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COMPARISON OF 1690 MDS PATIENTS FROM THE EUROPEAN LEUKEMIANET REGISTRY AND REFERENCE POPULATIONS ? EVIDENCE FOR A SIGNIFICANT IMPAIRMENT IN QOL IN MDS AND DEFINITION OF PREDICTORS OF DIMINISHED QOL
Author(s): ,
Reinhard Stauder
Affiliations:
Department of Internal Medicine V (Haematology and Oncology),Medical University Innsbruck,Innsbruck,Austria
,
Ge Yu
Affiliations:
Epidemiology and Cancer Statistics Group,Department of Health Sciences, University of York,York,United Kingdom
,
Tim Bagguley
Affiliations:
Epidemiology and Cancer Statistics Group,Department of Health Sciences, University of York,York,United Kingdom
,
Pierre Fenaux
Affiliations:
Service d'Hématologie,Hôpital Saint-Louis, Assistance Publique des Hôpitaux de Paris (AP-HP) and Université Paris 7,Paris,France
,
Argiris Symeonidis
Affiliations:
Dep. of Medicine,Div. Hematology, University of Patras Medical School,Patras,Greece
,
Guillermo Sanz
Affiliations:
Dep. of Haematology,Hospital Universitario y Politécnico La Fe,Valencia,Spain
,
Jaroslav Cermak
Affiliations:
Dep. of Clinical Hematology,Inst. of Hematology & Blood Transfusion,Praha,Czech Republic
,
Moshe Mittelman
Affiliations:
Dep. of Medicine A,Tel Aviv Sourasky (Ichilov) Medical Center,Tel Aviv,Israel
,
Eva Hellström-Lindberg
Affiliations:
Dep. of Medicine,Div. Hematology, Karolinska Institutet,Stockholm,Sweden
,
Saskia Langemeijer
Affiliations:
Dep. of Hematology,Radboud University Medical Center,Nijmegen,Netherlands
,
Mette Skov Holm
Affiliations:
Dep. of Hematology,Aarhus University Hospital,Aarhus,Denmark
,
Krzysztof Mądry
Affiliations:
Dep. of Hematology, Oncology and Internal Medicine,Warszawa Medical University,Warszawa,Poland
,
Luca Malcovati
Affiliations:
Dep. of Hematology Oncology,Fondazione IRCCS Policlinico San Matteo, University of Pavia,Pavia,Italy
,
Aurelia Tatic
Affiliations:
Center of Hematology and Bone Marrow Transplantation,Fundeni Clinical Institute,Bucharest,Romania
,
Ulrich Germing
Affiliations:
Dep. of Hematology, Oncology and Clinical Immunology,Universitätsklinik Düsseldorf,Düsseldorf,Germany
,
Aleksandar Savic
Affiliations:
Clinic of Hematology - Clinical Center of Vojvodina,University of Novi Sad,Novi Sad,Serbia
,
Corine van Marrewijk
Affiliations:
Dep. of Hematology,Radboud University Medical Center,Nijmegen,Netherlands
,
Agnès Guerci-Bresler
Affiliations:
Service d'Hématologie,Centre Hospitalier Universitaire Brabois Vandoeuvre, Nancy,Nancy,France
,
Elisa Luño
Affiliations:
Servicio d'Hematología,Servicio de Salud del Principado de Asturias Oviedo,Oviedo,Spain
,
Jackie Droste
Affiliations:
Dep. of Hematology,Radboud University Medical Center,Nijmegen,Netherlands
,
Karin Koinig
Affiliations:
Dep. of Internal Medicine V (Haematology and Oncology),Innsbruck Medical University,Innsbruck,Austria
,
Alex Smith
Affiliations:
Epidemiology and Cancer Statistics Group,Department of Health Sciences, University of York,York,United Kingdom
,
David Bowen
Affiliations:
St. James's Institute of Oncology,Leeds Teaching Hospitals,Leeds,United Kingdom
Theo de Witte
Affiliations:
Dep. of Tumor Immunology - Nijmegen Center for Molecular Life Sciences,Radboud University Medical Center,Nijmegen,Netherlands
(Abstract release date: 05/19/16) EHA Library. Stauder R. 06/10/16; 135165; S132
Dr. Reinhard Stauder
Dr. Reinhard Stauder
Contributions
Abstract
Abstract: S132

Type: Oral Presentation

Presentation during EHA21: On Friday, June 10, 2016 from 12:30 - 12:45

Location: Hall C14

Background
Health-related quality of life (HRQoL) has been introduced by authorities, stakeholders and clinicians as a relevant patient reported outcome. Description of HRQoL-profile in MDS-patients is essential for individualized treatment algorithms.

Aims
To analyze the impact of MDS on HRQoL at initial diagnosis as compared to sex- and age-matched reference populations and to define predictors of impaired HRQoL.

Methods
A prospective European Registry (EUMDS) for newly diagnosed IPSS low-/int-1 MDS was initiated by the European Leukemianet.  The EQ-5D descriptive system was introduced in EUMDS at initial diagnosis. EQ-5D data from MDS-patients were compared with sex- and age-matched reference populations published by the Euroquol Group.

Results
1985 EUMDS patients from 140 hematology centers in 15 European countries diagnosed between December 2007 to February 2016 were included. 1690 (85.1%) patients (median age 74; range 18 – 95 yrs) and 61.5% male, completed both EQ-5D descriptive system and EQ VAS at the time of inclusion. Demographic characteristics of patients who completed EQ-5D questionnaire did not differ substantially from the whole cohort. Overall, the HRQoL-data in the sample analyzed were likely missing at random. A significant proportion of MDS-patients were characterized by moderate/severe restrictions in the dimensions mobility in 41%, self-care 13.3%, usual activities 36.1%, pain/discomfort 49.5%, and anxiety/depression 37.9%, respectively. Overall, Wilcoxon signed ranks tests showed that in MDS a significantly higher proportion of patients reported problems in mobility (41.0 vs 33.5%), usual activities (36.1 vs 26.0%) and anxiety/depression (37.9 vs 14.9%) than in European norms (p<0.001). Similarly, both EQ-5D index and VAS were more unfavorable in MDS as compared to references (0.74 vs 0.76; p<0.05) (69.6 vs 71.8; p<0.05) (paired t-tests). Most impairments in HRQoL were significantly correlated with advanced age, female sex, a higher comorbidity burden (defined by HCT-CI or MDS-CI), low Hb-level (<10 vs ≥10 g/dl) and red blood cell transfusion need (0 vs ≥1))(p<0.001). In contrast the impact of WHO-diagnosis and IPSS-R on HRQoL was only marginal.Comparisons with European reference norms revealed pronounced impairments in MDS-patients in usual activities and anxiety/depression in all age groups (<60 vs 60-75 vs 75+ yrs) (p<0.001 for each subgroup) and in both sexes (p<0.001). The impact of MDS on mobility was most prominent in male (p<0.001) and elderly persons (60-75 (p<0.01) vs 75+ yrs (p<0.001)). VAS was more often diminished in women (p<0.05) and at advanced age (75+ yrs (p<0.001)), as compared to reference cohorts. A hierarchical multilevel analysis was preformed to assess whether there was a significant difference in HRQoL between groups with different demographic and clinical parameters. Based on univariate analyses advanced age, female gender, pronounced comorbidities, low Hb and transfusion need were major determinants, both of EQ-5D index and VAS (p<.001). In multivariate modeling there was a significant loss in HRQoL for elderly (-0.082 for EQ-5D index and -7.33 for VAS for those 75+ yrs), for advanced comorbidities (-0.059;  -6.21 for MDS-CI int/high), low Hb-levels (-0.053;  -5.56), transfusion need (-0.045; -4.02) and female sex (-0.077; -3.64).  

Conclusion
This study demonstrates profound restrictions in distinct dimensions of the EQ-5D in MDS-patients at diagnosis as compared with age- and sex-matched reference populations and defines major predictors of HRQoL. This analysis forms the basis to address specific needs of MDS-patients and provides data for benchmark analyses.

Session topic: Myelodysplastic syndromes - Clinical

Keyword(s): Elderly, MDS/AML, Quality of life
Abstract: S132

Type: Oral Presentation

Presentation during EHA21: On Friday, June 10, 2016 from 12:30 - 12:45

Location: Hall C14

Background
Health-related quality of life (HRQoL) has been introduced by authorities, stakeholders and clinicians as a relevant patient reported outcome. Description of HRQoL-profile in MDS-patients is essential for individualized treatment algorithms.

Aims
To analyze the impact of MDS on HRQoL at initial diagnosis as compared to sex- and age-matched reference populations and to define predictors of impaired HRQoL.

Methods
A prospective European Registry (EUMDS) for newly diagnosed IPSS low-/int-1 MDS was initiated by the European Leukemianet.  The EQ-5D descriptive system was introduced in EUMDS at initial diagnosis. EQ-5D data from MDS-patients were compared with sex- and age-matched reference populations published by the Euroquol Group.

Results
1985 EUMDS patients from 140 hematology centers in 15 European countries diagnosed between December 2007 to February 2016 were included. 1690 (85.1%) patients (median age 74; range 18 – 95 yrs) and 61.5% male, completed both EQ-5D descriptive system and EQ VAS at the time of inclusion. Demographic characteristics of patients who completed EQ-5D questionnaire did not differ substantially from the whole cohort. Overall, the HRQoL-data in the sample analyzed were likely missing at random. A significant proportion of MDS-patients were characterized by moderate/severe restrictions in the dimensions mobility in 41%, self-care 13.3%, usual activities 36.1%, pain/discomfort 49.5%, and anxiety/depression 37.9%, respectively. Overall, Wilcoxon signed ranks tests showed that in MDS a significantly higher proportion of patients reported problems in mobility (41.0 vs 33.5%), usual activities (36.1 vs 26.0%) and anxiety/depression (37.9 vs 14.9%) than in European norms (p<0.001). Similarly, both EQ-5D index and VAS were more unfavorable in MDS as compared to references (0.74 vs 0.76; p<0.05) (69.6 vs 71.8; p<0.05) (paired t-tests). Most impairments in HRQoL were significantly correlated with advanced age, female sex, a higher comorbidity burden (defined by HCT-CI or MDS-CI), low Hb-level (<10 vs ≥10 g/dl) and red blood cell transfusion need (0 vs ≥1))(p<0.001). In contrast the impact of WHO-diagnosis and IPSS-R on HRQoL was only marginal.Comparisons with European reference norms revealed pronounced impairments in MDS-patients in usual activities and anxiety/depression in all age groups (<60 vs 60-75 vs 75+ yrs) (p<0.001 for each subgroup) and in both sexes (p<0.001). The impact of MDS on mobility was most prominent in male (p<0.001) and elderly persons (60-75 (p<0.01) vs 75+ yrs (p<0.001)). VAS was more often diminished in women (p<0.05) and at advanced age (75+ yrs (p<0.001)), as compared to reference cohorts. A hierarchical multilevel analysis was preformed to assess whether there was a significant difference in HRQoL between groups with different demographic and clinical parameters. Based on univariate analyses advanced age, female gender, pronounced comorbidities, low Hb and transfusion need were major determinants, both of EQ-5D index and VAS (p<.001). In multivariate modeling there was a significant loss in HRQoL for elderly (-0.082 for EQ-5D index and -7.33 for VAS for those 75+ yrs), for advanced comorbidities (-0.059;  -6.21 for MDS-CI int/high), low Hb-levels (-0.053;  -5.56), transfusion need (-0.045; -4.02) and female sex (-0.077; -3.64).  

Conclusion
This study demonstrates profound restrictions in distinct dimensions of the EQ-5D in MDS-patients at diagnosis as compared with age- and sex-matched reference populations and defines major predictors of HRQoL. This analysis forms the basis to address specific needs of MDS-patients and provides data for benchmark analyses.

Session topic: Myelodysplastic syndromes - Clinical

Keyword(s): Elderly, MDS/AML, Quality of life

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