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@ARTICLE{KappSchwoerer:157548,
      author       = {S. Kapp-Schwoerer and D. Weber and A. Corbacioglu and V. I.
                      Gaidzik and P. Paschka and J. Krönke and F. Theis and F. G.
                      Rücker and M.-V. Teleanu$^*$ and E. Panina and N. Jahn and
                      J. K. Herzig and L. Kubanek and A. Schrade and G. Gohring
                      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. G. Wulf and J. Schleicher and M. Bentz
                      and J. Krauter and L. Bullinger and J. Krzykalla$^*$ and A.
                      Benner$^*$ and R. F. Schlenk and F. Thol and M. Heuser and
                      A. Ganser and H. Döhner and K. Döhner},
      title        = {{I}mpact of gemtuzumab ozogamicin on {MRD} and relapse risk
                      in {NPM}1 mutated {AML} patients: results from the {AMLSG}
                      09-09 {T}rial.},
      journal      = {Blood},
      volume       = {136},
      number       = {26},
      issn         = {1528-0020},
      address      = {Stanford, Calif.},
      publisher    = {HighWire Press},
      reportid     = {DKFZ-2020-01703},
      pages        = {3041-3050},
      year         = {2020},
      note         = {2020 Dec 24;136(26):3041-3050},
      abstract     = {Monitoring of measurable residual disease (MRD) provides
                      prognostic information in patients with Nucleophosmin1
                      mutated (NPM1mut) acute myeloid leukemia (AML) and
                      represents a powerful tool to evaluate treatment effects
                      within clinical trials. We determined NPM1mut transcript
                      levels (TL) by RQ-PCR and evaluated the prognostic impact of
                      NPM1mut MRD and the effect of gemtuzumab ozogamicin (GO) on
                      NPM1mut TL and the cumulative incidence of relapse (CIR) in
                      patients with NPM1mut AML enrolled in the randomized phase
                      III AMLSG 09-09 trial. 3733 bone marrow (BM) and 3793
                      peripheral blood (PB) samples from 469 patients were
                      analyzed. NPM1mut TL log10 reduction ≥3 and achievement of
                      MRD negativity in BM and PB were significantly associated
                      with a lower CIR rate, after two treatment cycles and at end
                      of treatment (EOT). In multivariate analyses, MRD positivity
                      consistently revealed as poor prognostic factor in BM and
                      PB. With regard to treatment effect, the median NPM1mut TL
                      were significantly lower in the GO-Arm across all treatment
                      cycles, resulting in a significantly higher proportion of
                      patients achieving MRD negativity at EOT $(56\%$ vs $41\%;$
                      P=.01). The betterreduction of NPM1mut TL after two
                      treatment cycles in MRD-positive patients by the addition of
                      GO led to a significantly lower CIR rate (4-year CIR
                      $29.3\%$ vs $45.7\%,$ P=.009). In conclusion, the addition
                      of GO to intensive chemotherapy in NPM1mut AML resulted in a
                      significantly better reduction of NPM1mut TL across all
                      treatment cycles leading to a significantly lower relapse
                      rate. The AMLSG 09-09 trial was registered at
                      www.clinicaltrials.gov as #NCT00893399.},
      cin          = {C060 / B340},
      ddc          = {610},
      cid          = {I:(DE-He78)C060-20160331 / I:(DE-He78)B340-20160331},
      pnm          = {313 - Cancer risk factors and prevention (POF3-313)},
      pid          = {G:(DE-HGF)POF3-313},
      typ          = {PUB:(DE-HGF)16},
      pubmed       = {pmid:32812041},
      doi          = {10.1182/blood.2020005998},
      url          = {https://inrepo02.dkfz.de/record/157548},
}