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@ARTICLE{Schlenk:143062,
      author       = {R. Schlenk and D. Weber and W. Fiedler and H. R. Salih and
                      G. Wulf and H. Salwender and T. Schroeder and T. Kindler and
                      M. Lübbert and D. Wolf and J. Westermann and D. Kraemer and
                      K. S. Götze and H.-A. Horst and J. Krauter and M.
                      Girschikofsky and M. Ringhoffer and T. Südhoff and G. Held
                      and H.-G. Derigs and R. Schroers and R. Greil and M.
                      Grießhammer and E. Lange and A. Burchardt and U. Martens
                      and B. Hertenstein and L. Marretta and M. Heuser and F. Thol
                      and V. I. Gaidzik and W. Herr and J. Krzykalla$^*$ and A.
                      Benner$^*$ and K. Döhner and A. Ganser and P. Paschka and
                      H. Döhner},
      collaboration = {G. A. S. Group},
      title        = {{M}idostaurin added to chemotherapy and continued
                      single-agent maintenance therapy in acute myeloid leukemia
                      with {FLT}3-{ITD}.},
      journal      = {Blood},
      volume       = {133},
      number       = {8},
      issn         = {0006-4971},
      address      = {Stanford, Calif.},
      publisher    = {HighWire Press},
      reportid     = {DKFZ-2019-00681},
      pages        = {840 - 851},
      year         = {2019},
      abstract     = {Patients with acute myeloid leukemia (AML) and a FLT3
                      internal tandem duplication (ITD) have poor outcomes to
                      current treatment. A phase 2 hypothesis-generating trial was
                      conducted to determine whether the addition of the
                      multitargeted kinase inhibitor midostaurin to intensive
                      chemotherapy followed by allogeneic hematopoietic cell
                      transplantation (alloHCT) and single-agent maintenance
                      therapy of 12 months is feasible and favorably influences
                      event-free survival (EFS) compared with historical controls.
                      Patients 18 to 70 years of age with newly diagnosed AML and
                      centrally confirmed FLT3-ITD were eligible: 284 patients
                      were treated, including 198 younger (18-60 years) and 86
                      older (61-70 years) patients. Complete remission (CR) rate,
                      including CR with incomplete hematological recovery (CRi)
                      after induction therapy, was $76.4\%$ (younger, $75.8\%;$
                      older, $77.9\%).$ The majority of patients in CR/CRi
                      proceeded to alloHCT $(72.4\%).$ Maintenance therapy was
                      started in 97 patients $(34\%):$ 75 after alloHCT and 22
                      after consolidation with high-dose cytarabine (HiDAC).
                      Median time receiving maintenance therapy was 9 months after
                      alloHCT and 10.5 months after HiDAC; premature termination
                      was mainly a result of nonrelapse causes (gastrointestinal
                      toxicity and infections). EFS and overall survival at 2
                      years were $39\%$ $(95\%$ confidence interval [CI],
                      $33\%-47\%)$ and $34\%$ $(95\%$ CI, $24\%-47\%)$ and $53\%$
                      $(95\%$ CI, $46\%-61\%)$ and $46\%$ $(95\%$ CI, $35\%-59\%)$
                      in younger and older patients, respectively. EFS was
                      evaluated in comparison with 415 historical controls treated
                      within 5 prospective trials. Propensity score-weighted
                      analysis revealed a significant improvement of EFS by
                      midostaurin (hazard ratio [HR], 0.58; $95\%$ CI, 0.48-0.70;
                      P < .001) overall and in older patients (HR, 0.42; $95\%$
                      CI, 0.29-0.61). The study was registered at
                      www.clinicaltrials.gov as #NCT01477606.},
      cin          = {C060},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331},
      pnm          = {312 - Functional and structural genomics (POF3-312)},
      pid          = {G:(DE-HGF)POF3-312},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:30563875},
      doi          = {10.1182/blood-2018-08-869453},
      url          = {https://inrepo02.dkfz.de/record/143062},
}