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| Verfasst von: | Hehlmann, Rüdiger [VerfasserIn]  |
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| | Berger, Ute [VerfasserIn] |
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| | Pfirrmann, M. [VerfasserIn] |
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| | Hochhaus, Andreas [VerfasserIn] |
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| | Metzgeroth, Georgia [VerfasserIn] |
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| | Maywald, O. [VerfasserIn] |
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| | Hasford, J. [VerfasserIn] |
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| | Reiter, Andreas [VerfasserIn] |
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| | Hossfeld, D. K. [VerfasserIn] |
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| | Kolb, H.-J. [VerfasserIn] |
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| | Löffler, H. [VerfasserIn] |
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| | Pralle, H. [VerfasserIn] |
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| | Queißer, Wolfgang [VerfasserIn] |
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| | Griesshammer, M. [VerfasserIn] |
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| | Nerl, C. [VerfasserIn] |
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| | Kuse, R. [VerfasserIn] |
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| | Tobler, A. [VerfasserIn] |
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| | Eimermacher, H. [VerfasserIn] |
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| | Tichelli, A. [VerfasserIn] |
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| | Aul, C. [VerfasserIn] |
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| | Wilhelm, M. [VerfasserIn] |
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| | Fischer, J. T. [VerfasserIn] |
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| | Perker, M. [VerfasserIn] |
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| | Scheid, C. [VerfasserIn] |
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| | Schenk, M. [VerfasserIn] |
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| | Weiß, J. [VerfasserIn] |
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| | Meier, C. R. [VerfasserIn] |
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| | Kremers, S. [VerfasserIn] |
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| | Labedzki, L. [VerfasserIn] |
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| | Schmeiser, T. [VerfasserIn] |
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| | Lohrmann, H.-P. [VerfasserIn] |
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| | Heimpel, H. [VerfasserIn] |
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| Titel: | Randomized comparison of interferon α and hydroxyurea with hydroxyurea monotherapy in chronic myeloid leukemia (CML-study II) |
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| Titelzusatz: | prolongation of survival by the combination of interferon α and hydroxyurea |
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| Verf.angabe: | R. Hehlmann, U. Berger, M. Pfirrmann, A. Hochhaus, G. Metzgeroth, O. Maywald, J. Hasford, A. Reiter, D.K. Hossfeld, H.-J. Kolb, H. Löffler, H. Pralle, W. Queißer, M. Griesshammer, C. Nerl, R. Kuse, A. Tobler, H. Eimermacher, A. Tichelli, C. Aul, M. Wilhelm, J.T. Fischer, M. Perker, C. Scheid, M. Schenk, J. Weiß, C.R. Meier, S. Kremers, L. Labedzki, T. Schmeiser, H.-P. Lohrmann, H. Heimpel and the German CML-Study Group |
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| E-Jahr: | 2003 |
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| Jahr: | 29 July 2003 |
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| Umfang: | 9 S. |
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| Fussnoten: | Gesehen am 13.05.2022 |
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| Titel Quelle: | Enthalten in: Leukemia |
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| Ort Quelle: | London : Springer Nature, 1997 |
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| Jahr Quelle: | 2003 |
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| Band/Heft Quelle: | 17(2003), 8, Seite 1529-1537 |
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| ISSN Quelle: | 1476-5551 |
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| Abstract: | The optimum treatment conditions of interferon (IFN) α therapy in chronic myeloid leukemia (CML) are still controversial. To evaluate the role of hydroxyurea (HU) for the outcome of IFN therapy, we conducted a randomized trial to compare the combination of IFN and HU vs HU monotherapy (CML-study II). From February 1991 to December 1994, 376 patients with newly diagnosed CML in chronic phase were randomized. In all, 340 patients were Ph/BCR-ABL positive and evaluable. Randomization was unbalanced 1:2 in favor of the combination therapy, since study conditions were identical to the previous CML-study I and it had been planned in advance to add the HU patients of study I (n=194) to the HU control group. Therefore, a total of 534 patients were evaluable (226 patients with IFN/HU and 308 patients with HU). Analyses were according to intention-to-treat. Median observation time of nontransplanted living patients was 7.6 years (7.9 years for IFN/HU and 7.3 years for HU). The risk profile (new CML score) was available for 532 patients: 200 patients (38%) were low, 239 patients (45%) intermediate, and 93 patients (17%) high risk. Complete hematologic response rates were higher in IFN/HU-treated patients (59 vs 32%). Of 169 evaluable IFN/HU-treated patients (75%), 104 patients (62%) achieved a cytogenetic response that was complete in 12% (n=21), major in 14% (n=24), and at least minimal in 35% (n=59). Of the 534 patients, 105 (20%) underwent allogeneic stem cell transplantation in first chronic phase. In the low-risk group, 65 of 200 patients were transplanted (33%), 30 (13%) in the intermediate-risk group, and nine (10%) in the high-risk group. Duration of chronic phase was 55 months for IFN/HU and 41 months for HU (P<0.0001). Median survival was 64 months for IFN/HU and 53 months for HU-treated patients (P=0.0063). We conclude that IFN in combination with HU achieves a significant long-term survival advantage over HU monotherapy. In view of the data of CML-study I, these results suggest that IFN/HU is also superior to IFN alone. HU should be combined with IFN in IFN-based therapies and for comparisons with new therapies. |
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| DOI: | doi:10.1038/sj.leu.2403006 |
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| URL: | Bitte beachten Sie: Dies ist ein Bibliographieeintrag. Ein Volltextzugriff für Mitglieder der Universität besteht hier nur, falls für die entsprechende Zeitschrift/den entsprechenden Sammelband ein Abonnement besteht oder es sich um einen OpenAccess-Titel handelt.
Volltext ; Verlag: https://doi.org/10.1038/sj.leu.2403006 |
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| | Volltext: https://www.nature.com/articles/2403006 |
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| | DOI: https://doi.org/10.1038/sj.leu.2403006 |
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| Datenträger: | Online-Ressource |
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| Sprache: | eng |
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| Sach-SW: | Cancer Research |
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| | general |
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| | Hematology |
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| | Intensive / Critical Care Medicine |
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| | Internal Medicine |
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| | Medicine/Public Health |
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| | Oncology |
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| K10plus-PPN: | 180171715X |
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| Verknüpfungen: | → Zeitschrift |
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Randomized comparison of interferon α and hydroxyurea with hydroxyurea monotherapy in chronic myeloid leukemia (CML-study II) / Hehlmann, Rüdiger [VerfasserIn]; 29 July 2003 (Online-Ressource)
