High Efficacy and Significantly Shortened Neutropenia Of Dose-Dense S-HAM As Compared To Standard Double Induction: First Results Of a Prospective Randomized Trial (AML-CG 2008)

• Published in: Blood 2013-11, Vol.122 (21), p.619-619
• Main Authors: Braess, Jan, 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., Korsten, Stefan, De Wit, Maike, Peceny, Rudolf, Gaska, Tobias, Schiel, Xaver, Behringer, Dirk M, Kiehl, Michael G., Zinngrebe, Bettina, Meckenstock, Gerald, Roemer, Eva, Medgenberg, Dirk, Spaeth-Schwalbe, Ernst, Braess, Birgit, Massenkeil, Gero, Hindahl, Heidrun, Trenn, Guido, Schwerdtfeger, Rainer, Amler, Susanne, Sauerland, Cristina, Faldum, Andreas, Unterhalt, Michael, Bohlander, Stefan K., Schneider, Stephanie, Dufour, Annika, Buske, Christian, Fiegl, Michael, Subklewe, Marion, Baumgartner, Anja, Woermann, Bernhard J., Beelen, Dietrich, Hiddemann, Wolfgang
• Format: Article
• Language: English
• ISSN: 0006-4971; 1528-0020
• DOI: 10.1182/blood.V122.21.619.619

For curative treatment of younger patients with acute myeloid leukemia (AML) double induction with two cycles of intensive cytarabine/ anthracycline based chemotherapy 21 days apart is the current standard of care. In the prospective randomized AML-CG 2008 trial we asked question whether current results could be improved on by a dose-dense regimen (S-HAM – Sequential High-dose cytArabine and Mitoxantrone) in which the interval between cycles was minimized to 3 days. A prior large one-armed study (AML-CG 2004) had demonstrated a high antileukemic efficacy and shortened neutropenia of the S-HAM regimen as compared to a historical control of standard double induction treatment. The first clinical results of the randomized comparison are presented here. All patients with first diagnosis of a de-novo or secondary AML (excluding APL) that were deemed fit for intensive induction chemotherapy by their treating physician were eligible for this study. Younger patients in the standard arm were treated with one cycle of TAD-9 (standard dose cytarabine and daunorubicine 60mg/m2 for 3 days) and a mandatory second cycle of HAM (high dose cytarabine and mitoxantrone) starting at day 21. Elderly patients were treated with one cycle of HAM followed by a second cycle of HAM only in case of residual leukemia in the day 16 bone marrow aspirate. Patients in the experimental arm all received S-HAM (two sequential cycles of high-dose cytarabine on days 1+2, mitoxantrone days 3+4) with a 3 days interval. Patients in the age cohort 60 – 69 could be allocated to the “younger” or “elderly” cohort according to their biological fitness at the discretion of the treating physician. However high-dose cytarabine dosages were allocated according to chronological age with patients