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472 results on '"Kuliczkowski, K."'

1. Efficacy and safety of lenalidomide treatment in multiple myeloma (MM) patients—Report of the Polish Myeloma Group

Author

Usnarska-Zubkiewicz, L., Dębski, J., Butrym, A., Legieć, W., Hus, M., Dmoszyńska, A., Stella-Hołowiecka, B., Zaucha, J.M., Januszczyk, J., Rymko, M., Torosian, T., Charliński, G., Lech-Marańda, E., Malenda, A., Jurczyszyn, A., Urbańska-Ryś, H., Druzd-Sitek, A., Błońska, D., Urbanowicz, A., Hołojda, J., Pogrzeba, J., Rzepecki, P., Hałka, J., Subocz, E., Becht, R., Zdziarska, B., Dytfeld, D., Nowicki, A., Bołkun, Ł., Kłoczko, J., Knopińska-Posłuszny, W., Zubkiewicz-Kucharska, A., and Kuliczkowski, K.

Published
2016
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8. Outcome of treatment in adults with Philadelphia chromosome-positive and/or BCR–ABL-positive acute lymphoblastic leukemia—retrospective analysis of Polish Adult Leukemia Group (PALG)

Author

Wrzesień-Kuś, A., Robak, T., Pluta, A., Zwolińska, M., Wawrzyniak, E., Wierzbowska, A., Skotnicki, A., Jakubas, B., Hołowiecki, J., Nowak, K., Kuliczkowski, K., Mazur, G., Haus, O., Dmoszyńska, A., Adamczyk-Cioch, M., Jędrzejczak, W. W., Paluszewska, M., Konopka, L., and Pałynyczko, G.

Published
2006
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9. A multicenter, open, noncomparative, phase II study of the combination of cladribine (2-chlorodeoxyadenosine), cytarabine, granulocyte colony-stimulating factor and mitoxantrone as induction therapy in refractory acute myeloid leukemia: a report of the Polish Adult Leukemia Group

Author

Wrzesień-Kuś, A., Robak, T., Wierzbowska, A., Lech-Marańda, E., Pluta, A., Wawrzyniak, E., Krawczyńska, A., Kuliczkowski, K., Mazur, G., Kiebiński, M., Dmoszyńska, A., Wach, M., Hellmann, A., Baran, W., Hołowiecki, J., Kyrcz-Krzemień, S., and Grosicki, S.

Published
2005
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10. Addition of cladribine to daunorubicin and cytarabine increases complete remission rate after a single course of induction treatment in acute myeloid leukemia. Multicenter, phase III study

Author

Holowiecki, J, Grosicki, S, Robak, T, Kyrcz-Krzemien, S, Giebel, S, Hellmann, A, Skotnicki, A, Jedrzejczak, W W, Konopka, L, Kuliczkowski, K, Zdziarska, B, Dmoszynska, A, Marianska, B, Pluta, A, Zawilska, K, Komarnicki, M, Kloczko, J, Sulek, K, Haus, O, Stella-Holowiecka, B, Baran, W, Jakubas, B, Paluszewska, M, Wierzbowska, A, Kielbinski, M, and Jagoda, K

Published
2004
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13. High-dose chemotherapy with autologous stem cell transplantation is an effective treatment of primary refractory Hodgkin's disease. Retrospective study of the Polish Lymphoma Research Group

Author

Czyż, J, Hellmann, A, Dziadziuszko, R, Hansz, J, Goździk, J, Hołowiecki, J, Stella-Hołowiecka, B, Kachel, Ł, Knopińska-Posłuszny, W, Nagler, A, Meder, J, Walewski, J, Lampka, E, Sułek, K, Sawicki, W, Lange, A, Forgacz, K, Suchnicki, K, Pacuszko, T, Skotnicki, A, Mensah, P, Jurczak, W, Kuliczkowski, K, Wróbel, T, Mazur, G, Dmoszyńska, A, Wach, M, Robak, T, and Warzocha, K

Published
2002
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15. Rituximab (Mabthera™, rituxan™) in patients with recurrent indolent lymphoma: Evaluation of safety and efficacy in a multicenter study

Author

Walewski, J., Kraszewska, E., Mioduszewska, O., Romejko-Jarosińska, J., Hellmann, A., Czyż, J., Hołowiecki, J., Kopera, M., Grosicki, S., Komarnicki, M., Rumianowski, L., Kuliczkowski, K., Wróbel, T., Dwilewicz-Trojaczek, J., Robak, T., Warzocha, K., Załuski, J., Wójcik, E., Dmoszyńska, A., Walter-Croneck, A., and the Polish Lymphoma Research Group

Published
2001
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27. A multicenter, open, non-comparative, phase II study of the combination of cladribine (2-chlorodeoxyadenosine), cytarabine, and G-CSF as induction therapy in refractory acute myeloid leukemia – a report of the Polish Adult Leukemia Group (PALG)

Author

Wrzesień-Kuś, A., Robak, T., Lech-Marańda, E., Wierzbowska, A., Dmoszyńska, A., Kowal, M., Hołowiecki, J., Kyrcz-Krzemień, S., Grosicki, S., Maj, S., Hellmann, A., Skotnicki, A., J&OV0311;drzejczak, W., and Kuliczkowski, K.

Published
2003

28. Cladribine with or without prednisone in the treatment of previously treated and untreated B-cell chronic lymphocytic leukaemia - updated results of the multicentre study of 378 patients

Author

Robak, T., Błoński, J. Z., Kasznicki, M., Konopka, L., Ceglarek, B., Dmoszyńska, A., Soroka-Wojtaszko, M., Skotnicki, A. B., Nowak, W., Dwilewicz-Trojaczek, J., Tomaszewska, A., Hellmann, A., Lewandowski, K., Kuliczkowski, K., Potoczek, S., Zdziarska, B., Hansz, J., Kroll, R., Komarnicki, M., Hołowiecki, J., and Grieb, P.

Published
2000

29. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Mohty, M. Terpos, E. Mateos, M.-V. Cavo, M. Lejniece, S. Beksac, M. Bekadja, M.A. Legiec, W. Dimopoulos, M. Stankovic, S. Durán, M.S. De Stefano, V. Corso, A. Kochkareva, Y. Laane, E. Berthou, C. Salwender, H. Masliak, Z. Pečeliūnas, V. Willenbacher, W. Silva, J. Louw, V. Nemet, D. Borbényi, Z. Abadi, U. Pedersen, R.S. Černelč, P. Potamianou, A. Couturier, C. Feys, C. Thoret-Bauchet, F. Boccadoro, M. Bekadja, M. Hamladji, R.-M. Ali, H.A. Hamdi, S. Touhami, H. Mansour, N.S. Linkesch, W. Abildgaard, N. Hein, M. Eveillard, J.R. Yamani, A.E. Moreau, P. Sanhes, L. Lepeu, G. Laribi, K. Jourdan, E. Fitoussi, O. Allangba, O. Fleury, J. Escoffre, M. Benramdane, R. Cartron, G. Dine, G. Legouffe, E. Harich, H.-D. Illmer, T. Dörfel, S. Hannig, C.V. Koenigsmann, M. Prange-Krex, G. Tamm, I. Zeller, W. Maasberg, M. Schlag, R. Klausmann, M. Uhlig, J. Alkemper, B. Schütz, S. Tessen, H.-W. Mohr, B. Schmidt, P. Heinrich, B. Hebart, H. Seipelt, G. Zoeller, T. Heits, F. Müller-Naendrup, C. Hansen, R. Repp, R. Von Weikersthal, L.F. Schmits, R. Heßling, J. Krammer-Steiner, B. Janzen, V. Schauer, M. Grüner, M.W. Kisro, J. Denzlinger, C. Freier, W. Junghanss, C. Görner, M. Laichinger, K. Ostermann, H. Dürk, H. Hess, G. Reich, G. Matsouka, P. Pouli, A. Anagnostopoulos, A. Masszi, T. Ivanyi, J. Szomor, A. Nagler, A. Magen, H. Avivi, I. Quitt, M. Palumbo, A. Za, T. Vallisa, D. Foa, R. Bosi, A. Vacca, A. Lanza, F. Palazzo, G. Avvisati, G. Ferrara, F. Consoli, U. Cantonetti, M. Angelucci, E. Califano, C. Di Raimondo, F. Guarini, A. Musso, M. Pizzuti, M. Giuliani, N. Ardizzoia, A. Di Renzo, N. Gaidano, G. Gozzetti, A. Pitini, V. Farina, G. Centurioni, R. De Fabritiis, P. Iuliano, F. La Nasa, G. La Verde, G. Pane, F. Recine, U. La Targia, M. Mineo, G. Cangialosi, C. Fagnani, D. Federici, A. Romano, A. Specchia, G. Storti, S. Bongarzoni, V. Bacigalupo, A. Gobbi, M. Latte, G. Mannina, D. Capalbo, S. Jurgutis, M. Woszczyk, D. Hołojda, J. Gornik, S. Pluta, A. Morawiec-Szymonik, E. Kyrcz-Krzemien, S. Homenda, W. Grosicki, S. Sulek, K. Lange, A. Kloczko, J. Starzak-Gwozdz, J. Hellmann, A. Komarnicki, M. Kuliczkowski, K. Viveiros, C. Gonçalves, C. Esefyeva, N. Kaplanov, K. Volodicheva, E. Laricheva, E. Dergacheva, V. Chukavina, M. Volchenko, N. Nazarova, I. Anchukova, L. Ovanesova, E. Salogub, G. Magomedova, L. Kuznetsova, I. Osyunikhina, S. Serdyuk, O. Karyagina, E. Ivanova, V. Černelč, S.P. Coetzee, C. Gunther, K. Moodley, D. Duran, S. Gutiérrez, A.E. De Oteyza, J.P. Capote, F.J. Casanova, M. Sanchez, J.M. Rios-Herranz, E. Ibañez-Garcia, J. Herranz, M.J. Hernandez, B. Sanchez, S.S. Escalante, F. Carnicero, F. Lleonart, J.B. Gironella, M. Martínez, R. De La Guia, A.L. Palomera, L. Iglesias, R. Ramos, F.S. De La Serna, J. Sanchez, P.G. Vidal, J.B. Morfa, M.D. Beksac, T.-M. Vural, F. Aydin, Y. Unal, A. Goker, H. Bilgir, O. Guvenc, B. Turgut, M. Ozet, G.G. Ali, R. Kyselyova, M. Glushko, N. Vybyrana, R. Skrypnyk, I. Tretyak, N. Kharchevska, T. Dyagil, I. Popovs'ka, T. Shimanskiy, V. Lysa, T. Oliynyk, H. Vilchevskaya, K. Kryachok, I. Popovych, Y. Romanyuk, N. Yushchenko, N. Kaplan, P. Rekhtman, G. Pylypenko, H. Kozlov, V. Drach, J. Harousseau, J.-L. Einsele, H. Goldschmidt, H. Facon, T. Michalet, M. Savchenko, V.G. De la Rubia, J. Cook, G. Mellqvist, U.-H. Ludwig, H. EMMOS Investigators

Abstract

Multiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and 2%, and 27% and 27%, 27% and 23%, and 6% and 4%, respectively. In the SCT and non-SCT patients, the overall response rate was 86% to 97% and 64% to 85% in line 1, 74% to 78% and 59% to 68% in line 2, 55% to 83% and 48% to 60% in line 3, and 49% to 65% and 36% and 45% in line 4, respectively, for regimens that included bortezomib and/or thalidomide/lenalidomide. Conclusion: The results of our prospective study have revealed great diversity in the treatment regimens used to manage MM in real-life practice. This diversity was linked to factors such as novel agent accessibility and evolving treatment recommendations. Our results provide insight into associated clinical benefits. © 2018 The Authors

Published
2018

30. Multiple Myeloma Treatment in Real-world Clinical Practice: Results of a Prospective, Multinational, Noninterventional Study

Author

Mohty, M., Terpos, E., Mateos, M. -V., Cavo, M., Lejniece, S., Beksac, M., Bekadja, M. A., Legiec, W., Dimopoulos, M., Stankovic, S., Duran, M. S., De Stefano, Valerio, Corso, A., Kochkareva, Y., Laane, E., Berthou, C., Salwender, H., Masliak, Z., Peceliunas, V., Willenbacher, W., Silva, J., Louw, V., Nemet, D., Borbenyi, Z., Abadi, U., Pedersen, R. S., Cernelc, P., Potamianou, A., Couturier, C., Feys, C., Thoret-Bauchet, F., Boccadoro, M., Bekadja, M., Hamladji, R. -M., Ali, H. A., Hamdi, S., Touhami, H., Mansour, N. S., Linkesch, W., Abildgaard, N., Hein, M., Eveillard, J. R., Yamani, A. E., Moreau, P., Sanhes, L., Lepeu, G., Laribi, K., Jourdan, E., Fitoussi, O., Allangba, O., Fleury, J., Escoffre, M., Benramdane, R., Cartron, G., Dine, G., Legouffe, E., Harich, H. -D., Illmer, T., Dorfel, S., Hannig, C. V., Koenigsmann, M., Prange-Krex, G., Tamm, I., Zeller, W., Maasberg, M., Schlag, R., Klausmann, M., Uhlig, J., Alkemper, B., Schutz, S., Tessen, H. -W., Mohr, B., Schmidt, P., Heinrich, B., Hebart, H., Seipelt, G., Zoeller, T., Heits, F., Muller-Naendrup, C., Hansen, R., Repp, R., Von Weikersthal, L. F., Schmits, R., Hessling, J., Krammer-Steiner, B., Janzen, V., Schauer, M., Gruner, M. W., Kisro, J., Denzlinger, C., Freier, W., Junghanss, C., Gorner, M., Laichinger, K., Ostermann, H., Durk, H., Hess, G., Reich, G., Matsouka, P., Pouli, A., Anagnostopoulos, A., Masszi, T., Ivanyi, J., Szomor, A., Nagler, A., Magen, H., Avivi, I., Quitt, M., Palumbo, A., Za, Tommaso, Vallisa, D., Foa, R., Bosi, A., Vacca, A., Lanza, F., Palazzo, G., Avvisati, G., Ferrara, F., Consoli, U., Cantonetti, M., Angelucci, E., Califano, C., Di Raimondo, F., Guarini, A., Musso, M., Pizzuti, M., Giuliani, N., Ardizzoia, A., Di Renzo, N., Gaidano, G., Gozzetti, A., Pitini, V., Farina, G., Centurioni, R., De Fabritiis, P., Iuliano, F., La Nasa, G., La Verde, G., Pane, F., Recine, U., La Targia, M., Mineo, G., Cangialosi, C., Fagnani, D., Federici, A., Romano, A., Specchia, G., Storti, Sergio, Bongarzoni, V., Bacigalupo, Andrea, Gobbi, M., Latte, G., Mannina, D., Capalbo, S., Jurgutis, M., Woszczyk, D., Holojda, J., Gornik, S., Pluta, A., Morawiec-Szymonik, E., Kyrcz-Krzemien, S., Homenda, W., Grosicki, S., Sulek, K., Lange, A., Kloczko, J., Starzak-Gwozdz, J., Hellmann, A., Komarnicki, M., Kuliczkowski, K., Viveiros, C., Goncalves, C., Esefyeva, N., Kaplanov, K., Volodicheva, E., Laricheva, E., Dergacheva, V., Chukavina, M., Volchenko, N., Nazarova, I., Anchukova, L., Ovanesova, E., Salogub, G., Magomedova, L., Kuznetsova, I., Osyunikhina, S., Serdyuk, O., Karyagina, E., Ivanova, V., Cernelc, S. P., Coetzee, C., Gunther, K., Moodley, D., Duran, S., Gutierrez, A. E., De Oteyza, J. P., Capote, F. J., Casanova, M., Sanchez, J. M., Rios-Herranz, E., Ibanez-Garcia, J., Herranz, M. J., Hernandez, B., Sanchez, S. S., Escalante, F., Carnicero, F., Lleonart, J. B., Gironella, M., Martinez, R., De La Guia, A. L., Palomera, L., Iglesias, R., Ramos, F. S., De La Serna, J., Sanchez, P. G., Vidal, J. B., Morfa, M. D., Beksac, T. -M., Vural, F., Aydin, Y., Unal, A., Goker, H., Bilgir, O., Guvenc, B., Turgut, M., Ozet, G. G., Ali, R., Kyselyova, M., Glushko, N., Vybyrana, R., Skrypnyk, I., Tretyak, N., Kharchevska, T., Dyagil, I., Popovs'Ka, T., Shimanskiy, V., Lysa, T., Oliynyk, H., Vilchevskaya, K., Kryachok, I., Popovych, Y., Romanyuk, N., Yushchenko, N., Kaplan, P., Rekhtman, G., Pylypenko, H., Kozlov, V., Drach, J., Harousseau, J. -L., Einsele, H., Goldschmidt, H., Facon, T., Michalet, M., Savchenko, V. G., De la Rubia, J., Cook, G., Mellqvist, U. -H., Ludwig, H., De Stefano V. (ORCID:0000-0002-5178-5827), Za T., Storti S. (ORCID:0000-0002-4374-3985), Bacigalupo A. (ORCID:0000-0002-9119-567X), Mohty, M., Terpos, E., Mateos, M. -V., Cavo, M., Lejniece, S., Beksac, M., Bekadja, M. A., Legiec, W., Dimopoulos, M., Stankovic, S., Duran, M. S., De Stefano, Valerio, Corso, A., Kochkareva, Y., Laane, E., Berthou, C., Salwender, H., Masliak, Z., Peceliunas, V., Willenbacher, W., Silva, J., Louw, V., Nemet, D., Borbenyi, Z., Abadi, U., Pedersen, R. S., Cernelc, P., Potamianou, A., Couturier, C., Feys, C., Thoret-Bauchet, F., Boccadoro, M., Bekadja, M., Hamladji, R. -M., Ali, H. A., Hamdi, S., Touhami, H., Mansour, N. S., Linkesch, W., Abildgaard, N., Hein, M., Eveillard, J. R., Yamani, A. E., Moreau, P., Sanhes, L., Lepeu, G., Laribi, K., Jourdan, E., Fitoussi, O., Allangba, O., Fleury, J., Escoffre, M., Benramdane, R., Cartron, G., Dine, G., Legouffe, E., Harich, H. -D., Illmer, T., Dorfel, S., Hannig, C. V., Koenigsmann, M., Prange-Krex, G., Tamm, I., Zeller, W., Maasberg, M., Schlag, R., Klausmann, M., Uhlig, J., Alkemper, B., Schutz, S., Tessen, H. -W., Mohr, B., Schmidt, P., Heinrich, B., Hebart, H., Seipelt, G., Zoeller, T., Heits, F., Muller-Naendrup, C., Hansen, R., Repp, R., Von Weikersthal, L. F., Schmits, R., Hessling, J., Krammer-Steiner, B., Janzen, V., Schauer, M., Gruner, M. W., Kisro, J., Denzlinger, C., Freier, W., Junghanss, C., Gorner, M., Laichinger, K., Ostermann, H., Durk, H., Hess, G., Reich, G., Matsouka, P., Pouli, A., Anagnostopoulos, A., Masszi, T., Ivanyi, J., Szomor, A., Nagler, A., Magen, H., Avivi, I., Quitt, M., Palumbo, A., Za, Tommaso, Vallisa, D., Foa, R., Bosi, A., Vacca, A., Lanza, F., Palazzo, G., Avvisati, G., Ferrara, F., Consoli, U., Cantonetti, M., Angelucci, E., Califano, C., Di Raimondo, F., Guarini, A., Musso, M., Pizzuti, M., Giuliani, N., Ardizzoia, A., Di Renzo, N., Gaidano, G., Gozzetti, A., Pitini, V., Farina, G., Centurioni, R., De Fabritiis, P., Iuliano, F., La Nasa, G., La Verde, G., Pane, F., Recine, U., La Targia, M., Mineo, G., Cangialosi, C., Fagnani, D., Federici, A., Romano, A., Specchia, G., Storti, Sergio, Bongarzoni, V., Bacigalupo, Andrea, Gobbi, M., Latte, G., Mannina, D., Capalbo, S., Jurgutis, M., Woszczyk, D., Holojda, J., Gornik, S., Pluta, A., Morawiec-Szymonik, E., Kyrcz-Krzemien, S., Homenda, W., Grosicki, S., Sulek, K., Lange, A., Kloczko, J., Starzak-Gwozdz, J., Hellmann, A., Komarnicki, M., Kuliczkowski, K., Viveiros, C., Goncalves, C., Esefyeva, N., Kaplanov, K., Volodicheva, E., Laricheva, E., Dergacheva, V., Chukavina, M., Volchenko, N., Nazarova, I., Anchukova, L., Ovanesova, E., Salogub, G., Magomedova, L., Kuznetsova, I., Osyunikhina, S., Serdyuk, O., Karyagina, E., Ivanova, V., Cernelc, S. P., Coetzee, C., Gunther, K., Moodley, D., Duran, S., Gutierrez, A. E., De Oteyza, J. P., Capote, F. J., Casanova, M., Sanchez, J. M., Rios-Herranz, E., Ibanez-Garcia, J., Herranz, M. J., Hernandez, B., Sanchez, S. S., Escalante, F., Carnicero, F., Lleonart, J. B., Gironella, M., Martinez, R., De La Guia, A. L., Palomera, L., Iglesias, R., Ramos, F. S., De La Serna, J., Sanchez, P. G., Vidal, J. B., Morfa, M. D., Beksac, T. -M., Vural, F., Aydin, Y., Unal, A., Goker, H., Bilgir, O., Guvenc, B., Turgut, M., Ozet, G. G., Ali, R., Kyselyova, M., Glushko, N., Vybyrana, R., Skrypnyk, I., Tretyak, N., Kharchevska, T., Dyagil, I., Popovs'Ka, T., Shimanskiy, V., Lysa, T., Oliynyk, H., Vilchevskaya, K., Kryachok, I., Popovych, Y., Romanyuk, N., Yushchenko, N., Kaplan, P., Rekhtman, G., Pylypenko, H., Kozlov, V., Drach, J., Harousseau, J. -L., Einsele, H., Goldschmidt, H., Facon, T., Michalet, M., Savchenko, V. G., De la Rubia, J., Cook, G., Mellqvist, U. -H., Ludwig, H., De Stefano V. (ORCID:0000-0002-5178-5827), Za T., Storti S. (ORCID:0000-0002-4374-3985), and Bacigalupo A. (ORCID:0000-0002-9119-567X)

Abstract

Multiple myeloma (MM) remains an incurable disease, with little information available on its management in real-world clinical practice. The results of the present prospective, noninterventional observational study revealed great diversity in the treatment regimens used to treat MM. Our results also provide data to inform health economic, pharmacoepidemiologic, and outcomes research, providing a framework for the design of protocols to improve the outcomes of patients with MM. Background: The present prospective, multinational, noninterventional study aimed to document and describe real-world treatment regimens and disease progression in multiple myeloma (MM) patients. Patients and Methods: Adult patients initiating any new MM therapy from October 2010 to October 2012 were eligible. A multistage patient/site recruitment model was applied to minimize the selection bias; enrollment was stratified by country, region, and practice type. The patient medical and disease features, treatment history, and remission status were recorded at baseline, and prospective data on treatment, efficacy, and safety were collected electronically every 3 months. Results: A total of 2358 patients were enrolled. Of these patients, 775 and 1583 did and did not undergo stem cell transplantation (SCT) at any time during treatment, respectively. Of the patients in the SCT and non-SCT groups, 49%, 21%, 14%, and 15% and 57%, 20%, 12% and 10% were enrolled at treatment line 1, 2, 3, and ≥ 4, respectively. In the SCT and non-SCT groups, 45% and 54% of the patients had received bortezomib-based therapy without thalidomide/lenalidomide, 12% and 18% had received thalidomide/lenalidomide-based therapy without bortezomib, and 30% and 4% had received bortezomib plus thalidomide/lenalidomide-based therapy as frontline treatment, respectively. The corresponding proportions of SCT and non-SCT patients in lines 2, 3, and ≥ 4 were 45% and 37%, 30% and 37%, and 12% and 3%, 33% and 27%, 35% and 32%, and 8% and

Published
2018

31. Immune Thrombocytopenia and JAK2V617F Positive Essential Thrombocythemia: Literature Review and Case Report

Author

Sobas, M. A., Wróbel, T., Zduniak, K., Podolak-Dawidziak, M., Rybka, J., Biedroń, M., Sawicki, M., Dybko, J., and Kuliczkowski, K.

Subjects
Article Subject, hemic and lymphatic diseases
Abstract

We present the case where immune thrombocytopenia (ITP) and essential thrombocythemia (ET) sequentially appeared in the space of twenty-one years of follow-up. Impaired platelet production is present in both diseases, but clinical presentation and treatment are different. On the basis of this case history a possible role of autoimmunity as a predisposing factor to myeloproliferation has been discussed.

Published
2017
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32. Phase 2 study of tabalumab, a human anti-B-cell activating factor antibody, with bortezomib and dexamethasone in patients with previously treated multiple myeloma

Author

Raje, N.S. Moreau, P. Terpos, E. Benboubker, L. Grząśko, N. Holstein, S.A. Oriol, A. Huang, S.-Y. Beksac, M. Kuliczkowski, K. Tai, D.F. Wooldridge, J.E. Conti, I. Kaiser, C.J. Nguyen, T.S. Cronier, D.M. Palumbo, A.

Abstract

In this double-blind, Phase 2 study, 220 patients with relapsed/refractory multiple myeloma were randomly assigned 1:1:1 to receive placebo (N�=�72), tabalumab 100�mg (N�=�74), or tabalumab 300�mg (N�=�74), each in combination with dexamethasone 20�mg and subcutaneous bortezomib 1�3�mg/m2 on a 21-day cycle. No significant intergroup differences were observed among primary (median progression-free survival [mPFS]) or secondary efficacy outcomes. The mPFS was 6�6, 7�5 and 7�6�months for the tabalumab 100, 300�mg and placebo groups, respectively (tabalumab 100�mg vs. placebo Hazard ratio (HR) [95% confidence interval (CI)]�=�1�13 [0�80–1�59], P�=�0�480; tabalumab 300�mg vs. placebo HR [95% CI]�=�1�03 [0�72–1�45], P�=�0�884). The most commonly-reported treatment-emergent adverse events were thrombocytopenia (37%), fatigue (37%), diarrhoea (35%) and constipation (32%). Across treatments, patients with low baseline BAFF (also termed TNFSF13B) expression (n�=�162) had significantly longer mPFS than those with high BAFF expression (n�=�55), using the 75th percentile cut-off point (mPFS [95% CI]�=�8�3 [7�0–9�3] months vs. 5�8 [3�7–6�6] months; HR [95% CI]�=�1�59 [1�11–2�29], P�=�0�015). Although generally well tolerated, PFS was not improved during treatment with tabalumab compared to placebo. A higher dose of 300�mg tabalumab did not improve efficacy compared to the 100�mg dose. Nonetheless, BAFF appears to have some prognostic value in patients with multiple myeloma. � 2016 John Wiley & Sons Ltd

Published
2017

33. Increased percentage of CD8 CD28– suppressor lymphocytes in peripheral blood and skin infiltrates correlates with advanced disease in patients with cutaneous T-cell lymphomas

Author

Urbaniak-Kujda, D., Kapelko-Słowik, K., Wołowiec, D., Dybko, J., Hałoń, A., Bożena Jaźwiec, Maj, J., Jankowska-Konsur, A., and Kuliczkowski, K.

Subjects
Adult, Aged, 80 and over, Male, Skin Neoplasms, Cutaneous T-cell lymphoma, lcsh:R, lcsh:Medicine, Middle Aged, Lymphoma, T-Cell, Cutaneous, CD28 Antigens, T-Lymphocyte Subsets, Case-Control Studies, Humans, Female, CD8 CD28– lymphocytes, Aged, Neoplasm Staging
Abstract

Introduction: T cells with the CD8 CD28– phenotype are CD8 lymphocytes with regulatory function. Their increased numbers were observed in infections, autoimmune and neoplastic diseases, and in elderly healthy individuals. CD8 CD28– lymphocyte levels in patients with cutaneous T-cell lymphoma (CTCL) has not yet been described. The aim of the study was to determine their levels in these patients’ peripheral blood and cutaneous infiltrates and their relation to the clinical stage of disease.Material/Methods: Forty-one untreated patients, 26 males and 15 females, with CTCL were enrolled in the study. CD8 CD28– lymphocyte levels were determined by flow cytometry in peripheral blood and by immunochemistry in skin infiltrates.Results: The percentage of CD8 CD28– lymphocytes in the peripheral blood of the patients was significantly higher than in the controls. Patients with advanced disease displayed a higher percentage of CD8 CD28– lymphocytes in the peripheral blood and skin than did the individuals with early stages of the disease. Moreover, positive correlations between CD8 CD28– lymphocyte level in peripheral blood and age, clinical stage, and the levels in the skin infiltrates was revealed. Additionally, the percentage of CD8 CD28– T cells in the skin infiltrates correlated positively with age and clinical stage of the disease.Conclusions: These data suggest that CD8 CD28– lymphocytes play an important role in the development of immunotolerance in the progression of cutaneous T-cell lymphoma.

Published
2009

34. A phase 2, multicenter study investigating ofatumumab and bendamustine combination in patients with untreated or relapsed CLL

Author

Flinn, I.W. Panayiotidis, P. Afanasyev, B. Janssens, A. Grosicki, S. Homenda, W. Smolej, L. Kuliczkowski, K. Doubek, M. Domnikova, N. West, S.L. Chang, C.-N. Barker, A.M. Gupta, I.V. Wright, O.J. Offner, F.

Abstract

The purpose of this study is to assess the safety and efficacy of the combination of ofatumumab and bendamustine in patients with previously untreated or relapsed chronic lymphocytic leukemia. Patients received IV ofatumumab (cycle 1: 300 mg day 1 and 1,000 mg day 8; cycles 2–6: 1,000 mg on day 1 every 28 days) and IV bendamustine 90 mg m−2 (previously untreated) or 70 mg m−2 (relapsed) on days 1 and 2 of each 28-day cycle, for up to 6 cycles. Forty-four previously untreated and 53 relapsed patients were enrolled. Median age was 62.5 years (previously untreated) and 68 years (relapsed); relapsed patients had received a median of 1 (range 1–11) prior therapy. The investigator-assessed overall response rate was 95% (43% complete response [CR]) for the previously untreated, and 74% (11% CR) for the relapsed patients. The regimen was well tolerated with 89% (previously untreated) and 85% (relapsed patients) receiving all 6 cycles. No unexpected toxicities were reported. Grade 3/4 events occurred in 57% of previously untreated, and 72% of relapsed patients. At ∼29 months’ follow-up, the median progression-free survival (PFS) was not reached for the previously untreated population, and the 28-month PFS estimate was 72.3%. The median PFS for the relapsed population was 22.5 months (95% CI: 14.0–27.3 months). The combination of ofatumumab and bendamustine was well tolerated and effective in these previously untreated or relapsed populations. Am. J. Hematol. 91:900–906, 2016. © 2016 Wiley Periodicals, Inc. © 2016 Wiley Periodicals, Inc.

Published
2016

35. Eltrombopag before procedures in patients with cirrhosis and thrombocytopenia

Author

Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Bessonova E, Bilodeau M, Bloomer J, Botta Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, ANDREONE, PIETRO, MAZZELLA, GIUSEPPE, Afdhal, NH, Giannini, EG, Tayyab, G, Mohsin, A, Lee, JW, Andriulli, A, Jeffers, L, McHutchison, J, Chen, PJ, Han, KH, Campbell, F, Hyde, D, Brainsky, A, Theodore, D, Craxi, A, Afdhal NH, Giannini EG, Tayyab G, Mohsin A, Lee JW, Andriulli A, Jeffers L, McHutchison J, Chen PJ, Han KH, Campbell F, Hyde D, Brainsky A, Theodore D, ELEVATE Study Group […, Akram J, Andreone P, Bessonova E, Bilodeau M, Bloomer J, Botta-Fridlund D, Bzowej N, Calmus Y, Carbonell N, Caro Patón A, Cholewinska G, Chuang WL, Colombato L, Colombo M, Craxi A, Di Leo A, Diago M, Dumortier J, Elkasahab M, Everson G, Fallon M, Fedeli G, Finazzi R, Fontanella A, Francavilla A, Gadano A, Gambarin-Gelwan M, Gordon F, Graus Morales J, Grieco A, Gugenheim J, Homenda W, Iaquinto G, Kang H, Khan Z, Kuliczkowski K, Kwo P, Lee JH, Lee W, Lee YS, Mazur W, Mazzella G, Moreno C, Morozov V, Muñoz A, Navasa Anadón M, Nijhawan S, Pinzello G, Poordad F, Prieto Castillo M, Rafalsky V, Rapaccini G, Regenstein F, Rewak W, Riley T, Ripoll Noiseux C, Rizzetto M, Rodrigo Lopez J, Russo M, Samuel D, Sánchez Antolín G, Satyanaryana R, Savarino V, Shiffman M, Sigal S, Solá Lamoglia R, Sterling R, Tanno H, Te H, Terg R, Thuluvath P, Trepo C, Vargas H, Xiol Quingles X, Zaman A, Fontana R, Kim K, Abrams C, Gish R, Cardenas A, and …]

Subjects
Liver Cirrhosis, Male, Cirrhosis, Chronic liver disease, Benzoates, law.invention, chemistry.chemical_compound, Randomized controlled trial, law, Receptors, Clinical endpoint, 80 and over, Medicine, CIRRHOSIS, Aged, 80 and over, Benzoic Acids, General Medicine, CHRONIC LIVER DISEASE, Middle Aged, Hydrazines, Thrombopoietin, Elective Surgical Procedures, Anesthesia, Female, Elective Surgical Procedure, Receptors, Thrombopoietin, Adult, Adolescent, Eltrombopag, ELTROMBOPAG, Hemorrhage, Platelet Transfusion, Placebo, Young Adult, Double-Blind Method, Elective, Surgical Procedures, Elective, Humans, Aged, THROMBOCYTOPENIA, Surgical Procedures, business.industry, Platelet Count, cirrhosis, Settore MED/09 - MEDICINA INTERNA, medicine.disease, Thrombocytopenia, Platelet transfusion, chemistry, Chronic Disease, Pyrazoles, business
Abstract

Eltrombopag is an oral thrombopoietin-receptor agonist. This study evaluated the efficacy of eltrombopag for increasing platelet counts and reducing the need for platelet transfusions in patients with thrombocytopenia and chronic liver disease who are undergoing an elective invasive procedure.We randomly assigned 292 patients with chronic liver disease of diverse causes and platelet counts of less than 50,000 per cubic millimeter to receive eltrombopag, at a dose of 75 mg daily, or placebo for 14 days before a planned elective invasive procedure that was performed within 5 days after the last dose. The primary end point was the avoidance of a platelet transfusion before, during, and up to 7 days after the procedure. A key secondary end point was the occurrence of bleeding (World Health Organization [WHO] grade 2 or higher) during this period.A platelet transfusion was avoided in 104 of 145 patients who received eltrombopag (72%) and in 28 of 147 who received placebo (19%) (P0.001). No significant difference between the eltrombopag and placebo groups was observed in bleeding episodes of WHO grade 2 or higher, which were reported in 17% and 23% of patients, respectively. Thrombotic events of the portal venous system were observed in 6 patients who received eltrombopag, as compared with 1 who received placebo, resulting in the early termination of the study. The incidence and severity of other adverse events were similar in the eltrombopag and placebo groups.Eltrombopag reduced the need for platelet transfusions in patients with chronic liver disease who were undergoing elective invasive procedures, but it was associated with an increased incidence of portal-vein thrombosis, as compared with placebo. (Funded by GlaxoSmithKline; ELEVATE ClinicalTrials.gov number, NCT00678587.).

Published
2012

36. Nilotinib versus imatinib for newly diagnosed chronic myeloid leukemia

Author

Saglio G, Kim DW, Issaragrisil S, le Coutre P, Etienne G, Lobo C, Pasquini R, Clark RE, Hochhaus A, Hughes TP, Gallagher N, Hoenekopp A, Dong M, Haque A, Larson RA, Kantarjian HM, Moiraghi B, Perez M, Greil R, Valent P, Bosly A, Martiat P, Noens L, André M, Verhoef G, Conchon M, Souza C, Nonino A, Hungria V, Zanichelli MA, Colturato V, Forrest D, Lipton JH, Savoie ML, Delage R, Lalancette M, Quintero G, Gomez M, Klamova H, Faber E, Bjerrum OW, Fredriksen H, Vestergaard H, Marcher C, Kamel H, Elzawam H, Porkka K, Remes K, Reiffers J, Guilhot F, Facon T, Tulliez M, Guerci Bresler AP, Nicolini FE, Charbonnier A, Rea D, Johnson Ansah A, Legros L, Harousseau JL, Rigal Huguet F, Escoffre M, Gardembas M, Guyotat D, Cahn JY, Gattermann N, Ottmann O, Niederwieser D, Stegelmann F, Schafhausen P, Brümmendorf T, Duyster J, Blumenstengel K, Scheid C, Kneba M, Kwong YL, Masszi T, Petrini M, Alimena G, Di Raimondo F, Rosti G, Rotoli B, Pungolino E, Amadori S, Abruzzese E, Fioritoni G, Lauria F, Bosi A, Martelli M, Rambaldi A, Ferrara F, Nobile F, Gobbi M, Carella AM, Orlandi EM, Leoni P, Tiribelli M, Levis A, Imamura M, Takahashi N, Tsukamoto N, Chiba S, Nagai T, Okamoto S, Miura O, Kurokawa M, Ohnishi K, Toba K, Nakao S, Tomita A, Miyamura K, Hino M, Maeda Y, Kimura A, Kawaguchi T, Miyazaki Y, Nakaseko C, Jinnai I, Matsuda A, Matsumura I, Ishikawa J, Ohyashiki K, Okada M, Usuki K, Kobayashi Y, Ohishi K, Imai K, Miyawaki S, Kanda Y, Park SY, Kim HJ, Sohn SK, Lee KH, Jung CW, Ong TC, Gómez Almaguer D, Kassack J, Ossenkoppele GJ, Gedde Dahl T, Hjorth Hansen H, Jedrzejczak W, Dmoszynska A, Starzak Dwozdz J, Holowiecki J, Kyrcz Krzemieñ S, Kuliczkowski K, Zaritsky A, Turkina A, Pospelova T, Goh YT, Koh LP, Demitrovicova L, Mistrik M, Ruff P, Louw V, Dreosti LM, Novitzky N, Cohen G, Cervantes F, Cañizo C, de Paz R, del Castillo S, Perez Encinas M, Sanz Alonso M, Marin F, Pérez López R, Hernandez Boluda J, Echeveste Gutierrez MA, Odriozola J, Herrera P, Steegman JL, Conde E, Lopez P, Giraldo P, Boque C, Heredia B, Font AJ, Rodriguez RF, Rodriguez MJ, Batlle J, Stenke L, Lehmann S, Wadenvik H, Simonsson B, Markevärn B, Själander A, Richter J, Bjoreman M, Eriksson KM, Chalandon Y, Shih LY, Yao M, Wang MC, Jootar S, Bunworasate U, Ulkü B, Haznedar R, Undar B, Sahin B, Marin D, Smith G, Byrne J, Holyoake T, Kalaycio M, Akard L, Heaney M, Al Janadi A, Goldberg S, Powell B, Harker WG, Shea T, Gingrich R, Glass J, Paquette R, Siegrist C, Woodson M, Fehrenbacher L, Koh H, Flinn I, Arrowsmith E, Ervin T, Guerra M, Wallach H, Berry W, Burke J, Edenfield W, Guzley G, Davis J, Richards D, Schlossman D, Kolibaba K, Alemany C, Savin M, Robbins G, Lopez J, Goldman JM, Camm J, Schiffer CA, Sargent D.J., PANE, FABRIZIO, Saglio, G, Kim, Dw, Issaragrisil, S, le Coutre, P, Etienne, G, Lobo, C, Pasquini, R, Clark, Re, Hochhaus, A, Hughes, Tp, Gallagher, N, Hoenekopp, A, Dong, M, Haque, A, Larson, Ra, Kantarjian, Hm, Moiraghi, B, Perez, M, Greil, R, Valent, P, Bosly, A, Martiat, P, Noens, L, André, M, Verhoef, G, Conchon, M, Souza, C, Nonino, A, Hungria, V, Zanichelli, Ma, Colturato, V, Forrest, D, Lipton, Jh, Savoie, Ml, Delage, R, Lalancette, M, Quintero, G, Gomez, M, Klamova, H, Faber, E, Bjerrum, Ow, Fredriksen, H, Vestergaard, H, Marcher, C, Kamel, H, Elzawam, H, Porkka, K, Remes, K, Reiffers, J, Guilhot, F, Facon, T, Tulliez, M, Guerci Bresler, Ap, Nicolini, Fe, Charbonnier, A, Rea, D, Johnson Ansah, A, Legros, L, Harousseau, Jl, Rigal Huguet, F, Escoffre, M, Gardembas, M, Guyotat, D, Cahn, Jy, Gattermann, N, Ottmann, O, Niederwieser, D, Stegelmann, F, Schafhausen, P, Brümmendorf, T, Duyster, J, Blumenstengel, K, Scheid, C, Kneba, M, Kwong, Yl, Masszi, T, Petrini, M, Alimena, G, Di Raimondo, F, Rosti, G, Rotoli, B, Pane, Fabrizio, Pungolino, E, Amadori, S, Abruzzese, E, Fioritoni, G, Lauria, F, Bosi, A, Martelli, M, Rambaldi, A, Ferrara, F, Nobile, F, Gobbi, M, Carella, Am, Orlandi, Em, Leoni, P, Tiribelli, M, Levis, A, Imamura, M, Takahashi, N, Tsukamoto, N, Chiba, S, Nagai, T, Okamoto, S, Miura, O, Kurokawa, M, Ohnishi, K, Toba, K, Nakao, S, Tomita, A, Miyamura, K, Hino, M, Maeda, Y, Kimura, A, Kawaguchi, T, Miyazaki, Y, Nakaseko, C, Jinnai, I, Matsuda, A, Matsumura, I, Ishikawa, J, Ohyashiki, K, Okada, M, Usuki, K, Kobayashi, Y, Ohishi, K, Imai, K, Miyawaki, S, Kanda, Y, Park, Sy, Kim, Hj, Sohn, Sk, Lee, Kh, Jung, Cw, Ong, Tc, Gómez Almaguer, D, Kassack, J, Ossenkoppele, Gj, Gedde Dahl, T, Hjorth Hansen, H, Jedrzejczak, W, Dmoszynska, A, Starzak Dwozdz, J, Holowiecki, J, Kyrcz Krzemieñ, S, Kuliczkowski, K, Zaritsky, A, Turkina, A, Pospelova, T, Goh, Yt, Koh, Lp, Demitrovicova, L, Mistrik, M, Ruff, P, Louw, V, Dreosti, Lm, Novitzky, N, Cohen, G, Cervantes, F, Cañizo, C, de Paz, R, del Castillo, S, Perez Encinas, M, Sanz Alonso, M, Marin, F, Pérez López, R, Hernandez Boluda, J, Echeveste Gutierrez, Ma, Odriozola, J, Herrera, P, Steegman, Jl, Conde, E, Lopez, P, Giraldo, P, Boque, C, Heredia, B, Font, Aj, Rodriguez, Rf, Rodriguez, Mj, Batlle, J, Stenke, L, Lehmann, S, Wadenvik, H, Simonsson, B, Markevärn, B, Själander, A, Richter, J, Bjoreman, M, Eriksson, Km, Chalandon, Y, Shih, Ly, Yao, M, Wang, Mc, Jootar, S, Bunworasate, U, Ulkü, B, Haznedar, R, Undar, B, Sahin, B, Marin, D, Smith, G, Byrne, J, Holyoake, T, Kalaycio, M, Akard, L, Heaney, M, Al Janadi, A, Goldberg, S, Powell, B, Harker, Wg, Shea, T, Gingrich, R, Glass, J, Paquette, R, Siegrist, C, Woodson, M, Fehrenbacher, L, Koh, H, Flinn, I, Arrowsmith, E, Ervin, T, Guerra, M, Wallach, H, Berry, W, Burke, J, Edenfield, W, Guzley, G, Davis, J, Richards, D, Schlossman, D, Kolibaba, K, Alemany, C, Savin, M, Robbins, G, Lopez, J, Goldman, Jm, Camm, J, Schiffer, Ca, and Sargent, D. J.

Published
2010

37. Efficacy and safety of rVIII-SingleChain: Results of a phase 1/3 multicenter clinical trial in severe hemophilia A

Author

Mahlangu, J., Kuliczkowski, K., Karim, F.A., Stasyshyn, O., Kosinova, M.V., Lepatan, L.M., Skotnicki, A., Boggio, L.N., Klamroth, R., Oldenburg, J., Hellmann, A., Santagostino, E., Baker, R.I., Fischer, K., Gill, J.C., Ng, S.P., Chowdary, P., Escobar, M.A., Khayat, C.D., Rusen, L., Bensen-Kennedy, D., Blackman, N., Limsakun, T., Veldman, A., St. Ledger, K., Pabinger, I., Mahlangu, J., Kuliczkowski, K., Karim, F.A., Stasyshyn, O., Kosinova, M.V., Lepatan, L.M., Skotnicki, A., Boggio, L.N., Klamroth, R., Oldenburg, J., Hellmann, A., Santagostino, E., Baker, R.I., Fischer, K., Gill, J.C., Ng, S.P., Chowdary, P., Escobar, M.A., Khayat, C.D., Rusen, L., Bensen-Kennedy, D., Blackman, N., Limsakun, T., Veldman, A., St. Ledger, K., and Pabinger, I.

Abstract

Recombinant VIII (rVIII)-SingleChain is a novel B-domain-truncated recombinant factor VIII (rFVIII), comprised of covalently bonded factor VIII (FVIII) heavy and light chains. It was designed to have a higher binding affinity for von Willebrand factor (VWF). This phase 1/3 study investigated the efficacy and safety of rVIII-SingleChain in the treatment of bleeding episodes, routine prophylaxis, and surgical prophylaxis. Participants were ≥12 years of age, with severe hemophilia A (endogenous FVIII <1%). The participants were allocated by the investigator to receive rVIII-SingleChain in either an on-demand or prophylaxis regimen. Of the 175 patients meeting study eligibility criteria, 173 were treated with rVIII-SingleChain, prophylactically (N = 146) or on-demand (N = 27). The total cumulative exposure was 14 306 exposure days (EDs), with 120 participants reaching ≥50 EDs and 52 participants having ≥100 EDs. Hemostatic efficacy was rated by the investigator as excellent or good in 93.8% of the 835 bleeds treated and assessed. Across all prophylaxis regimens, the median annualized spontaneous bleeding rate was 0.00 (Q1, Q3: 0.0, 2.4) and the median overall annualized bleeding rate (ABR) was 1.14 (Q1, Q3: 0.0, 4.2). Surgical hemostasis was rated as excellent/good in 100% of major surgeries by the investigator. No participant developed FVIII inhibitors. In conclusion, rVIII-SingleChain is a novel rFVIII molecule showing excellent hemostatic efficacy in surgery and in the control of bleeding events, low ABR in patients on prophylaxis, and a favorable safety profile in this large clinical study. This trial was registered at www.clinicaltrials.gov as #NCT01486927.

Published
2016

39. Bortezomib plus rituximab versus rituximab alone in patients with relapsed, rituximab-naive or rituximab-sensitive, follicular lymphoma: a randomised phase 3 trial

Author

Coiffier, B, Osmanov, E, Hong, X, Scheliga, A, Mayer, J, Offner, F, Rule, S, Teixeira, A, Walewski, J, de Vos, S, Crump, M, Shpilberg, O, Esseltine, D, Zhu, E, Enny, C, Theocharous, P, van de Velde, H, Elsayed, Y, Zinzani, P, Abdulkadyrov, K, Afanasiev, B, Aguayo Gonzalez, A, Andre, M, Belada, D, Ben Yehuda, D, Bezares, R, Biakhov, M, Bolam, S, Borbenyi, Z, Bron, D, Buckstein, R, Bumbea, H, Caballero Barrigon, M, Campos, L, Cantonetti, M, Capra Zanella, M, Christiansen, N, Cohen, G, Colita, N, Cosgriff, T, Culligan, D, Del Giglio, A, Dichmann, R, Dietzfelbinger, H, Digumarti, R, Dmoszynska, A, Domnikova, N, Dubinsky, P, Dunaev, Y, Easow, J, Eberwine, S, Economopoulos, T, Egyed, M, Ellerton, J, Eom, H, Farmer, L, Fenske, T, Fields, P, Fillet, G, Frank, R, Gaisarova, G, Garicochea, B, Gasztonyi, Z, Gavish, I, Gheorghita, E, Gladkov, O, Goldberg, V, Golenkov, A, Gomez Almaguer, D, Gonzalez Barca, E, Guan, Z, Gupta, S, Hellmann, A, Hermann, R, Honkanen, T, Hu, E, Huang, X, Hudecek, J, Illes, A, Intragumtornchai, T, Jedrzejczak, W, Jones, L, Jootar, S, Kahanic, S, Karamanesht, E, Ke, X, Khuageva, N, Kim, W, Kimby, E, Komisarenko, V, Kouroukis, T, Kuliczkowski, K, Kuzina, L, Kyselyova, M, Labanca, V, Lange, A, Le Gouill, S, Leahy, M, Liberati, A, Linden, O, Liu, T, Lubennikov, V, Lundin, J, Lysa, T, Lysenko, I, Lytvyn, I, Makhson, A, Manikhas, G, Masliak, Z, Mcintyre, R, Medvedeva, N, Mena, R, Merkulov, V, Mesters, R, Milpied, N, Min, Y, Moezi, M, Mohrbacher, A, Mollee, P, Morgan, D, Morschhauser, F, Mysanikov, A, Nagler, A, Nair, S, Naparstek, E, Nawarawong, W, Noga, S, Oliveira, I, Okada, C, Oriol Rocafiguera, A, Page, R, Papajik, T, Pasquini, R, Patel, M, Patel, R, Paton, E, Pavlov, V, Pospelova, T, Prasad, S, Pylypenko, H, Raposo, J, Rekhtman, G, Rivas, S, Robak, T, Saba, S, Salles, G, Saltzman, M, Samoilova, O, Samuels, B, Sanani, S, Sebban, C, Silva da Gomes, M, Shen, Z, Shi, Y, Shtalrid, M, Siritanaratkul, N, Skotnicki, A, Solal Celigny, P, Soubeyran, P, Spencer, A, Stevens, D, Suh, C, Sulek, K, Suvorov, A, Szer, J, Theunissen, K, To Bik, L, Tothova, E, Trneny, M, Van De Velde, A, Van Hoof, A, Van Steenweghen, S, Vanhatalo, S, Varma, S, Vidyasagar, M, Vilchevskaya, K, Vitolo, U, Wang, H, Warzocha, K, Wild, A, Zachee, P, Zanichelli, M, Zhang, W, Zoppegno, L, Zoumbos, N, Coiffier B., Osmanov E.A., Hong X., Scheliga A., Mayer J., Offner F., Rule S., Teixeira A., Walewski J., de Vos S., Crump M., Shpilberg O., Esseltine D.L., Zhu E., Enny C., Theocharous P., van de Velde H., Elsayed Y.A., Zinzani P.L., and LYM-3001 study investigators

Subjects
Oncology, Male, Lymphoma, Settore MED/06 - Oncologia Medica, Follicular lymphoma, Bortezomib, Antibodies, Monoclonal, Murine-Derived, 0302 clinical medicine, Maintenance therapy, Prednisone, immune system diseases, Recurrence, hemic and lymphatic diseases, Monoclonal, Antineoplastic Combined Chemotherapy Protocols, 80 and over, Lymphoma, Follicular, Multiple myeloma, Infusion Pumps, Aged, 80 and over, Middle Aged, Boronic Acids, 3. Good health, 030220 oncology & carcinogenesis, Pyrazines, Rituximab, Female, medicine.drug, Murine-Derived, Adult, medicine.medical_specialty, rituximab-naive, Antineoplastic Agents, Antibodies, Disease-Free Survival, 03 medical and health sciences, Young Adult, follicular lymphoma, Internal medicine, Neoplasm Staging, Humans, Aged, medicine, business.industry, Follicular, medicine.disease, Clinical trial, rituximab-sensitive, Immunology, business, Settore MED/15 - Malattie del Sangue, 030215 immunology
Abstract

BACKGROUND: Bortezomib and rituximab have shown additive activity in preclinical models of lymphoma, and have been shown to be active and generally well tolerated in a randomised phase 2 study in patients with follicular and marginal zone lymphoma. We compared the efficacy and safety of rituximab alone or combined with bortezomib in patients with relapsed or refractory follicular lymphoma in a phase 3 setting. METHODS: In this multicentre phase 3 trial, rituximab-naive or rituximab-sensitive patients aged 18 years or older with relapsed grade 1 or 2 follicular lymphoma were randomly assigned (1:1) to receive five 35-day cycles consisting of intravenous infusions of rituximab 375 mg/m(2) on days 1, 8, 15, and 22 of cycle 1, and on day 1 of cycles 2-5, either alone or with bortezomib 1·6 mg/m(2), administered by intravenous injection on days 1, 8, 15, and 22 of all cycles. Randomisation was stratified by FLIPI score, previous use of rituximab, time since last therapy, and region. Treatment assignment was based on a computer-generated randomisation schedule prepared by the sponsor. Patients and treating physicians were not masked to treatment allocation. The primary endpoint was progression-free survival analysed by intention to treat. This trial has been completed and is registered with ClinicalTrials.gov, number NCT00312845. FINDINGS: Between April 10, 2006, and Aug 12, 2008, 676 patients were randomised to receive rituximab (n=340) or bortezomib plus rituximab (n=336). After a median follow-up of 33·9 months (IQR 26·4-39·7), median progression-free survival was 11·0 months (95% CI 9·1-12·0) in the rituximab group and 12·8 months (11·5-15·0) in the bortezomib plus rituximab group (hazard ratio 0·82, 95% CI 0·68-0·99; p=0·039). The magnitude of clinical benefit was not as large as the anticipated prespecified improvement of 33% in progression-free survival. Patients in both groups received a median of five treatment cycles (range 1-5); 245 of 339 (72%) and 237 of 334 (71%) patients in the rituximab and bortezomib plus rituximab groups, respectively, completed five cycles. Of patients who did not complete five cycles, most discontinued early because of disease progression (77 [23%] patients in the rituximab group, and 56 [17%] patients in the bortezomib plus rituximab group). Rates of adverse events of grade 3 or higher (70 [21%] of 339 rituximab-treated patients vs 152 [46%] of 334 bortezomib plus rituximab treated patients), and serious adverse events (37 [11%] patients vs 59 [18%] patients) were lower in the rituximab group than in the combination group. The most common adverse events of grade 3 or higher were neutropenia (15 [4%] patients in the rituximab group and 37 [11%] patients in the bortezomib plus rituximab group), infection (15 [4%] patients and 36 [11%] patients, respectively), diarrhoea (no patients and 25 [7%] patients, respectively), herpes zoster (one [

Published
2011

42. Favorable outcome of patients with normal karyotype acute myeloid leukemia harboring FLT3-ITD and treated with cladribine added to daunorubicin and cytarabine induction

Author

Libura, M., primary, Giebel, S., additional, Piątkowska-Jakubas, B., additional, Pawełczyk, M. Przestrzelska, additional, Florek, I., additional, Matiakowska, K., additional, Jaźwiec, B., additional, Borg, K., additional, Solarska, I., additional, Zawada, M., additional, Czekalska, S., additional, Libura, J., additional, Jakóbczyk, M., additional, Karabin, K., additional, Całbecka, M., additional, Gajkowska-Kulig, J., additional, Gadomska, G., additional, Kiełbiński, M., additional, Ejduk, A., additional, Kata, D., additional, Grosicki, S., additional, Wierzbowska, A., additional, Kyrcz-Krzemień, S., additional, Warzocha, K., additional, Kuliczkowski, K., additional, Skotnicki, A., additional, Hołowiecki, J., additional, Jedrzejczak, W.W., additional, and Haus, O., additional

Published
2015
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43. Leczenie inhibitorami kinazy tyrozynowej drugiej generacji u pacjentów z przewlekłą białaczką szpikową może zmniejszyć ryzyko występowania choroby przeszczep-przeciwko-gospodarzowi po allotransplantacji komórek krwiotwórczych

Author

Dybko, J., primary, Piekarska, A., additional, Gil, L., additional, Zaucha, J.M., additional, Prejzner, W., additional, Urbaniak-Kujda, D., additional, Biernat, M., additional, Wróbel, T., additional, Lewandowski, K., additional, Gniot, M., additional, Hellmann, A., additional, Komarnicki, M., additional, and Kuliczkowski, K., additional

Published
2015
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44. Leczenie sekwencyjne chorych na ostre białaczki szpikowe oporne na chemioterapię z zastosowaniem transplantacji allogenicznych komórek krwiotwórczych po przygotowaniu o zredukowanej toksyczności opartym na fludarabinie i treosulfanie poprzedzonym podaniem melfalanu

Author

Czyż, A., primary, Matuszak, M., additional, Gil, L., additional, Dybko, J., additional, Łojko-Dankowska, A., additional, Dytfeld, D., additional, Nowicki, A., additional, Wróbel, T., additional, Kuliczkowski, K., additional, and Komarnicki, M., additional

Published
2015
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47. Efficacy of azacitidine compared with that of conventional care regimens in the treatment of higher-risk myelodysplastic syndromes: a randomised, open-label, phase III study

Author

Fenaux, P, Mufti, Gj, Hellstrom Lindberg, E, Santini, V, Finelli, C, Giagounidis, A, Schoch, R, Gattermann, N, Sanz, G, List, A, Gore, Sd, Seymour, Jf, Bennett, Jm, Byrd, J, Backstrom, J, Zimmerman, L, Mckenzie, D, Beach, C, Silverman, Lr, Durrant, S, Enno, A, Herrmann, R, Horvath, N, Mills, A, Spencer, A, Szer, J, Gallo, J, Dunlop, L, Arthur, C, Goranov, S, Peytchev, D, Gercheva, L, Cermak, J, Voglova, J, Vey, N, Dreyfus, F, Laurent, G, Quesnel, B, Dombret, H, Stamatoullas, A, Wattel, E, Hunault Berger, M, Aul, C, Duhrsen, U, Platzbecker, U, Schmid, M, Hanel, M, Haase, D, Fiedler, W, Schmitz, N, Hofmann, W, Horst, H, Anagnostopoulos, N, Pappa, V, Papadaki, E, Zoumbos, N, Borbenyi, Z, Masszi, T, Baccarani, M, Bacigalupo, A, Corradini, P, Leone, G, Sacchi, Stefano, Bosi, A, Musto, P, Muus, P, Dmoszynska, A, Robak, T, Sulek, K, Kuliczkowski, K, Jedrzejczak, W, Zaritsky, A, Abdulkadyrov, K, Podoltseva, E, Afanasiev, B, Bargay, J, Brunet, S, Del Canizo, C, Ribera, J, Figuera Alvarez, A, Diaz Mediavilla, J, Canales, M, Ortega F, Ramos y., Nilsson, L, Olsson, A, Cavenagh, J, Parker, J, Killick, S, Kruger, A, Vyas, P, Dennis, M, Cripe, L, Dipersio, J, and Emanuel, P.

Subjects
Adult, Male, medicine.medical_specialty, azacitidine, Antimetabolites, Antineoplastic, Azacitidine, Decitabine, Article, law.invention, Randomized controlled trial, law, Internal medicine, medicine, Clinical endpoint, Humans, Intensive care medicine, Aged, Proportional Hazards Models, Aged, 80 and over, Intention-to-treat analysis, business.industry, Hazard ratio, Middle Aged, Oncology, Hypomethylating agent, International Prognostic Scoring System, Myelodysplastic Syndromes, Female, business, medicine.drug
Abstract

Drug treatments for patients with high-risk myelodysplastic syndromes provide no survival advantage. In this trial, we aimed to assess the effect of azacitidine on overall survival compared with the three commonest conventional care regimens.In a phase III, international, multicentre, controlled, parallel-group, open-label trial, patients with higher-risk myelodysplastic syndromes were randomly assigned one-to-one to receive azacitidine (75 mg/m(2) per day for 7 days every 28 days) or conventional care (best supportive care, low-dose cytarabine, or intensive chemotherapy as selected by investigators before randomisation). Patients were stratified by French-American-British and international prognostic scoring system classifications; randomisation was done with a block size of four. The primary endpoint was overall survival. Efficacy analyses were by intention to treat for all patients assigned to receive treatment. This study is registered with ClinicalTrials.gov, number NCT00071799.Between Feb 13, 2004, and Aug 7, 2006, 358 patients were randomly assigned to receive azacitidine (n=179) or conventional care regimens (n=179). Four patients in the azacitidine and 14 in the conventional care groups received no study drugs but were included in the intention-to-treat efficacy analysis. After a median follow-up of 21.1 months (IQR 15.1-26.9), median overall survival was 24.5 months (9.9-not reached) for the azacitidine group versus 15.0 months (5.6-24.1) for the conventional care group (hazard ratio 0.58; 95% CI 0.43-0.77; stratified log-rank p=0.0001). At last follow-up, 82 patients in the azacitidine group had died compared with 113 in the conventional care group. At 2 years, on the basis of Kaplan-Meier estimates, 50.8% (95% CI 42.1-58.8) of patients in the azacitidine group were alive compared with 26.2% (18.7-34.3) in the conventional care group (p0.0001). Peripheral cytopenias were the most common grade 3-4 adverse events for all treatments.Treatment with azacitidine increases overall survival in patients with higher-risk myelodysplastic syndromes relative to conventional care.

Published
2009

48. Nilotinib (formerly AMN107), a highly selectiveBCR-ABL tyrosine kinase inhibitor, is active in patients with imatinib-resistant or -intolerant accelerated-phase chronic myelogenous leukemia

Author

le Coutre, P, Ottmann, Og, Giles, F, Kim, Dw, Cortes, J, Gattermann, N, Apperley, Jf, Larson, Ra, Abruzzese, E, O'Brien, Sg, Kuliczkowski, K, Hochhaus, A, Mahon, Fx, Saglio, Giuseppe, Gobbi, M, Kwong, Yl, Baccarani, M, Hughes, T, Martinelli, G, Radich, Jp, Zheng, M, Shou, Y, and Kantarjian, H.

Published
2008

49. Marrow versus peripheral blood for geno-identical allogeneic stem cell transplantation in acute myelocytic leukemia: Influence of dose and stem cell source shows better outcome with rich marrow

Author

Gorin N.C., Labopin M., Rocha V., Arcese W., Beksac M., Gluckman E., Ringden O., Ruutu T., Reiffers J., Bandini G., Falda M., Zikos P., Willemze R., Frassoni F., Abecasis M., Abráhamová J., Afanassiev B.V., Aglietta M., Alabdulaaly A., Aleinikova O., Paolo Alessandrino E., Al Shemmari S.H., Amadori D., Amadori S., Amos T., Andolina M., Andreesen R., Angelucci E., Anhuf J., Arnold R., Arpaci F., Attal M., Azevedo W., Azim H.A., Baccarani M., Bacigalupo A., Barbui T., Bargetzi M., Barnard D.L., Bartsch H.H., Baruchel A., Battista C., Bay J.-O., Bayik M., Bazarbachi A., Beguin Y., López J.L.B., Benedek I., Benedetti F., Bengala C., Berrebi A., Besalduch J., Biesma D., Biron P., Björkholm M., Blaise D., Blesing N.E., Boasson M., Bobev D., Boccadoro M., Bolaman Z., Boogaerts M.A., Bordessoule D., Bosi A., Aida B.S., Bourhis J.H., Bourikas G., Bowen D.T., Bregni M., Bries G., Brinch L., Brittain D., Bron D., Brune M., Bullorsky E.O., Bunjes D., Burdach S., Burnett A.K., Buzyn A., Caballero D., Cagirgan S., Cahn J.-Y., Canepa C.O., Cao A., Carella A.M., Carrera F.D., Carret A.-S., Cascinu S., Castel V., Caswell M., Cavanna L., Cetto G.L., Chapuis B., Chasty R., Chen Y.-C., Chisesi T., Chopra R., Chybicka A., Clark R.E., Colombat P., Colovic M.D., Constenla-Figueiras M., Contreras M., Contu L., Cordonnier C., Cornelissen J.J., Cornish J., Coser P., Costa N., Coze C., Craddock C., Crown J., Culligan D.J., Danova M., Darbyshire P.J., Davies J.M., de Bock R., de Pablos Gallego J.M., De Prijck B., de Revel T., De Rossi G., De Souza C.A., Deb G., Degos L., Demuynck H., Dervenoulas I., Di Bartolomeo P., Di Renzo N., Diaz M.A., Diehl V., Diez-Martin J.L., Dincer S., Giorgio D., Dmoszynska A., Doelken G., Peter P.D., Dulley F., Easow J., Ebell W., Efremidis A., Ehninger G., Eichler H., Eimermacher H., Enno A., Errazquin L., Aguado J.E., Everaus H., Fagioli F., Fanin R., Fassas A., Fasth A., Faulkner L.B., Fauser A.A., Feldman L., Feremans W., Ferhanoglu B., Fernández M.N., Fernández-Ranada J.M., Ferrant A., Ferrara F., Finke J., Fischer A., Fischer J., Fitzsimons T., Floristan F., Forjaz de Lacerda J.M.F., Fossati-Bellani F., Fosser V., Franklin I., Freund M., Frickhofen N., Gabbas A., Gadner H., Gallamini A., Galvin M.C., López J.G., García-Conde J., Gaska T., Gastl G., Gedikoglu G., Ghavamzadeh A., Gianni A., Gibson B.E., Gil J.L., Gilleece M.H., Gisselbrecht C., Glass B., Gmür J., Göbel U., Goldman J.M., Goldstone A.H., San Miguel J.D.G., González-López M.-A., Grafakos S., Gramatzki M., Grañena A., Gratecos N., Gratwohl A., Greinix H.T., Gugliotta L., Guilhot F., Guimaraes J.E., Gülbas Z., Gulyuz O., Gurman G., Gutierrez M.M., Haas R., Hamladji R.-M., Hamon M.D., Hansen N.E., Harhalakis N., Harousseau J.L., Hartenstein R., Hartmann C.O., Hausmaninger H., Haznedar R., Heit W., Hellmann A., Herrmann R.P., Hertenstein B., Hess U., Hinterberger W., Ho A.D., Hoelzer D., Holowiecki J., Horst H.-A., Hossfeld D.K., Huebsch L., Hunter A.E., Iacopino P., Iannitto E., Indrák K., Iriondo A., Izzi T., Jackson G.L., Jacobs P., Jacobsen N., Janvier M., Jebavy L., Joensuu H., Joerg S., Jones F.G.C., Jouet J.P., Joyner M.V., Juliusson G., Jürgens H., Kalayoglu-Besisik S., Kalman N., Kalmanti M., Kansoy S., Kansu E., Kanz L., Karianakis G., Kernéis Y., Khalifeh O., Khomenko V., Kienast J., Killick S., Kirchner H.H., Klingebiel T., Knauf W., Koenigsmann M., Koistinen P., Koivunen E., Kolb H.-J., Kolbe K., Koller E., Komarnicki M., Koscielniak E., Kovacsovics T., Kowalczyk J.R., Koza V., Kozak T., Kugler J., Kuliczkowski K., Kvaloy S., Labar B., Laciura P., Palacios J.J.L., Lakota J., Lambertenghi D.G., Lange A., Lanza F., Isasti R.L., Lauria F., Le Moine F., Leblond V., Lelli G., Lenhoff S., Leon L.A., Leoncini-Franscini L., Leone G., Leoni P., Levis A., Leyvraz S., Liberati M., Link H., Linkesch W., Liso V., Lisukov I.A., Littlewood T., Ljungman P., Locatelli F., Losonczy H., Lotz J.-P., Ludwig H., Lukac J., Lutz D., Macchia P., Madrigal A., Maiolino A., Majolino I., Eloy-García J.M., Malesevic M., Mandelli F., Marc A., Marcus R., Marianska B., Markuljak I., Marsh J.C.W., Martelli M.F., Marti Tutusaus J.M., Martin S., Martin M., Martinelli G., Martínez-Rubio A.M., Martoni A., Maschan A., Maschmeyer G., Masszi T., Mazza P., McCann S., Meier C.R., Messina C., Mettivier V., Metzner B., Michallet M., Michieli M., Michon J., Milligan D.W., Milone J.H., Giuseppe G.M., Minigo H., Mistrik M., Moicean A.D., Monfardini S., Montserrat E., Moraleda Jimenez J.M., Morales-Lazaro A., Morandi S., Morra E., Mufti G.J., Musso M., Nagler A., Nalli G., Naparstek E., Narni F., Nenadov-Beck M., Neubauer A., Newland A.C., Niederwieser D., Niethammer D., Noens L.A., Nousiainen T., Novik A., Novitzky N., Occhini D., Odriozolas J., Ojanguren J.M., O’meara A., Onat H., Orchard K., Ortega J.J., Osieka R., Ossenkoppele G.J., Othman B., Ovali E., Ozcebe O.I., Ozerkan K., Ozturk A., Papatryfonos A., Parker J.E., Pastore M., Patrone F., Patton N., Pejin D., Peñarrubia M.J., Equiza E.P., Peschel C., Pession A., Pigaditou A., Pignon B., Pihkala U., Pimentel P., Pitini V., Podoltseva E., Pogliani E.M., Anna A.P., Porta F., Potter M., Powles R., Prentice G.H., Pretnar J., Ptushkin V., Quarta G., Reiter A., Remes K., Reykdal S., Santasusana J.M.R., Rifón J., Rio B., Rizzoli V., Robak T., Robinson A.J., Rodeghiero F., Rodríguez Fernández J.M., Rombos Y., Romeril K.R., Rosenmayr A., Rossi J.F., Rosti G., Rotoli B., Rowe J.M., Russell N.H., Ryzhak O., Rzepecki P., Saglio G., Salwender H., Samonigg H., Santoro A., Sanz M.A., Sayer H.G., Scanni A., Schaafsma M.R., Schaefer U.W., Schanz U., Schattenberg A., Schey S.A.M., Schlimok G., Schmoll H.-J., Schots R., Schouten H., Schwarer A.P., Schwerdtfeger R., Scimè R., Segel E., Seger R., Selleslag D., Serban M., Shamaa S., Shaw P.J., Siegert W., Siena S., Sierra J., Simonsson B., Singer C.R.J., Sirchia G., Skotnicki A.B., Slavin S., Snowden J., Sotto J.J., Tanyeli A., Tedeschi L., Tidefelt U., Tissot J.-D., Tobler A., Tomas J.F., Torres J.P., Torres G.A., Touraine J.-L., Trneny M., Uderzo C., Unal E., Unal A., Undar L., Urban C., Van den Berg H., van Marwijk K.M., Vellenga E., Venturini M., Verdonck L.F., Veys P., Vilardell J., Vinante O., Visani G., Vitek A., Vivancos P., Volpe E., Vora A., Vorlicek J., Vowels M., Vujic D., Wachowiak J., Wagner T., Wahlin A., Walewski J., Wandt H., Weissinger F., Wijermans P.W., Wiktor-Jedrzejczak W., Will A.M., Woell E., Wörmann B., Yaniv I., Yesilipek M.A., Yilmaz U., Yong A., Zachée P., Zambelli A., Zander A.R., Zintl F., Zoumbos N.C., Çukurova Üniversitesi, Maltepe Üniversitesi, and Ege Üniversitesi

Subjects
Myeloid, Male, Pathology, Time Factors, Graft vs Host Disease, Biochemistry, Gastroenterology, Blood cell, Bone Marrow, Child, Bone Marrow Transplantation, Leukemia, Remission Induction, Hematology, Middle Aged, Prognosis, Leukemia, Myeloid, Acute, ComputingMilieux_MANAGEMENTOFCOMPUTINGANDINFORMATIONSYSTEMS, medicine.anatomical_structure, Treatment Outcome, Child, Preschool, Female, Stem cell, InformationSystems_MISCELLANEOUS, Homologous, Adult, medicine.medical_specialty, Adolescent, Immunology, Acute, Disease-Free Survival, Internal medicine, medicine, Transplantation, Homologous, Humans, Preschool, Aged, Transplantation, business.industry, ComputerSystemsOrganization_COMPUTER-COMMUNICATIONNETWORKS, Cell Biology, medicine.disease, Peripheral blood, Histocompatibility, Multivariate Analysis, Stem Cell Transplantation, ComputingMethodologies_PATTERNRECOGNITION, Myelocytic leukemia, Bone marrow, business, Settore MED/15 - Malattie del Sangue
Abstract

PubMed ID: 12829583, Several studies have compared bone marrow (BM) and peripheral blood (PB) as stem cell sources in patients receiving allografts, but the cell doses infused have not been considered, especially for BM. Using the ALWP/EBMT registry, we retrospectively studied 881 adult patients with acute myelocytic leukemia (AML), who received a non-T-depleted allogeneic BM (n = 515) or mobilized PB (n = 366) standard transplant, in first remission (CR1), from an HLA-identical sibling, over a 5-year period from January 1994. The BM cell dose ranged from 0.17 to 29 × 10 8 /kg with a median of 2.7 × 10 8 /kg. The PB cell dose ranged from 0.02 to 77 × 10 8 /kg with a median of 9.3 × 10 8 /kg. The median dose for patients receiving BM (2.7 × 10 8 /kg) gave the greatest discrimination. In multivariate analyses, high-dose BM compared to PB was associated with lower transplant-related mortality (RR = 0.61; 95% CI, 0.39-0.98; P = .04), better leukemia-free survival (RR = 0.65; 95% CI, 0.46-0.91; P = .013), and better overall survival (RR = 0.64; 95% CI, 0.44-0. 92; P = .016). The present study in patients with AML receiving allografts in first remission indicates a better outcome with BM as compared to PB, when the dose of BM infused is rich. © 2003 by The American Society of Hematology.

Published
2003

50. Marrow versus peripheral blood for geno-identical allogeneic stem cell transplantation in acute myelocytic leukemia: Influence of dose and stem cell source shows better outcome with rich marrow

Author

Gorin, N.C. Labopin, M. Rocha, V. Arcese, W. Beksac, M. Gluckman, E. Ringden, O. Ruutu, T. Reiffers, J. Bandini, G. Falda, M. Zikos, P. Willemze, R. Frassoni, F. Abecasis, M. Abráhamová, J. Afanassiev, B.V. Aglietta, M. Alabdulaaly, A. Aleinikova, O. Paolo Alessandrino, E. Al Shemmari, S.H. Amadori, D. Amadori, S. Amos, T. Andolina, M. Andreesen, R. Angelucci, E. Anhuf, J. Arnold, R. Arpaci, F. Attal, M. Azevedo, W. Azim, H.A. Baccarani, M. Bacigalupo, A. Barbui, T. Bargetzi, M. Barnard, D.L. Bartsch, H.H. Baruchel, A. Battista, C. Bay, J.-O. Bayik, M. Bazarbachi, A. Beguin, Y. López, J.L.B. Benedek, I. Benedetti, F. Bengala, C. Berrebi, A. Besalduch, J. Biesma, D. Biron, P. Björkholm, M. Blaise, D. Blesing, N.E. Boasson, M. Bobev, D. Boccadoro, M. Bolaman, Z. Boogaerts, M.A. Bordessoule, D. Bosi, A. Aida, B.S. Bourhis, J.H. Bourikas, G. Bowen, D.T. Bregni, M. Bries, G. Brinch, L. Brittain, D. Bron, D. Brune, M. Bullorsky, E.O. Bunjes, D. Burdach, S. Burnett, A.K. Buzyn, A. Caballero, D. Cagirgan, S. Cahn, J.-Y. Canepa, C.O. Cao, A. Carella, A.M. Carrera, F.D. Carret, A.-S. Cascinu, S. Castel, V. Caswell, M. Cavanna, L. Cetto, G.L. Chapuis, B. Chasty, R. Chen, Y.-C. Chisesi, T. Chopra, R. Chybicka, A. Clark, R.E. Colombat, P. Colovic, M.D. Constenla-Figueiras, M. Contreras, M. Contu, L. Cordonnier, C. Cornelissen, J.J. Cornish, J. Coser, P. Costa, N. Coze, C. Craddock, C. Crown, J. Culligan, D.J. Danova, M. Darbyshire, P.J. Davies, J.M. de Bock, R. de Pablos Gallego, J.M. De Prijck, B. de Revel, T. De Rossi, G. De Souza, C.A. Deb, G. Degos, L. Demuynck, H. Dervenoulas, I. Di Bartolomeo, P. Di Renzo, N. Diaz, M.A. Diehl, V. Diez-Martin, J.L. Dincer, S. Giorgio, D. Dmoszynska, A. Doelken, G. Peter, P.D. Dulley, F. Easow, J. Ebell, W. Efremidis, A. Ehninger, G. Eichler, H. Eimermacher, H. Enno, A. Errazquin, L. Aguado, J.E. Everaus, H. Fagioli, F. Fanin, R. Fassas, A. Fasth, A. Faulkner, L.B. Fauser, A.A. Feldman, L. Feremans, W. Ferhanoglu, B. Fernández, M.N. Fernández-Ranada, J.M. Ferrant, A. Ferrara, F. Finke, J. Fischer, A. Fischer, J. Fitzsimons, T. Floristan, F. Forjaz de Lacerda, J.M.F. Fossati-Bellani, F. Fosser, V. Franklin, I. Freund, M. Frickhofen, N. Gabbas, A. Gadner, H. Gallamini, A. Galvin, M.C. López, J.G. García-Conde, J. Gaska, T. Gastl, G. Gedikoglu, G. Ghavamzadeh, A. Gianni, A. Gibson, B.E. Gil, J.L. Gilleece, M.H. Gisselbrecht, C. Glass, B. Gmür, J. Göbel, U. Goldman, J.M. Goldstone, A.H. San Miguel, J.D.G. González-López, M.-A. Grafakos, S. Gramatzki, M. Grañena, A. Gratecos, N. Gratwohl, A. Greinix, H.T. Gugliotta, L. Guilhot, F. Guimaraes, J.E. Gülbas, Z. Gulyuz, O. Gurman, G. Gutierrez, M.M. Haas, R. Hamladji, R.-M. Hamon, M.D. Hansen, N.E. Harhalakis, N. Harousseau, J.L. Hartenstein, R. Hartmann, C.O. Hausmaninger, H. Haznedar, R. Heit, W. Hellmann, A. Herrmann, R.P. Hertenstein, B. Hess, U. Hinterberger, W. Ho, A.D. Hoelzer, D. Holowiecki, J. Horst, H.-A. Hossfeld, D.K. Huebsch, L. Hunter, A.E. 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Tidefelt, U. Tissot, J.-D. Tobler, A. Tomas, J.F. Torres, J.P. Torres, G.A. Touraine, J.-L. Trneny, M. Uderzo, C. Unal, E. Unal, A. Undar, L. Urban, C. Van den Berg, H. van Marwijk, K.M. Vellenga, E. Venturini, M. Verdonck, L.F. Veys, P. Vilardell, J. Vinante, O. Visani, G. Vitek, A. Vivancos, P. Volpe, E. Vora, A. Vorlicek, J. Vowels, M. Vujic, D. Wachowiak, J. Wagner, T. Wahlin, A. Walewski, J. Wandt, H. Weissinger, F. Wijermans, P.W. Wiktor-Jedrzejczak, W. Will, A.M. Woell, E. Wörmann, B. Yaniv, I. Yesilipek, M.A. Yilmaz, U. Yong, A. Zachée, P. Zambelli, A. Zander, A.R. Zintl, F. Zoumbos, N.C. The Acute Leukemia Working Party (ALWP) of the European Cooperative Group for Blood Marrow Transplantation (EBMT)

Abstract

Several studies have compared bone marrow (BM) and peripheral blood (PB) as stem cell sources in patients receiving allografts, but the cell doses infused have not been considered, especially for BM. Using the ALWP/EBMT registry, we retrospectively studied 881 adult patients with acute myelocytic leukemia (AML), who received a non-T-depleted allogeneic BM (n = 515) or mobilized PB (n = 366) standard transplant, in first remission (CR1), from an HLA-identical sibling, over a 5-year period from January 1994. The BM cell dose ranged from 0.17 to 29 × 108/kg with a median of 2.7 × 108/kg. The PB cell dose ranged from 0.02 to 77 × 10 8/kg with a median of 9.3 × 108/kg. The median dose for patients receiving BM (2.7 × 108/kg) gave the greatest discrimination. In multivariate analyses, high-dose BM compared to PB was associated with lower transplant-related mortality (RR = 0.61; 95% CI, 0.39-0.98; P = .04), better leukemia-free survival (RR = 0.65; 95% CI, 0.46-0.91; P = .013), and better overall survival (RR = 0.64; 95% CI, 0.44-0. 92; P = .016). The present study in patients with AML receiving allografts in first remission indicates a better outcome with BM as compared to PB, when the dose of BM infused is rich. © 2003 by The American Society of Hematology.

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2003

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