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4. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study.

Author

Gattermann N., Finelli C., Della Porta M., Fenaux P., Ganser A., Guerci-Bresler A., Schmid M., Taylor K., Vassilieff D., Habr D., Domokos G., Roubert B., Rose C., Agaoglu L., Alimena G., Alonso D., Ame S., Angelucci E., Arrizabalaga B., Athanasiou-Metaxa M., Augustson B., Aydinok Y., Baba A., Baccarani M., Beck J., Beris P., Beyne-Rauzy O., Birgens H., Bordessoule D., Borgna-Pignatti C., Bosly A., Bouabdallah K., Bowden D., Bowen D., Bron D., Cappellini M.D., Capra M., Cartron G., Cazzola M., Chalkias C., Chan L.L., Chancharunee S., Chapman C., Charoenkwan P., Chasapopoulou E., Cheze S., Chuansumrit A., Cianciulli P., Dauriac C., Delforge M., Dolken G., Dombret H., Duyster J., Economopoulos T., Ehninger G., Elalfy M., El-Beshlawy A., Enggaard L., Fillet G., Filosa A., Forni G., Galanello R., Gastl G., Giraudier S., Goldfarb A., Grigg A., Gumruk F., Ha S.Y., Haase D., Heinrich B., Hertzberg M., Ho J., Hsu H.-C., Huang S., Hunault-Berger M., Inusa B., Jaulmes D., Jensen J., Kattamis A., Kilinc Y., Kim K.-H., Kinsey S., Kjeldsen L., Koren A., Lai M.E., Lai Y., Lee J.-W., Lee K.-H., Lee S.-H., Legros L., Li C., Li C.-K., Li Q., Lin K.-H., Linkesch W., Lubbert M., Lutz D., Mohamed Thalha A.J., Mufti G., Muus P., Nobile F., Papadopoulos N., Perrotta S., Petrini M., Pfeilstocker M., Piga A., Poole J., Porter J.B., Pungolino E., Quarta G., Ravoet C., Jolimont Lobbes H.H., Remacha A.F., Roy L., Saglio G., Sanz G., Schmugge M., Schots H., Secchi G., Seymour J.F., Shah F., Shah H., Shen Z., Slama B., Sutcharitchan P., Taher A., Tamary H., Tesch H.-J., Thein S.L., Troncy J., Villegas A., Viprakasit V., Wainwright L., Wassmann B., Wettervald M., Will A., Wormann B., Wright J., Yeh S.-P., Yoon S.-S., Zoumbos N.C., Zweegman S., Gattermann N., Finelli C., Della Porta M., Fenaux P., Ganser A., Guerci-Bresler A., Schmid M., Taylor K., Vassilieff D., Habr D., Domokos G., Roubert B., Rose C., Agaoglu L., Alimena G., Alonso D., Ame S., Angelucci E., Arrizabalaga B., Athanasiou-Metaxa M., Augustson B., Aydinok Y., Baba A., Baccarani M., Beck J., Beris P., Beyne-Rauzy O., Birgens H., Bordessoule D., Borgna-Pignatti C., Bosly A., Bouabdallah K., Bowden D., Bowen D., Bron D., Cappellini M.D., Capra M., Cartron G., Cazzola M., Chalkias C., Chan L.L., Chancharunee S., Chapman C., Charoenkwan P., Chasapopoulou E., Cheze S., Chuansumrit A., Cianciulli P., Dauriac C., Delforge M., Dolken G., Dombret H., Duyster J., Economopoulos T., Ehninger G., Elalfy M., El-Beshlawy A., Enggaard L., Fillet G., Filosa A., Forni G., Galanello R., Gastl G., Giraudier S., Goldfarb A., Grigg A., Gumruk F., Ha S.Y., Haase D., Heinrich B., Hertzberg M., Ho J., Hsu H.-C., Huang S., Hunault-Berger M., Inusa B., Jaulmes D., Jensen J., Kattamis A., Kilinc Y., Kim K.-H., Kinsey S., Kjeldsen L., Koren A., Lai M.E., Lai Y., Lee J.-W., Lee K.-H., Lee S.-H., Legros L., Li C., Li C.-K., Li Q., Lin K.-H., Linkesch W., Lubbert M., Lutz D., Mohamed Thalha A.J., Mufti G., Muus P., Nobile F., Papadopoulos N., Perrotta S., Petrini M., Pfeilstocker M., Piga A., Poole J., Porter J.B., Pungolino E., Quarta G., Ravoet C., Jolimont Lobbes H.H., Remacha A.F., Roy L., Saglio G., Sanz G., Schmugge M., Schots H., Secchi G., Seymour J.F., Shah F., Shah H., Shen Z., Slama B., Sutcharitchan P., Taher A., Tamary H., Tesch H.-J., Thein S.L., Troncy J., Villegas A., Viprakasit V., Wainwright L., Wassmann B., Wettervald M., Will A., Wormann B., Wright J., Yeh S.-P., Yoon S.-S., Zoumbos N.C., and Zweegman S.

Abstract

The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ~50% were chelation-naive. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naive or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p<0.0001). This large dataset prospectively confirms the efficacy and well characterizes the safety profile of deferasirox in MDS. © 2010 Elsevier Ltd.

Published
2021

17. Response of iron overload to deferasirox in rare transfusion-dependent anaemias: equivalent effects on serum ferritin and labile plasma iron for haemolytic or production anaemias

Author

Porter, Jb, Lin, Kh, Beris, P, Forni, Gl, Taher, A, Habr, D, Domokos, G, Roubert, B, Thein, Sl, EPIC study investigators including Agaoglu, L, Alimena, G, Alonso, D, Ame, S, Angelucci, E, Arrizabalaga, B, Athanasiou Metaxa, M, Augustson, B, Aydinok, Y, Baba, A, Baccarani, M, Beck, J, Beyne Rauzy, O, Birgens, H, Bordessoule, D, Borgna Pignatti, C, Bosly, A, Bouabdallah, K, Bowen, D, Bron, D, Cappellini, Md, Capra, M, Cartron, G, Cazzola, M, Chalkias, C, Chan, Ll, Chancharunee, S, Chapman, C, Charoenkwan, P, Chasapopoulou, E, Cheze, S, Chuansumrit, A, Cianciulli, P, Dauriac, C, Delforge, M, Dölken, G, Dombret, H, Duyster, J, Economopoulos, T, Ehninger, G, Elalfy, M, El Beshlawy, A, Enggaard, L, Fenaux, P, Fillet, G, Filosa, A, Galanello, R, Ganser, A, Gastl, G, Gattermann, N, Giraudier, S, Goldfarb, A, Grigg, A, Guerci Bresler, A, Gumruk, F, Ha, Sy, Haase, D, Heinrich, B, Hertzberg, M, Ho, J, Hsu, Hc, Huang, S, Hunault Berger, M, Inusa, B, Jalumes, D, Jensen, J, Kattamis, A, Kilinc, Y, Kim, Kh, Kinsey, S, Kjeldsen, L, Koren, A, Lai, Me, Lai, Y, Lee, Jw, Lee, Kh, Lee, Sh, Legros, L, Li, C, Li, Ck, Li, Q, Linkesch, W, Lübbert, M, Lutz, D, Mohamed Thalha AJ, Mufti, G, Muus, P, Nobile, F, Ozsahin, H, Papadopoulos, N, Perrotta, S, Petrini, M, Pfeilstöcker, M, Piga, Antonio Giulio, Poole, J, Pungolino, E, Quarta, G, Ravoet, C, Remacha, Af, Rose, C, Roy, L, Saglio, Giuseppe, Sanz, G, Schmid, M, Schmugge, M, Schots, H, Secchi, G, Seymour, Jf, Shah, F, Shah, H, Shen, Z, Slama, B, Sutcharitchan, P, Tamary, H, Taylor, K, Tesch, Hj, Troncy, J, Vassilieff, D, Villegas, A, Viprakasit, V, Wainwright, L, Wassmann, B, Wettervald, M, Will, A, Wörmann, B, Wright, J, Yeh, Sp, Yoon, Ss, Zoumbos, Nc, Zweegman, S., Ozsahin, Ayse Hulya, Porter, Jb, Lin, Kh, Beris, P, Forni, Gl, Taher, A, Habr, D, Domokos, G, Roubert, B, Thein, Sl, on behalf of the EPIC study, Investigator, and Perrotta, Silverio

Subjects
safety, Male, Iron Overload, Adolescent, iron chelation therapy, Iron, Iron Chelating Agents/therapeutic use, Iron Chelating Agents, Benzoates, Anemia/drug therapy, Humans, Blood Transfusion, Benzoates/therapeutic use, Child, Iron/blood, ddc:616, ddc:618, iron overload, rare anaemias, serum ferritin, Ferritins/blood, Anemia, Original Articles, Triazoles, Deferasirox, Child, Preschool, Ferritins, rare anaemia, Female, Triazoles/therapeutic use
Abstract

Objectives: It is widely assumed that, at matched transfusional iron-loading rates, responses to chelation therapy are similar, irrespective of the underlying condition. However, data are limited for rare transfusiondependent anaemias, and it remains to be elucidated if response differs, depending on whether the anaemia has a primary haemolytic or production mechanism. Methods: The efficacy and safety of deferasirox (Exjade) in rare transfusion-dependent anaemias were evaluated over 1 yr, with change in serum ferritin as the primary efficacy endpoint. Initial deferasirox doses were 10–30 mg⁄ kg ⁄ d, depending on transfusion requirements; 34 patients had production anaemias, and 23 had haemolytic anaemias. Results: Patients with production anaemias or haemolytic anaemias had comparable transfusional iron-loading rates (0.31 vs. 0.30 mL red blood cells ⁄ kg ⁄ d), mean deferasirox dosing (19.3 vs. 19.0 mg⁄ kg ⁄ d) and baseline median serum ferritin (2926 vs. 2682 ng ⁄ mL). Baseline labile plasma iron (LPI) levels correlated significantly with the transfusional iron-loading rates and with serum ferritin levels in both cohorts. Reductions in median serum ferritin levels were initially faster in the production than the haemolytic anaemias, but at 1 yr, similar significant reductions of 940 and 617 ng ⁄mL were attained, respectively ()26.0% overall). Mean LPI decreased significantly in patients with production (P < 0.0001) and haemolytic (P = 0.037) anaemias after the first dose and was maintained at normal mean levels (

Published
2011

18. Iron chelation therapy with deferasirox in patients with aplastic anemia: a subgroup analysis of 116 patients from the EPIC trial

Author

Lee, Jw, Yoon, Ss, Shen, Zx, Ganser, A, Hsu, Hc, Habr, D, Domokos, G, Roubert, B, Porter, Jb, Agaoglu, L, Alimena, G, Alonso, D, Ame, S, Angelucci, E, Arrizabalaga, B, Athanasiou Metaxa, M, Augustson, B, Aydinok, Y, Baba, A, Baccarani, M, Beck, J, Beris, P, Beyne Rauzy, O, Birgens, H, Bordessoule, D, Borgna, Caterina, Bosly, A, Bouabdallah, K, Bowden, D, Bowen, D, Bron, D, Cappellini, Md, Capra, M, Cartron, G, Cazzola, M, Chalkias, C, Chan, Ll, Chancharunee, S, Chapman, C, Charoenkwan, P, Chasapopoulou, E, Cheze, S, Chuansumrit, A, Cianciulli, P, Dauriac, C, Delforge, M, Dölken, G, Dombret, H, Duyster, J, Economopoulos, T, Ehninger, G, Elalfy, M, El Beshlawy, A, Enggaard, L, Fenaux, P, Fillet, G, Filosa, A, Forni, G, Galanello, R, Gastl, G, Gattermann, N, Giraudier, S, Goldfarb, A, Grigg, A, Guerci Bresler, A, Gumruk, F, Ha, Sy, Haase, D, Heinrich, B, Hertzberg, M, Ho, J, Huang, S, Hunault Berger, M, Inusa, B, Jaulmes, D, Jensen, J, Kattamis, A, Kilinc, Y, Kim, Kh, Kinsey, S, Kjeldsen, L, Koren, A, Lai, Me, Lai, Y, Lee, Kh, Lee, Sh, Legros, L, Li, C, Li, Ck, Li, Q, Lin, Kh, Linkesch, W, Lübbert, M, Lutz, D, Mohamed Thalha AJ, Mufti, G, Muus, P, Nobile, F, Papadopoulos, N, Perrotta, S, Petrini, M, Pfeilstöcker, M, Piga, A, Poole, J, Pungolino, E, Quarta, G, Ravoet, C, Remacha, Af, Rose, C, Roy, L, Saglio, G, Sanz, G, Schmid, M, Schmugge, M, Schots, H, Secchi, G, Seymour, Jf, Shah, F, Shah, H, Shen, Z, Slama, B, Sutcharitchan, P, Taher, A, Tamary, H, Taylor, K, Tesch, Hj, Thein, Sl, Troncy, J, Vassilieff, D, Villegas, A, Viprakasit, V, Wainwright, L, Wassmann, B, Wettervald, M, Will, A, Wörmann, B, Wright, J, Yeh, Sp, Zoumbos, Nc, Zweegman, S., Lee, Jw, Yoon, S, Shen, Zx, Ganser, A, Hsu, Hc, Habr, D, Domokos, G, Roubert, B, Porter, Jb, EPIC study, Investigator, and Perrotta, Silverio

Subjects
Male, Biochemistry, Gastroenterology, Benzoates, beta-thalassemia, chemistry.chemical_compound, overloaded patients, oxidative stress, Prospective Studies, Prospective cohort study, pathophysiology, Beta thalassemia, complications, epidemiology, labile plasma iron, myelodysplastic syndromes, serum ferritin, transfusion-dependent anemias, Anemia, Aplastic, Hematology, Middle Aged, Tolerability, Creatinine, Iron chelation, Female, medicine.drug, Adult, medicine.medical_specialty, aplastic anemia, Adolescent, Anemia, Immunology, Iron Chelating Agents, Young Adult, Internal medicine, medicine, Humans, Aplastic anemia, therapy, business.industry, Myelodysplastic syndromes, Deferasirox, deferasirox, Cell Biology, Triazoles, medicine.disease, Chelation Therapy, Surgery, chemistry, Ferritins, business
Abstract

The prospective 1-year Evaluation of Patients' Iron Chelation with Exjade (EPIC) study enrolled a large cohort of 116 patients with aplastic anemia; the present analyses evaluated the efficacy and safety of deferasirox in this patient population. After 1 year, median serum ferritin decreased significantly from 3254 ng/mL at baseline to 1854 ng/mL (P < .001). Decreases occurred in chelation-naive (3229-1520 ng/mL; P < .001, last-observation-carried-forward analysis), and previously chelated (3263-2585 ng/mL; P = .21, last-observation-carried-forward analysis) patients and were reflective of dose adjustments and ongoing iron intake. Baseline labile plasma iron levels were within normal range despite high serum ferritin levels. The most common drug-related adverse events were nausea (22%) and diarrhea (16%). Serum creatinine increases more than 33% above baseline and the upper limit of normal occurred in 29 patients (25%), but there were no progressive increases; concomitant use of cyclosporine had a significant impact on serum creatinine levels. The decrease in mean alanine aminotransferase levels at 1 year correlated significantly with reduction in serum ferritin (r = 0.40, P < .001). Mean absolute neutrophil and platelet counts remained stable during treatment, and there were no drug-related cytopenias. This prospective dataset confirms the efficacy and well characterizes the tolerability profile of deferasirox in a large population of patients with aplastic anemia. This study was registered at www.clinicaltrials.gov as #NCT00171821.

Published
2010

19. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study

Author

Gattermann, N. Finelli, C. Della Porta, M. Fenaux, P. Ganser, A. Guerci-Bresler, A. Schmid, M. Taylor, K. Vassilieff, D. Habr, D. Domokos, G. Roubert, B. Rose, C. Agaoglu, L. Alimena, G. Alonso, D. Ame, S. Angelucci, E. Arrizabalaga, B. Athanasiou-Metaxa, M. Augustson, B. Aydinok, Y. Baba, A. Baccarani, M. Beck, J. Beris, P. Beyne-Rauzy, O. Birgens, H. Bordessoule, D. Borgna-Pignatti, C. Bosly, A. Bouabdallah, K. Bowden, D. Bowen, D. Bron, D. Cappellini, M.D. Capra, M. Cartron, G. Cazzola, M. Chalkias, C. Chan, L.L. Chancharunee, S. Chapman, C. Charoenkwan, P. Chasapopoulou, E. Cheze, S. Chuansumrit, A. Cianciulli, P. Dauriac, C. Delforge, M. Dölken, G. Dombret, H. Duyster, J. Economopoulos, T. Ehninger, G. Elalfy, M. El-Beshlawy, A. Enggaard, L. Fillet, G. Filosa, A. Forni, G. Galanello, R. Gastl, G. Giraudier, S. Goldfarb, A. Grigg, A. Gumruk, F. Ha, S.Y. Haase, D. Heinrich, B. Hertzberg, M. Ho, J. Hsu, H.-C. Huang, S. Hunault-Berger, M. Inusa, B. Jaulmes, D. Jensen, J. Kattamis, A. Kilinc, Y. Kim, K.-H. Kinsey, S. Kjeldsen, L. Koren, A. Lai, M.E. Lai, Y. Lee, J.-W. Lee, K.-H. Lee, S.-H. Legros, L. Li, C. Li, C.-K. Li, Q. Lin, K.-H. Linkesch, W. Lübbert, M. Lutz, D. Mohamed Thalha, A.J. Mufti, G. Muus, P. Nobile, F. Papadopoulos, N. Perrotta, S. Petrini, M. Pfeilstöcker, M. Piga, A. Poole, J. Porter, J.B. Pungolino, E. Quarta, G. Ravoet, C. Jolimont Lobbes, H.H. Remacha, A.F. Roy, L. Saglio, G. Sanz, G. Schmugge, M. Schots, H. Secchi, G. Seymour, J.F. Shah, F. Shah, H. Shen, Z. Slama, B. Sutcharitchan, P. Taher, A. Tamary, H. Tesch, H.-J. Thein, S.L. Troncy, J. Villegas, A. Viprakasit, V. Wainwright, L. Wassmann, B. Wettervald, M. Will, A. Wörmann, B. Wright, J. Yeh, S.-P. Yoon, S.-S. Zoumbos, N.C. Zweegman, S.

Abstract

The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ∼50% were chelation-naïve. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naïve or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p

Published
2010

20. Deferasirox in iron-overloaded patients with transfusion-dependent myelodysplastic syndromes: Results from the large 1-year EPIC study

Author

Gattermann, N., Finelli, C., Porta, M. D., Fenaux, P., Ganser, A., Guerci Bresler, A., Schmid, M., Taylor, K., Vassilieff, D., Habr, D., Domokos, G., Roubert, B., Rose, C., Agaoglu, L., Alimena, G., Alonso, D., Ame, S., Angelucci, E., Businco, A., Arrizabalaga, B., Athanasiou Metaxa, M., Augustson, B., Aydinok, Y., Baba, A., Baccarani, M., Beck, J., Beris, P., Beyne Rauzy, O., Birgens, H., Bordessoule, D., Borgna, Caterina, Bosly, A., Bouabdallah, K., Bowden, D., Bowen, D., Bron, D., Cappellini, M. D., Capra, M., Cartron, G., Cazzola, M., Chalkias, C., Chan, L. L., Chancharunee, S., Chapman, C., Charoenkwan, P., Chasapopoulou, E., Cheze, S., Chuansumrit, A., Cianciulli, P., Dauriac, C., Delforge, M., Dölken, G., Dombret, H., Duyster, J., Economopoulos, T., Ehninger, G., Elalfy, M., El Beshlawy, A., Enggaard, L., Fillet, G., Filosa, A., Forni, G., Galanello, R., Gastl, G., Giraudier, S., Goldfarb, A., Grigg, A., Gumruk, F., S. Y., Ha, Haase, D., Heinrich, B., Hertzberg, M., Ho, J., Hsu, H. C., Huang, S., Hunault Berger, M., Inusa, B., Jaulmes, D., Jensen, J., Kattamis, A., Kilinc, Y., Kim, K. H., Kinsey, S., Kjeldsen, L., Koren, A., Lai, M. E., Lai, Y., Lee, J. W., Lee, K. H., Lee, S. H., Legros, L., Li, C., C. K., Li, Li, Q., Lin, K. H., Linkesch, W., Lübbert, M., Lutz, D., Mohamed Thalha, A. J., Mufti, G., Muus, P., Nobile, F., Papadopoulos, N., Perrotta, S., Petrini, M., Pfeilstöcker, M., Piga, A., Poole, J., Porter, J. B., Pungolino, E., Quarta, G., Ravoet, C., Jolimont Lobbes, H. H., Remacha, A. F., Roy, L., Saglio, G., Sanz, G., Schmugge, M., Schots, H., Secchi, G., Seymour, J. F., Shah, F., Shah, H., Shen, Z., Slama, B., Sutcharitchan, P., Taher, A., Tamary, H., Tesch, H. J., Thein, S. L., Troncy, J., Villegas, A., Viprakasit, V., Wainwright, L., Wassmann, B., Wettervald, M., Will, A., Wörmann, B., Wright, J., Yeh, S. P., Yoon, S. S., Zoumbos, N. S., Zweegman, S., Gattermann, N, Finelli, C, Porta, Md, Fenaux, P, Ganser, A, GUERCI BRESLER, A, Schmid, M, Taylor, K, Vassilieff, D, Habr, D, Domokos, G, Roubert, B, Rose, C, EPIC study, Investigator, Perrotta, Silverio, Gattermann N, Finelli C, Porta MD, Fenaux P, Ganser A, Guerci-Bresler A, Schmid M, Taylor K, Vassilieff D, Habr D, Domokos G, Roubert B, Rose C, Baccarani M, EPIC study investigators., and Çukurova Üniversitesi

Subjects
Male, Pediatrics, Cancer Research, Blood transfusion, Thalassemia, medicine.medical_treatment, Gastroenterology, Benzoates, Child, Hematology, biology, Benzoic Acids, Alanine Transaminase, Adolescent, Adult, Aged, Blood Transfusion, Preschool, Female, Ferritins, Humans, Iron Chelating Agents, Iron Overload, Middle Aged, Myelodysplastic Syndromes, Triazoles, Young Adult, Oncology, Child, Preschool, medicine.drug, medicine.medical_specialty, Myelodysplastic syndromes, deferasirox, iron chelation therapy, labile plasma iron, myelodysplastic syndromes, serum ferritin, Serum ferritin, Deferasirox, Iron chelation therapy, Labile plasma iron, Internal medicine, medicine, Adverse effect, iron-overloaded patients, transfusion, Labile plasmairon, business.industry, medicine.disease, Discontinuation, Iron chelationtherapy, Alanine transaminase, biology.protein, business, Myelodysplastic syndrome
Abstract

PubMedID: 20451251 The prospective 1-year EPIC study enrolled 341 patients with myelodysplastic syndromes (MDS); although baseline iron burden was >2500. ng/mL, ~50% were chelation-naïve. Overall median serum ferritin decreased significantly at 1 year (p=0.002). Decreases occurred irrespective of whether patients were chelation-naïve or previously chelated; changes were dependent on dose adjustments and ongoing iron intake. Sustained reductions in labile plasma iron were observed. Discontinuation rate (48.7%) and adverse event profile were consistent with previously reported deferasirox data in MDS. Alanine aminotransferase levels decreased significantly; change correlated significantly with reduction in serum ferritin (p

Published
2010

21. Tailoring iron chelation by iron intake and serum ferritin: the prospective EPIC study of deferasirox in 1744 patients with transfusion-dependent anemias

Author

Cappellini, M. D., Porter, J., El Beshlawy, A., C. K., Li, Seymour, J. F., Elalfy, M., Gattermann, N., Giraudier, S., Lee, J. W., Chan, L. L., Lin, K. H., Rose, C., Taher, A., Thein, S. L., Viprakasit, V., Habr, D., Domokos, G., Roubert, B., Kattamis, A., Agaoglu, L., Alimena, G., Alonso, D., Ame, S., Angelucci, E., Businco, A., Arrizabalaga, B., Athanasiou Metaxa, M., Augustson, B., Aydinok, Y., Baba, A., Baccarani, M., Beck, J., Beris, P., Beyne Rauzy, O., Birgens, H., Bordessoule, D., Borgna, Caterina, Bosly, A., Bouabdallah, K., Bowden, D., Bowen, D., Bron, D., Capra, M., Cartron, G., Cazzola, M., Chalkias, C., Chancharunee, S., Chapman, C., Charoenkwan, P., Chasapopoulou, E., Cheze, S., Chuansumrit, A., Cianciulli, P., Dauriac, C., Delforge, M., Dölken, G., Dombret, H., Duyster, J., Economopoulos, T., Ehninger, G., Enggaard, L., Fillet, G., Filosa, A., Forni, G., Galanello, R., Gastl, G., Goldfarb, A., Grigg, A., Gumruk, F., S. Y., Ha, Haase, D., Heinrich, B., Hertzberg, M., Ho, J., Hsu, H. C., Huang, S., Hunault Berger, M., Inusa, B., Jaulmes, D., Jensen, J., Kilinc, Y., Kim, K. H., Kinsey, S., Kjeldsen, L., Koren, A., Lai, M. E., Lai, Y., Lee, K. H., Lee, S. H., Legros, L., Li, C., Li, Q., Linkesch, W., Lübbert, M., Lutz, D., Mohamed Thalha, A. J., Mufti, G., Muus, P., Nobile, F., Papadopoulos, N., Perrotta, S., Petrini, M., Pfeilstöcker, M., Piga, A., Poole, J., Porter, J. B., Pungolino, E., Quarta, G., Ravoet, C., Jolimont Lobbes, H. H., Remacha, A. F., Roy, L., Saglio, G., Sanz, G., Schmugge, M., Schots, H., Secchi, G., Shah, F., Shah, H., Shen, Z., Slama, B., Sutcharitchan, P., Tamary, H., Tesch, H. J., Troncy, J., Villegas, A., Wainwright, L., Wassmann, B., Wettervald, M., Will, A., Wörmann, B., Wright, J., Yeh, S. P., Yoon, S. S., Zoumbos, N. S., and Zweegman, S.

Subjects
Adult, Male, medicine.medical_specialty, Pediatrics, Blood transfusion, Iron Overload, Adolescent, Anemia, Thalassemia, medicine.medical_treatment, Iron chelation therapy, Transfusion medicine, Transfusion-dependent anemias, Hemosiderosis, Iron Chelating Agents, Gastroenterology, Benzoates, Young Adult, IRON CHELATION, Internal medicine, medicine, Humans, Blood Transfusion, Tissue Distribution, SERUM FERRITIN, Chelation therapy, Prospective Studies, Child, Aged, Aged, 80 and over, business.industry, Myelodysplastic syndromes, Deferasirox, Hematology, Middle Aged, Triazoles, medicine.disease, DEFERASOROX, Deferoxamine, Child, Preschool, Ferritins, Female, Original Article, business, TRANSFUSION-DEPENDENT ANEMIAS, Iron, Dietary, medicine.drug
Abstract

Background Following a clinical evaluation of deferasirox (Exjade) it was concluded that, in addition to baseline body iron burden, ongoing transfusional iron intake should be considered when selecting doses. The 1-year EPIC study, the largest ever investigation conducted for an iron chelator, is the first to evaluate whether fixed starting doses of deferasirox, based on transfusional iron intake, with dose titration guided by serum ferritin trends and safety markers, provides clinically acceptable chelation in patients (agedor=2 years) with transfusional hemosiderosis from various types of anemia.The recommended initial dose was 20 mg/kg/day for patients receiving 2-4 packed red blood cell units/month and 10 or 30 mg/kg/day was recommended for patients receiving less or more frequent transfusions, respectively. Dose adjustments were based on 3-month serum ferritin trends and continuous assessment of safety markers. The primary efficacy end-point was change in serum ferritin after 52 weeks compared with baseline.The 1744 patients enrolled had the following conditions; thalassemia (n=1115), myelodysplastic syndromes (n=341), aplastic anemia (n=116), sickle cell disease (n=80), rare anemias (n=43) and other transfused anemias (n=49). Overall, there was a significant reduction in serum ferritin from baseline (-264 ng/mL; P0.0001), reflecting dosage adjustments and ongoing iron intake. The most common (5%) adverse events were gastrointestinal disturbances (28%) and skin rash (10%). Conclusions Analysis of this large, prospectively collected data set confirms the response to chelation therapy across various anemias, supporting initial deferasirox doses based on transfusional iron intake, with subsequent dose titration guided by trends in serum ferritin and safety markers (clinicaltrials.gov identifier: NCT00171821).

Published
2009

22. Hepatic disorders during the simultaneous therapy with intraconazole and amphotericin B in leukemic patients

Author

Schwartzbrod, P.E., Persat, F., Troncy, J., Timour, Q., Maul, A., Piens, M.A., Fiere, D., Picot, S., Laboratoire Méthodes Mathématiques pour l'Analyse des Systèmes (MMAS), Centre National de la Recherche Scientifique (CNRS)-Université Paul Verlaine - Metz (UPVM), and Université Paul Verlaine - Metz (UPVM)-Centre National de la Recherche Scientifique (CNRS)

Subjects
[SDV]Life Sciences [q-bio], [CHIM]Chemical Sciences, ComputingMilieux_MISCELLANEOUS
Abstract

International audience

Published
1999

23. Improved patient satisfaction, adherence and health-related quality of life with deferasirox (Exjade) in beta-thalassemia patients previously receiving other iron chelation therapies.

Author

Rofail D., Gater A., Cappellini M.D., Baladi J.-F., Porter J.B., Athanasiou-Metaxa M., Bowden D.K., Troncy J., Habr D., Domokos G., Roubert B., Rofail D., Gater A., Cappellini M.D., Baladi J.-F., Porter J.B., Athanasiou-Metaxa M., Bowden D.K., Troncy J., Habr D., Domokos G., and Roubert B.

Abstract

Introduction: Iron chelation therapy (ICT) is essential in removing excess iron deposited in body organs, ultimately preventing organ failure and extending the lives of patients (pts) with transfusion-dependent hematological disorders such as beta-thalassemia. Conventional ICT (deferoxamine, Desferal, DFO) requires a burdensome regimen (subcutaneous delivery 5-7 times a week) that has been shown to negatively impact pts' health-related quality of life (HRQL) and adherence to therapy. Adherence to ICT affects survival and therefore a well-tolerated and effective ICT regimen is required. The once-daily oral chelator, deferasirox (Exjade) offers 24-hour ICT, 7 days a week and is potentially less burdensome to pts. Method(s): As part of a larger single-arm, multicenter, open-label trial investigating the efficacy and safety of deferasirox (EPIC study), 217 beta-thalassemia pts >16 years of age were included in this subanalysis. Findings reported here investigate differences in satisfaction, adherence and HRQoL following treatment with deferasirox, in beta-thalassemia patients with prior experience of DFO monotherapy, or DFO in combination with deferiprone (Ferriprox, L1). All pts were asked at baseline and week 52 (end of study [EOS]) to complete the 19-item Satisfaction with ICT questionnaire (SICT) and the 36-item Short Form health survey (SF-36). Mean change scores between baseline and EOS on the four domains of the SICT (Perceived Effectiveness of ICT, Side Effects of ICT, Acceptance of ICT, and Burden of ICT) and the eight domains (Physical Functioning, Role-Physical, Bodily Pain, General Health, Vitality, Social Functioning, Role-Emotional, and Mental Health) and two summary scores (Physical and Mental Component Scores) of the SF-36 were calculated for patients who completed the respective instruments at both timepoints. Higher scores on the SICT and SF-36 represent greater HRQL, satisfaction with, and adherence to treatment. Adherence to deferasirox was assessed

Published
2010

24. Quality of life after successful treatment of early-stage Hodgkin's lymphoma: 10-year follow-up of the EORTC-GELA H8 randomised controlled trial.

Author

Heutte, N., Flechtner, H.H., Mounier, N., Mellink, W.A.M., Meerwaldt, J.H., Eghbali, H., Veer, M.B. van 't, Noordijk, E.M., Kluin-Nelemans, H.C., Lampka, E., Thomas, J., Lugtenburg, P.J., Viterbo, L., Carde, P., Hagenbeek, A., Maazen, R.W.M. van der, Smit, W.G., Brice, P., Marwijk-Kooy, M. van, Baars, J.W., Poortmans, P.M.P., Tirelli, U., Leeksma, O.C., Tomsic, R., Feugier, P., Salles, G., Gabarre, J., Kersten, M.J., Neste, E. van den, Creemers, G.J., Gaillard, I., Meijnders, P., Tertian, G., Reman, O., Muller, H.P., Troncy, J., Blanc, M., Schroyens, W., Voogt, P.J., Wijermans, P., Rieux, C., Ferme, C., Henry-Amar, M., Heutte, N., Flechtner, H.H., Mounier, N., Mellink, W.A.M., Meerwaldt, J.H., Eghbali, H., Veer, M.B. van 't, Noordijk, E.M., Kluin-Nelemans, H.C., Lampka, E., Thomas, J., Lugtenburg, P.J., Viterbo, L., Carde, P., Hagenbeek, A., Maazen, R.W.M. van der, Smit, W.G., Brice, P., Marwijk-Kooy, M. van, Baars, J.W., Poortmans, P.M.P., Tirelli, U., Leeksma, O.C., Tomsic, R., Feugier, P., Salles, G., Gabarre, J., Kersten, M.J., Neste, E. van den, Creemers, G.J., Gaillard, I., Meijnders, P., Tertian, G., Reman, O., Muller, H.P., Troncy, J., Blanc, M., Schroyens, W., Voogt, P.J., Wijermans, P., Rieux, C., Ferme, C., and Henry-Amar, M.

Abstract

Contains fulltext : 81805.pdf (publisher's version ) (Closed access), BACKGROUND: Little is known about the longitudinal course of health-related quality of life (HRQoL) in patients with Hodgkin's lymphoma during their post-treatment follow-up and re-adaptation to normal life. We report on the HRQoL of patients treated in the randomised H8 trial of the European Organisation for Research and Treatment of Cancer (EORTC) Lymphoma Group and the Groupe d'Etudes des Lymphomes de l'Adulte (GELA). We aimed to assess HRQoL and fatigue following treatment, to analyse relations with treatment, and to identify factors that predict persistent fatigue. METHODS: Patients received HRQoL questionnaires at the end of primary therapy and during follow-up. The EORTC QLQ-C30 was used to assess HRQoL, and the Multidimensional Fatigue Inventory (MFI-20) was used to assess fatigue. Changes of mean HRQoL scores over time were analysed with mixed models. Multiple polytomic nominal logistic regression was done to identify independent baseline predictors of fatigue within MFI-20 dimensions. Analyses were done on an intention-to-treat basis. This study is registered with www.ClinicalTrials.gov, number NCT00379041. FINDINGS: 2666 assessments from 935 patients were analysed. Mean follow-up was 90 months (range 52-118). Age affected all functioning and symptom scores except emotional functioning, with younger age associated with higher functioning and lower severity of symptoms; improvement with time showed similar patterns between age groups. Women reported lower HRQoL and higher symptom scores than did men. Overall, 3.2% (14/439 for role functioning) to 9.7% (43/442 for social functioning) and 5.8% (29/498 for reduced motivation) to 9.9% (49/498 for general fatigue) of patients reported impairments of 10 points or more (on a 0-100 scale) in QLQ-C30 and MFI-20 scores, respectively, independent of age and sex. Emotional domains were more affected than physical ones. There was no relation between HRQoL outcome and type of treatment. Fatigue (MFI-20 scores) at the end

Published
2009

25. Evaluation de la tolérance clinique et biologique de l’intraconazole chez des patients présentant des taux sériques élevés

Author

Schwartzbrod, P.E., Persat, F., Troncy, J., Timour, Q., Maul, A., Piens, M.A., Fiere, D., Picot, S., Laboratoire Méthodes Mathématiques pour l'Analyse des Systèmes (MMAS), Université Paul Verlaine - Metz (UPVM)-Centre National de la Recherche Scientifique (CNRS), and MAUL, Armand

Subjects
[SDV] Life Sciences [q-bio], [STAT]Statistics [stat], [SDV]Life Sciences [q-bio], ComputingMilieux_MISCELLANEOUS, [STAT] Statistics [stat]
Abstract

International audience

Published
1998

26. Need Of Reconsideration Of Mobilization Strategy In Autologous Stem Cell Transplantation For Multiple Myeloma: Results Of The Positive Impact Of High Number Of CD34+Infused Cells

Author

Michallet, M., primary, Sobh, M., additional, Nicolini, F.E., additional, Raus, N., additional, Baracco, F., additional, Cannas, G., additional, Chelghoum, Y., additional, Clapisson, G., additional, Thomas, X., additional, Troncy, J., additional, and Ducastelle, S., additional

Published
2010
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31. Major Superiority of Melphalan - Prednisone (MP) + Thalidomide (THAL) over MP and Autologous Stem Cell Transplantation in the Treatment of Newly Diagnosed Elderly Patients with Multiple Myeloma.

Author

Facon, Thierry, primary, Mary, J.Y., primary, Hulin, C., primary, Benboubker, L., primary, Attal, M., primary, Renaud, M., primary, Harousseau, J.L., primary, Pegourie, B., primary, Guillerm, G., primary, Chaleteix, C., primary, Dib, M., primary, Voillat, L., primary, Maisonneuve, H., primary, Troncy, J., primary, Dorvaux, V., primary, Monconduit, M., primary, Martin, C., primary, Casassus, P., primary, Jaubert, J., primary, Jardel, H., primary, Kolb, B., primary, and Bauters, F., primary

Published
2005
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32. Autologous or allogeneic stem cell transplantation as post-remission therapy in refractory or relapsed acute myeloid leukemia after highly intensive chemotherapy

Author

Thomas, X, primary, Le, QH, additional, de Botton, S, additional, Raffoux, E, additional, Chelghoum, Y, additional, Pautas, C, additional, Dreyfus, F, additional, Dhedin, N, additional, Vekhoff, A, additional, Troncy, J, additional, Pigneux, A, additional, de Revel, T, additional, Reman, O, additional, Travade, P, additional, Thiebaut, A, additional, Guerci, A, additional, Elhamri, M, additional, Fenaux, P, additional, Dombret, H, additional, and Michallet, M, additional

Published
2005
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42. Phase II trial of plicamycin and hydroxyurea in acute myelogenous leukemia.

Author

Archimbaud, Eric, Troncy, Jacques, Sebban, Catherine, Guyotat, Denis, Devaux, Yves, French, Martine, Moriceau, Michel, Viala, Jean-Jacques, Fiere, Denis, Archimbaud, E, Troncy, J, Sebban, C, Guyotat, D, Devaux, Y, French, M, Moriceau, M, Viala, J J, and Fiere, D

Abstract

A total of 23 patients with high-risk acute myelogenous leukemia (AML) at diagnosis (2 patients), relapsing AML (14) or resistant AML (6) were treated with 25 micrograms/kg i.v. plicamycin every other day for 3 weeks and 500-4,000 mg hydroxyurea per day p. o. according to the WBC count. Aplasia was observed in only two patients. Severe extrahematologic toxicity included sepsis (four cases), vomiting (four patients), toxic hepatitis (three cases), and fibrinopenia (one patient). No partial or complete responses were observed. The 95% confidence interval limit of the overall response rate (CR + PR) was 0-14%. [ABSTRACT FROM AUTHOR]

Published
1989
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43. Candidemia in cancer patients: A prospective, multicenter surveillance study by the invasive fungal infection group (IFIG) of the European organization for research and treatment of cancer (EORTC)

Author

Corrado GIRMENIA, Marinus, A., Collette, L., Doyen, C., Meunier, F., Martino, P., Lebeau, B., Kremery, V., Spence, D., Vandercam, B., Herbrecht, R., Troncy, J., Aoun, M., Nemet, D., Viviani, M. A., Viscoli, C., Cometta, A., Hemmer, R., Cordonnier, C., Cohen, J., Thyss, A., Engelhard, D., Hennequin, C., Marie, S., Giacchino, M., Ljungmen, P., Sehrijvers, D., Pauw, B., Moreau, P., Todeschini, G., Offner, F., Tjean, M., Gregor, A., and Giacchino, R.

47. Melphalan and prednisone plus thalidomide versus melphalan and prednisone alone or reduced-intensity autologous stem cell transplantation in elderly patients with multiple myeloma (IFM 99-06): a randomised trial.

Author

Facon T, Mary JY, Hulin C, Benboubker L, Attal M, Pegourie B, Renaud M, Harousseau JL, Guillerm G, Chaleteix C, Dib M, Voillat L, Maisonneuve H, Troncy J, Dorvaux V, Monconduit M, Martin C, Casassus P, Jaubert J, and Jardel H

Abstract

BACKGROUND: In multiple myeloma, combination chemotherapy with melphalan plus prednisone is still regarded as the standard of care in elderly patients. We assessed whether the addition of thalidomide to this combination, or reduced-intensity stem cell transplantation, would improve survival. METHODS: Between May 22, 2000, and Aug 8, 2005, 447 previously untreated patients with multiple myeloma, who were aged between 65 and 75 years, were randomly assigned to receive either melphalan and prednisone (MP; n=196), melphalan and prednisone plus thalidomide (MPT; n=125), or reduced-intensity stem cell transplantation using melphalan 100 mg/m2 (MEL100; n=126). The primary endpoint was overall survival. Analysis was by intention to treat. This trial is registered with ClinicalTrials.gov, number NCT00367185. FINDINGS: After a median follow-up of 51.5 months (IQR 34.4-63.2), median overall survival times were 33.2 months (13.8-54.8) for MP, 51.6 months (26.6-not reached) for MPT, and 38.3 months (13.0-61.6) for MEL100. The MPT regimen was associated with a significantly better overall survival than was the MP regimen (hazard ratio 0.59, 95% CI 0.46-0.81, p=0.0006) or MEL100 regimen (0.69, 0.49-0.96, p=0.027). No difference was seen for MEL100 versus MP (0.86, 0.65-1.15, p=0.32). INTERPRETATION: The results of our trial provide strong evidence to indicate that the use of thalidomide in combination with melphalan and prednisone should, at present, be the reference treatment for previously untreated elderly patients with multiple myeloma. [ABSTRACT FROM AUTHOR]

Published
2007
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49. Health-Related Quality of Life, Treatment Satisfaction, Adherence and Persistence in β-Thalassemia and Myelodysplastic Syndrome Patients with Iron Overload Receiving Deferasirox: Results from the EPIC Clinical Trial.

Author

Porter J, Bowden DK, Economou M, Troncy J, Ganser A, Habr D, Martin N, Gater A, Rofail D, Abetz-Webb L, Lau H, and Cappellini MD

Abstract

Treatment of iron overload using deferoxamine (DFO) is associated with significant deficits in patients' health-related quality of life (HRQOL) and low treatment satisfaction. The current article presents patient-reported HRQOL, satisfaction, adherence, and persistence data from β-thalassemia (n = 274) and myelodysplastic syndrome (MDS) patients (n = 168) patients participating in the Evaluation of Patients' Iron Chelation with Exjade (EPIC) study (NCT00171821); a large-scale 1-year, phase IIIb study investigating the efficacy and safety of the once-daily oral iron chelator, deferasirox. HRQOL and satisfaction, adherence, and persistence to iron chelation therapy (ICT) data were collected at baseline and end of study using the Medical Outcomes Short-Form 36-item Health Survey (SF-36v2) and the Satisfaction with ICT Questionnaire (SICT). Compared to age-matched norms, β-thalassemia and MDS patients reported lower SF-36 domain scores at baseline. Low levels of treatment satisfaction, adherence, and persistence were also observed. HRQOL improved following treatment with deferasirox, particularly among β-thalassemia patients. Furthermore, patients reported high levels of satisfaction with deferasirox at end of study and greater ICT adherence, and persistence. Findings suggest deferasirox improves HRQOL, treatment satisfaction, adherence, and persistence with ICT in β-thalassemia and MDS patients. Improving such outcomes is an important long-term goal for patients with iron overload.

Published
2012
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50. A single dose pegfilgrastim for supporting neutrophil recovery in patients treated for high-risk acute myeloid leukemia by the EMA 2000 schedule.

Author

Derbel O, Cannas G, Le QH, Elhamri M, Chelghoum Y, Nicolas-Virelizier E, Nicolini F, Troncy J, Barraco F, Michallet M, and Thomas X

Subjects
Adult, Antineoplastic Combined Chemotherapy Protocols therapeutic use, Cytarabine administration & dosage, Cytarabine adverse effects, Drug Administration Schedule, Etoposide administration & dosage, Etoposide adverse effects, Female, Filgrastim, Humans, Male, Middle Aged, Mitoxantrone administration & dosage, Mitoxantrone adverse effects, Neutropenia chemically induced, Polyethylene Glycols, Prognosis, Recombinant Proteins, Remission Induction, Survival Analysis, Treatment Outcome, Young Adult, Antineoplastic Combined Chemotherapy Protocols adverse effects, Granulocyte Colony-Stimulating Factor administration & dosage, Leukemia, Myeloid, Acute blood, Leukemia, Myeloid, Acute drug therapy, Neutropenia drug therapy
Abstract

Dose intensity has been demonstrated to be one determinant for treatment efficacy in younger adults with high-risk (relapsed and refractory) acute myelogenous leukemia. Between 2000 and 2006, 56 patients entered the EMA 2000 study and received timed sequential reinduction chemotherapy. From 2004, chemotherapy was also followed by one subcutaneous dose of pegfilgrastim. Thirty-six patients reached a complete remission, while nine obtained a partial remission. Median time to granulocyte and platelet recovery was 34 and 38 days respectively. The major non-hematologic toxicities were severe infections but despite this 23 remitters could proceed to their post-remission treatment, although 13 did not because of severe toxicity or early relapse. The median overall survival was 9.3 months. The EMA 2000 regimen is a highly effective treatment with a response rate of 64% and a low early death rate. The period of critical neutropenia was relatively short in both phases and the supportive use of pegfilgrastim, although showing a trend toward reduced neutropenic period, did not appear to reduce the risk of infection in this group and may not be a critical requirement for reducing the risk of treatment-related toxicity.

Published
2010
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