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@ARTICLE{Schlenk:154483,
      author       = {R. F. Schlenk and P. Paschka and J. Krzykalla$^*$ and D.
                      Weber and S. Kapp-Schwoerer and V. I. Gaidzik and C. Leis
                      and W. Fiedler and T. Kindler and T. Schroeder and K. Mayer
                      and M. Lübbert and M. Wattad and K. Götze and H. A. Horst
                      and E. Koller and G. Wulf and J. Schleicher and M. Bentz and
                      R. Greil and B. Hertenstein and J. Krauter and U. Martens
                      and D. Nachbaur and M. Abu Samra and M. Girschikofsky and N.
                      Basara and A. Benner and F. Thol and M. Heuser and A. Ganser
                      and K. Döhner and H. Döhner},
      title        = {{G}emtuzumab {O}zogamicin in {NPM}1-{M}utated {A}cute
                      {M}yeloid {L}eukemia: {E}arly {R}esults {F}rom the
                      {P}rospective {R}andomized {AMLSG} 09-09 {P}hase {III}
                      {S}tudy.},
      journal      = {Journal of clinical oncology},
      volume       = {38},
      number       = {6},
      issn         = {1527-7755},
      address      = {Alexandria, Va.},
      publisher    = {American Society of Clinical Oncology},
      reportid     = {DKFZ-2020-00805},
      pages        = {623 - 632},
      year         = {2020},
      abstract     = {High 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.Between 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.Five 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.The 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.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:31851556},
      pmc          = {pmc:PMC7030890},
      doi          = {10.1200/JCO.19.01406},
      url          = {https://inrepo02.dkfz.de/record/154483},
}