THE EFFECT OF LENALIDOMIDE ON HEALTH-RELATED QUALITY OF LIFE IN PATIENTS WITH MYELODYSPLASTIC SYNDROMES: RESULTS FROM THE MDS-005 TRIAL
EHA Library. Santini V. 06/12/15; 100494; P242
Disclosure(s): University of FlorenceDipartimento di Medicina Sperimentale e Clinica
Prof. Valeria Santini
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Abstract
Abstract: P242
Type: Poster Presentation
Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45
Location: Poster area (Hall C)
Background
Health-related quality of life (HRQoL) is compromised among patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS). In the phase 3 MDS-005 study, significantly more lenalidomide-treated patients with MDS achieved RBC transfusion independence (TI) versus placebo (26.9% vs 2.5%; P < 0.001; Santini V, et al. Blood 2014;124:abstract 409); assessment of HRQoL was a pre-specified secondary endpoint.
Aims
The current analysis evaluated changes in HRQoL between treatment arms in the MDS-005 study.
Methods
In MDS-005, transfusion-dependent patients with International Prognostic Scoring System-defined Low or Intermediate-1-risk MDS without del(5q), unresponsive or refractory to erythropoiesis-stimulating agents, were randomized to lenalidomide (n = 160) or placebo (n = 79). Patients with RBC-TI ≥ 56 days or erythroid response by Day 168 (24 weeks) continued double-blind treatment until erythroid relapse, disease progression, unacceptable toxicity, or consent withdrawal. HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, Week 12, Week 24, every 12 weeks thereafter, and at discontinuation. Analyses were performed among patients who completed a baseline HRQoL assessment and had ≥ 1 post-baseline assessment (lenalidomide, n = 122; placebo, n = 56). Changes from baseline were analyzed; 5 HRQoL domains were pre-selected as clinically relevant: Fatigue, Dyspnea, Physical Functioning, Emotional Functioning, and Global Quality of Life. Between-group comparisons were limited to weeks 12 and 24 due to low patient numbers after 24 weeks. A post hoc analysis assessed the impact of RBC-TI on pre-selected HRQoL domains. Clinically meaningful improvement in HRQoL was defined as a score difference of at least 10 points versus baseline.
Results
Questionnaire compliance rates were high (> 72% in almost all visits) and not significantly different across all assessment visits (P > 0.05). At Week 12, mean changes in HRQoL scores from baseline were similar between treatment arms across pre-selected domains. At Week 24, lenalidomide was associated with benefit versus placebo in all pre-selected domains; after adjusting for baseline scores, benefit was only significant for Emotional Functioning (P = 0.047). For lenalidomide patients with RBC-TI and/or erythroid response at Week 24 who continued treatment, an improving trend in all pre-selected domains was observed. In a post hoc analysis, RBC-TI was associated with significant improvement (P < 0.01) across all pre-selected domains, with benefit also exceeding the pre-specified threshold for clinically meaningful improvement in all 5 domains.
Summary
At Week 24, treatment with lenalidomide was associated with benefit compared with placebo across all 5 pre-selected HRQoL domains relevant to MDS; however, after adjusting for baseline scores, benefit was only significant for Emotional Functioning. Further improvement versus baseline was observed after Week 24 for patients continuing treatment with lenalidomide. RBC-TI was associated with statistically significant (P < 0.01) and clinically meaningful improvement in all 5 pre-selected domains. These data may be important given the superior effect of lenalidomide over placebo in achievement of RBC-TI and highlight the beneficial effects of lenalidomide on HRQoL in this patient population.
Keyword(s): MDS, Quality of life
Session topic: Myelodysplastic syndromes -Clinical 1
Type: Poster Presentation
Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45
Location: Poster area (Hall C)
Background
Health-related quality of life (HRQoL) is compromised among patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS). In the phase 3 MDS-005 study, significantly more lenalidomide-treated patients with MDS achieved RBC transfusion independence (TI) versus placebo (26.9% vs 2.5%; P < 0.001; Santini V, et al. Blood 2014;124:abstract 409); assessment of HRQoL was a pre-specified secondary endpoint.
Aims
The current analysis evaluated changes in HRQoL between treatment arms in the MDS-005 study.
Methods
In MDS-005, transfusion-dependent patients with International Prognostic Scoring System-defined Low or Intermediate-1-risk MDS without del(5q), unresponsive or refractory to erythropoiesis-stimulating agents, were randomized to lenalidomide (n = 160) or placebo (n = 79). Patients with RBC-TI ≥ 56 days or erythroid response by Day 168 (24 weeks) continued double-blind treatment until erythroid relapse, disease progression, unacceptable toxicity, or consent withdrawal. HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, Week 12, Week 24, every 12 weeks thereafter, and at discontinuation. Analyses were performed among patients who completed a baseline HRQoL assessment and had ≥ 1 post-baseline assessment (lenalidomide, n = 122; placebo, n = 56). Changes from baseline were analyzed; 5 HRQoL domains were pre-selected as clinically relevant: Fatigue, Dyspnea, Physical Functioning, Emotional Functioning, and Global Quality of Life. Between-group comparisons were limited to weeks 12 and 24 due to low patient numbers after 24 weeks. A post hoc analysis assessed the impact of RBC-TI on pre-selected HRQoL domains. Clinically meaningful improvement in HRQoL was defined as a score difference of at least 10 points versus baseline.
Results
Questionnaire compliance rates were high (> 72% in almost all visits) and not significantly different across all assessment visits (P > 0.05). At Week 12, mean changes in HRQoL scores from baseline were similar between treatment arms across pre-selected domains. At Week 24, lenalidomide was associated with benefit versus placebo in all pre-selected domains; after adjusting for baseline scores, benefit was only significant for Emotional Functioning (P = 0.047). For lenalidomide patients with RBC-TI and/or erythroid response at Week 24 who continued treatment, an improving trend in all pre-selected domains was observed. In a post hoc analysis, RBC-TI was associated with significant improvement (P < 0.01) across all pre-selected domains, with benefit also exceeding the pre-specified threshold for clinically meaningful improvement in all 5 domains.
Summary
At Week 24, treatment with lenalidomide was associated with benefit compared with placebo across all 5 pre-selected HRQoL domains relevant to MDS; however, after adjusting for baseline scores, benefit was only significant for Emotional Functioning. Further improvement versus baseline was observed after Week 24 for patients continuing treatment with lenalidomide. RBC-TI was associated with statistically significant (P < 0.01) and clinically meaningful improvement in all 5 pre-selected domains. These data may be important given the superior effect of lenalidomide over placebo in achievement of RBC-TI and highlight the beneficial effects of lenalidomide on HRQoL in this patient population.
Keyword(s): MDS, Quality of life
Session topic: Myelodysplastic syndromes -Clinical 1
Abstract: P242
Type: Poster Presentation
Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45
Location: Poster area (Hall C)
Background
Health-related quality of life (HRQoL) is compromised among patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS). In the phase 3 MDS-005 study, significantly more lenalidomide-treated patients with MDS achieved RBC transfusion independence (TI) versus placebo (26.9% vs 2.5%; P < 0.001; Santini V, et al. Blood 2014;124:abstract 409); assessment of HRQoL was a pre-specified secondary endpoint.
Aims
The current analysis evaluated changes in HRQoL between treatment arms in the MDS-005 study.
Methods
In MDS-005, transfusion-dependent patients with International Prognostic Scoring System-defined Low or Intermediate-1-risk MDS without del(5q), unresponsive or refractory to erythropoiesis-stimulating agents, were randomized to lenalidomide (n = 160) or placebo (n = 79). Patients with RBC-TI ≥ 56 days or erythroid response by Day 168 (24 weeks) continued double-blind treatment until erythroid relapse, disease progression, unacceptable toxicity, or consent withdrawal. HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, Week 12, Week 24, every 12 weeks thereafter, and at discontinuation. Analyses were performed among patients who completed a baseline HRQoL assessment and had ≥ 1 post-baseline assessment (lenalidomide, n = 122; placebo, n = 56). Changes from baseline were analyzed; 5 HRQoL domains were pre-selected as clinically relevant: Fatigue, Dyspnea, Physical Functioning, Emotional Functioning, and Global Quality of Life. Between-group comparisons were limited to weeks 12 and 24 due to low patient numbers after 24 weeks. A post hoc analysis assessed the impact of RBC-TI on pre-selected HRQoL domains. Clinically meaningful improvement in HRQoL was defined as a score difference of at least 10 points versus baseline.
Results
Questionnaire compliance rates were high (> 72% in almost all visits) and not significantly different across all assessment visits (P > 0.05). At Week 12, mean changes in HRQoL scores from baseline were similar between treatment arms across pre-selected domains. At Week 24, lenalidomide was associated with benefit versus placebo in all pre-selected domains; after adjusting for baseline scores, benefit was only significant for Emotional Functioning (P = 0.047). For lenalidomide patients with RBC-TI and/or erythroid response at Week 24 who continued treatment, an improving trend in all pre-selected domains was observed. In a post hoc analysis, RBC-TI was associated with significant improvement (P < 0.01) across all pre-selected domains, with benefit also exceeding the pre-specified threshold for clinically meaningful improvement in all 5 domains.
Summary
At Week 24, treatment with lenalidomide was associated with benefit compared with placebo across all 5 pre-selected HRQoL domains relevant to MDS; however, after adjusting for baseline scores, benefit was only significant for Emotional Functioning. Further improvement versus baseline was observed after Week 24 for patients continuing treatment with lenalidomide. RBC-TI was associated with statistically significant (P < 0.01) and clinically meaningful improvement in all 5 pre-selected domains. These data may be important given the superior effect of lenalidomide over placebo in achievement of RBC-TI and highlight the beneficial effects of lenalidomide on HRQoL in this patient population.
Keyword(s): MDS, Quality of life
Session topic: Myelodysplastic syndromes -Clinical 1
Type: Poster Presentation
Presentation during EHA20: From 12.06.2015 17:15 to 12.06.2015 18:45
Location: Poster area (Hall C)
Background
Health-related quality of life (HRQoL) is compromised among patients with transfusion-dependent anemia due to myelodysplastic syndromes (MDS). In the phase 3 MDS-005 study, significantly more lenalidomide-treated patients with MDS achieved RBC transfusion independence (TI) versus placebo (26.9% vs 2.5%; P < 0.001; Santini V, et al. Blood 2014;124:abstract 409); assessment of HRQoL was a pre-specified secondary endpoint.
Aims
The current analysis evaluated changes in HRQoL between treatment arms in the MDS-005 study.
Methods
In MDS-005, transfusion-dependent patients with International Prognostic Scoring System-defined Low or Intermediate-1-risk MDS without del(5q), unresponsive or refractory to erythropoiesis-stimulating agents, were randomized to lenalidomide (n = 160) or placebo (n = 79). Patients with RBC-TI ≥ 56 days or erythroid response by Day 168 (24 weeks) continued double-blind treatment until erythroid relapse, disease progression, unacceptable toxicity, or consent withdrawal. HRQoL was assessed using the European Organization for Research and Treatment of Cancer QLQ-C30 questionnaire at baseline, Week 12, Week 24, every 12 weeks thereafter, and at discontinuation. Analyses were performed among patients who completed a baseline HRQoL assessment and had ≥ 1 post-baseline assessment (lenalidomide, n = 122; placebo, n = 56). Changes from baseline were analyzed; 5 HRQoL domains were pre-selected as clinically relevant: Fatigue, Dyspnea, Physical Functioning, Emotional Functioning, and Global Quality of Life. Between-group comparisons were limited to weeks 12 and 24 due to low patient numbers after 24 weeks. A post hoc analysis assessed the impact of RBC-TI on pre-selected HRQoL domains. Clinically meaningful improvement in HRQoL was defined as a score difference of at least 10 points versus baseline.
Results
Questionnaire compliance rates were high (> 72% in almost all visits) and not significantly different across all assessment visits (P > 0.05). At Week 12, mean changes in HRQoL scores from baseline were similar between treatment arms across pre-selected domains. At Week 24, lenalidomide was associated with benefit versus placebo in all pre-selected domains; after adjusting for baseline scores, benefit was only significant for Emotional Functioning (P = 0.047). For lenalidomide patients with RBC-TI and/or erythroid response at Week 24 who continued treatment, an improving trend in all pre-selected domains was observed. In a post hoc analysis, RBC-TI was associated with significant improvement (P < 0.01) across all pre-selected domains, with benefit also exceeding the pre-specified threshold for clinically meaningful improvement in all 5 domains.
Summary
At Week 24, treatment with lenalidomide was associated with benefit compared with placebo across all 5 pre-selected HRQoL domains relevant to MDS; however, after adjusting for baseline scores, benefit was only significant for Emotional Functioning. Further improvement versus baseline was observed after Week 24 for patients continuing treatment with lenalidomide. RBC-TI was associated with statistically significant (P < 0.01) and clinically meaningful improvement in all 5 pre-selected domains. These data may be important given the superior effect of lenalidomide over placebo in achievement of RBC-TI and highlight the beneficial effects of lenalidomide on HRQoL in this patient population.
Keyword(s): MDS, Quality of life
Session topic: Myelodysplastic syndromes -Clinical 1
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