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3. Topic: AS01-Diagnosis/AS01a-Cytomorphology: ARTIFICIAL INTELLIGENCE MAY HELP THE HEMATOPATHOLOGIST IN EVALUATION OF BONE MASS AND CELLULARITY IN BONE MARROW SPECIMENS OF PATIENTS WITH MDS

Author

Kolomansky, A., primary, Karlik, E. Cohen, additional, Malka, R., additional, Rahamim, M., additional, Kislev, S., additional, Ben-Ezra, J., additional, Shahar, S., additional, Globerson, A., additional, Neumann, D., additional, Mittelman, M., additional, and Oster, H., additional

Published
2023
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5. Topic: AS03-Health Economics & Outcome Research/AS03a-Cost of care: ARE WE READY TO PERFORM NGS FOR ALL MDS PATIENTS ?

Author

Santini, V., primary, Bejar, R., additional, Belli, C., additional, Buckstein, R., additional, Campelo, M., additional, Dezern, A., additional, Fontenay, M., additional, Griffiths, E., additional, Grille, S., additional, Haferlach, T., additional, Iastrebner, M., additional, Kosmider, O., additional, Magalhaes, S., additional, Mittelman, M., additional, Platzbecker, U., additional, Wei, A., additional, and Zeidan, A., additional

Published
2023
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10. Determinants of low health-related quality of life in patients with myelodysplastic syndromes: EUMDS registry study

Author

Stojkov, I., Conrads-Frank, A., Rochau, U., Arvandi, M., Koinig, K.A., Schomaker, M., Mittelman, M., Fenaux, P., Bowen, D., Sanz, G.F., Malcovati, L., Langemeijer, S.M.C., Germing, U., Madry, K., Guerci-Bresler, A., Culligan, D.J., Kotsianidis, I., Sanhes, L., Mills, J., Puntscher, S., Schmid, D., Marrewijk, C.J. van, Smith, A, Efficace, F., Witte, T.J. de, Stauder, R., and Siebert, U.

Subjects
Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], All institutes and research themes of the Radboud University Medical Center, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2]
Abstract

Item does not contain fulltext Patients with myelodysplastic syndromes (MDS) frequently experience a significant symptom burden, which reduces health-related quality of life (HRQoL). We aimed to identify determinants of low HRQoL in patients recently diagnosed with MDS, for guiding early intervention strategies. We evaluated longitudinal data in 2205 patients with MDS during their first year after diagnosis. Median values of EQ-5D 3-level (EQ-5D-3L) index (0.78) and visual analog scale (VAS) score (0.70) were used as thresholds for low HRQoL. In addition, the 5 dimensions of EQ-5D-3L were analyzed for impairments (any level vs "no problem" category). After multiple imputation of missing values, we used generalized estimating equations (GEE) to estimate odds ratios (OR) for univariable determinant screening (P < .15), and to subsequently derive multivariable models for low HRQoL with 95% confidence intervals (CI). Multivariable GEE analysis showed the following independent determinants (OR, 95% CI) for low EQ-5D index: increased age (60-75 years: 1.33, 1.01-1.75; >75: 1.84, 1.39-2.45), female sex (1.70, 1.43-2.03), high serum ferritin level (≥1000 vs ≤300 μg/L: 1.41, 1.06-1.87), comorbidity burden (per unit: 1.11, 1.02-1.20), and reduced Karnofsky performance status (KPS, per 10 units: 0.62, 0.58-0.67). For low VAS score, additional determinants were transfusion dependence (1.53, 1.03-2.29), low hemoglobin

Published
2022

11. Erythropoiesis‐stimulating agents significantly delay the onset of a regular transfusion need in nontransfused patients with lower‐risk myelodysplastic syndrome

Author

Garelius, H. K. G., Johnston, W. T., Smith, A. G., Park, S., de Swart, L., Fenaux, P., Symeonidis, A., Sanz, G., Čermák, J., Stauder, R., Malcovati, L., Mittelman, M., van de Loosdrecht, A. A., van Marrewijk, C. J., Bowen, D., Crouch, S., de Witte, T. J. M., and Hellström‐Lindberg, E.

Published
2017
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17. O08 - Topic: AS06-Prognosis/AS06a-Prognostic factors of outcome and risk assessment: LYMPHOPENIA IS HIGHLY PREVALENT IN MDS AND PROVIDES ADDITIONAL PROGNOSTIC INFORMATION FOR IPSS-R VERY-LOW AND LOW-RISK PATIENTS. AN ANALYSIS FROM THE EU-MDS REGISTRY

Author

Silzle, T., Taylor, A., De Witte, T., Malcovati, L., Fenaux, P., Bowen, D., Symeonidis, A., Mittelman, M., Stauder, R., Cermak, J., Sanz, G., Hellström-Lindberg, E., Langemeijer, S., Holm, M. Skov, Madry, K., Tatic, A., Almeida, A. Medina, Savic, A., Rogulj, I. Mandac, Germing, U., and Smith, A.

Published
2021
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18. Toxic iron species in lower-risk myelodysplastic syndrome patients : course of disease and effects on outcome

Author

Hoeks, Marlijn, Bagguley, Tim, van Marrewijk, Corine, Smith, Alex, Bowen, David, Culligan, Dominic, Kolade, Seye, Symeonidis, Argiris, Garelius, Hege, Spanoudakis, Michail, Langemeijer, Saskia, Roelofs, Rian, Wiegerinck, Erwin, Tatic, Aurelia, Killick, Sally, Panagiotidis, Panagiotis, Stanca, Oana, Hellström-Lindberg, Eva, Cermak, Jaroslav, van der Klauw, Melanie, Wouters, Hanneke, van Kraaij, Marian, Blijlevens, Nicole, Swinkels, Dorine W., de Witte, Theo, Stauder, R., Walder, A., Pfeilstöcker, M., Schoenmetzler-Makrai, A., Burgstaller, S., Thaler, J., Mandac Rogulj, I., Krejci, M., Voglova, J., Rohon, P., Jonasova, A., Cermak, J., Mikulenkova, D., Hochova, I., Jensen, P. D., Holm, M. S., Kjeldsen, L., Dufva, I. H., Vestergaard, H., Re, D., Slama, B., Fenaux, P., Choufi, B., Cheze, S., Klepping, D., Salles, B., de Renzis, B., Willems, L., De Prost, D., Gutnecht, J., Courby, S., Siguret, V., Tertian, G., Pascal, L., Chaury, M., Wattel, E., Guerci, A., Legros, L., Itzykson, R., Ades, L., Isnard, F., Sanhes, L., Benramdane, R., Stamatoullas, A., Amé, S., Beyne-Rauzy, O., Gyan, E., Platzbecker, U., Badrakan, C., Germing, U., Lübbert, M., Schlenk, R., Kotsianidis, I., Tsatalas, C., Pappa, V., Galanopoulos, A., Michali, E., Panagiotidis, P., Viniou, N., Katsigiannis, A., Roussou, P., Terpos, E., Kostourou, A., Kartasis, Z., Pouli, A., Palla, K., Briasoulis, V., Hatzimichael, E., Vassilopoulos, G., Symeonidis, A., Kourakli, A., Zikos, P., Anagnostopoulos, A., Kotsopoulou, M., Megalakaki, K., Protopapa, M., Vlachaki, E., Konstantinidou, P., Stemer, G., Nemetz, A., Gotwin, U., Cohen, O., Koren, M., Levy, E., Greenbaum, U., Gino-Moor, S., Price, M., Ofran, Y., Winder, A., Goldshmidt, N., Elias, S., Sabag, R., Hellman, I., Ellis, M., Braester, A., Rosenbaum, H., Berdichevsky, S., Itzhaki, G., Wolaj, O., Yeganeh, S., Katz, O., Filanovsky, K., Dali, N., Mittelman, M., Malcovati, L., Fianchi, L., vd Loosdrecht, A., Matthijssen, V., Herbers, A., Pruijt, H., Aboosy, N., de Vries, F., Velders, G., Jacobs, E., Langemeijer, S., MacKenzie, M., Lensen, C., Kuijper, P., Madry, K., Camara, M., Almeida, A., Vulkan, G., Stanca Ciocan, O., Tatic, A., Savic, A., Pedro, C., Xicoy, B., Leiva, P., Munoz, J., Betes, V., Benavente, C., Lozano, M., Martinez, M., Iniesta, P., Bernal, T., Diez Campelo, M., Tormo, D., Andreu Lapiedra, R., Sanz, G., Hesse Sundin, E., Garelius, H., Karlsson, C., Antunovic, P., Jönsson, A., Brandefors, L., Nilsson, L., Kozlowski, P., Hellstrom-Lindberg, E., Grövdal, M., Larsson, K., Wallvik, J., Lorenz, F., Ejerblad, E., Culligan, D., Craddock, C., Kolade, S., Cahalin, P., Killick, S., Ackroyd, S., Wong, C., Warren, A., Drummond, M., Hall, C., Rothwell, K., Green, S., Ali, S., Bowen, D., Karakantza, M., Dennis, M., Jones, G., Parker, J., Bowen, A., Radia, R., Das-Gupta, E., Vyas, P., Nga, E., Creagh, D., Ashcroft, J., Mills, J., Bond, L., Life Course Epidemiology (LCE), and VU University medical center

Subjects
Adult, Male, 0301 basic medicine, Cancer Research, medicine.medical_specialty, Iron Overload, Iron, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], Ferroportin, Lower risk, Gastroenterology, Article, Cancer development and immune defence Radboud Institute for Health Sciences [Radboudumc 2], 03 medical and health sciences, 0302 clinical medicine, Hepcidin, Internal medicine, Humans, Medicine, Blood Transfusion, Prospective Studies, Aged, Soluble transferrin receptor, biology, business.industry, Transferrin saturation, Hematology, Middle Aged, Erythroferrone, Prognosis, 3. Good health, Survival Rate, Ferritin, Renal disorders Radboud Institute for Molecular Life Sciences [Radboudumc 11], 030104 developmental biology, Oncology, Myelodysplastic Syndromes, 030220 oncology & carcinogenesis, biology.protein, Erythropoiesis, Female, business, Myelodysplastic syndrome, Follow-Up Studies, Rare cancers Radboud Institute for Health Sciences [Radboudumc 9]
Abstract

Red blood cell transfusions (RBCT) remain the cornerstone of supportive care in lower-risk myelodysplastic syndrome (LRMDS) [1]. Transfusion dependency in LRMDS patients is associated with inferior outcomes, mainly attributed to severe bone marrow failure [2]. However, iron toxicity, due to frequent RBCT or ineffective erythropoiesis, may be an additional negative prognostic factor [3,4,5,6]. Recently, much progress has been made in unraveling the iron metabolism. The peptide hormone hepcidin is the key regulator by inhibiting iron uptake through degradation of ferroportin, a cellular iron exporter [7]. Erythroferrone and GDF15, produced by erythroblasts, inhibit hepcidin production, which leads to increased uptake and cellular release of iron for the purpose of erythropoiesis [8]. The pathophysiology of iron metabolism in MDS is still not completely understood. Exceedingly high reactive oxygen species (ROS) levels are associated with iron toxicity, disease development, and progression in MDS patients [9,10,11,12]. Malondialdehyde (MDA), resulting from lipid peroxidation of polyunsaturated fatty acids, is a biomarker of oxidative stress [10, 12]. Currently, little is known about the prognostic impact of ROS in MDS patients. The aim of this study is twofold: (1) describe iron and oxidative stress parameters over time in LRMDS patients and (2) to assess their effect on overall and progression-free survival. The EUMDS registry prospectively collects observational data on newly diagnosed LRMDS patients from 148 centers in 16 countries in Europe and Israel as of January 2008. All patients provided informed consent. Clinical data were collected at baseline and at each six-monthly follow-up visit. Serum samples were collected prospectively at each visit from 256 patients included in six participating countries. Conventional iron parameters were measured with routine assays. We additionally analyzed hepcidin, growth differentiation factor 15 (GDF15), soluble transferrin receptor (sTfR), non-transferrin bound iron (NTBI), labile plasma iron (LPI), and MDA. Subjects were prospectively followed until death, loss to follow-up, or withdrawal of consent. All iron parameters were measured centrally at the department of Laboratory Medicine of the Radboudumc, Nijmegen, The Netherlands. Serum samples were collected just prior to transfusion in transfusion-dependent patients and stored at −80 °C. Details on the assays and reference ranges of hepcidin, GDF15, sTfR, NTBI, LPI, and MDA are provided in the supplement. The Spearman rank test was used to evaluate correlations between iron parameters. We stratified the results by transfusion dependency per visit and the presence of ring sideroblasts. When evaluating temporal changes in iron parameters, with linear quantile mixed models, we excluded patients from the timepoint they received iron chelation therapy. Overall survival (OS) was defined as the time from MDS diagnosis to death or, in case of progression-free survival, to date of progression or death; patients still alive at the end of follow-up were censored. Time-dependent Kaplan–Meier curves and cox proportional hazards models were used. In total, 256 consecutive patients, were included in this study. Over five six-monthly visits, 1040 samples were collected. Table 1 describes the patient characteristics. Most patients without ring sideroblasts were transfusion-independent at diagnosis (nonRS-TI; 55.9%), 18.8% with ring sideroblasts were transfusion-independent (RS-TI), 18.4% without ring sideroblasts were transfusion-dependent (nonRS-TD), and 7% with ring sideroblasts were transfusion-dependent patients (RS-TD). The median follow-up time was 6.6 years (95% CI 5.9–7.0). LPI was positively correlated with transferrin saturation (TSAT) (r = 0.15, p < 0.001, Fig. S1). LPI values increased exponentially at TSAT values above 80%. This effect was most pronounced in the transfusion-dependent groups, but also observed in the RS-TI group. MDA was weakly correlated with NTBI (r = 0.09, p = 0.069) and negatively correlated with hemoglobin level (r = −0.1, p = 0.033). GDF15 and hepcidin were negatively correlated in the RS-TI and nonRS-TD group and significantly negatively correlated in the RS-TD group (r = −0.34, p = 0.007, Fig. S2). Serum ferritin levels were elevated in all subgroups with a mean value of 858 µg/L at visit 5. The highest serum ferritin levels were observed in the RS-TD group (mean value at visit 5: 2092 µg/L, Table S1). Serum ferritin increased significantly per visit in the RS-TD group (beta 454.46 µg/L; 95% CI 334.65–574.27), but not in the other groups (Table S2). All subgroups, except for the nonRS-TI, had elevated TSAT levels. TSAT levels were most markedly increased in the RS-TD group with a mean TSAT of 88% at visit 5 (Table S1). In both transfusion-dependent groups the median increase per visit was significant (Table S2). LPI was elevated in the RS-TD group exclusively with a mean value of 0.59 µmol/L at visit 5 (Table S1). NTBI was elevated in all subgroups, with the highest values in the RS-TD group (Table S1). The increase in median NTBI level was significant in both transfusion-dependent groups (Table S2). Hepcidin levels were markedly elevated in the nonRS-TD group. Interestingly, hepcidin levels were lower in the RS-TD group, probably reflecting ineffective erythropoiesis, likewise supported by lower hepcidin/ferritin ratios in RS groups (Table S1). Median hepcidin levels increased over time in the transfusion-dependent subgroups only (Table S2). GDF15 levels, analyzed in the light of its potential role in hepcidin suppression, were increased in all subgroups (Table S1). The RS subgroups had higher GDF15 levels compared to the nonRS groups, reflecting increased erythropoiesis. Mean sTfR levels were within the reference range in all subgroups except for the RS-TI group, which showed elevated levels, reflecting...

Published
2021

20. Topic: AS06-Prognosis/AS06a-Prognostic factors of outcome and risk assessment

Author

Silzle, T., primary, Taylor, A., additional, De Witte, T., additional, Malcovati, L., additional, Fenaux, P., additional, Bowen, D., additional, Symeonidis, A., additional, Mittelman, M., additional, Stauder, R., additional, Cermak, J., additional, Sanz, G., additional, Hellström-Lindberg, E., additional, Langemeijer, S., additional, Holm, M. Skov, additional, Madry, K., additional, Tatic, A., additional, Almeida, A. Medina, additional, Savic, A., additional, Rogulj, I. Mandac, additional, Germing, U., additional, and Smith, A., additional

Published
2021
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24. Toxic iron species in lower-risk myelodysplastic syndrome patients: course of disease and effects on outcome

Author

Hoeks, M. Bagguley, T. van Marrewijk, C. Smith, A. Bowen, D. Culligan, D. Kolade, S. Symeonidis, A. Garelius, H. Spanoudakis, M. Langemeijer, S. Roelofs, R. Wiegerinck, E. Tatic, A. Killick, S. Panagiotidis, P. Stanca, O. Hellström-Lindberg, E. Cermak, J. van der Klauw, M. Wouters, H. van Kraaij, M. Blijlevens, N. Swinkels, D.W. de Witte, T. Stauder, R. Walder, A. Pfeilstöcker, M. Schoenmetzler-Makrai, A. Burgstaller, S. Thaler, J. Mandac Rogulj, I. Krejci, M. Voglova, J. Rohon, P. Jonasova, A. Cermak, J. Mikulenkova, D. Hochova, I. Jensen, P.D. Holm, M.S. Kjeldsen, L. Dufva, I.H. Vestergaard, H. Re, D. Slama, B. Fenaux, P. Choufi, B. Cheze, S. Klepping, D. Salles, B. de Renzis, B. Willems, L. De Prost, D. Gutnecht, J. Courby, S. Siguret, V. Tertian, G. Pascal, L. Chaury, M. Wattel, E. Guerci, A. Legros, L. Itzykson, R. Ades, L. Isnard, F. Sanhes, L. Benramdane, R. Stamatoullas, A. Amé, S. Beyne-Rauzy, O. Gyan, E. Platzbecker, U. Badrakan, C. Germing, U. Lübbert, M. Schlenk, R. Kotsianidis, I. Tsatalas, C. Pappa, V. Galanopoulos, A. Michali, E. Panagiotidis, P. Viniou, N. Katsigiannis, A. Roussou, P. Terpos, E. Kostourou, A. Kartasis, Z. Pouli, A. Palla, K. Briasoulis, V. Hatzimichael, E. Vassilopoulos, G. Symeonidis, A. Kourakli, A. Zikos, P. Anagnostopoulos, A. Kotsopoulou, M. Megalakaki, K. Protopapa, M. Vlachaki, E. Konstantinidou, P. Stemer, G. Nemetz, A. Gotwin, U. Cohen, O. Koren, M. Levy, E. Greenbaum, U. Gino-Moor, S. Price, M. Ofran, Y. Winder, A. Goldshmidt, N. Elias, S. Sabag, R. Hellman, I. Ellis, M. Braester, A. Rosenbaum, H. Berdichevsky, S. Itzhaki, G. Wolaj, O. Yeganeh, S. Katz, O. Filanovsky, K. Dali, N. Mittelman, M. Malcovati, L. Fianchi, L. vd Loosdrecht, A. Matthijssen, V. Herbers, A. Pruijt, H. Aboosy, N. de Vries, F. Velders, G. Jacobs, E. Langemeijer, S. MacKenzie, M. Lensen, C. Kuijper, P. Madry, K. Camara, M. Almeida, A. Vulkan, G. Stanca Ciocan, O. Tatic, A. Savic, A. Pedro, C. Xicoy, B. Leiva, P. Munoz, J. Betes, V. Benavente, C. Lozano, M. Martinez, M. Iniesta, P. Bernal, T. Diez Campelo, M. Tormo, D. Andreu Lapiedra, R. Sanz, G. Hesse Sundin, E. Garelius, H. Karlsson, C. Antunovic, P. Jönsson, A. Brandefors, L. Nilsson, L. Kozlowski, P. Hellstrom-Lindberg, E. Grövdal, M. Larsson, K. Wallvik, J. Lorenz, F. Ejerblad, E. Culligan, D. Craddock, C. Kolade, S. Cahalin, P. Killick, S. Ackroyd, S. Wong, C. Warren, A. Drummond, M. Hall, C. Rothwell, K. Green, S. Ali, S. Karakantza, M. Dennis, M. Jones, G. Parker, J. Bowen, A. Radia, R. Das-Gupta, E. Vyas, P. Nga, E. Creagh, D. Ashcroft, J. Mills, J. Bond, L. the EUMDS Registry Participants

Published
2021

25. Impact of red blood cell transfusion dose density on progression-free survival in lower-risk myelodysplastic syndromes patients

Author

de Swart L, Crouch S, Hoeks M, Smith A, Langemeijer S, Fenaux P, Symeonidis A, Cermák J, Hellström-Lindberg E, Stauder R, Sanz G, Mittelman M, Holm MS, Malcovati L, Madry K, Germing U, Tatic A, Savic A, Almeida AM, Gredelj-Šimec N, Guerci-Bresler A, Beyne-Rauzy O, Culligan D, Kotsianidis I, Itzykson R, van Marrewijk C, Blijlevens N, Bowen D, de Witte T, and EUMDS Registry Participants

Subjects
Myelodysplastic Syndromes, lower-risk, progression-free survival, red blood cell transfusions, transfusion dose density
Abstract

Progression-free survival of lower-risk myelodysplastic syndromes patients treated with red blood cell transfusions is usually reduced, but it is unclear whether transfusion dose density is an independent prognostic factor. The European MDS Registry collects prospective data at 6-monthly intervals of newly diagnosed lower-risk myelodysplastic syndromes patients from 16 European countries and Israel. Data on the transfusion dose density - the cumulative dose received at the end of each interval divided by the time since the beginning of the interval in which the first transfusion was received - were analyzed using proportional hazards regression with time-varying co-variates, with death and progression to higher-risk myelodysplastic syndromes /acute myeloid leukemia as events. Of the 1267 patients included in the analyses, 317 patients died without progression, in 162 patients the disease had progressed. Progression-free survival was significantly associated with age, EQ-5D index, baseline WHO classification, bone marrow blast count, cytogenetic risk category, number of cytopenias, and country. Transfusion dose density was inversely associated with progression-free survival (p1x10-4): dose density had an increasing effect on hazard until a dose density of 3 units/16 weeks. The transfusion dose density effect continued to increase beyond 8 units/16 weeks after correction for the impact of treatment with erythropoietin agents, lenalidomide and/or iron chelators. Conclusion: the negative effect of transfusion treatment on progression-free survival already occurs at transfusion densities below 3 units/16 weeks. This indicates that transfusion dependency, even at relatively low dose densities, may be considered as an indicator of inferior progression-free survival. This trial was registered at www.clinicaltrials.gov as #NCT00600860.

Published
2020

26. Contributors

Author

Aalen, Reidunn B., primary, Abdel-Wahab, Yasser H.A., additional, Adams, Michael E., additional, Adan, Roger A.H., additional, Ahima, Rexford S., additional, Ahmed, Naima, additional, Al-Massadi, Omar, additional, Altstein, Miriam, additional, Anouar, Youssef, additional, Anselmi, Laura, additional, Ansorge, Siegfried, additional, Antcheva, Nikolinka, additional, Antonova-Koch, Yevgeniya, additional, Appel, Jon R., additional, Arik, Anam J., additional, Arter, Alison L., additional, Arvan, Peter, additional, Ashkenazi, Avraham, additional, Baas, P.W., additional, Bado, André, additional, Baird, Andrew, additional, Baiula, Monica, additional, Bakaletz, Lauren O., additional, Bakken, Earl E., additional, Balaskó, Márta, additional, Baldwin, Graham S., additional, Banks, William A., additional, Barra, Donatella, additional, Barson, Jessica R., additional, Basille, Magali, additional, Bauer, Natalie N., additional, Bedini, Andrea, additional, Beeton, Christine, additional, Begley, David J., additional, Beinfeld, Margery C., additional, Bendena, William G., additional, Benoit, Stephen C., additional, Bentov, Itay, additional, Bern, Howard, additional, Bierbaum, Gabriele, additional, Billington, Charles J., additional, Blasiak, Anna, additional, Block, Norman L., additional, Bloom, Stephen. R., additional, Bonney, Iwona, additional, Bowie, John H., additional, Boyd, Sunny K., additional, Brain, Susan D., additional, Brede, Dag A., additional, Broeck, Jozef Vanden, additional, Brown, Kelly L., additional, Brown, Mark R., additional, Bugni, James M., additional, Bundgaard, Jens R., additional, Burel, Delphine, additional, Butenko, Melinka A., additional, Call, Melissa J., additional, Calò, Girolamo, additional, Campbell, Duncan John, additional, Carlsson, Anna, additional, Carr, Daniel B., additional, Carraway, Robert E., additional, Carreira, Marcos C., additional, Casanueva, Felipe F., additional, Cassella, Sarah N., additional, Casson, Stuart A., additional, Castaño, Justo P., additional, Cebrat, Marek, additional, Chappe, Valerie, additional, Chatenet, David, additional, Chen, Keqiang, additional, Chen, Chen, additional, Chen, Longchuan, additional, Chen, Duan, additional, Cheng, Carrie Y.Y., additional, Cho, Sung Ki, additional, Chow, Billy K.C., additional, Christopoulos, Arthur, additional, Chu, Shijian, additional, Clarke, Iain J., additional, Coast, Geoffrey M., additional, Compere, Vincent, additional, Concepcion, Gisela P., additional, Cone, Roger D., additional, Conlon, J. Michael, additional, Cornélissen, Germaine, additional, Courel, Maité, additional, Couture, Réjean, additional, Cramer, W.A., additional, Croft, Nathan P., additional, Crujeiras, Ana B., additional, Cuttitta, Frank, additional, Cynis, Holger, additional, D’Acquisto, F., additional, Davis, Jon F., additional, Davis, Thomas P., additional, de La Serre, Claire Barbier, additional, de Lartigue, Guillaume, additional, de Lecea, Luis, additional, de Oliveira Santos, Marcelo, additional, De Waard, Michel, additional, Bolette Hartmann, Carolyn F. Deacon, additional, Delestre, Charlène, additional, Delgado, Mario, additional, Demuth, Hans-Ulrich, additional, Deng, Xiaoming, additional, Dharmawardhana, Palitha, additional, Di Cosmo, Anna, additional, Dias, Simoni Campos, additional, Dickerson, Jonathan W., additional, Diep, Dzung B., additional, Dircksen, H., additional, Dischinger, Jasmin, additional, do Rego, Jean-Claude, additional, Dobner, Paul R., additional, Dockray, Graham J., additional, Dores, Robert M., additional, Ducroc, Robert, additional, Dudek, Nadine L., additional, Dumont, Yvan, additional, Duraffourd, Celine, additional, Duterte-Boucher, Dominique, additional, Eberlé, Alex N., additional, Egleton, Richard D., additional, Eipper, Betty A., additional, Engel, Jorg B., additional, Englander, Ella W., additional, Epelbaum, Jacques, additional, Erlanson-Albertsson, Charlotte, additional, Evangelista, S., additional, Fagan, Karen A., additional, Farber, Joshua M., additional, Farkasfalvi, Klára, additional, Fekete, Csaba, additional, Flatt, Peter R., additional, Flower, R.J., additional, Forssmann, Wolf-Georg, additional, Fournier, Alain, additional, Foy, Kevin Chu, additional, Franco, Octávio Luiz, additional, Frenkel, Dan, additional, Fricker, Lloyd D., additional, de la Fuente-Núñez, César, additional, Fukuda, Hiroo, additional, Gäde, Gerd, additional, Galas, Ludovic, additional, Gallagher, Patricia E., additional, Gandolfo, Pierrick, additional, Garcia-Espinosa, Maria A., additional, García-Sanmartín, Josune, additional, Geary, Nori, additional, Geng, Hua, additional, Germano, Patrizia M., additional, Goetze, Jens P., additional, Gonzalez, Alexis A., additional, Gonzalez, Ana, additional, Gosnell, Blake A., additional, Goto, Katsutoshi, additional, Gourcerol, Guillaume, additional, Gozes, I., additional, Gracia-Navarro, Francisco, additional, Grayson, Bernadette E., additional, Greeley, George H., additional, Greenwald-Yarnell, Megan, additional, Gressens, Pierre, additional, Grider, John R., additional, Grünewald, Jan, additional, Guerreiro, Juliano R., additional, Guerrini, Remo, additional, Guida, Filomena, additional, Guilhaudis, Laure, additional, Guilmeau, Sandra, additional, Gundlach, Andrew L., additional, Gutkowska, Jolanta, additional, Hackbarth, Clifton, additional, Haim Ohana, Y., additional, Halberg, Franz, additional, Hallberg, Mathias, additional, Hamidi, Sayyed A., additional, Han, Song, additional, Han, Ji-Sheng, additional, Hancock, Robert E.W., additional, Haque, Samer-ul, additional, Hara-Nishimura, Ikuko, additional, Hariton, Aliza, additional, Hartsock, Wendy J., additional, Harvey, Alan L., additional, Hasunuma, Itaru, additional, Henning, Robert J., additional, Heppner, Kristy M., additional, Hertweck, Kate L., additional, Herzog, Herbert, additional, Higashiyama, Tetsuya, additional, Hinuma, Shuji, additional, Hippenstiel, Stefan, additional, Hirakawa, Yuki, additional, Hirose, Shuichi, additional, Hirsch, Jochen R., additional, Hocke, Andreas C., additional, Hodges, Robert S., additional, Hoffmann, Werner, additional, Hökfelt, Tomas, additional, Holst, Jens Juul, additional, Holzer, Peter, additional, Horodyski, Frank M., additional, Hosoda, Hiroshi, additional, Hou, Xiaowen, additional, Huffaker, Alisa, additional, Iijima, Norio, additional, Ikeuchi, Momoko, additional, Imperial, Julita S., additional, Improta, Giovanna, additional, Inui, Akio, additional, Irwin, Nigel, additional, Ishii, Munehiro, additional, Iturrioz, Xavier, additional, Ivanisevic, Ljubica, additional, Iwao, Hiroshi, additional, Iwata, Takeo, additional, Izumi, Yasukatsu, additional, Izumiyama, Hajime, additional, Jankowski, Marek, additional, Janssen, Tom, additional, Jégou, Sylvie, additional, Jensen, Robert T., additional, Jethwa, Preeti H., additional, Johannessen, Helene, additional, Johanson, Conrad, additional, Judkowski, Valeria, additional, Kaczmarek, Przemyslaw, additional, Kageyama, Haruaki, additional, Kakimoto, Tatsuo, additional, Kang, Ki Sung, additional, Kangawa, Kenji, additional, Kastin, Abba J., additional, Kato, Johji, additional, Kaumaya, Pravin T.P., additional, Keep, Richard F., additional, Kem, William R., additional, Khomenko, Tetyana, additional, Kikuyama, Sakae, additional, Kim, Young-Joon, additional, Kimura, Sadao, additional, King, Ross, additional, Kiptoo, Paul, additional, Kishimoto, Ichiro, additional, Kitamura, Kazuo, additional, Kluczyk, Alicja, additional, Kobori, Hiroyuki, additional, Kodama, Yosuke, additional, Kojima, Masayasu, additional, Kondo, Yuki, additional, Körner, Meike, additional, Kosson, Piotr, additional, Kotz, Catherine M., additional, Krishnan, Bhavani, additional, Kulseng, Bård, additional, Kumpf, Robert, additional, Laburthe, Marc, additional, Lacaille, Hélène, additional, Ladenheim, Ellen E., additional, Ladram, Ali, additional, Laksitorini, Marlyn D., additional, Lambert, David G., additional, Lange, Angela B., additional, Langhans, Wolfgang, additional, Larauche, Muriel, additional, Larhammar, Dan, additional, Larráyoz, Ignacio M., additional, Lattanzi, Roberta, additional, Lechan, Ronald M., additional, Lefranc, Benjamin, additional, Leibowitz, Sarah F., additional, Lelièvre, Vincent, additional, Leprince, Jérôme, additional, Levine, Allen S., additional, Li, Qun, additional, Lifshitz, Veronica, additional, Lihrmann, Isabelle, additional, Chi-Jen Lin, James, additional, Lindberg, Iris, additional, Lindsey, Keith, additional, Lipkowski, Andrzej W., additional, Liron, T., additional, Liu, Junli, additional, Liu, Ying, additional, Liu, Min, additional, Llorens-Cortes, Catherine, additional, Loizidou, Marilena, additional, Lopez, C., additional, Lovejoy, David A., additional, Luca, Vincenzo, additional, Lutz, Thomas A., additional, Ma, Sherie, additional, Mains, Richard E., additional, Malagon, Maria M., additional, Malendowicz, Ludwik K., additional, Wan, Jennifer Man-Fan, additional, Mangoni, Maria Luisa, additional, Manigrasso, Michaele B, additional, Marahiel, Mohamed A., additional, Marco, Heather G., additional, Maric-Bilkan, Christine, additional, Marks, Nikki J., additional, Martin, Roland, additional, Martinez, Vicente, additional, Martínez, Alfredo, additional, Martinez-Fuentes, Antonio J., additional, Masler, Edward P., additional, Matsubayashi, Yoshikatsu, additional, Mattu, Harman S., additional, Maule, Aaron G., additional, McLaughlin, Patricia J., additional, McMurtry, Ivan F., additional, Meelkop, Ellen, additional, Mehdi, Saher, additional, Melchiorri, Pietro, additional, Millar, R.P., additional, Miller, Laurence J., additional, Miller, Miles, additional, Million, Mulugeta, additional, Minamino, Naoto, additional, Mittelman, M., additional, Miyauchi, Takashi, additional, Miyazato, Mikiya, additional, Mizoguchi, Hirokazu, additional, Mohme, Malte, additional, Montero-Hadjadje, Maité, additional, Moody, Terry W., additional, Mookherjee, Neeloffer, additional, Moran, Timothy H., additional, Morganstern, Irene, additional, Mori, Masatomo, additional, Morin, Fabrice, additional, Morris, John F., additional, Moura, Daniel S., additional, Mudge, Anna J., additional, Mul, Joram D., additional, Murthy, Karnam S., additional, Myers, Martin G., additional, Nachman, Ronald J., additional, Nahon, Jean-Louis, additional, Naithani, Sushma, additional, Nakada, Tomoaki, additional, Nakamachi, Tomoya, additional, Nakamura, Yuki, additional, Nalivaeva, Natalia N., additional, Nasrallah, June B., additional, Nässel, Dick R., additional, Navar, L. Gabriel, additional, Neelakantan, Pratap, additional, Negri, Lucia, additional, Nes, Ingolf F., additional, Neumann, D., additional, Neveu, Cindy, additional, Ng, Tzi Bun, additional, Ng, Stephanie Y.L., additional, Nicholson, Graham M., additional, Nicolas, Pierre, additional, Nishikimi, Toshio, additional, Nishiyama, Mariko, additional, Nogueiras, Rubén, additional, Norton, Raymond S., additional, Novotny, Laura A., additional, Nowak, Krzysztof W., additional, Nyberg, Fred, additional, Ochoa-Callejero, Laura, additional, Ove Ögren, Sven, additional, Ohgusu, Hideko, additional, Oh-I, Shinsuke, additional, Ojo, Opeolu O., additional, Olivera, Baldomero M., additional, Olucha-Bordonau, Francisco E., additional, Oppenheim, Joost J., additional, Orchard, Ian, additional, Ouellette, André J., additional, Pacheco-López, Gustavo, additional, Page, Nigel M., additional, Palma, Mario Sergio, additional, Pan, Weihong, additional, Park, Yoonseong, additional, Parmentier, Marc, additional, Passemard, Sandrine, additional, Patterson, Michael, additional, Paunovic, Brankica, additional, Pearce, Gregory, additional, Pedersen, Jens, additional, Peeters, Theo L., additional, Eugene Pekary, A., additional, Pelletier, Georges, additional, Perboni, Simona, additional, Pérez-Tilve, Diego, additional, Perjés, Ábel, additional, Perretti, M., additional, Pétervári, Erika, additional, Pinilla, Clemencia, additional, Pinskim, Jacek, additional, Pisegna, Joseph R., additional, Plankensteiner, Kristof, additional, Podvin, Sonia, additional, Poitras, Pierre, additional, Polese, Gianluca, additional, Pollock, David M., additional, Porto, William Farias, additional, Possani, Lourival D., additional, Pothoulakis, Charalabos, additional, Presse, Françoise, additional, Prieto, Minolfa C., additional, Prutchi-Sagiv, S., additional, Purcell, Anthony W., additional, Purtell, Louise, additional, Quirion, Rémi, additional, Rabat, Catalina Abad, additional, Rademaker, Miriam, additional, Rajpal, Gautam, additional, Randeva, Harpal S., additional, Rebuffat, Sylvie, additional, Reeve, Joseph R., additional, Rehfeld, Jens F., additional, Reinhold, Dirk, additional, Reinscheid, Rainer K., additional, Reubi, Jean Claude, additional, Rezvani, Katayoun, additional, Ribeiro, Suzana Meira, additional, Richard, D., additional, Richards, Mark, additional, Riehle, Michael A., additional, Rinaldi, Andrea C., additional, Rode, Bernd M., additional, de la Vega, Ricardo C. Rodríguez, additional, Rotzinger, Susan, additional, Rucinski, Marcin, additional, Ruskoaho, Heikki, additional, Ryan, Philip J., additional, Sabatier, Jean-Marc, additional, Sahl, Hans-Georg, additional, Said, Sami I., additional, Sakurada, Tsukasa, additional, Sakurada, Shinobu, additional, Salomon, David S., additional, Samson, Willis K., additional, Sandor, Zsuzsanna, additional, Saragovi, H. Uri, additional, Sasaki, Kazuki, additional, Sato, Takahiro, additional, Satou, Ryousuke, additional, Sawa, Shinichiro, additional, Sayegh, Ayman I., additional, Schally, Andrew V., additional, Schilling, Stephan, additional, Schoofs, Liliane, additional, Schooley, David A., additional, Schubert, Mitchell L., additional, Segalas-Milazzo, Isabelle, additional, Seidah, Nabil G., additional, Selsted, Michael E., additional, Seroogy, Kim B., additional, Severini, Cinzia, additional, Sexton, Patrick M., additional, Shai, Yechiel, additional, Sharma, O., additional, Shichiri, Masayoshi, additional, Shimada, Tomoo, additional, Shimizu, Hiroyuki, additional, Shioda, Seiji, additional, Shulkes, Arthur, additional, Siahaan, Teruna J., additional, Siemion, Ignacy Z., additional, Silva, Osmar Nascimento, additional, Silva-Filho, Marcio C., additional, Skwarczynski, Mariusz, additional, Small, Caroline. J., additional, Smith, Craig M., additional, Smith, David E., additional, Smith, A. Ian, additional, Solomon, Beka, additional, Solomon, Travis E., additional, Sospedra, Mireia, additional, Souroujon, M.C., additional, Spampinato, Santi, additional, Spindel, Eliot R., additional, Steiger, A., additional, Stengel, Andreas, additional, Sternini, Catia, additional, Steyn, Frederik J., additional, Stopa, Edward, additional, Strowski, Mathias Z., additional, Sugano, Shigeo S., additional, Sundström, Görel, additional, Sutcliffe, J. Gregor, additional, Suttorp, Norbert, additional, Sweedler, Jonathan V., additional, Szabo, Sandor, additional, Székely, Miklós, additional, Szokodi, István, additional, Taché, Yvette, additional, Takahashi, Kazuhiro, additional, Takei, Yoshio, additional, Takenoya, Fumiko, additional, Talbot, Sébastien, additional, Tallant, E. Ann, additional, Tan, Tricia M., additional, Temmerman, Liesbet, additional, Temmesfeld-Wollbrück, Bettina, additional, Tena-Sempere, Manuel, additional, Thorsell, Annika, additional, Tilakaratne, Nanda, additional, Tobe, Stephen S., additional, Tokudome, Takeshi, additional, Tolstanova, Ganna, additional, Tonon, Marie-Christine, additional, Topping, Jennifer F., additional, Tossi, Alessandro, additional, Tostivint, Hervé, additional, Toth, Istvan, additional, Totsune, Kazuhito, additional, Toyoda, Fumiyo, additional, Troke, Rachel, additional, Tschöp, Matthias H., additional, Tso, Patrick, additional, Tsukaya, Hirokazu, additional, Tsutsui, Kazuyoshi, additional, Tu, Hong, additional, Turner, Anthony J., additional, Ubuka, Takayoshi, additional, Valdivia, Elene R., additional, Vandersmissen, Hans Peter, additional, Vaudry, David, additional, Vaudry, Hubert, additional, Vazquez-Martinez, Rafael, additional, Verbalis, Joseph G., additional, Vicari, Daniele, additional, Vidal, Nicolas, additional, Vignoni, Marzia, additional, Viollet, Cécile, additional, Vishwanatha, K.S., additional, Vivoli, Mirella, additional, Voisin, Thierry, additional, Vu, John P., additional, Walker, John C., additional, Wallace, B.A., additional, Wang, Ji Ming, additional, Wang, Lixin, additional, Wardman, Jonathan H., additional, Watanabe, Takuya, additional, Welch, Hazel, additional, Werner, Haim, additional, Whitmore, L., additional, Wiedemann, Imke, additional, Winsky-Sommerer, Raphaelle, additional, Witt, Ken A., additional, Wojciechowicz, Tatiana, additional, Wong, Jack Ho, additional, Woods, Stephen C., additional, Wootten, Denise, additional, Wu, Vincent, additional, Wurtz, Olivier, additional, Xiong, Ximing, additional, David Xu, Zhi-Qing, additional, Yamaguchi, Yube, additional, Yamaguchi, Takahiro, additional, Yamamoto, Kazutoshi, additional, Yamashita, E., additional, Yamazaki, Hiroyuki, additional, Yang, De, additional, Yoshikawa, Masaaki, additional, Yuan, Pu-Qing, additional, Yung, Sunny C., additional, Zagon, Ian S., additional, Zakharov, S.D., additional, Zaman, Mehfuz, additional, Zhalnina, M.V., additional, Zhang, Ning, additional, Zhang-Auberson, Lixin, additional, Zhao, Chun-Mei, additional, Ziolkowska, Agnieszka, additional, and Zitnan, Dusan, additional

Published
2013
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27. Erythropoietin

Author

Ohana, Y. Haim, primary, Liron, T., additional, Prutchi-Sagiv, S., additional, Mittelman, M., additional, Souroujon, M.C., additional, and Neumann, D., additional

Published
2013
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39. Erythropoiesis-stimulating agents significantly delay the onset of a regular transfusion need in nontransfused patients with lower-risk myelodysplastic syndrome

Author

Garelius, H K G, Johnston, William Thomas, Smith, Alexandra Gwen, Park, S, de Swart, L, Fenaux, P, Symeonidis, A, Sanz, G, Cermak, J, Stauder, R, Malcovati, L, Mittelman, M., van de Loosdrecht, A A, van Marrewijk, C J, Bowen, David, Crouch, Simon, de Witte, T J M, Hellstrom-Lindberg, E, CCA - Cancer Treatment and quality of life, and Hematology

Subjects
Male, Pediatrics, Blood transfusion, Time Factors, medicine.medical_treatment, Cancer development and immune defence Radboud Institute for Molecular Life Sciences [Radboudumc 2], 0302 clinical medicine, Risk Factors, hemic and lymphatic diseases, MDS, Prospective Studies, Young adult, Prospective cohort study, Aged, 80 and over, Middle Aged, 3. Good health, Survival Rate, Treatment Outcome, 030220 oncology & carcinogenesis, Disease Progression, haematology, Female, Original Article, Adult, medicine.medical_specialty, Adolescent, Anemia, Myelodysplasia, Lower risk, 03 medical and health sciences, Young Adult, Internal Medicine, medicine, Humans, Blood Transfusion, Survival rate, Aged, anaemia, business.industry, Proportional hazards model, Myelodysplastic syndromes, Original Articles, medicine.disease, haemoglobin, Myelodysplastic Syndromes, Hematinics, business, 030215 immunology, Follow-Up Studies
Abstract

Contains fulltext : 169659.pdf (Publisher’s version ) (Open Access) BACKGROUND: The EUMDS registry is an unique prospective, longitudinal observational registry enrolling newly diagnosed patients with lower-risk myelodysplastic syndrome (MDS) from 17 European countries from both university hospitals and smaller regional hospitals. OBJECTIVE: The aim of this study was to describe the usage and clinical impact of erythropoiesis-stimulating agents (ESAs) in 1696 patients enrolled between 2008 and 2014. METHODS: The effects of ESAs on outcomes were assessed using proportional hazards models weighting observations by propensity to receive ESA treatment within a subset of anaemic patients with or without a regular transfusion need. RESULTS: ESA treatment (median duration of 27.5 months, range 0-77 months) was administered to 773 patients (45.6%). Outcomes were assessed in 897 patients (484 ESA treated and 413 untreated). ESA treatment was associated with a nonsignificant survival benefit (HR 0.82, 95% CI: 0.65-1.04, P = 0.09); this benefit was larger amongst patients without prior transfusions (P = 0.07). Amongst 539 patients for whom response to ESA treatment could be defined, median time to first post-ESA treatment transfusion was 6.1 months (IQR: 4.3-15.9 months) in those transfused before ESA treatment compared to 23.3 months (IQR: 7.0-47.8 months) in patients without prior transfusions (HR 2.4, 95% CI: 1.7-3.3, P < 0.0001). Responding patients had a better prognosis in terms of a lower risk of death (HR 0.65, 95% CI: 0.45-0.893, P = 0.018), whereas there was no significant effect on the risk of progression to acute myeloid leukaemia (HR 0.71, 95% CI: 0.39-1.29, P = 0.27). CONCLUSION: Appropriate use of ESAs can significantly delay the onset of a regular transfusion need in patients with lower-risk MDS.

Published
2016
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41. Impact of Red Blood Cell Transfusions on Survival in Lower-Risk MDS Patients Included in the European Leukemianet MDS (EUMDS) Registry

Author

de Swart, L., primary, Crouch, S., additional, Smith, A., additional, Fenaux, P., additional, Symeonidis, A., additional, Cermak, J., additional, Hellström-Lindberg, E., additional, Sanz, G., additional, Stauder, R., additional, Malcovati, L., additional, Germing, U., additional, Langemeijer, S., additional, Skov Holm, M., additional, Mittelman, M., additional, Mądry, K., additional, Almeida, A., additional, Savic, A., additional, Itzykson, R., additional, Bowen, D., additional, and de Witte, T., additional

Published
2017
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42. Prognostic Value of Early Drop in Platelets in Lower-Risk MDS. A Sub-Study from the European Leukemianet Lower-Risk MDS (EUMDS) Registry

Author

Itzykson, R., primary, Smith, A., additional, Fenaux, P., additional, Symeonidis, A., additional, Mittelman, M., additional, Stauder, R., additional, Sanz, G., additional, Čermák, J., additional, Hellström-Lindberg, E., additional, Malcovati, L., additional, Langemeijer, S., additional, Germing, U., additional, Mądry, K., additional, Holm, M.S., additional, Tatic, A., additional, Almeida, A.M., additional, Savic, A., additional, Gredelj Šimec, N., additional, Bowen, D., additional, and de Witte, T., additional

Published
2017
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43. Health-Related Quality of Life is Substantially Impaired in Lower-Risk MDS when Compared with Reference Populations and Significantly Affects Overall Survival

Author

Stauder, R., primary, Yu, G., additional, Koinig, K., additional, Fenaux, P., additional, Symeonidis, A., additional, Sanz, G., additional, Cermak, J., additional, Mittelman, M., additional, Hellström-Lindberg, E., additional, Langemeijer, S., additional, Skov Holm, M., additional, Mądry, K., additional, Malcovati, L., additional, Tatic, A., additional, Germing, U., additional, Savic, A., additional, Efficace, F., additional, Smith, A., additional, Bowen, D., additional, and de Witte, T., additional

Published
2017
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48. Outcomes in RBC transfusion-dependent patients with Low-/Intermediate-1-risk myelodysplastic syndromes with isolated deletion 5q treated with lenalidomide: a subset analysis from the MDS-004 study

Author

Giagounidis, A., Mufti, G.J., Mittelman, M., Sanz, G., Platzbecker, U., Muus, P., Selleslag, D., Beyne-Rauzy, O., Boekhorst, P. Te, Canizo, C. Del, Guerci-Bresler, A., Nilsson, L., Lubbert, M., Quesnel, B., Ganser, A., Bowen, D., Schlegelberger, B., Gohring, G., Fu, T., Benettaib, B., Hellstrom-Lindberg, E., and Fenaux, P.

Subjects
Adult, Male, Risk, Vascular damage Radboud Institute for Health Sciences [Radboudumc 16], lenalidomide, Antineoplastic Agents, Drug Administration Schedule, Humans, del(5q), acute myeloid leukaemia, Aged, Retrospective Studies, Aged, 80 and over, transfusion independence, Original Articles, Middle Aged, Survival Analysis, myelodysplastic syndromes, Thalidomide, Leukemia, Myeloid, Acute, Treatment Outcome, Cytogenetic Analysis, Disease Progression, Chromosomes, Human, Pair 5, Female, Chromosome Deletion, Erythrocyte Transfusion
Abstract

Item does not contain fulltext OBJECTIVE: A subset analysis of the randomised, phase 3, MDS-004 study to evaluate outcomes in patients with International Prognostic Scoring System (IPSS)-defined Low-/Intermediate (Int)-1-risk myelodysplastic syndromes (MDS) with isolated del(5q). METHODS: Patients received lenalidomide 10 mg/d (days 1-21; n = 47) or 5 mg/d (days 1-28; n = 43) on 28-d cycles or placebo (n = 45). From the placebo and lenalidomide 5 mg groups, 84% and 58% of patients, respectively, crossed over to lenalidomide 5 or 10 mg at 16 wk, respectively. RESULTS: Rates of red blood cell-transfusion independence (RBC-TI) >/=182 d were higher in the lenalidomide 10 mg (57.4%; P < 0.0001) and 5 mg (37.2%; P = 0.0001) groups vs. placebo (2.2%). Cytogenetic response rates (major + minor responses) were 56.8% (P < 0.0001), 23.1% (P = 0.0299) and 0%, respectively. Two-year cumulative risk of acute myeloid leukaemia progression was 12.6%, 17.4% and 16.7% in the lenalidomide 10 mg, 5 mg, and placebo groups, respectively. In a 6-month landmark analysis, overall survival was longer in lenalidomide-treated patients with RBC-TI >/=182 d vs. non-responders (P = 0.0072). The most common grade 3-4 adverse event was myelosuppression. CONCLUSIONS: These data support the clinical benefits and acceptable safety profile of lenalidomide in transfusion-dependent patients with IPSS-defined Low-/Int-1-risk MDS with isolated del(5q).

Published
2014

50. Diagnosis and treatment of primary myelodysplastic syndromes in adults: recommendations from the European LeukemiaNet

Author

Malcovati L, Hellström-Lindberg E, Bowen D, Adès L, Cermak J, Del Cañizo C, Della Porta MG, Fenaux P, Gattermann N, Germing U, Jansen JH, Mittelman M, Mufti G, Platzbecker U, Sanz GF, Selleslag D, Skov-Holm M, Stauder R, Symeonidis A, van de Loosdrecht AA, de Witte T, Cazzola M, and European Leukemia Net

Abstract

Within the myelodysplastic syndrome (MDS) work package of the European LeukemiaNet, an Expert Panel was selected according to the framework elements of the National Institutes of Health Consensus Development Program. A systematic review of the literature was performed that included indexed original papers, indexed reviews and educational papers, and abstracts of conference proceedings. Guidelines were developed on the basis of a list of patient- and therapy-oriented questions, and recommendations were formulated and ranked according to the supporting level of evidence. MDSs should be classified according to the 2008 World Health Organization criteria. An accurate risk assessment requires the evaluation of not only disease-related factors but also of those related to extrahematologic comorbidity. The assessment of individual risk enables the identification of fit patients with a poor prognosis who are candidates for up-front intensive treatments, primarily allogeneic stem cell transplantation. A high proportion of MDS patients are not eligible for potentially curative treatment because of advanced age and/or clinically relevant comorbidities and poor performance status. In these patients, the therapeutic intervention is aimed at preventing cytopenia-related morbidity and preserving quality of life. A number of new agents are being developed for which the available evidence is not sufficient to recommend routine use. The inclusion of patients into prospective clinical trials is strongly recommended.

Published
2013

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