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037 _ _ |a DKFZ-2018-01610
041 _ _ |a eng
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100 1 _ |a Braess, Jan
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245 _ _ |a Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.
260 _ _ |a London
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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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700 1 _ |a Amler, Susanne
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700 1 _ |a Kreuzer, Karl-Anton
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700 1 _ |a Spiekermann, Karsten
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700 1 _ |a Lindemann, Hans Walter
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700 1 _ |a Lengfelder, Eva
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700 1 _ |a Graeven, Ullrich
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700 1 _ |a Staib, Peter
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700 1 _ |a Ludwig, Wolf-Dieter
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700 1 _ |a Biersack, Harald
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700 1 _ |a Ko, Yon-Dschun
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700 1 _ |a Uppenkamp, Michael J
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700 1 _ |a De Wit, Maike
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700 1 _ |a Korsten, Stefan
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700 1 _ |a Peceny, Rudolf
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700 1 _ |a Gaska, Tobias
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700 1 _ |a Schiel, Xaver
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700 1 _ |a Behringer, Dirk M
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700 1 _ |a Kiehl, Michael G
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700 1 _ |a Zinngrebe, Bettina
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700 1 _ |a Meckenstock, Gerald
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700 1 _ |a Roemer, Eva
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700 1 _ |a Medgenberg, Dirk
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700 1 _ |a Spaeth-Schwalbe, Ernst
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700 1 _ |a Massenkeil, Gero
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700 1 _ |a Hindahl, Heidrun
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700 1 _ |a Schwerdtfeger, Rainer
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700 1 _ |a Trenn, Guido
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700 1 _ |a Sauerland, Cristina
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700 1 _ |a Koch, Raphael
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700 1 _ |a Lablans, Martin
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700 1 _ |a Faldum, Andreas
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700 1 _ |a Görlich, Dennis
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700 1 _ |a Bohlander, Stefan K
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700 1 _ |a Schneider, Stephanie
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700 1 _ |a Dufour, Annika
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700 1 _ |a Buske, Christian
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700 1 _ |a Fiegl, Michael
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700 1 _ |a Subklewe, Marion
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700 1 _ |a Braess, Birgit
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700 1 _ |a Unterhalt, Michael
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700 1 _ |a Baumgartner, Anja
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700 1 _ |a Wörmann, Bernhard
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700 1 _ |a Beelen, Dietrich
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700 1 _ |a Hiddemann, Wolfgang
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700 1 _ |a AML-CG
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773 _ _ |a 10.1038/s41375-018-0268-9
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