Real-world experience of CPX-351 as first-line treatment for patients with acute myeloid leukemia View Full Text


Ontology type: schema:ScholarlyArticle      Open Access: True


Article Info

DATE

2021-10-04

AUTHORS

Christina Rautenberg, Friedrich Stölzel, Christoph Röllig, Matthias Stelljes, Verena Gaidzik, Michael Lauseker, Oliver Kriege, Mareike Verbeek, Julia Marie Unglaub, Felicitas Thol, Stefan W. Krause, Mathias Hänel, Charlotte Neuerburg, Vladan Vucinic, Christian-Friedrich Jehn, Julia Severmann, Maxi Wass, Lars Fransecky, Jens Chemnitz, Udo Holtick, Kerstin Schäfer-Eckart, Josephine Schröder, Sabrina Kraus, William Krüger, Ulrich Kaiser, Sebastian Scholl, Kathrin Koch, Lea Henning, Guido Kobbe, Rainer Haas, Nael Alakel, Maximilian-Alexander Röhnert, Katja Sockel, Maher Hanoun, Uwe Platzbecker, Tobias A. W. Holderried, Anke Morgner, Michael Heuser, Tim Sauer, Katharina S. Götze, Eva Wagner-Drouet, Konstanze Döhner, Hartmut Döhner, Christoph Schliemann, Johannes Schetelig, Martin Bornhäuser, Ulrich Germing, Thomas Schroeder, Jan Moritz Middeke

ABSTRACT

To investigate the efficacy and toxicities of CPX-351 outside a clinical trial, we analyzed 188 patients (median age 65 years, range 26–80) treated for therapy-related acute myeloid leukemia (t-AML, 29%) or AML with myelodysplasia-related changes (AML-MRC, 70%). Eighty-six percent received one, 14% two induction cycles, and 10% received consolidation (representing 22% of patients with CR/CRi) with CPX-351. Following induction, CR/CRi rate was 47% including 64% of patients with available information achieving measurable residual disease (MRD) negativity (<10−3) as measured by flow cytometry. After a median follow-up of 9.3 months, median overall survival (OS) was 21 months and 1-year OS rate 64%. In multivariate analysis, complex karyotype predicted lower response (p = 0.0001), while pretreatment with hypomethylating agents (p = 0.02) and adverse European LeukemiaNet 2017 genetic risk (p < 0.0001) were associated with lower OS. Allogeneic hematopoietic cell transplantation (allo-HCT) was performed in 116 patients (62%) resulting in promising outcome (median survival not reached, 1-year OS 73%), especially in MRD-negative patients (p = 0.048). With 69% of patients developing grade III/IV non-hematologic toxicity following induction and a day 30-mortality of 8% the safety profile was consistent with previous findings. These real-world data confirm CPX-351 as efficient treatment for these high-risk AML patients facilitating allo-HCT in many patients with promising outcome after transplantation. More... »

PAGES

164

Journal

TITLE

Blood Cancer Journal

ISSUE

10

VOLUME

11

Author Affiliations

  • Department of Hematology, Oncology and Clinical Immunology, University Hospital Duesseldorf, Medical Faculty, Heinrich Heine—University, Duesseldorf, Germany
  • Medizinische Klinik und Poliklinik I, University Hospital Carl Gustav Carus Dresden, Technical University Dresden, Dresden, Germany
  • Department of Medicine A, University Hospital Münster, Münster, Germany
  • Department of Internal Medicine III, University Hospital of Ulm, Ulm, Germany
  • Institute for Medical Information Processing, Biometry and Epidemiology, Ludwig-Maximilians-University, Munich, Germany
  • Department of Medicine III, University Medical Center, Johannes Gutenberg University Mainz, Mainz, Germany
  • Department of Medicine III, Technical University of Munich, Munich, Germany
  • Department of Internal Medicine V, University Hospital Heidelberg, Heidelberg, Germany
  • Department of Hematology, Hemostasis, Oncology and Stem Cell Transplantation, Hannover Medical School, Hannover, Germany
  • Department V for Internal Medicine, University Hospital Erlangen, Erlangen, Germany
  • Department of Internal Medicine III, Klinikum Chemnitz, Chemnitz, Germany
  • Department of Oncology, Hematology and Rheumatology, University Hospital Bonn, Bonn, Germany
  • Leipzig: Department of Hematology and Cell Therapy, Medical Oncology, Hemostaseology, Leipzig, Germany
  • Department of Hematology, Oncology and Stem Cell Transplantation, Asklepios Clinic St. Georg, Hamburg, Germany
  • Department of Hematology and Stem Cell Transplantation, West German Cancer Center Essen, University Hospital Essen, Essen, Germany
  • Clinic and Policlinic for Internal Medicine IV, University Hospital Halle (Saale), Halle (Saale), Germany
  • Departmenf for Internal Medicine II, University Schleswig-Holstein, Kiel, Germany
  • Gemeinschaftsklinikum Mittelrhein GGmbH, Koblenz, Germany
  • Department I of Internal Medicine, University Hospital of Cologne, Cologne, Germany
  • Department of Internal Medicine V, Oncology and Hematology, Klinikum Nürnberg, Nürnberg, Germany
  • Clinic for Heaematology and Stem Cell Transplantation HELIOS Clinic Berlin-Buch GmbH, Berlin, Germany
  • Division of Hematology and Oncology, Department of Internal Medicine II, University of Würzburg, Medical Center, Würzburg, Germany
  • Clinic and Policlinic for Internal Medicine C, Hematology and Oncology, University of Greifswald, Greifswald, Germany
  • Department of Hematology and Oncology, St. Bernward Krankenhaus, Hildesheim, Germany
  • Department of Internal Medicine II, Hematology and Oncology, University Hospital Jena, Jena, Germany
  • Identifiers

    URI

    http://scigraph.springernature.com/pub.10.1038/s41408-021-00558-5

    DOI

    http://dx.doi.org/10.1038/s41408-021-00558-5

    DIMENSIONS

    https://app.dimensions.ai/details/publication/pub.1141605699

    PUBMED

    https://www.ncbi.nlm.nih.gov/pubmed/34608129


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    27 schema:description To investigate the efficacy and toxicities of CPX-351 outside a clinical trial, we analyzed 188 patients (median age 65 years, range 26–80) treated for therapy-related acute myeloid leukemia (t-AML, 29%) or AML with myelodysplasia-related changes (AML-MRC, 70%). Eighty-six percent received one, 14% two induction cycles, and 10% received consolidation (representing 22% of patients with CR/CRi) with CPX-351. Following induction, CR/CRi rate was 47% including 64% of patients with available information achieving measurable residual disease (MRD) negativity (<10−3) as measured by flow cytometry. After a median follow-up of 9.3 months, median overall survival (OS) was 21 months and 1-year OS rate 64%. In multivariate analysis, complex karyotype predicted lower response (p = 0.0001), while pretreatment with hypomethylating agents (p = 0.02) and adverse European LeukemiaNet 2017 genetic risk (p < 0.0001) were associated with lower OS. Allogeneic hematopoietic cell transplantation (allo-HCT) was performed in 116 patients (62%) resulting in promising outcome (median survival not reached, 1-year OS 73%), especially in MRD-negative patients (p = 0.048). With 69% of patients developing grade III/IV non-hematologic toxicity following induction and a day 30-mortality of 8% the safety profile was consistent with previous findings. These real-world data confirm CPX-351 as efficient treatment for these high-risk AML patients facilitating allo-HCT in many patients with promising outcome after transplantation.
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