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Impact of TP53 mutation status in elderly AML patients when adding all-trans retinoic acid or valproic acid to decitabine

In a randomized phase II trial (AMLSG 14-09, NCT00867672) of elderly, newly diagnosed AML patients, ATRA combined with decitabine (DEC) significantly improved the overall response rate (ORR) and survival also in patients with adverse-risk genetics, without adding toxicity. We performed a post hoc an...

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Main Authors: Bresser, Helena (Author) , Schmoor, Claudia (Author) , Grishina, Olga (Author) , Pfeifer, Dietmar (Author) , Thomas, Johanna (Author) , Rehman, Usama-Ur (Author) , Crysandt, Martina (Author) , Jost, Edgar (Author) , Thol, Felicitas (Author) , Heuser, Michael (Author) , Götze, Katharina S. (Author) , Schlenk, Richard Friedrich (Author) , Salih, Helmut R. (Author) , Schittenhelm, Marcus M. (Author) , Heil, Gerhard (Author) , Schwaenen, Carsten (Author) , Müller-Tidow, Carsten (Author) , Brugger, Wolfram (Author) , Kündgen, Andrea (Author) , de Wit, Maike (Author) , Giagounidis, Aristoteles (Author) , Scholl, Sebastian (Author) , Neubauer, Andreas (Author) , Krauter, Jürgen (Author) , Bug, Gesine (Author) , May, Annette (Author) , Wäsch, Ralph (Author) , Duyster, Justus (Author) , Döhner, Konstanze (Author) , Ganser, Arnold (Author) , Döhner, Hartmut (Author) , Hackanson, Björn (Author) , Becker, Heiko (Author) , Lübbert, Michael (Author)
Format: Article (Journal)
Language:English
Published: 13 October 2024
In: European journal of haematology
Year: 2025, Volume: 114, Issue: 2, Pages: 231-237
ISSN:1600-0609
DOI:10.1111/ejh.14304
Online Access:Verlag, kostenfrei, Volltext: https://doi.org/10.1111/ejh.14304
Verlag, kostenfrei, Volltext: https://onlinelibrary.wiley.com/doi/abs/10.1111/ejh.14304
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Author Notes:Helena Bresser, Claudia Schmoor, Olga Grishina, Dietmar Pfeifer, Johanna Thomas, Usama-Ur Rehman, Martina Crysandt, Edgar Jost, Felicitas Thol, Michael Heuser, Katharina S. Götze, Richard F. Schlenk, Helmut R. Salih, Marcus M. Schittenhelm, Gerhard Heil, Carsten Schwaenen, Carsten Müller-Tidow, Wolfram Brugger, Andrea Kündgen, Maike de Wit, Aristoteles Giagounidis, Sebastian Scholl, Andreas Neubauer, Jürgen Krauter, Gesine Bug, Annette M. May, Ralph Wäsch, Justus Duyster, Konstanze Döhner, Arnold Ganser, Hartmut Döhner, Björn Hackanson, Heiko Becker, Michael Lübbert
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Summary:In a randomized phase II trial (AMLSG 14-09, NCT00867672) of elderly, newly diagnosed AML patients, ATRA combined with decitabine (DEC) significantly improved the overall response rate (ORR) and survival also in patients with adverse-risk genetics, without adding toxicity. We performed a post hoc analysis to determine the predictive impact of TP53 status. Despite a nominally higher ORR, the clinically meaningful survival benefit when adding ATRA to DEC was diminished, but not completely negated, in TP53-mutated patients. Indeed, 2 out of 14 TP53-mutated patients (14%) randomized to a DEC + ATRA-containing regimen lived for > 36 months. Further studies of ATRA combined with hypomethylating agents appear warranted in non-M3 AML patients ineligible for HMA/venetoclax therapy.
Item Description:Gesehen am 10.06.2025
Physical Description:Online Resource
ISSN:1600-0609
DOI:10.1111/ejh.14304

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