A LONGITUDINAL OBSERVATIONAL STUDY ON THE HEALTH-RELATED QUALITY OF LIFE IN IPSS LOW-RISK MDS - IMPACT OF TIME COURSE AND TRANSFUSION NEED

Konference: 2013 18th Congress of the European Hematology Association - účast ČR

Kategorie: Myelodysplastický syndrom

Téma: Myelodysplastic syndromes - Clinical

Číslo abstraktu: P187

Autoři: MD Reinhard Stauder; Dr. Tom Johnston; Alexandra Smith; Jackie Droste; MD Pierre Fenaux, PhD; Dr. Argyris Symeonidis, Ph.D.; MD Eva Hellström-Lindberg; MD Guillermo F Sanz, PhD; Doc.MUDr. Jaroslav Čermák, CSc.; Otilia Georgescu; MD Ulrich Germing; Marius MacKenzie; MD Odile Beyne Rauzy, PhD; MD Luca Malcovati; MD Agnès Guerci-Bresler, Ph.D.; MD Laurence Sanhes; Dr. Borhane Slama ; MD David Bowen, Ph.D.; Dr. Elisa Luno; MD Theo de Witte, PhD

Background:

The EuropeanLeukemiaNet has initiated a prospective, multicenter European Registry (EUMDS) for newly diagnosed IPSS low and intermediate- 1 MDS. In MDS health-related quality of life (HR-QoL) represents an important parameter in patient reported outcome as well as in individualized therapy planning. Thus, the EQ-5D (European quality group 5 dimensions) descriptive system was used in this registry to evaluate HR-QoL at initial diagnosis and at follow-up visits every six months.

Aims:

To describe the time course as well as the impact of blood transfusions and hemoglobin (Hb)-levels on HR-QoL in this cohort of MDS-patients.

Methods:

Results from EQ-5D Visual analog scale (VAS) were analyzed. A multiple linear regression model incorporating random effects (allowing both the baseline score and the rate of change over time to vary between patients) was performed. Adjusting factors included in the model are age at diagnosis, sex, WHO-subgroup, country and haemoglobin measured at each follow-up visit. The effect of transfusions was assessed in two ways: First, all patients that received any transfusion during follow-up were compared to all patients who received no transfusions. Second, the transfusion intensity (defined as the average number of units received per month) recorded for the previous six months at each visit was included. Interactions between the trend in VAS over time and the other factors were analysed.

Results: Median age among the first 1000 patients in the registry is 74.2 years (range 18.7-95.3) with 60.3% male patients and a median follow-up of two years. 936 patients with a definable follow-up period were eligible for this analysis. The mean VAS at the first visit was 69 (}20 SD). In both regression models, in the absence of any interacting effects, there was a moderate average decrease in VAS of approximately 0.2 units per month (95% CI: -0.28, -0.15) identified. Analyses of the random effects indicated that the baseline VAS varied between patients as did the rate of decrease over time. Older patients had a lower average VAS score (0.46 lower per life year; [-0.56; - 0.35] 95% CI; P<0.001). There was no evidence of difference in VAS between men and women (-2.23 lower among women; [-4.51; 0.04] 95% CI; P=0.055). VAS varied between the diagnostic groups and varied between countries. VAS was varied by WHO-subtype with RAEB-2 displaying the lowest levels and 5q-syndrome the highest (P=0.045). Marked differences between different countries were also observed (P<0.0001) and there was some evidence that the rate of decrease in VAS over time varied by country. VAS was positively associated with Hb values over time: VAS increased by 1.6 for each 1 g/dL increase in Hb ([1.2; 2.01] 95% CI; P<0.001). These effects were consistent regardless of which of the regression models were examined. Transfused patients had, on average, lower VAS scores (3.06 units lower [-5.52; -0.59] 95% CI; P=0.015) than untransfused patients. In addition, there was evidence that the rate of change in VAS over time was different for transfused and untransfused patients: no significant change over time among untransfused patients (-0.09 units/months; 95%CI: -0.19, 0.01) but a decline of 0.32 units/month (95% CI: - 0.41, -0.23) in transfused patients. When transfusion intensity that varies over time is incorporated into the model, higher rates of transfusion are associated with lower VAS scores (-1.64 lower VAS for each additional unit transfused per month, 95% CI: -2.84, -0.44). There was no interaction detected between this effect and the change in VAS over time.

Summary / Conclusion:

HR-QoL in MDS is associated with diagnostic subgroups, Hb-values and transfusion need. Analyses of time course reveal a faster decrease in VAS over time in transfused as compared to untransfused patients. Moreover, high rates of transfusions are associated with lower HR-Qol VAS. Prevention of transfusion need might sustain and improve the QoL in MDS patients.

Abstrakta v časopise Haematologica 2013, Suppl1

Online Program

Datum přednesení příspěvku: 14. 6. 2013