Journal Article

DKFZ-2018-01610

http://join2-wiki.gsi.de/foswiki/pub/Main/Artwork/join2_logo100x88.png Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.

Braess, J. ; Amler, S. ; Kreuzer, K.-A. ; Spiekermann, K. ; Lindemann, H. W. ; Lengfelder, E. ; Graeven, U. ; Staib, P. ; Ludwig, W.-D. ; Biersack, H. ; Ko, Y.-D. ; Uppenkamp, M. J. ; De Wit, M. ; Korsten, S. ; Peceny, R. ; Gaska, T. ; Schiel, X. ; Behringer, D. M. ; Kiehl, M. G. ; Zinngrebe, B. ; Meckenstock, G. ; Roemer, E. ; Medgenberg, D. ; Spaeth-Schwalbe, E. ; Massenkeil, G. ; Hindahl, H. ; Schwerdtfeger, R. ; Trenn, G. ; Sauerland, C. ; Koch, R. ; Lablans, M.DKFZ* ; Faldum, A. ; Görlich, D. ; Bohlander, S. K. ; Schneider, S. ; Dufour, A. ; Buske, C. ; Fiegl, M. ; Subklewe, M. ; Braess, B. ; Unterhalt, M. ; Baumgartner, A. ; Wörmann, B. ; Beelen, D. ; Hiddemann, W. ; AML-CG (Collaboration Author)

2018
Springer Nature London

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Please use a persistent id in citations: doi:10.1038/s41375-018-0268-9

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.

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Contributing Institute(s):

1. Medizinische Informatik in der Translationalen Onkologie (G230)

Research Program(s):

1. 317 - Translational cancer research (POF3-317) (POF3-317)

Appears in the scientific report 2018

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Database coverage:
; BIOSIS Previews ; Clarivate Analytics Master Journal List ; Current Contents - Life Sciences ; Ebsco Academic Search ; IF >= 10 ; JCR ; NCBI Molecular Biology Database ; SCOPUS ; Science Citation Index ; Science Citation Index Expanded ; Web of Science Core Collection

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