux P, Platzbecker U. Luspatercept versus epoetin alfa in erythropoiesis-stimulating agent-naive, transfusion-dependent, lower-risk myelodysplastic syndromes (COMMANDS): primary analysis of a phase 3, open-label, randomised, controlled trial. The Lancet Haematology 2024, 11: e646-e658. PMID: 39038479, DOI: 10.1016/s2352-3026(24)00203-5.Peer-Reviewed Original ResearchLower-risk myelodysplastic syndromesRed blood cell transfusion independenceTreatment-emergent adverse eventsMedian follow-upEpoetin alfa groupMyelodysplastic syndromeLuspatercept groupTransfusion-dependentSerum erythropoietin concentrationPrimary endpointEpoetin alfaTransfusion independenceOpen-labelAlfa groupAdverse eventsFollow-upRed blood cell transfusion burdenErythropoietin concentrationIntention-to-treat populationControlled trialsCommon grade 3Epoetin alfa recipientsMean haemoglobin increasePrimary analysisProportion of patients