Rautenberg, Christina, Stoelzel, Friedrich, Roellig, Christoph, Stelljes, Matthias, Gaidzik, Verena, Lauseker, Michael, Kriege, Oliver, Verbeek, Mareike, Unglaub, Julia Marie, Thol, Felicitas, Krause, Stefan W., Haenel, Mathias, Neuerburg, Charlotte, Vucinic, Vladan, Jehn, Christian-Friedrich, Severmann, Julia, Wass, Maxi, Fransecky, Lars, Chemnitz, Jens, Holtick, Udo, Schaefer-Eckart, Kerstin, Schroeder, Josephine, Kraus, Sabrina, Krueger, William, Kaiser, Ulrich, Scholl, Sebastian, Koch, Kathrin, Henning, Lea, Kobbe, Guido, Haas, Rainer, Alakel, Nael, Roehnert, Maximilian-Alexander, Sockel, Katja, Hanoun, Maher, Platzbecker, Uwe, Holderried, Tobias A. W., Morgner, Anke, Heuser, Michael, Sauer, Tim, Goetze, Katharina S., Wagner-Drouet, Eva, Doehner, Konstanze, Doehner, Hartmut, Schliemann, Christoph, Schetelig, Johannes, Bornhaeuser, Martin, Germing, Ulrich, Schroeder, Thomas and Middeke, Jan Moritz (2021). Real-world experience of CPX-351 as first-line treatment for patients with acute myeloid leukemia. Blood Cancer J., 11 (10). LONDON: SPRINGERNATURE. ISSN 2044-5385

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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.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Rautenberg, ChristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stoelzel, FriedrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roellig, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stelljes, MatthiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaidzik, VerenaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lauseker, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kriege, OliverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Verbeek, MareikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unglaub, Julia MarieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thol, FelicitasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krause, Stefan W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haenel, MathiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Neuerburg, CharlotteUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Vucinic, VladanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Jehn, Christian-FriedrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Severmann, JuliaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wass, MaxiUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fransecky, LarsUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Chemnitz, JensUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holtick, UdoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schaefer-Eckart, KerstinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schroeder, JosephineUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kraus, SabrinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Krueger, WilliamUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kaiser, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Scholl, SebastianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koch, KathrinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Henning, LeaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kobbe, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haas, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Alakel, NaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roehnert, Maximilian-AlexanderUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sockel, KatjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hanoun, MaherUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Platzbecker, UweUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Holderried, Tobias A. W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Morgner, AnkeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heuser, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sauer, TimUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goetze, Katharina S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Wagner-Drouet, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, KonstanzeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Doehner, HartmutUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schliemann, ChristophUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schetelig, JohannesUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bornhaeuser, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Germing, UlrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schroeder, ThomasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Middeke, Jan MoritzUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-606241
DOI: 10.1038/s41408-021-00558-5
Journal or Publication Title: Blood Cancer J.
Volume: 11
Number: 10
Date: 2021
Publisher: SPRINGERNATURE
Place of Publication: LONDON
ISSN: 2044-5385
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
VERSUS-HOST-DISEASE; AML; AZACITIDINE; VENETOCLAX; DIAGNOSIS; SECONDARY; ADULTSMultiple languages
Oncology; HematologyMultiple languages
URI: http://kups.ub.uni-koeln.de/id/eprint/60624

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