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

Braess, Jan; Amler, Susanne GND; 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; Görlich, Dennis; Bohlander, Stefan K; Schneider, Stephanie; Dufour, Annika; Buske, Christian; Fiegl, Michael; Subklewe, Marion; Braess, Birgit; Unterhalt, Michael; Baumgartner, Anja; Wörmann, Bernhard; Beelen, Dietrich; Hiddemann, Wolfgang

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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Braess, Jan / Amler, Susanne / Kreuzer, Karl-Anton / et al: Sequential high-dose cytarabine and mitoxantrone (S-HAM) versus standard double induction in acute myeloid leukemia-a phase 3 study.. 2018.

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