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1. Evaluation of the inflammation-based modified Glasgow Prognostic Score (mGPS) as a prognostic and predictive biomarker in patients with metastatic colorectal cancer receiving first-line chemotherapy: a post hoc analysis of the randomized phase III XELAVIRI trial (AIO KRK0110)

Author

Boukovala, M., Modest, D.P., Ricard, I., Fischer von Weikersthal, L., Decker, T., Vehling-Kaiser, U., Uhlig, J., Schenk, M., Freiberg-Richter, J., Peuser, B., Denzlinger, C., Peveling Genannt Reddemann, C., Graeven, U., Schuch, G., Schwaner, I., Heinrich, K., Neumann, J., Jung, A., Held, S., Stintzing, S., Heinemann, V., and Michl, M.

Published
2024
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2. 1301P Sequential therapy of metastatic pancreatic ductal adenocarcinoma (PDAC) after failure of gemcitabine plus nab-paclitaxel with either 5-FU/folinic acid (5FU/LV) plus irinotecan (FOLFIRI) followed by 5FU/LV plus oxaliplatin (OFF) or the reverse sequence: The PANTHEON trial (AIO PAK 0116)

Author

Modest, D.P., primary, Heinemann, V., additional, Schütt, P., additional, Angermeier, S., additional, Haberkorn, M., additional, Waidmann, O., additional, Graeven, U., additional, Wille, K., additional, Kunzmann, V., additional, Henze, L., additional, Constantin, C., additional, De Wit, M., additional, Denzlinger, C., additional, Kurreck, A., additional, Alig, A.H.S., additional, Stahler, A., additional, Pelzer, U., additional, Stintzing, S., additional, and Oettle, H., additional

Published
2022
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3. Correction:High-risk additional chromosomal abnormalities at low blast counts herald death by CML (Leukemia, (2020), 34, 8, (2074-2086), 10.1038/s41375-020-0826-9)

Author

Hehlmann, Rüdiger, Voskanyan, Astghik, Lauseker, Michael, Pfirrmann, Markus, Kalmanti, Lida, Rinaldetti, Sebastien, Kohlbrenner, Katharina, Haferlach, Claudia, Schlegelberger, Brigitte, Fabarius, Alice, Seifarth, Wolfgang, Spieß, Birgit, Wuchter, Patrick, Krause, Stefan, Kolb, Hans Jochem, Neubauer, Andreas, Hossfeld, Dieter K., Nerl, Christoph, Gratwohl, Alois, Baerlocher, Gabriela M., Burchert, Andreas, Brümmendorf, Tim H., Hasford, Jörg, Hochhaus, Andreas, Saußele, Susanne, Baccarani, Michele, von Weikersthal, L. Fischer, Hahn, M., Schlimok, G., Reichert, D., Janssen, J., Martens, U., Majunke, P., Reichert, Peter, Neben, K., Korsten, S., Scholz, Ch, Oldenkott, B., Heßling, J., Kingreen, D., Sperling, C., Schelenz, C., Blau, I., Urmersbach, A., Ludwig, W., Le Coutre, P., Arnold, R., de Wit, M., Pezzutto, A., Schäfer, E., Schroers, R., Lochter, A., Behringer, D., Ko, Y., Weidenhöfer, S., Verbeek, W., Brossart, P., Trenn, G., Pommerien, W., Krauter, J., Doering, G., Munzinger, H., Diekmann, C., Hertenstein, B., Stier, S., Möller-Faßbender, F., Hänel, M., Zöller, T., Lamberti, C., Koch, B., Henzel, A., Wagner, S., Schmalenbach, A., Hoffknecht, M., Ehninger, G., Kiani, A., Illmer, T., Aul, C., Flaßhove, M., Henneke, F., Simon, M., Müller, L., Becker, H., Janz, R., Eckart, M. J., Fuchs, R., Schlegel, F., Wattad, M., Rudolph, R., Beelen, D. W., Lindemann, A., Linck, D., Wassman, Jäger, E., Al-Batran, S., Reiber, T., Waller, C. F., Hoeffkes, H., Schulz, L., Tajrobehkar, K., Mittermüller, J., Pralle, H., Runde, V., Hoyer, A., Tessen, H., Trümper, L., Schmidt, C., Sieber, M., Eschenburg, H., Depenbusch, R., Rösel, S., Lindemann, H. W., Wolf, H., Spohn, C., Moeller, R., Hossfeld, D., Zander, A., Schafhausen, P., Köster, H., Hollburg, W., Schmitz, N., Dürk, H., Hemeier, M., Grote-Metke, A., Weischer, H., Bechtel, B., Balleisen, L., Sosada, M., Ho, A., Petersen, V., Dengler, J., Bildat, S., Hahn, L., Dietzfelbinger, H., Gröschel, W., Bartholomäus, A., Freier, W., Sievers, B., Pfreundschuh, I. M., Herrmann, T., Fauser, A., Menzel, J., Kemmerling, M., Hansen, R., Link, H., Schatz, M., Bentz, M., Prümmer, O., Kneba, M., Heymanns, J., Schmitz, S., Scheid, C., Lollert, A., Neise, M., Planker, M., Stauch, M., Schröder, M., Kempf, B., Vehling-Kaiser, U., Kremers, S., Köchling, G., Hartmann, F., Neuhaus, T., Fetscher, S., Kämpfe, D., Heil, G., Uppenkamp, M., Goldmann, B., Huber, T. Fischer, Hieber, U., Plöger, C., Griesshammer, M., Lange, C., Göttler, B., Lunscken, C., Schiel, X., Scheidegger, C., Stötzer, O., Hitz, H., Schick, H., Völkl, S., Spiekermann, K., Berdel, W., Hebart, H., Ladda, E., Schmidt, P., Burkhardt, U., Hentschke, S., Falge, C., Reschke, D., Köhne, C. A., Müller-Naendrup, C., Sauer, M., Frühauf, S., Ranft, K., Dencausse, Y., Sandritter, B., Baake, G., Hofknecht, M., Dengler, R., Edinger, M., Schenk, M., Wehmeier, A., Weidelich, H. P., Pihusch, R., Stahlhut, K., Baldus, M., Matzdorff, A., Geer, T., Schanz, S., Käfer, G., Gassmann, W., Priebe-Richter, C., Demandt, M., Springer, G., Fiechtner, H., Denzlinger, C., Schleicher, J., Assman, D., Gaeckler, R., Adam, G., Waladkhani, A., Rendenbach, B., Forstbauer, H., Kanz, L., Jacki, S., Stegelmann, F., Kalhori, N., Nusch, A., Langer, W., Müller, F., Brettner, S., Uebelmesser, B., Kamp, T., Schadeck-Gressel, C., Josten, K., Klein, O., Schwerdtfeger, R., Baurmann, H., Strotkötter, H., Fett, W., Raghavachar, A., Maintz, C., Goebler, M. C., Schlag, R., Elsel, W., Wernli, M., Heim, D., Wuillemin, W., Hess, U., Gmür, J., and Mayer, J.

Abstract

An amendment to this paper has been published and can be accessed via a link at the top of the paper.

Published
2020
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5. CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine plus sorafenib/placebo in patients with R1 resection of pancreatic cancer - Final results

Author

Sinn, M., Liersch, T., Riess, H., Gellert, K., Stuebs, P., Waldschmidt, D., Lammert, F., Maschmeyer, G., Bechstein, W., Bitzer, M., Denzlinger, C., Hofheinz, R., Lindig, U., Ghadimi, M., Hinke, A., Striefler, J. K., Pelzer, U., Bischoff, S., Bahra, M., Oettle, H., Sinn, M., Liersch, T., Riess, H., Gellert, K., Stuebs, P., Waldschmidt, D., Lammert, F., Maschmeyer, G., Bechstein, W., Bitzer, M., Denzlinger, C., Hofheinz, R., Lindig, U., Ghadimi, M., Hinke, A., Striefler, J. K., Pelzer, U., Bischoff, S., Bahra, M., and Oettle, H.

Abstract

Background: CONKO-006 was designed for patients with pancreatic adenocarcinoma with postsurgical R1 residual status to evaluate the efficacy and safety of the combination of gemcitabine and sorafenib (GemSorafenib) compared with those of gemcitabine + placebo (GemP) for 12 cycles. Patients and methods: This randomised, double-blind, placebo-controlled, multicenter study was planned to detect an improvement in recurrence-free survival (RFS) from 42% to 60% after 18 months. Secondary objectives were overall survival (OS), safety and duration of treatment. Results: 122 patients were included between 02/2008 and 09/2013; 57 were randomised to GemSorafenib and 65 to GemP. Patient characteristics were wellbalanced (GemSorafenib/GemP) in terms of median age (63/63 years), tumour size (T3/T4: 97/97%), and nodal positivity (86/85%). Grade 3/4 toxicities comprised diarrhoea (GemSorafenib: 12%; GemP: 2%), elevated gamma-glutamyl transferase (GGT) (19%; 9%), fatigue (5%; 2%) and hypertension (5%; 2%), as well as neutropenia (18%; 25%) and thrombocytopenia (9%; 2%). By August 2017, 118 (97%) RFS event had occurred. There were no difference in RFS (median GemSorafenib: 8.5 versus GemP: 9.4 months; p = 0.730) nor OS (median GemSorafenib: 17.6 versus GemP: 17.5 months; p = 0.481). Landmark analyses suggest that patients who received more than six cycles of postoperative chemotherapy had significantly longer OS (p = 0.021). Conclusion: CONKO-006 is the first randomised clinical trial to include exclusively patients with PDAC with postsurgical R1 status thus far. Sorafenib added to gemcitabine did neither improve RFS nor OS. However, postoperative treatment exceeding six months seemed to prolong survival and should be further investigated in these high-risk patients. (C) 2020 Published by Elsevier Ltd.

Published
2020

6. Gemtuzumab ozogamicin (Mylotarg®) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups

Author

Amadori, S, Suciu, S, Stasi, R, Willemze, R, Mandelli, F, Selleslag, D, Denzlinger, C, Muus, P, Stauder, R, Berneman, Z, Pruijt, J, Nobile, F, Cassibba, V, Marie, J-P, Beeldens, F, Baila, L, Vignetti, M, and de Witte, T

Published
2005
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9. CONKO-006: A randomised double-blinded phase IIb-study of additive therapy with gemcitabine + sorafenib/placebo in patients with R1 resection of pancreatic cancer – Final results

Author

Sinn, M., primary, Liersch, T., additional, Riess, H., additional, Gellert, K., additional, Stübs, P., additional, Waldschmidt, D., additional, Lammert, F., additional, Maschmeyer, G., additional, Bechstein, W., additional, Bitzer, M., additional, Denzlinger, C., additional, Hofheinz, R., additional, Lindig, U., additional, Ghadimi, M., additional, Hinke, A., additional, Striefler, J.K., additional, Pelzer, U., additional, Bischoff, S., additional, Bahra, M., additional, and Oettle, H., additional

Published
2020
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20. 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

22. 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

23. Age and RAS status to select patients with metastatic colorectal cancer (mCRC) for initial sequential versus combination therapy including fluoropyrimidines (FP), irinotecan (Iri) and bevacizumab (Bev): XELAVIRI- study

Author

Modest, D., primary, von Weikersthal, L. Fischer, additional, Decker, T., additional, Vehling-Kaiser, U., additional, Uhlig, J., additional, Schenk, M., additional, Freiberg-Richter, J., additional, Peuser, B., additional, Denzlinger, C., additional, Reddemann, C. Peveling genannt, additional, Graeven, U., additional, Schuch, G., additional, Schwaner, I., additional, Stahler, A., additional, Jung, A., additional, Kirchner, T., additional, Held, S., additional, Stintzing, S., additional, Giessen-Jung, C., additional, and Heinemann, V., additional

Published
2018
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26. Leukotrienes in Endotoxin Shock

Author

Hagmann, W., Denzlinger, C., Rapp, S., Keppler, D., Paubert-Braquet, M., editor, Braquet, P., editor, Demling, B., editor, Fletcher, J. R., editor, and Foegh, M., editor

Published
1987
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28. Sequential first-line therapy of metastatic colorectal cancer (mCRC) starting with fluoropyrimidine (FP) plus bevacizumab (BEV) vs. initial FP plus irinotecan (IRI) and BEV: German AIO KRK0110 (ML22011) study

Author

Modest, D.P., primary, Fischer von Weikersthal, L., additional, Decker, T., additional, Vehling-Kaiser, U., additional, Uhlig, J., additional, Schenk, M., additional, Freiberg-Richter, J., additional, Peuser, B., additional, Denzlinger, C., additional, Peveling Genannt Reddemann, C., additional, Graeven, U., additional, Schuch, G., additional, Schwaner, I., additional, Stahler, A., additional, Jung, A., additional, Held, S., additional, Stintzing, S., additional, Giessen-Jung, C., additional, and Heinemann, V., additional

Published
2017
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29. Clonal Evolution and Blast Crisis Correlate with Enhanced Proteolytic Activity of Separase in BCR-ABL b3a2 Fusion Type CML under Imatinib Therapy

Author

Haaß, Wiltrud, Kleiner, Helga, Schweizerische Arbeitsgemeinschaft für Klinische Krebsforschung, Morgner, A., Herbst, R., Matek, W., Lamberti, C., Zöller, T., Koch, B., Marth, T., Henzel, A., Wagner, S., Woska, E., German CML Study Group, Neumann, F., Hoffknecht, M. M., Illmer, T., Wolf, T., Ehninger, G., Kiani, A., Platzbecker, U., Aul, C., Badrakhan, C. D., Giagounidis, A., Wernli, M., Flaßhove, M., Henneke, F., Moritz, T., Simon, M., Müller, L. L., Janz, R., Eckart, M., Häcker, B., Rech, D., Mackensen, A., Bargetzi, M., Krause, S. W., Staib, P., Schlegel, F., Wätzig, K., Rudolph, R., Wattad, M., Baur, F. K., Heit, W., Beelen, D. W., Hüttmann, A., Fischer von Weikersthal, L., Novotny, J., Trenschel, R., Lindemann, A., Linck, D., Jäger, E., Al-Batran, Salah-Eddin, Ottmann, O. G., Serve, H., Reiber, T., Semsek, D., Gro, V., Waller, C., Kühnemund, A., Hoeffkes, H. G., Lambertz, H., Schulz, L., Tajrobehkar, K., Mittermüller, J., Rummel, M. J., Burchardt, A., Pralle, H., Müller, S., Runde, V., Klei, M., Westheider, J., Hoyer, A., Tessen, H. W., Hesse, A., Trümper, L., Binder, C., Schmidt, C. A., Hirt, C., Hahn, M., Sieber, M., Eschenburg, H., Wilhelm, S., Depenbusch, R., Rösel, S., Eimermacher, H., Spohn, C., Moeller, R., Schmitz, N., Nickelsen, M., Schlimok, G., Engel, E., Haatanen, T., Hollburg, W., Platz, D., Köster, H., Bokemeyer, C., Schafhausen, P., Grote-Metke, A., Bechtel, B., Hemeier, M., Reichert, D., Sosada, M., Ganser, A., Schlegelberger, B., Ho, A. D., Rohlfing, S., Dengler, J., Petersen, V., Porowski, P., Hahn, L., Dietzfelbinger, H., Weiß, Christel, Janssen, J., Gröschel, W., Bartholomäus, A., Pfreundschuh, M., Kemmerling, M., Hansen, R., Reeb, M., Link, H., Mahlmann, S., Mezger, J., Schatz, M., Furkert, J., Schmier, M., Gatter, J., Neumann, S., Heymanns, J., Steinmetz, H. T., Schmitz, S., Scheid, C., Planker, M., Frieling, T., Lollert, A., Mandel, T., Neise, M., Schröder, M., Greif, D., Kempf, B., März, W., Kremers, S., Müller, L., Hartmann, F., Heil, G., Goldmann, B., Majunke, P. J., Heinkele, P., Gregor, M., Theobald, M., Fischer, T., Thomas, S., Hensel, M., Plöger, C., Schuster, D., Brust, J., Hieber, U., Paliege, R., Hehlmann, R., Neubauer, A., Burchert, A., Graeven, U., Lange, C., Schmidt, G., Völkl, S., Schmidt, B., Hitz, H., Spiekermann, K., Reichert, P., Hiddemann, W., Haferlach, T., Haferlach, C., Schnittger, S., Stötzer, O., Scheidegger, C., Fischer, C., Berdel, W. E., Koppele, A., Hebart, H., Fuss, H., Snaga, A., Schmidt, P., Hoffmann, R., Reschke, D., Zirpel, I., Sauer, M., Lenk, G., Theilmann, L., Sandritter, B., Neben, K., Schenk, M., Dengler, R., Herr, W., Krause, S., Braun, B., Günther, E., Wacker, A., Pihusch, R., Baldus, M., Matzdorff, A., Staiger, H. J., Pollmeier, G., Grimminger, W., Geer, T., Schanz, S., Jür, C., Gassmann, W., Seitz, K., Kaesberger, J., Mück, R., Heim, D., Illerhaus, G., Denzlinger, C., Fiechtner, H., Springer, G., Hoffmann, D., Jacki, S. H., Kanz, L., Bross-Bach, U., Döhner, H., Stegelmann, F., Haferlach, Claudia, Gratwohl, A., Kalhori, N., Langer, W., Nusch, A., Wei, J., Kamp, T., Schadeck-Gressel, C., Schwerdtfeger, R., Josten, K. M., Klein, O., Fett, W., Tichelli, A., Strotkötter, H., Maintz, C., Groschek, M., Schlag, R., Elsel, W., Schüler, F., Dölken, G., Lindemann, H. W., Wolf, H. H., Schmoll, H. J., Korsten, S., Braumann, D., Hoelzer, P., Kleeberg, U., Hossfeld, D., Lange, E., Schubert, J., Weischer, H., Dürk, H. A., Kirchner, H. H., Bu, E C., Henesser, D., Sievers, B., Freier, W., Kaiser, U., Peest, D., Römer, E., Hermann, T., Fauser, A., Valverde, M. L., Menzel, J., Kemper, J., le Coutre, P., Hochhaus, A., La Rosée, P., Bentz, M., Prümmer, O., Kneba, M., Strack, U., Schoch, R., Severin, K., Stauch, M., Arnold, R., Karbach, U., Vehling-Kaiser, U., Köchling, G., Wei, U., Middeke, H., Neuhaus, T., Martin, H., Fetscher, S., Schmielau, J., Kämpfe, D., Ludwig, W. D., Uppenkamp, M., Wei, B., Thum, P., Wuillemin, W., Hofmann, W. K., Griesshammer, M., Tischler, H. J., Becker, M., Hanfstein, B., Müller, M., Ratei, R., Saußele, S., Lunscken, C., Kolb, H. J., Lutz, L., Hentrich, M., Nerl, C., Wendtner, C., Ladda, E., Gnad, M., Teutsch, C., Suna, H., Schmidt, E., Koschmieder, S., Falge, C., Wandt, H., Wilhelm, M., Köhne, C. H., Schweiger, C., Müller-Naendrup, C., Frühauf, S., Ludwig, F., Ranft, K., Dencausse, Y., Baake, G., Ritter, P. R., Kloke, O., Göttler, B., Schick, H. D., Schlegelberger, Brigitte, Urmersbach, A., Weidenhöfer, S., Weidinger, P., Wacker, D., Wehmeyer, J., Kreuser, E. D., Schlenska-Lange, A., Edinger, R., Andreesen, R., Wehmeier, A., Stahlhut, K., Blau, I., Käfer, G., Cerny, T., Hess, U., Priebe-Richter, C., Stange-Budumlu, O., Demandt, M., Freunek, G., Heidemann, E., Schleicher, J., Mergenthaler, H. G., Ihle, H., Boewer, C., Zeller, C., Laubenstein, H. P., Rendenbach, B., Clemens, M., Waladkhani, A. R., Forstbauer, H., Müller, F., Brettner, S., Raghavachar, A., Sperling, C., Kunzmann, V., Goebeler, M. E., Gmür, J., Schelenz, C., Koschuth, A., Kingreen, D., Heßling, J., Derwahl, K. M., Oldenkott, B., Müller, Martin C., Englisch, H. J., Thiel, E., Burmeister, T., Notter, M., de Wit, M., Rothaug, W., Büschel, G., Beyer, J., Dahmen, E., Hehlmann, Rüdiger, Biaggi, C., Lämmle, B., Friess, D., Baerlocher, G., Oppliger Leibundgut, E., Tobler, A., Just, M., Schäfer, E., Behringer, D., Brandt, M., Hofmann, Wolf-Karsten, Schmiegel, W., Vaupel, H. A., Verbeek, W., Ko, Y. D., Sauerbruch, T., Hahn-Ast, C., Janzen, V., Schmidt-Wolf, Ingo G. H., Trenn, G., Fabarius, Alice, van der Linde, M., Pommerien, W., Fritz, L., Krauter, J., Lordick, F., Fritsch, G., Pflüger, K. H., Diekmann, C., Kullmer, J., Doering, G., Seifarth, Wolfgang, Munzinger, H., Hertenstein, B., Peyn, A., Mayer, J., Zácková, D., Kujickova, J., Stier, S., Wejda, B., Möller-Faßbender, F., and Hänel, M.

Subjects
Adult, Aged, 80 and over, Chromosome Aberrations, Adolescent, Fusion Proteins, bcr-abl, Antineoplastic Agents, Chromosome Breakage, Middle Aged, Clonal Evolution, Young Adult, hemic and lymphatic diseases, Cell Line, Tumor, Leukemia, Myelogenous, Chronic, BCR-ABL Positive, Proteolysis, Imatinib Mesylate, Humans, Blast Crisis, Separase, Research Article, Aged
Abstract

PLoS ONE 10(6), e0129648 (2015). doi:10.1371/journal.pone.0129648, Published by PLoS, Lawrence, Kan.

Published
2015
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30. PD-020 - Age and RAS status to select patients with metastatic colorectal cancer (mCRC) for initial sequential versus combination therapy including fluoropyrimidines (FP), irinotecan (Iri) and bevacizumab (Bev): XELAVIRI- study

Author

Modest, D., von Weikersthal, L. Fischer, Decker, T., Vehling-Kaiser, U., Uhlig, J., Schenk, M., Freiberg-Richter, J., Peuser, B., Denzlinger, C., Reddemann, C. Peveling genannt, Graeven, U., Schuch, G., Schwaner, I., Stahler, A., Jung, A., Kirchner, T., Held, S., Stintzing, S., Giessen-Jung, C., and Heinemann, V.

Published
2018
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31. 486O - Sequential first-line therapy of metastatic colorectal cancer (mCRC) starting with fluoropyrimidine (FP) plus bevacizumab (BEV) vs. initial FP plus irinotecan (IRI) and BEV: German AIO KRK0110 (ML22011) study

Author

Modest, D.P., Fischer von Weikersthal, L., Decker, T., Vehling-Kaiser, U., Uhlig, J., Schenk, M., Freiberg-Richter, J., Peuser, B., Denzlinger, C., Peveling Genannt Reddemann, C., Graeven, U., Schuch, G., Schwaner, I., Stahler, A., Jung, A., Held, S., Stintzing, S., Giessen-Jung, C., and Heinemann, V.

Published
2017
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33. Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups

Author

Sergio Amadori, Suciu, S., Willemze, R., Mandelli, F., Selleslag, D., Stauder, R., Ho, A., Denzlinger, C., Leone, G., Fabris, P., Muus, P., Vignetti, M., Hagemeijer, A., Beeldens, F., Anak, O., and Witte, T.

Subjects
Male, Vindesine, Mitomycin, Antibodies, Monoclonal, Reproducibility of Results, Immunotherapy, gene therapy and transplantation [UMCN 1.4], Antineoplastic Agents, Middle Aged, Antibodies, Monoclonal, Humanized, Gemtuzumab, Survival Analysis, Drug Administration Schedule, acute disease, administration /&/ dosage, administration /&/ dosage/therapeutic use, administration /&/ dosage/therapeutic use/toxicity, aged, aminoglycosides, aml, antibodies, antineoplastic agents, antineoplastic combined chemotherapy protocols, chemotherapy, cisplatin, drug administration schedule, drug therapy/mortality, female, gemtuzumab ozogamicin, humans, ifosfamide, infusions, intravenous, leukemia, male, middle aged, mitomycin, monoclonal, myeloid, older patients, reproducibility of results, survival analysis, therapeutic use, vindesine, Aminoglycosides, Leukemia, Myeloid, Acute Disease, Antineoplastic Combined Chemotherapy Protocols, Humans, Female, Ifosfamide, Cisplatin, Infusions, Intravenous, Aged
Abstract

Contains fulltext : 57737.pdf (Publisher’s version ) (Open Access) BACKGROUND AND OBJECTIVES: Acute myeloid leukemia (AML) in the elderly is associated with low rates of response to conventional chemotherapy and long-term survival, highlighting the need for innovative treatment strategies. Gemtuzumab ozogamicin (GO) is an immunoconjugate that has shown activity in relapsed AML with a favorable safety profile. The aim of this collaborative trial was to assess the feasibility, safety, and antileukemic activity of administering GO followed by conventional chemotherapy as first line therapy in patients aged 61-75 years with AML. DESIGN AND METHODS: Eligible patients received frontline treatment with GO 9 mg/m2 infused intravenously on days 1 and 15. Following response assessment to GO, patients were started on conventional chemotherapy consisting of the MICE regimen (mitoxantrone, cytarabine, etoposide). No further treatment was planned for complete responders. RESULTS: Among the 57 evaluable patients, 38 (67%) completed the entire sequential treatment as planned. The overall response rate to the entire induction sequence was 54.4% (31/57), with complete remission (CR) in 35.1% and complete remission with incomplete platelet recovery (CRp) in 19.3%. Rates of failure due to treatment-related mortality or resistant disease were 14.1% (3 toxic deaths during the GO segment, 5 during MICE) and 29.9%, respectively. An initial response to GO was documented in 20 patients (35.1%), with CR in 22.8% and CRp in 12.3%; 6 additional patients entered a partial remission. Reversible myelosuppression and liver toxicity were the main adverse events during both segments of induction. Frontline GO was associated with modest mucosal and gastrointestinal toxicity, but grade 3-4 pancytopenia was universal and prolonged. Hepatic veno-occlusive disease developed in 3 patients after GO and 2 after MICE, resulting in 4 deaths from liver failure. One-year survival at follow-up was 34%. Twelve patients continue in CR/CRp after a median of 226 days. INTERPRETATION AND CONCLUSIONS: The sequential combination of GO and conventional chemotherapy is a feasible and active treatment strategy for older patients with untreated AML. This novel regimen is now being compared in a phase III trial (AML-17).

Published
2004

39. Value of infliximab (Remicade(R)) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group.

Author

Baron, F., Suciu, S., Amadori, S., Muus, P., Zwierzina, H., Denzlinger, C., Delforge, M., Thyss, A., Selleslag, D., Indrak, K., Ossenkoppele, G., Witte, T.J. de, Baron, F., Suciu, S., Amadori, S., Muus, P., Zwierzina, H., Denzlinger, C., Delforge, M., Thyss, A., Selleslag, D., Indrak, K., Ossenkoppele, G., and Witte, T.J. de

Abstract

1 april 2012, Contains fulltext : 110161.pdf (publisher's version ) (Open Access), Tumor-necrosis factor alpha activity has been correlated to ineffective erythropoiesis in lower risk myelodysplastic syndromes. Infliximab (Remicade((R))) is an anti-tumor necrosis factor alpha chimeric antibody that is used in the treatment of patients with rheumatoid arthritis or Crohn's disease. Forty-six patients with myelodysplastic syndromes and a relatively low risk of developing acute leukemia were included in a randomized phase II study assessing the therapeutic activity of two dosages of infliximab administration (3 mg/kg vs. 5 mg/kg). The primary end point was the response rate. Responses were observed in 3 of 22 patients (13.1%) randomized to the 3 mg/kg arm, versus 0 of 21 patients randomized in the 5 mg/kg arm. According to the statistical design of the current study, neither of the two infliximab dose schedules tested showed sufficient activity as a single agent in this cohort of unselected patients with early myelodysplastic syndrome.

Published
2012

40. Time course of regorafenib-associated adverse events in the phase III CORRECT study

Author

Denzlinger, C, primary, Grothey, A, additional, Sobrero, AF, additional, van Cutsem, E, additional, Siena, S, additional, Falcone, A, additional, Ychou, M, additional, Humblet, Y, additional, Bouche, O, additional, Mineur, L, additional, Barone, C, additional, Adenis, A, additional, Tabernero, J, additional, Yoshino, T, additional, Lenz, HJ, additional, Goldberg, RM, additional, Cihon, F, additional, Wagner, A, additional, and Laurent, D, additional

Published
2013
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41. Gemtuzumab ozogamicin (Mylotarg) as single-agent treatment for frail patients 61 years of age and older with acute myeloid leukemia: final results of AML-15B, a phase 2 study of the European Organisation for Research and Treatment of Cancer and Gruppo Italiano Malattie Ematologiche dell'Adulto Leukemia Groups.

Author

Amadori, S., Suciu, S., Stasi, R., Willemze, R., Mandelli, F., Selleslag, D., Denzlinger, C., Muus, P., Stauder, R., Berneman, Z., Pruijt, J.F.M., Nobile, F., Cassibba, V., Marie, J.P., Beeldens, F., Baila, L., Vignetti, M., Witte, T.J.M. de, Amadori, S., Suciu, S., Stasi, R., Willemze, R., Mandelli, F., Selleslag, D., Denzlinger, C., Muus, P., Stauder, R., Berneman, Z., Pruijt, J.F.M., Nobile, F., Cassibba, V., Marie, J.P., Beeldens, F., Baila, L., Vignetti, M., and Witte, T.J.M. de

Abstract

Contains fulltext : 47837.pdf (publisher's version ) (Closed access), The therapeutic activity and toxicity profile of gemtuzumab ozogamicin were assessed in 40 patients >60 years of age with acute myeloid leukemia (AML) who were not considered eligible for conventional chemotherapy because of advanced age or poor performance status. The drug was administered at the dose of 9 mg/m2 as a single 2-h i.v. infusion on days 1 and 15. Patients who achieved a complete remission (CR/CRp) were to receive a consolidation with two additional injections of the immunotoxin at the same dose. The overall CR/CRp rate was 17% (95% CI, 8-32%). The CR/CRp rate in patients 61-75 years old was 33% (6/18), and 5% (1/22) in patients older than 75 years. Induction death occurred in seven patients (17%), all aged above 75 years. Overall survival was significantly longer in patients aged 61-75 years than in older individuals (P=0.05), and in CD33+ cases than in CD33- cases (P=0.05). We conclude that the dose/schedule of gemtuzumab ozogamicin used in this trial is too toxic in the age group over 75 years. For these patients, additional studies with reduced doses of the immunotoxin are warranted.

Published
2005

42. Use of glycosylated recombinant human G-CSF (lenograstim) during and/or after induction chemotherapy in patients 61 years of age and older with acute myeloid leukemia: final results of AML-13, a randomized phase-3 study.

Author

Amadori, S., Suciu, S., Jehn, U., Stasi, R., Thomas, X., Marie, J.P., Muus, P., Lefrere, F., Berneman, Z., Fillet, G., Denzlinger, C., Willemze, R., Leoni, P., Leone, G., Casini, M., Ricciuti, F., Vignetti, M., Beeldens, F., Mandelli, F., Witte, T.J.M. de, Amadori, S., Suciu, S., Jehn, U., Stasi, R., Thomas, X., Marie, J.P., Muus, P., Lefrere, F., Berneman, Z., Fillet, G., Denzlinger, C., Willemze, R., Leoni, P., Leone, G., Casini, M., Ricciuti, F., Vignetti, M., Beeldens, F., Mandelli, F., and Witte, T.J.M. de

Abstract

Contains fulltext : 47992.pdf (publisher's version ) (Closed access), The role of glycosylated recombinant human granulocyte colony-stimulating factor (G-CSF) in the induction treatment of older adults with acute myeloid leukemia (AML) is still uncertain. In this trial, a total of 722 patients with newly diagnosed AML, median age 68 years, were randomized into 4 treatment arms: (A) no G-CSF; (B) G-CSF during chemotherapy; (C) G-CSF after chemotherapy until day 28 or recovery of polymorphonuclear leukocytes; and (D) G-CSF during and after chemotherapy. The complete remission (CR) rate was 48.9% in group A, 52.2% in group B, 48.3% in group C, and 64.4% in group D. Analysis according to the 2 x 2 factorial design indicated that the CR rate was significantly higher in patients who received G-CSF during chemotherapy (58.3% for groups B + D vs 48.6% for groups A + C; P = .009), whereas no significant difference was observed between groups A + B and C + D (50.6% vs 56.4%, P = .12). In terms of overall survival, no significant differences were observed between the various groups. Patients who received G-CSF after chemotherapy had a shorter time to neutrophil recovery (median, 20 vs 25 days; P < .001) and a shorter hospitalization (mean, 27.2 vs 29.7 days; P < .001). We conclude that although priming with G-CSF can improve the CR rate, the use of G-CSF during and/or after chemotherapy has no effect on the long-term outcome of AML in older patients.

Published
2005

43. Zur Behandlung der chronischen myeloischen Leukämie mit dem selektiven bcr-abl Tyrosinkinaseinhibitor Imatinib

Author

Dörken, B., Denzlinger, C., Schleyer, E., Na, Il-Kang, Dörken, B., Denzlinger, C., Schleyer, E., and Na, Il-Kang

Abstract

HINTERGRUND: Der selektive Tyrosinkinase-Inhibitor Imatinib inhibiert das Wachstum von bcr/abl positiven Zellen und stellt somit eine neue Therapieoption in der Behandlung der CML dar. Mittlerweile sind verschiedene Mutationen innerhalb der abl Sequenz beschrieben worden, die eine adäquate Imatinibbindung verhindern und zu einer zellulären Resistenz der CML Zellen führen. METHODE: Wir untersuchten 69 Patienten unter Behandlung mit Imatinib im Rahmen von laufenden klinischen Studien. Bei Studieneinschluss waren 37 Patienten in chronischer Phase, 21 Patienten in akzelerierter Phase und 11 Patienten in Blastenkrise. Mittels Real-time PCR wurden bcr/abl, WT1, MDR1 und AGP RNA Traskripte aus peripheren Leukozyten quantifiziert. AGP Proteinlevel wurden turbidimetrisch bestimmt. Ausserdem entwickelten wir eine neue, hochsensitive Technik zur Detektion bekannter Mutationen innerhalb der bcr/abl Domäne, indem wir das DNA-Clamping mittels Peptidnukleinsäure (PNA) mit einem Hybridisationssonden-Assay kombinierten. ERGEBNISSE: 1. Unsere Resultate bestätigen die hämatologische Effizienz von Imatinib in Übereinstimmung mit bereits publizierten Daten. 2. Eine komplette molekulare Remission konnte bei einem Patienten erzielt werden. 3. Wir konnten die bcr/abl Mutationen Thr315Ile, Glu255Lys and Tyr253His mit hoher Sensivität nachweisen. In einem Falle konnte die Gly255Lys Mutation vor der Behandlung detektiert werden. SCHLUSSFOLGERUNG: Bcr/abl und WT1 mRNA stellen in der Behandlung der CML Verlaufs- und Prognosemarker dar. Ein Zusammenhang zwischen MDR1 mRNA bzw. AGP mRNA und einer Resistenzentwicklung gegenüber Imatinib konnte nicht bestätigt werden. Durch den PNA-Clamping Assay konnten präexistente und sich entwickelnde bcr/abl Mutationen mit ungünstiger Prognose sicher und frühzeitig detektiert werden. Diese Tatsache ermöglicht eventuell eine Risikostratifizierung der CML und könnte als Model zum individuellen molekularen Monitoring und zur therapeutischen Strategie in anderen m, BACKROUND: The selective tyrosine kinase inhibitor imatinib inhibits growth of bcr/abl positive cells and, thus, has become a novel therapeutic option for the treatment of Ph+ leukaemic patients. Various mutations within the abl sequence have been described that prevent adequate imatinib binding to bcr/abl resulting in cellular resistance of CML cells. METHODS: We investigated 69 CML patients under treatment with imatinib as part of an ongoing clinical trial. At recruitment 37 patients were in chronic phase, 21 patients in accelerated phase and 11 patients in blast crisis. Bcr/abl, WT1, MDR1and AGP RNA transcripts were quantified in peripheral leucocytes by real time PCR. AGP protein levels in plasma were measured by turbidimetric analysis. By combining peptide nucleic acid (PNA) based DNA clamping with a fluorescence hybridisation probe assay we developed a new and highly sensitive technique for the detection of known mutations within the bcr/abl kinase domain. RESULTS: 1. Our results demonstrate efficacy of imatinib on the haematological level in accordance with previously published data. 2. Complete molecular remission could be achieved in one patient. 3. We could effectively enhance the detection sensitivity (0,2%) for the BCR/ABL mutations Thr315Ile, Glu255Lys and Tyr253His. In one case the Gly255Lys mutation was detectable before treatment. CONCLUSION: Bcr/abl and WT1 mRNA are predictive marker in the treatment of CML. Our investigation could not confirm any relation between MDR1 mRNA nor AGP mRNA and a resistance to imatinib. By the PNA clamping assay pre-existing and evolving bcr/abl mutations associated with an unfavorable prognosis could be safely detected. This may facilitate risk stratification in CML and may serve as a model for individualized molecular monitoring and therapeutic strategies in other malignant diseases.

Published
2005

44. Sequential administration of gemtuzumab ozogamicin and conventional chemotherapy as first line therapy in elderly patients with acute myeloid leukemia: a phase II study (AML-15) of the EORTC and GIMEMA leukemia groups.

Author

Amadori, S., Suciu, S., Willemze, R., Mandelli, F., Selleslag, D., Stauder, R., Ho, A., Denzlinger, C., Leone, G., Fabris, P., Muus, P., Vignetti, M., Hagemeijer, A., Beeldens, F., Anak, O., Witte, T.J.M. de, Amadori, S., Suciu, S., Willemze, R., Mandelli, F., Selleslag, D., Stauder, R., Ho, A., Denzlinger, C., Leone, G., Fabris, P., Muus, P., Vignetti, M., Hagemeijer, A., Beeldens, F., Anak, O., and Witte, T.J.M. de

Abstract

Contains fulltext : 57737.pdf (publisher's version ) (Open Access), BACKGROUND AND OBJECTIVES: Acute myeloid leukemia (AML) in the elderly is associated with low rates of response to conventional chemotherapy and long-term survival, highlighting the need for innovative treatment strategies. Gemtuzumab ozogamicin (GO) is an immunoconjugate that has shown activity in relapsed AML with a favorable safety profile. The aim of this collaborative trial was to assess the feasibility, safety, and antileukemic activity of administering GO followed by conventional chemotherapy as first line therapy in patients aged 61-75 years with AML. DESIGN AND METHODS: Eligible patients received frontline treatment with GO 9 mg/m2 infused intravenously on days 1 and 15. Following response assessment to GO, patients were started on conventional chemotherapy consisting of the MICE regimen (mitoxantrone, cytarabine, etoposide). No further treatment was planned for complete responders. RESULTS: Among the 57 evaluable patients, 38 (67%) completed the entire sequential treatment as planned. The overall response rate to the entire induction sequence was 54.4% (31/57), with complete remission (CR) in 35.1% and complete remission with incomplete platelet recovery (CRp) in 19.3%. Rates of failure due to treatment-related mortality or resistant disease were 14.1% (3 toxic deaths during the GO segment, 5 during MICE) and 29.9%, respectively. An initial response to GO was documented in 20 patients (35.1%), with CR in 22.8% and CRp in 12.3%; 6 additional patients entered a partial remission. Reversible myelosuppression and liver toxicity were the main adverse events during both segments of induction. Frontline GO was associated with modest mucosal and gastrointestinal toxicity, but grade 3-4 pancytopenia was universal and prolonged. Hepatic veno-occlusive disease developed in 3 patients after GO and 2 after MICE, resulting in 4 deaths from liver failure. One-year survival at follow-up was 34%. Twelve patients continue in CR/CRp after a median of 226 days. INTERPRETATION

Published
2004

45. IL-4 renders mast cells functionally responsive to endothelin-1

Author

Egger D, Geuenich S, Denzlinger C, Schmitt E, Mailhammer R, Hannelore Ehrenreich, Dörmer P, and Hültner L

Subjects
Endothelin Receptor Antagonists, Serotonin, Immunology, Molecular Sequence Data, Bone Marrow Cells, Hematopoietic Cell Growth Factors, Histamine Release, Mice, Th2 Cells, Immunology and Allergy, Animals, Amino Acid Sequence, Mast Cells, Peritoneal Cavity, Cells, Cultured, Mice, Inbred BALB C, Stem Cell Factor, Dose-Response Relationship, Drug, Receptors, Endothelin, Endothelins, Cell Differentiation, Leukotriene C4, Recombinant Proteins, Organ Specificity, Interleukin-3, Interleukin-4
Abstract

It has previously been shown that mouse bone marrow-derived mast cells (BMMC) synthesize and secrete endothelin-1 (ET-1) and express ETA-type endothelin receptors (ETA-R). The study presented here was designed to elucidate the influence of different cytokine conditions for cellular differentiation and maturation on the ability of primary mouse BMMC to respond to exogenous ET-1. BMMC were grown for 2 wk in IL-3 alone and then cultured for 2 to 3 wk with kit ligand (KL) and/or IL-3 in the presence or absence of IL-4. ET-1 induced a very rapid (< or = 1 min) and dose-dependent release of histamine and serotonin from BMMC cultured in the presence of both IL-3 and IL-4. The effect of ET-1 was quantitatively comparable with IgE/Ag-induced mediator release and comprised up to 20% and 16% of total cellular histamine and serotonin, respectively. In BMMC grown with KL or KL plus IL-3, a substantial effect of ET-1 on amine release was only observed when IL-4 had been included in the culture medium. These IL-4 effects could not be observed if BMMC grown in IL-3 and/or KL were preincubated for 1 or 24 h with IL-4 before activation with ET-1, suggesting that a differentiation process rather than a functional priming effect had been initiated by IL-4. In BMMC, the histamine and serotonin release induced by ET-1 (10(-6) M) was inhibited by an ETA-R-specific antagonist (cyclic [D-Asp-Pro-D-Val-Leu-D-Trp]) in a dose-dependent manner, with complete inhibition at an antagonist concentration of 10(-8) M. ET-1 stimulated leukotriene C4 biosynthesis up to 4.5-fold in BMMC cultured in the presence of IL-4. No such ET-1 effect was observed in BMMC cultured in media containing IL-3, KL, or a combination of both cytokines. Peritoneal cells (containing 2 to 3% serosal mast cells) obtained from BALB/c mice released 87 +/- 2% of histamine within 1 min after challenge with ET-1. Our results demonstrate that ET-1 can directly act as a histamine and serotonin secretagogue and as a stimulator of leukotriene C4 production in mast cells. IL-4 appears to be critically involved in the differentiation of immature mast cell precursors to an ET-1-reactive phenotype.(ABSTRACT TRUNCATED AT 400 WORDS)

Published
1995

46. Value of infliximab (Remicade(R)) in patients with low-risk myelodysplastic syndrome: final results of a randomized phase II trial (EORTC trial 06023) of the EORTC Leukemia Group

Author

Baron, F., primary, Suciu, S., additional, Amadori, S., additional, Muus, P., additional, Zwierzina, H., additional, Denzlinger, C., additional, Delforge, M., additional, Thyss, A., additional, Selleslag, D., additional, Indrak, K., additional, Ossenkoppele, G., additional, and de Witte, T., additional

Published
2011
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48. Up-Front Window Trial of Gemtuzumab Ozogamicin (GO) in Previously Untreated Elderly Patients with AML: An EORTC Leukemia Group Study.

Author

Amadori, Sergio, primary, Suciu, S., additional, Willemze, R., additional, Mandelli, F., additional, Selleslag, D., additional, Stauder, R., additional, Ho, A., additional, Denzlinger, C., additional, Leone, G., additional, Fillet, G., additional, Muus, P., additional, Beeldens, F., additional, Anak, O., additional, and De Witte, T., additional

Published
2004
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