Braess, 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., De Wit, Maike, Korsten, Stefan, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M., Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Massenkeil, Gero, Hindahl, Heidrun, Schwerdtfeger, Rainer, Trenn, Guido, Sauerland, Cristina, Koch, Raphael, Lablans, Martin, Faldum, Andreas, Goerlich, Dennis, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Braess, Birgit, Unterhalt, Michael, Baumgartner, Anja, Woermann, Bernhard, Beelen, Dietrich and Hiddemann, Wolfgang (2018). Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study. Leukemia, 32 (12). S. 2558 - 2572. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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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
Creators:
CreatorsEmailORCIDORCID Put Code
Braess, JanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Amler, SusanneUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kreuzer, Karl-AntonUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spiekermann, KarstenUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lindemann, Hans WalterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lengfelder, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Graeven, UllrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staib, PeterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ludwig, Wolf-DieterUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Biersack, HaraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ko, Yon-DschunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Uppenkamp, Michael J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
De Wit, MaikeUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Korsten, StefanUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Peceny, RudolfUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gaska, TobiasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schiel, XaverUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Behringer, Dirk M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kiehl, Michael G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Zinngrebe, BettinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Meckenstock, GeraldUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Roemer, EvaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Medgenberg, DirkUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spaeth-Schwalbe, ErnstUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Massenkeil, GeroUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hindahl, HeidrunUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schwerdtfeger, RainerUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Trenn, GuidoUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sauerland, CristinaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koch, RaphaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lablans, MartinUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Faldum, AndreasUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goerlich, DennisUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Bohlander, Stefan K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schneider, StephanieUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Dufour, AnnikaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buske, ChristianUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Fiegl, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Subklewe, MarionUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braess, BirgitUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Unterhalt, MichaelUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Baumgartner, AnjaUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woermann, BernhardUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beelen, DietrichUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hiddemann, WolfgangUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-164087
DOI: 10.1038/s41375-018-0268-9
Journal or Publication Title: Leukemia
Volume: 32
Number: 12
Page Range: S. 2558 - 2572
Date: 2018
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
CYTOSINE-ARABINOSIDE; CRITICAL NEUTROPENIA; SALVAGE THERAPY; ADULTS; DIAGNOSIS; AML; TRANSPLANTATION; RECOMMENDATIONS; CONSOLIDATION; CHEMOTHERAPYMultiple languages
Oncology; HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/16408

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