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

Affiliation
Department of Oncology and Hematology, Hospital Barmherzige Brüder, Regensburg, Germany. Jan.Braess@barmherzige-regensburg.de.
Braess, Jan;
GND
1111120358
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Amler, Susanne;
Affiliation
Department of Internal Medicine I, University Hospital, Cologne, Germany.
Kreuzer, Karl-Anton;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Spiekermann, Karsten;
Affiliation
Department of Hematology and Oncology, Catholic Hospital, Hagen, Germany.
Lindemann, Hans Walter;
Affiliation
Department of Medicine III, University Hospital, Mannheim, Germany.
Lengfelder, Eva;
Affiliation
Department of Medicine I, Hospital Maria Hilf, Mönchengladbach, Germany.
Graeven, Ullrich;
Affiliation
Department of Hematology and Medical Oncology, St. Antonius Hospital, Eschweiler, Germany.
Staib, Peter;
Affiliation
Department of Hematology and Oncology and Tumor Immunology, Helios Hospital, Berlin-Buch, Germany.
Ludwig, Wolf-Dieter;
Affiliation
Department of Medicine I, University Hospital, Lübeck, Germany.
Biersack, Harald;
Affiliation
Department of Medicine I, Johanniter Hospital, Bonn, Germany.
Ko, Yon-Dschun;
Affiliation
Department of Medicine A, Klinikum Ludwigshafen, Ludwigshafen, Germany.
Uppenkamp, Michael J;
Affiliation
Department of Hematology, Oncology and Palliative Care, Vivantes Klinikum Neukölln, Berlin, Germany.
De Wit, Maike;
Affiliation
Department of Medicine, Vinzenz Pallotti Hospital, Bergisch-Gladbach, Germany.
Korsten, Stefan;
Affiliation
Department of Hematology and Oncology, Klinikum Osnabrück, Osnabrück, Germany.
Peceny, Rudolf;
Affiliation
Department of Hematology and Oncology, St. Josef Hospital, Paderborn, Germany.
Gaska, Tobias;
Affiliation
Department of Hematology and Oncology, Klinikum Harlaching, Munich, Germany.
Schiel, Xaver;
Affiliation
Department of Hematology, Oncology and Palliative Care, Augusta Hospital, Bochum, Germany.
Behringer, Dirk M;
Affiliation
Department of Medicine I, Klinikum Frankfurt/Oder, Frankfurt/Oder, Germany.
Kiehl, Michael G;
Affiliation
Department of Hematology, Oncology and Palliative Care, Evangelisches Krankenhaus, Bielefeld, Germany.
Zinngrebe, Bettina;
Affiliation
Department of Medical Oncology, Radiooncology, Hematology and Palliative Care, St. Josef Hospital, Gelsenkirchen, Germany.
Meckenstock, Gerald;
Affiliation
Department of Hematology and Oncology, Klinikum Idar-Oberstein, Idar-Oberstein, Germany.
Roemer, Eva;
Affiliation
Department of Medicine III, Klinikum Leverkusen, Leverkusen, Germany.
Medgenberg, Dirk;
Affiliation
Department of Medicine, Vivantes Klinikum Spandau, Berlin, Germany.
Spaeth-Schwalbe, Ernst;
Affiliation
Department of Medicine II, Klinikum Gütersloh, Gütersloh, Germany.
Massenkeil, Gero;
Affiliation
Department of Medicine I, St. Johannes Hospital, Dortmund, Germany.
Hindahl, Heidrun;
Affiliation
Department for Bone Marrow and Blood Stem Cell Transplantation, DKD Deutsche Klinik für Diagnostik, Wiesbaden, Germany.
Schwerdtfeger, Rainer;
Affiliation
Department of Medicine I, Knappschaftskrankenhaus, Bottrop, Germany.
Trenn, Guido;
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Sauerland, Cristina;
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Koch, Raphael;
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Lablans, Martin;
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Faldum, Andreas;
Affiliation
Insitute for Biostatistics and Clinical Research, University Hospital, Münster, Germany.
Görlich, Dennis;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Bohlander, Stefan K;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Schneider, Stephanie;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Dufour, Annika;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Buske, Christian;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Fiegl, Michael;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Subklewe, Marion;
Affiliation
Department of Oncology and Hematology, Hospital Barmherzige Brüder, Regensburg, Germany.
Braess, Birgit;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Unterhalt, Michael;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
Baumgartner, Anja;
Affiliation
German Society of Hematology and Oncology DGHO, Berlin, Germany.
Wörmann, Bernhard;
Affiliation
Department of Bone Marrow Transplantation, University Hospital, Essen, Germany.
Beelen, Dietrich;
Affiliation
Department of Medicine III, University Hospital LMU Campus Grosshadern, Munich, Germany.
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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