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Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.

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?

SUBMITTER: Braess J 

PROVIDER: S-EPMC6286323 | biostudies-literature | 2018 Dec

REPOSITORIES: biostudies-literature

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Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.

Braess Jan J   Amler Susanne S   Kreuzer Karl-Anton KA   Spiekermann Karsten K   Lindemann Hans Walter HW   Lengfelder Eva E   Graeven Ullrich U   Staib Peter P   Ludwig Wolf-Dieter WD   Biersack Harald H   Ko Yon-Dschun YD   Uppenkamp Michael J MJ   De Wit Maike M   Korsten Stefan S   Peceny Rudolf R   Gaska Tobias T   Schiel Xaver X   Behringer Dirk M DM   Kiehl Michael G MG   Zinngrebe Bettina B   Meckenstock Gerald G   Roemer Eva E   Medgenberg Dirk D   Spaeth-Schwalbe Ernst E   Massenkeil Gero G   Hindahl Heidrun H   Schwerdtfeger Rainer R   Trenn Guido G   Sauerland Cristina C   Koch Raphael R   Lablans Martin M   Faldum Andreas A   Görlich Dennis D   Bohlander Stefan K SK   Schneider Stephanie S   Dufour Annika A   Buske Christian C   Fiegl Michael M   Subklewe Marion M   Braess Birgit B   Unterhalt Michael M   Baumgartner Anja A   Wörmann Bernhard B   Beelen Dietrich D   Hiddemann Wolfgang W  

Leukemia 20181001 12

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  ...[more]

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