The Effect of Lenalidomide on Health-Related Quality of Life in Patients With Lower- Risk Non-del(5q) Myelodysplastic Syndromes: Results From the MDS-005.

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The Effect of Lenalidomide on Health-Related Quality of Life in Patients With Lower- Risk Non-del(5q) Myelodysplastic Syndromes: Results From the MDS-005 Study Valeria Santini, Antonio Almeida, Aristoteles Giagounidis, Uwe Platzbecker, Rena Buckstein, C.L. Beach, Shien Guo, Arman Altincatal, Chengqing Wu, Pierre Fenaux Clinical Lymphoma, Myeloma and Leukemia Volume 18, Issue 2, Pages 136-144.e7 (February 2018) DOI: 10.1016/j.clml.2017.12.004 Copyright © 2018 Elsevier Inc. Terms and Conditions

Figure 1 Mean Change From Baseline in HRQoL Scores Without Adjusting for Baseline Scores for Preselected EORTC QLQ-C30 Scales: (A) Fatigue, (B) Dyspnea, (C) Global Quality of Life, (D) Physical Functioning, and (E) Emotional Functioning, According to Randomized Treatment Group. * Significant Difference (P < .05) Between Treatment Groups. †Data for Placebo Group at Week 48 Not Shown Because of Low Patient Number Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life; SE = standard error. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Figure 2 Mean Change From Baseline in HRQoL Scores After Adjusting for Baseline Scores for Preselected EORTC QLQ-C30 Scales According to Randomized Treatment Group Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Figure 3 Difference in Predicted Least-Squares Mean Changes for Preselected EORTC QLQ-C30 HRQoL Scales Between Lenalidomide Versus Placebo at Week 24. The Model Included the Following Covariates: Treatment Group, Time (in Weeks), Baseline Score, and a Treatment Group × Time Interaction Term, With Intercept and Time as Random Effects Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Figure 4 Proportion of Patients With Clinically Meaningful Improvement or Worsening in Scores for Preselected EORTC QLQ-C30 HRQoL Scales at Week 24. A Clinically Meaningful Change Was Defined as a Change of ≥ 10 Points From Baseline Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Figure 5 Relationship Between Achievement of RBC-TI ≥ 8 Weeks and Change in HRQoL. For Each EORTC QLQ-C30 Scale, the Effect of RBC-TI ≥ 8 Weeks Achievement on HRQoL Was Adjusted for Other Relevant Covariates, Including Baseline Score, Time (Visits), and Treatment Group Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life; RBC-TI = red blood cell transfusion independence. Reproduced with permission from Santini et al. 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 2016; 34:2988-96.19 Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Supplemental Figure 1 Assessment of HRQoL in the MDS-005 Study Abbreviations: HRQoL = health-related quality of life; LEN = lenalidomide; MDS = myelodysplastic syndromes; RBC-TI = red blood cell transfusion independence. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions

Supplemental Figure 2 Mean Change From Baseline in HRQoL Scores Without Adjusting for Baseline Scores for Preselected EORTC QLQ-C30 Scales (A: Fatigue, B: Dyspnea, C: Global Quality of Life, D: Physical Functioning, E: Emotional Functioning) in Lenalidomide Responders, Lenalidomide Nonresponders, and Placebo Patients. *P < .05 for the Comparison of Lenalidomide Responders Versus Lenalidomide Nonresponders; Lenalidomide Nonresponders Versus Placebo; Lenalidomide Responders Versus Placebo Abbreviations: EORTC QLQ-C30 = European Organisation for Research and Treatment of Cancer Quality of Life Questionnaire–Core 30; HRQoL = health-related quality of life; SE = standard error. Clinical Lymphoma, Myeloma and Leukemia 2018 18, 136-144.e7DOI: (10.1016/j.clml.2017.12.004) Copyright © 2018 Elsevier Inc. Terms and Conditions