Clinical Benefit-Risk Profile of Lenalidomide in Patients With Lower-risk Myelodysplastic Syndromes Without del(5q): Results of a Phase III Trial

National Comprehensive Cancer Network Park, 2010, Early introduction of ESA in low risk MDS patients may delay the need for RBC transfusion: a retrospective analysis on 112 patients, Leuk Res, 34, 1430, 10.1016/j.leukres.2010.05.030 Platzbecker, 2016, ARCADE (20090160): a phase 3 randomized placebo-controlled double-blind trial of darbepoetin alfa in the treatment of anemia in patients with low or intermediate-1 risk myelodysplastic syndromes (MDS), Haematologica, 101 Fenaux, 2016, Randomized, double-blind, placebo-controlled, multicentre study evaluating epoeitin alfa versus placebo in anemic patients with IPSS low- INT1 risk MDS, Haematologica, 101 Hellström-Lingberg, 1997, Erythroid response to treatment with G-CSF plus erythropoietin for the anaemia of patients with myelodysplastic syndromes: proposal for a predictive model, Br J Haematol, 99, 344, 10.1046/j.1365-2141.1997.4013211.x Santini, 2016, Randomized phase III study of lenalidomide versus placebo in RBC transfusion-dependent patients with lower-risk non-del(5q) myelodysplastic syndromes and ineligible for or refractory to erythropoiesis-stimulating agents, J Clin Oncol, 34, 2988, 10.1200/JCO.2015.66.0118 Malcovati, 2005, Prognostic factors and life expectancy in myelodysplastic syndromes classified according to WHO criteria: a basis for clinical decision making, J Clin Oncol, 23, 7594, 10.1200/JCO.2005.01.7038 Oliva, 2012, Quality of life and physicians’ perception in myelodysplastic syndromes, Am J Blood Res, 2, 136 List, 2005, Efficacy of lenalidomide in myelodysplastic syndromes, N Engl J Med, 352, 549, 10.1056/NEJMoa041668 List, 2006, Lenalidomide in the myelodysplastic syndrome with chromosome 5q deletion, N Engl J Med, 355, 1456, 10.1056/NEJMoa061292 Fenaux, 2011, A randomized phase 3 study of lenalidomide versus placebo in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes, Blood, 118, 3765, 10.1182/blood-2011-01-330126 Almeida, 2018, Safety profile of lenalidomide in patients with lower-risk myelodysplastic syndromes without del(5q): results of a phase 3 trial, Leuk Lymphoma, 59, 2135, 10.1080/10428194.2017.1421758 Cheson, 2006, Clinical application and proposal for modification of the International Working Group (IWG) response criteria in myelodysplasia, Blood, 108, 419, 10.1182/blood-2005-10-4149 Liang, 1986, Longitudinal data analysis using generalized linear models, Biometrika, 73, 13, 10.1093/biomet/73.1.13 Lefkopoulou, 1993, Global tests for multiple binary outcomes, Biometrics, 49, 975, 10.2307/2532240 Oliva, 2005, Hemoglobin level threshold for cardiac remodelling and quality of life in myelodysplastic syndrome, Leuk Res, 29, 1217, 10.1016/j.leukres.2005.03.004 Szende, 2009, Valuation of transfusion-free living in MDS: results of health utility interviews with patients, Health Qual Life Outcomes, 7, 81, 10.1186/1477-7525-7-81 Sekeres, 2015, Effect of lenalidomide (LEN) exposure on AML-free survival and overall survival in LEN-treated patients with IPSS low- or intermediate-1-risk myelodysplastic syndromes (MDS) with del(5q), Blood, 126, 10.1182/blood.V126.23.2870.2870 List, 2011, Early lenalidomide (LEN) dose intensity and durable RBC-transfusion independence (RBC-TI) in patients (pts) with low-/int-1-risk myelodysplastic syndromes (MDS) and del5q, J Clin Oncol, 29, 10.1200/jco.2011.29.15_suppl.6522 Toma, 2016, Lenalidomide with or without erythropoietin in transfusion-dependent erythropoiesis-stimulating agent-refractory lower risk MDS without 5q deletion, Leukemia, 30, 897, 10.1038/leu.2015.296 Sekeres, 2008, Relationship of treatment-related cytopenias and response to lenalidomide in patients with lower-risk myelodysplastic syndromes, J Clin Oncol, 26, 5943, 10.1200/JCO.2007.15.5770 Lefkopoulou, 1993, Global tests for multiple binary outcomes, Biometrics, 49, 975, 10.2307/2532240 Liang, 1986, Longitudinal data analysis using generalized linear models, Biometrika, 73, 13, 10.1093/biomet/73.1.13 Kerman, 2011, Neutral noninformative and informative conjugate beta and gamma prior distributions, Electron J Stat, 5, 1450, 10.1214/11-EJS648