| Online-Ressource |
Verfasst von: | Schlenk, Richard Friedrich [VerfasserIn]  |
| Paschka, Peter [VerfasserIn]  |
| Krzykalla, Julia [VerfasserIn]  |
| Weber, Daniela [VerfasserIn]  |
| Kapp-Schwoerer, Silke [VerfasserIn]  |
| Gaidzik, Verena I. [VerfasserIn]  |
| Leis, Claudia [VerfasserIn]  |
| Fiedler, Walter [VerfasserIn]  |
| Kindler, Thomas [VerfasserIn]  |
| Schroeder, Thomas [VerfasserIn]  |
| Mayer, Karin [VerfasserIn]  |
| Lübbert, Michael [VerfasserIn]  |
| Wattad, Mohammed [VerfasserIn]  |
| Götze, Katharina [VerfasserIn]  |
| Horst, Heinz A. [VerfasserIn]  |
| Koller, Elisabeth [VerfasserIn]  |
| Wulf, Gerald [VerfasserIn]  |
| Schleicher, Jan [VerfasserIn]  |
| Bentz, Martin [VerfasserIn]  |
| Greil, Richard [VerfasserIn]  |
| Hertenstein, Bernd [VerfasserIn]  |
| Krauter, Jürgen [VerfasserIn]  |
| Martens, Uwe [VerfasserIn]  |
| Nachbaur, David [VerfasserIn]  |
| Abu Samra, Maisun [VerfasserIn]  |
| Girschikofsky, Michael [VerfasserIn]  |
| Basara, Nadezda [VerfasserIn]  |
| Benner, Axel [VerfasserIn]  |
| Thol, Felicitas [VerfasserIn]  |
| Heuser, Michael [VerfasserIn]  |
| Ganser, Arnold [VerfasserIn]  |
| Döhner, Konstanze [VerfasserIn]  |
| Döhner, Hartmut [VerfasserIn]  |
Titel: | Gemtuzumab ozogamicin in NPM1-mutated acute myeloid leukemia |
Titelzusatz: | early results from the prospective randomized AMLSG 09-09 phase III study |
Verf.angabe: | Richard F. Schlenk, MD; Peter Paschka, MD; Julia Krzykalla, MSc; Daniela Weber, MSc; Silke Kapp-Schwoerer, MD; Verena I. Gaidzik, MD; Claudia Leis, BSc; Walter Fiedler, MD; Thomas Kindler, MD; Thomas Schroeder, MD; Karin Mayer, MD; Michael Lübbert, MD; Mohammed Wattad, MD; Katharina Götze, MD; Heinz A. Horst, MD, PhD; Elisabeth Koller, MD; Gerald Wulf, MD; Jan Schleicher, MD; Martin Bentz, MD; Richard Greil, MD; Bernd Hertenstein, MD, PhD; Jürgen Krauter, MD; Uwe Martens, MD; David Nachbaur, MD; Maisun Abu Samra, MD; Michael Girschikofsky, MD; Nadezda Basara, MD, DSc; Axel Benner, Dipl-Stat; Felicitas Thol, MD; Michael Heuser, MD; Arnold Ganser, MD; Konstanze Döhner, MD; and Hartmut Döhner, MD |
E-Jahr: | 2019 |
Jahr: | December 18, 2019 |
Umfang: | 10 S. |
Fussnoten: | Gesehen am 08.04.2020 |
Titel Quelle: | Enthalten in: Journal of clinical oncology |
Ort Quelle: | Alexandria, Va. : American Society of Clinical Oncology, 1983 |
Jahr Quelle: | 2019 |
Band/Heft Quelle: | 38(2019), 6, Seite 623-632 |
ISSN Quelle: | 1527-7755 |
Abstract: | PURPOSEHigh CD33 expression in acute myeloid leukemia (AML) with mutated NPM1 provides a rationale for the evaluation of gemtuzumab ozogamicin (GO) in this AML entity. We conducted a randomized trial to evaluate GO in combination with intensive induction and consolidation therapy in NPM1-mutated AML.PATIENTS AND METHODSBetween May 2010 and September 2017, patients ≥ 18 years old and considered eligible for intensive therapy were randomly assigned up front for induction therapy with idarubicin, cytarabine, etoposide, and all-trans-retinoic acid with or without GO. The early (P = .02) primary end point of event-free survival (EFS) was evaluated 6 months after completion of patient recruitment.RESULTSFive hundred eighty-eight patients were randomly assigned (standard arm, n = 296; GO arm, n = 292). EFS in the GO arm was not significantly different compared with that in the standard arm (hazard ratio, 0.83; 95% CI, 0.65 to 1.04; P = .10). The early death rate during induction therapy was 10.3% in the GO arm and 5.7% in the standard arm (P = .05). Causes of death in both arms were mainly infections. The cumulative incidence of relapse (CIR) in patients achieving a complete remission (CR) or CR with incomplete hematologic recovery (CRi) was significantly reduced in the GO arm compared with the standard arm (P = .005), with no difference in the cumulative incidence of death (P = .80). Subgroup analysis revealed a significant beneficial effect of GO in female, younger (≤ 70 years), and FLT3 internal tandem duplication-negative patients with respect to EFS and CIR.CONCLUSIONThe trial did not meet its early primary end point of EFS, mainly as a result of a higher early death rate in the GO arm. However, in patients achieving CR/CRi after induction therapy, significantly fewer relapses occurred in the GO compared with the standard arm. |
DOI: | doi:10.1200/JCO.19.01406 |
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: https://doi.org/10.1200/JCO.19.01406 |
| Volltext: https://ascopubs.org/doi/10.1200/JCO.19.01406 |
| DOI: https://doi.org/10.1200/JCO.19.01406 |
Datenträger: | Online-Ressource |
Sprache: | eng |
K10plus-PPN: | 1694239357 |
Verknüpfungen: | → Zeitschrift |
Gemtuzumab ozogamicin in NPM1-mutated acute myeloid leukemia / Schlenk, Richard Friedrich [VerfasserIn]; December 18, 2019 (Online-Ressource)