Bräss, Jan; Amler, Susanne; Kreuzer, Karl-Anton; Spiekermann, Karsten; Lindemann, Hans Walter; Lengfelder, Eva; Graeven, Ullrich; Staib, Peter; Ludwig, Wolf-Dieter; Biersack, Harald; Ko, Yon-Dschun; Uppenkamp, Michael J.; Wit, Maike de; Korsten, Stefan; Peceny, Rudolf; Gaska, Tobias; Schiel, Xaver; Behringer, Dirk M.; Kiehl, Michael G.; Zinngrebe, Bettina; Meckenstock, Gerald; Römer, Eva; Medgenberg, Dirk; Spaeth-Schwalbe, Ernst; Massenkeil, Gero; Hindahl, Heidrun; Schwerdtfeger, Rainer; Trenn, Guido; Sauerland, Cristina; Koch, Raphael; Lablans, Martin; Faldum, Andreas; Görlich, Dennis; Bohlander, Stefan K.; Schneider, Stephanie; Dufour, Annika; Buske, Christian; Fiegl, Michael; Subklewe, Marion; Bräss, Birgit; Unterhalt, Michael; Baumgartner, Anja; Wörmann, Bernhard; Beelen, Dietrich; Hiddemann, Wolfgang (2018): Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study. In: Leukemia, Vol. 32, No. 12: pp. 2558-2571 |
Abstract
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.
Item Type: | Journal article |
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Faculties: | Medicine |
Subjects: | 600 Technology > 610 Medicine and health |
ISSN: | 0887-6924 |
Language: | English |
ID Code: | 63595 |
Deposited On: | 19. Jul 2019 12:13 |
Last Modified: | 04. Nov 2020 13:42 |
- BASE
- Bräss, Jan
- Amler, Susanne
- Kreuzer, Karl-Anton
- Spiekermann, Karsten
- Lindemann, Hans Walter
- Lengfelder, Eva
- Graeven, Ullrich
- Staib, Peter
- Ludwig, Wolf-Dieter
- Biersack, Harald
- Ko, Yon-Dschun
- Uppenkamp, Michael J.
- Wit, Maike de
- Korsten, Stefan
- Peceny, Rudolf
- Gaska, Tobias
- Schiel, Xaver
- Behringer, Dirk M.
- Kiehl, Michael G.
- Zinngrebe, Bettina
- Meckenstock, Gerald
- Römer, Eva
- Medgenberg, Dirk
- Spaeth-Schwalbe, Ernst
- Massenkeil, Gero
- Hindahl, Heidrun
- Schwerdtfeger, Rainer
- Trenn, Guido
- Sauerland, Cristina
- Koch, Raphael
- Lablans, Martin
- Faldum, Andreas
- Görlich, Dennis
- Bohlander, Stefan K.
- Schneider, Stephanie
- Dufour, Annika
- Buske, Christian
- Fiegl, Michael
- Subklewe, Marion
- Bräss, Birgit
- Unterhalt, Michael
- Baumgartner, Anja
- Wörmann, Bernhard
- Beelen, Dietrich
- Hiddemann, Wolfgang
- Google Scholar
- Bräss, Jan
- Amler, Susanne
- Kreuzer, Karl-Anton
- Spiekermann, Karsten
- Lindemann, Hans Walter
- Lengfelder, Eva
- Graeven, Ullrich
- Staib, Peter
- Ludwig, Wolf-Dieter
- Biersack, Harald
- Ko, Yon-Dschun
- Uppenkamp, Michael J.
- Wit, Maike de
- Korsten, Stefan
- Peceny, Rudolf
- Gaska, Tobias
- Schiel, Xaver
- Behringer, Dirk M.
- Kiehl, Michael G.
- Zinngrebe, Bettina
- Meckenstock, Gerald
- Römer, Eva
- Medgenberg, Dirk
- Spaeth-Schwalbe, Ernst
- Massenkeil, Gero
- Hindahl, Heidrun
- Schwerdtfeger, Rainer
- Trenn, Guido
- Sauerland, Cristina
- Koch, Raphael
- Lablans, Martin
- Faldum, Andreas
- Görlich, Dennis
- Bohlander, Stefan K.
- Schneider, Stephanie
- Dufour, Annika
- Buske, Christian
- Fiegl, Michael
- Subklewe, Marion
- Bräss, Birgit
- Unterhalt, Michael
- Baumgartner, Anja
- Wörmann, Bernhard
- Beelen, Dietrich
- Hiddemann, Wolfgang