Kategorie: Maligní lymfomy a leukémie
Číslo abstraktu: P243
Autoři: MD Reinhard Stauder; Tim Bagguley; Alexandra Smith; Anders Holm, Ph.D.; MD Pierre Fenaux, PhD; Dr. Argyris Symeonidis, Ph.D.; Doc.MUDr. Jaroslav Čermák, CSc.; MD Guillermo F Sanz, PhD; MD Eva Hellström-Lindberg; M.D. Moshe Mittelman; MD Luca Malcovati; MD Gerwin A Huls, PhD; MD Krzysztof Madry, PhD; MD Ulrich Germing; MD Aurelia Tatic; MD Mette Skov-Holm, PhD; M.D. Alexandar Savic, Ph.D.; Jackie Droste; MD Agnès Guerci-Bresler, Ph.D.; Dr. Borhane Slama ; Dr. Elisa Luno; Dr. Dominic Culligan; MD Louise de Swart; W. Thomas Johnston; MD David Bowen, Ph.D.; MD Theo de Witte, PhD
A prospective, multicenter European Registry (EUMDS) for newly diagnosed IPSS low and intermediate-1 Myelodysplastic Syndromes (MDS) was initiated by the European Leukemianet (ELN) to assess demographic data, disease-management and clinical course. Health-related quality of life (HRQoL) has become an important patient reported outcome (PRO) to address patients` needs and to tailor individualized therapy planning.
To analyze the impact of MDS on HRQoL as compared to a reference population.
The EQ-5D (European quality group 5 dimensions) descriptive system was introduced in EUMDS at initial diagnosis and at follow-up visits every six months. EQ-5D data from MDS-patients were compared with population norms published by the Euroquol Group (www.euroqol.org).
So far, 1814 EUMDS patients from 17
European countries diagnosed between December 2007 to December 2014
were included in the EUMDS. 1490 (82.1%) patients with a median age
of 74.2 years (range 18.7 – 95.3) and 61.9% male, completed an
EQ-5D questionnaire at the time of inclusion to the registry.
Moderate or severe restrictions in HRQoL were observed in a
significant proportion of MDS patients in the different dimensions
of EQ-5D: mobility in 41%, self-care in 13%, usual activities in
36%, pain/discomfort in 49%, and anxiety/depression in 40%,
respectively. Mean visual analog scale (VAS) in EUMDS patients was
69.6 ± 20.3 (mean, standard deviation).
Population norms were available for nine European countries: age and sex-matched analysis reveal a significantly (p<0.05) higher proportion of restrictions in MDS in the dimensions anxiety/depression in eight, in usual activities in six, and in mobility and in self-care in four out of nine countries. Remarkably, problems in the dimension pain/discomfort were significantly more often observed in the reference population than in MDS in two countries; in one country a trend towards significance was observed (p=0.07). It was possible to compute an index score for seven countries, which translates the five dimensions of EQ-5D into a single value, ranging from a score of 1 indicating no problems to a score of 0 indicating death. Compared to age- and sex-matched simulated populations using the population norms, EUMDS patients from France (n=340; mean [sd]: 0.69 [0.29]; p<0.001), Germany (26; 0.82 [0.28]; p<0.05), the Netherlands (48; 0.79 [0.20]; p<0.001) and Spain (120; 0.75 [0.32]; p<0.001) were characterized by significantly lower EQ-5D index scores than the corresponding reference populations. Visual analogue scores (VAS) in MDS ranged from 62.1 [20.5) (mean [sd]) in France to 73.4 [16.8] in Denmark. Four out of nine countries revealed significantly (p<0.05) lower VAS-values in MDS as compared to age- and sex-matched simulated populations based on the reference values. Significant differences were observed in France: n=340; VAS 62.08 [20.52]; p=0.02; The Netherlands: 48; 71.19 [16.61]; p=0.04; Sweden: 100; 67.45 [20.91]; p<0.001 and the United Kingdom: 252; 71.31 [20.14]; p=0.01.
This study demonstrates for the first time profound restrictions in self-reported health in VAS as well as in all dimensions of the EQ-5D, with the exception of pain/discomfort, in MDS-patients at diagnosis as compared with reference populations. Thus, the relevance of HRQoL in treatment algorithms and as an endpoint in clinical studies and registries is supported. This analysis will form the basis for the design of MDS-specific assessment scores.
Keyword(s): Elderly, MDS, Quality of life
Datum přednesení příspěvku: 12. 6. 2015