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60. 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

61. The addition of sorafenib to standard AML treatment results in a substantial reduction in relapse risk and improved survival : Updated results from long-term follow-up of the randomized-controlled SORAML trial

Author

Röllig, C., Serve, H., Hüttmann, Andreas, Noppeney, Richard, Müller-Tidow, Carsten, Krug, U., Baldus, C. D., Brandts, C. H., Kunzmann, V., Einsele, H., Krämer, A., Schäfer-Eckart, K., Neubauer, A., Burchert, A., Giagounidis, A., Krause, S. W., Mackensen, A., Aulitzky, W., Herbst, R., Hänel, M., Kiani, A., Frickhofen, N., Kullmer, J., Kaiser, U., Link, H., Geer, T., Reichle, A., Junghanß, C., Bornhäuser, M., Schaich, M., Thiede, C., Schetelig, J., Kramer, M., Berdel, W. E., Ehninger, G., and Studienallianz Leukämie (SAL)

Subjects
Medizin
Published
2018

63. PROSPECTIVE MULTICENTER REGISTRY FOR SECONDARY CNS INVOLVEMENT IN MALIGNANT LYMPHOMA: AN UPDATE WITH DATA FROM 181 PATIENTS

Author

Lammer, F., primary, May, L., additional, Martus, P., additional, Schroers, R., additional, Schlegel, U., additional, Hofer, S., additional, Bairey, O., additional, Schmitz, N., additional, Griesinger, F., additional, Schmidt-Hieber, M., additional, Weißinger, F., additional, Reimer, P., additional, le Coutre, P., additional, Fix, P., additional, Hopfer, O., additional, Junghanß, C., additional, Höffkes, H., additional, Heilmeier, B., additional, Möhle, R., additional, Lange, E., additional, Korfel, A., additional, and Keller, U., additional

Published
2019
Full Text
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64. 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

65. Randomized comparison of liposomal amphotericin B versus placebo to prevent invasive mycoses in acute lymphoblastic leukaemia

Author

Cornely, O. A., Leguay, T., Maertens, J., Vehreschild, M. J. G. T., Anagnostopoulos, A., Castagnola, C., Verga, L., Rieger, C., Kondakci, M., Harter, G., Duarte, R. F., Allione, B., Cordonnier, C., Heussel, C. P., Morrissey, C. O., Agrawal, S. G., Peter Donnelly, J., Bresnik, M., Hawkins, M. J., Garner, W., Gokbuget, N., Jarchum, G., Dictar, M., Ramirez Borga, S., Valledor, A., Knoebl, P., Greil, R., Linkesch, W., Sill, H., De Prijck, B., Sonet, A., Theunissen, K., Selleslag, D., Vargas Schwarzbold, A., Nucci, M. L. M., Lopes de Castro Lobo, C., Fogliatto, L., Bonmati, C., Turlure, P., Herbrecht, R., Thiebaut, A., Michallet, M., Egerer, G., Silling, G., Pfreundschuh, M., Hasenkamp, J., Kraemer, D. M., Topp, M., Heinz, W., Junghanss, C., Schaich, M. A., Parmentier, S., Roellig, C., Beck, H. J., Huttmann, A., Mousset, S., Duenzinger, U. N., Schwartz, S., Haerter, G., Ostermann, H., Tsirigotis, P., Matsouka, P., Angelopoulou, M. K., Karakantza, M., Spyridonidis, A., Kolomansky, A., Moses, A., Horowitz, N., Rahav, G., Aversa, F., Velardi, A., Pagano, Livio, Gentile, Giuseppe, Gobbi, M., Luppi, M., Nosari, A. M., Rambaldi, A., Candoni, A., Marbello, L., Rossi, G., Pogliani, E., Moreira, I., Nunes, A., Botelho de Sousa, A., Rubio Tejero, A. I., Vallejo, C., Vazquez, L., Besalduch Vidal, J., Gomez-Garcia de Soria, V., Jurado Chacon, M., Gonzalez Campos, J., Olavarria, E., Barba, P., de la Serna Torroba, J., Duarte, R., Heim, D., Zimmerli, S., Gerber, B., Akova, M., Bolaman, A. Z., Tabak, F., Akan, H., Senol, E., and Gilead Sciences

Subjects
0301 basic medicine, Male, Antifungal Agents, Administration, Intravenous, Adolescent, Adult, Aged, Aged, 80 and over, Amphotericin B, Chemoprevention, Double-Blind Method, Europe, Female, Humans, Invasive Fungal Infections, Middle Aged, Placebos, Precursor Cell Lymphoblastic Leukemia-Lymphoma, South America, Treatment Outcome, Young Adult, Medizin, law.invention, Randomized controlled trial, law, hemic and lymphatic diseases, Clinical endpoint, 80 and over, Pharmacology (medical), Original Research, hemic and immune systems, Chemotherapy regimen, Infectious Diseases, Tolerability, Administration, Intravenous, Inflammatory diseases Radboud Institute for Molecular Life Sciences [Radboudumc 5], Microbiology (medical), medicine.medical_specialty, 030106 microbiology, Neutropenia, Placebo, 03 medical and health sciences, Internal medicine, medicine, Pharmacology, Surrogate endpoint, business.industry, medicine.disease, Surgery, Regimen, Settore MED/15 - MALATTIE DEL SANGUE, business
Abstract

[Objectives] To prevent invasive fungal disease (IFD) in adult patients undergoing remission-induction chemotherapy for newly diagnosed acute lymphoblastic leukaemia (ALL)., [Patients and methods] In a double-blind multicentre Phase 3 study, patients received prophylactic liposomal amphotericin B (L-AMB) at 5 mg/kg intravenously or placebo twice weekly in a 2:1 random allocation during remission-induction treatment. The primary endpoint was the development of proven or probable IFD. Secondary endpoints included those focused on the safety and tolerability of prophylactic L-AMB., [Results] Three hundred and fifty-five patients from 86 centres in Europe and South America received at least one dose of L-AMB (n = 237) or placebo (n = 118). Rates of proven and probable IFD assessed independently were 7.9% (18/228) in the L-AMB group and 11.7% (13/111) in the placebo group (P = 0.24). Rates of possible IFD were 4.8% (11/228) in the L-AMB and 5.4% (6/111) in the placebo group (P = 0.82). The remission-induction phase was a median of 22 days for both groups. Overall mortality was similar between the groups: 7.2% (17/237) for L-AMB and 6.8% (8/118) for placebo (P = 1.00). Hypokalaemia and creatinine increase were significantly more frequent with L-AMB., [Conclusions] The IFD rate among adult patients undergoing remission-induction chemotherapy for newly diagnosed ALL was 11.7% in the placebo group, and was not significantly different in patients receiving L-AMB, suggesting that the L-AMB regimen studied is not effective as prophylaxis against IFD. The IFD rate appears higher than previously reported, warranting further investigation. Tolerability of L-AMB was what might be expected. Further studies are needed to determine the optimal antifungal strategy during remission-induction chemotherapy of ALL., This study was funded by Gilead Sciences, Inc. M. B., W. G. and M. J. H. are employees of Gilead Sciences. All other authors or their institutions have received compensation for study participation from Gilead Sciences International Ltd.

Published
2017

69. Pretreatment long interspersed element (LINE)-1 methylation levels, not early hypomethylation under treatment, predict hematological response to azacitidine in elderly patients with acute myeloid leukemia

Author

Cross M, Bach E, Tran T, Krahl R, Jaekel N, Niederwieser D, Junghanss C, Maschmeyer G, and Al-Ali HK

Subjects
lcsh:Neoplasms. Tumors. Oncology. Including cancer and carcinogens, lcsh:RC254-282
Abstract

Michael Cross,1 Enrica Bach,1 Thao Tran,1 Rainer Krahl,1 Nadja Jaekel,1 Dietger Niederwieser,1 Christian Junghanss,2 Georg Maschmeyer,3 Haifa Kathrin Al-Ali11Division of Hematology and Oncology, University of Leipzig, Leipzig, Germany; 2Clinic for Hematology, Oncology and Palliative Medicine, University of Rostock, Rostock, Germany; 3Clinic for Hematology, Oncology and Palliative Medicine, Ernst-von-Bergmann Clinic, Potsdam, GermanyBackground: Epigenetic modulations, including changes in DNA cytosine methylation, are implicated in the pathogenesis and progression of acute myeloid leukemia (AML). Azacitidine is a hypomethylating agent that is incorporated into RNA as well as DNA. Thus, there is a rationale to its use in patients with AML. We determined whether baseline and/or early changes in the methylation of long interspersed element (LINE)-1 or CDH13 correlate with bone marrow blast clearance, hematological response, or survival in patients with AML treated with azacitidine.Methods: An open label, phase I/II trial was performed in 40 AML patients (median bone marrow blast count was 42%) unfit for intensive chemotherapy treated with azacitidine 75 mg/m2/day subcutaneously for 5 days every 4 weeks. Bone marrow mononuclear cell samples were taken on day 0 (pretreatment) and day 15 during the first treatment cycle; LINE-1 and CDH13 methylation levels were quantified by methylation-specific, semiquantitative, real-time polymerase chain reaction.Results: Treatment with azacitidine significantly reduced LINE-1 but not CDH13 methylation levels over the first cycle (P < 0.0001). Absolute LINE-1 methylation levels tended to be lower on day 0 (P = 0.06) and day 15 of cycle 1 (P = 0.03) in patients who went on to achieve subsequent complete remission, partial remission or hematological improvement versus patients with stable disease. However, the decrease in LINE-1 methylation over the first treatment cycle did not correlate with subsequent response (P = 0.31). Baseline methylation levels of LINE-1 or CDH13 did not correlate with disease-related prognostic factors, including cytogenetic risk, relapsed/refractory AML, or presence of NPM1 or FLT3 mutations. No correlation was observed between LINE-1 or CDH13 methylation levels and overall survival.Conclusion: Analysis of baseline LINE-1 methylation levels may help identify elderly AML patients who are most likely to respond to azacitidine therapy.Keywords: DNA methylation, acute myeloid leukemia, azacitidine, clinical response, CDH13, LINE-1 methylation

Published
2013

70. Systems biologists seek fuller integration of systems biology approaches in new cancer research programs

Author

Drasdo, D, Fell, D, Ferrell, J, Gallahan, D, Gatenby, R, Guenther, U, Herzel, H, Junghanss, C, Kunz, M, Laplace, F, van Leeuwen, I, Lenormand, P, Levi, F, Linnebacher, M, Lowengrub, J, Maini, P, Marcus, F, Malik, A, Rateitschak, K, Sansom, O, Schafer, R, Schurrle, K, Sers, C, Schnell, S, Harms, B, Shibata, D, Tyson, J, Vera, J, White, M, Zhivotovsky, B, Jaster, R, Wolkenhauer, O, Auffray, C, Baltrusch, S, Bluthgen, N, Byrne, H, Cascante, M, Ciliberto, A, and Dale, T

Abstract

Systems biology takes an interdisciplinary approach to the systematic study of complex interactions in biological systems. This approach seeks to decipher the emergent behaviors of complex systems rather than focusing only on their constituent properties. As an increasing number of examples illustrate the value of systems biology approaches to understand the initiation, progression, and treatment of cancer, systems biologists from across Europe and the United States hope for changes in the way their field is currently perceived among cancer researchers. In a recent EU-US workshop, supported by the European Commission, the German Federal Ministry for Education and Research, and the National Cancer Institute of the NIH, the participants discussed the strengths, weaknesses, hurdles, and opportunities in cancer systems biology.

Published
2016

75. FOLFOX / Bevacizumab (Beva) +/- Irinotecan in advanced colorectal cancer (CRC): A randomized phase II trial (AIO KRK 0209, CHARTA)

Author

Schmoll, H.J., primary, Garlipp, B., additional, Junghanß, C., additional, Leithauser, M., additional, Vogel, A., additional, Schaefers, M., additional, Kaiser, U., additional, Hoeffkes, H.G., additional, Florschütz, A., additional, Ruessel, J., additional, Kanzler, S., additional, Edelmann, T., additional, Forstbauer, H., additional, Göhler, T., additional, Hannig, C., additional, Hildebrandt, B., additional, Steighardt, J., additional, Meinert, F.M., additional, Cygon, F., additional, and Stein, A., additional

Published
2016
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76. Randomized phase III study of whole-brain radiotherapy for primary CNS lymphoma

Author

Korfel, A, Thiel, E, Martus, P, Möhle, R, Griesinger, F, Rauch, Mi, Röth, A, Hertenstein, B, Fischer, T, Hundsberger, T; https://orcid.org/0000-0002-4419-2767, Mergenthaler, H G, Junghanß, C, Birnbaum, T, Fischer, L, Jahnke, K, Herrlinger, U, Roth, P, Bamberg, M, Pietsch, T, Weller, M, Korfel, A, Thiel, E, Martus, P, Möhle, R, Griesinger, F, Rauch, Mi, Röth, A, Hertenstein, B, Fischer, T, Hundsberger, T; https://orcid.org/0000-0002-4419-2767, Mergenthaler, H G, Junghanß, C, Birnbaum, T, Fischer, L, Jahnke, K, Herrlinger, U, Roth, P, Bamberg, M, Pietsch, T, and Weller, M

Abstract

OBJECTIVE This is the final report of a phase III randomized study to evaluate whole-brain radiotherapy (WBRT) in primary therapy of primary CNS lymphoma (PCNSL) after a median follow-up of 81.2 months. METHODS Patients with newly diagnosed PCNSL were randomized to high-dose methotrexate (HDMTX)-based chemotherapy alone or followed by WBRT. We hypothesized that the omission of WBRT would not compromise overall survival (OS; primary endpoint), using a noninferiority design with a margin of 0.9. RESULTS In the per-protocol population (n = 320), WBRT nonsignificantly prolonged progression-free survival (PFS) (median 18.2 vs 11.9 months, hazard ratio [HR] 0.83 [95% confidence interval (CI) 0.65-1.06], p = 0.14) and significantly PFS from last HDMTX (25.5 vs 12.0 months, HR 0.65 [95% CI 0.5-0.83], p = 0.001), but without OS prolongation (35.6 vs 37.1 months, HR 1.03 [95% CI 0.79-1.35], p = 0.82). In the intent-to-treat population (n = 410), there was a prolongation by WBRT of both PFS (15.4 vs 9.9 months, HR 0.79 [95% CI 0.64-0.98], p = 0.034) and PFS from last HDMTX (19.4 vs 11.9 months, HR 0.72 [95% CI 0.58-0.89], p = 0.003), but not of OS (32.4 vs 36.1 months, HR 0.98 [95% CI 0.79-1.26], p = 0.98). CONCLUSION Although the statistical proof of noninferiority regarding OS was not given, our results suggest no worsening of OS without WBRT in primary therapy of PCNSL. CLASSIFICATION OF EVIDENCE This study provides Class II evidence that in PCNSL HDMTX-based chemotherapy followed by WBRT does not significantly increase survival compared to chemotherapy alone. The study lacked the precision to exclude an important survival benefit or harm from WBRT.

Published
2015

79. Long-term follow-up of the AML97 study for patients aged 60 years and above with acute myeloid leukaemia: a study of the East German Haematology and Oncology Study Group (OSHO)

Author

Kahl, C., primary, Krahl, R., additional, Becker, C., additional, Al-Ali, H. K., additional, Sayer, H. G., additional, Schulze, A., additional, Herold, M., additional, Hänel, M., additional, Scholl, S., additional, Hochhaus, A., additional, Uharek, L., additional, Maschmeyer, G., additional, Haehling, D., additional, Junghanß, C., additional, Peter, N., additional, Kämpfe, D., additional, Kettner, E., additional, Heinicke, T., additional, Fischer, T., additional, Kreibich, U., additional, Wolf, H.-H., additional, and Niederwieser, D., additional

Published
2015
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80. Randomized phase III study of whole-brain radiotherapy for primary CNS lymphoma

Author

Korfel, A., primary, Thiel, E., additional, Martus, P., additional, Mohle, R., additional, Griesinger, F., additional, Rauch, M., additional, Roth, A., additional, Hertenstein, B., additional, Fischer, T., additional, Hundsberger, T., additional, Mergenthaler, H. G., additional, Junghanss, C., additional, Birnbaum, T., additional, Fischer, L., additional, Jahnke, K., additional, Herrlinger, U., additional, Roth, P., additional, Bamberg, M., additional, Pietsch, T., additional, and Weller, M., additional

Published
2015
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82. AT-59 * HIGH-DOSE MTX-BASED CHEMOTHERAPY FOR PRIMARY CNS LYMPHOMA: WITH OR WITHOUT WHOLE BRAIN RADIOTHERAPY? FINAL ANALYSIS OF G-PCNSL-SG-1

Author

Weller, M., primary, Thiel, E., additional, Martus, P., additional, Mohle, R., additional, Griesinger, F., additional, Rauch, M., additional, Roeth, A., additional, Hertenstein, B., additional, Fischer, T., additional, Hundsberger, T., additional, Mergenthaler, H.-G., additional, Junghanss, C., additional, Birnbaum, T., additional, Fischer, L., additional, Jahnke, K., additional, Herrlinger, U., additional, Pietsch, T., additional, Roth, P., additional, Bamberg, M., additional, and Korfel, A., additional

Published
2014
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83. Cetuximab (C), Fluorouracil (F) and Cisplatin (P) Alone or with Docetaxel (D) for Recurrent/Metastatic (Rm) Head and Neck Cancer (Hnscc). Final Analysis of Aio Trial # 1108 - Cefcid.

Author

Knoedler, M., primary, Gauler, T., additional, Dietz, A., additional, Grünwald, V., additional, Stoehlmacher-Williams, J., additional, Knipping, S., additional, Schroeder, M., additional, Guntinas-Lichius, O., additional, Frickhofen, N., additional, Lindemann, H., additional, Fietkau, R., additional, Haxel, B., additional, Junghanß, C., additional, Maschmeyer, G., additional, Zipfel, M., additional, Martus, P., additional, and Keilholz, U., additional

Published
2014
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91. Myeloproliferative Neoplasien

Author

Lange, T., primary, Kiefer, T., additional, Junghanss, C., additional, Wickenhauser, C., additional, Ernst, T., additional, and Heidel, F., additional

Published
2012
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92. Intergroup study in elderly patients with AML to compare complete remission rate and overall survival after intermediate-dose or low-dose AraC.

Author

Lange, T., primary, Niederwieser, D., additional, Hoffmann, V., additional, Pfirrmann, M., additional, Maschmeyer, G., additional, Fischer, T., additional, Herold, M., additional, Sayer, H. G., additional, Junghanss, C., additional, Krahl, R., additional, Al-Ali, H. K., additional, Pönisch, W., additional, Vucinic, V., additional, Doelken, G., additional, Sauerland, M. C., additional, Heinecke, A., additional, Hoelzer, D., additional, Hehlmann, R., additional, Berdel, W. E., additional, and Buchner, T., additional

Published
2011
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93. Relapse incidence and leukemia-free survival (LFS) in patients (pts) older than age 60 with AM undergoing stem cell transplantation: A report of the East German Study Group Hematology and Oncology (OSHO).

Author

Niederwieser, D., primary, Maschmeyer, G., additional, Fischer, T., additional, Uharek, L., additional, Kortmann, R., additional, Hegenbart, U., additional, Dreger, P., additional, Herold, M., additional, Sayer, H. G., additional, Wolf, H., additional, Kreibich, U., additional, Hähling, D., additional, Junghanss, C., additional, Grobe, N., additional, Krahl, R., additional, Lange, T., additional, Al-Ali, H. K., additional, Pönisch, W., additional, Nehring, C., additional, and Doelken, G., additional

Published
2011
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98. Viral encephalitis after allogeneic stem cell transplantation: a rare complication with distinct characteristics of different causative agents

Author

Schmidt-Hieber, M., primary, Schwender, J., additional, Heinz, W. J., additional, Zabelina, T., additional, Kuhl, J. S., additional, Mousset, S., additional, Schuttrumpf, S., additional, Junghanss, C., additional, Silling, G., additional, Basara, N., additional, Neuburger, S., additional, Thiel, E., additional, and Blau, I. W., additional

Published
2010
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