Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia: a phase 3 study
Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 = “dose-dense”) and double induction with TAD-...
Gespeichert in:
| Hauptverfasser: | , , , |
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| Dokumenttyp: | Article (Journal) |
| Sprache: | Englisch |
| Veröffentlicht: |
1 October 2018
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| In: |
Leukemia
Year: 2018, Jahrgang: 32, Heft: 12, Pages: 2558-2571 |
| ISSN: | 1476-5551 |
| DOI: | 10.1038/s41375-018-0268-9 |
| Online-Zugang: | Verlag, Volltext: http://dx.doi.org/10.1038/s41375-018-0268-9 Verlag, Volltext: https://www.nature.com/articles/s41375-018-0268-9 
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| Verfasserangaben: | Jan Braess, Susanne Amler, Karl-Anton Kreuzer, Karsten Spiekermann, Hans Walter Lindemann, Eva Lengfelder, Ullrich Graeven, Peter Staib, Wolf-Dieter Ludwig, Harald Biersack, Yon-Dschun Ko, Michael J. Uppenkamp, Maike De Wit, Stefan Korsten, Rudolf Peceny, Tobias Gaska, Xaver Schiel, Dirk M. Behringer, Michael G. Kiehl, Bettina Zinngrebe, Gerald Meckenstock, Eva Roemer, Dirk Medgenberg, Ernst Spaeth-Schwalbe, Gero Massenkeil, Heidrun Hindahl, Rainer Schwerdtfeger, Guido Trenn, Cristina Sauerland, Raphael Koch, Martin Lablans, Andreas Faldum, Dennis Görlich, Stefan K. Bohlander, Stephanie Schneider, Annika Dufour, Christian Buske, Michael Fiegl, Marion Subklewe, Birgit Braess, Michael Unterhalt, Anja Baumgartner, Bernhard Wörmann, Dietrich Beelen, Wolfgang Hiddemann, for the AML-CG |
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| 245 | 1 | 0 | |a Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia |b a phase 3 study |c Jan Braess, Susanne Amler, Karl-Anton Kreuzer, Karsten Spiekermann, Hans Walter Lindemann, Eva Lengfelder, Ullrich Graeven, Peter Staib, Wolf-Dieter Ludwig, Harald Biersack, Yon-Dschun Ko, Michael J. Uppenkamp, Maike De Wit, Stefan Korsten, Rudolf Peceny, Tobias Gaska, Xaver Schiel, Dirk M. Behringer, Michael G. Kiehl, Bettina Zinngrebe, Gerald Meckenstock, Eva Roemer, Dirk Medgenberg, Ernst Spaeth-Schwalbe, Gero Massenkeil, Heidrun Hindahl, Rainer Schwerdtfeger, Guido Trenn, Cristina Sauerland, Raphael Koch, Martin Lablans, Andreas Faldum, Dennis Görlich, Stefan K. Bohlander, Stephanie Schneider, Annika Dufour, Christian Buske, Michael Fiegl, Marion Subklewe, Birgit Braess, Michael Unterhalt, Anja Baumgartner, Bernhard Wörmann, Dietrich Beelen, Wolfgang Hiddemann, for the AML-CG |
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| 520 | |a Dose-dense induction with the S-HAM regimen was compared to standard double induction therapy in adult patients with newly diagnosed acute myeloid leukemia. Patients were centrally randomized (1:1) between S-HAM (2nd chemotherapy cycle starting on day 8 = “dose-dense”) and double induction with TAD-HAM or HAM(-HAM) (2nd cycle starting on day 21 = “standard”). 387 evaluable patients were randomly assigned to S-HAM (N = 203) and to standard double induction (N = 184). The primary endpoint overall response rate (ORR) consisting of complete remission (CR) and incomplete remission (CRi) was not significantly different (P = 0.202) between S-HAM (77%) and double induction (72%). The median overall survival was 35 months after S-HAM and 25 months after double induction (P = 0.323). Duration of critical leukopenia was significantly reduced after S-HAM (median 29 days) versus double induction (median 44 days)—P < 0.001. This translated into a significantly shortened duration of hospitalization after S-HAM (median 37 days) as compared to standard induction (median 49 days)—P < 0.001. In conclusion, dose-dense induction therapy with the S-HAM regimen shows favorable trends but no significant differences in ORR and OS compared to standard double induction. S-HAM significantly shortens critical leukopenia and the duration of hospitalization by 2 weeks. | ||
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