Krug, U., Berdel, W. E., Gale, R. P., Haferlach, C., Schnittger, S., Mueller-Tidow, C., Braess, J., Spiekermann, K., Staib, P., Beelen, D., Serve, H., Schliemann, C., Stelljes, M., Balleisen, L., Maschmeyer, G., Grueneisen, A., Eimermacher, H., Giagounidis, A., Rasche, H., Hehlmann, R., Lengfelder, E., Thiel, E., Reichle, A., Aul, C., Ludwig, W-D, Kern, W., Haferlach, T., Koepcke, W., Goerlich, D., Sauerland, M. C., Heinecke, A., Woermann, B. J., Hiddemann, W. and Buechner, T. (2016). Increasing intensity of therapies assigned at diagnosis does not improve survival of adults with acute myeloid leukemia. Leukemia, 30 (6). S. 1230 - 1237. LONDON: NATURE PUBLISHING GROUP. ISSN 1476-5551

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Abstract

We randomized 3375 adults with newly diagnosed acute myeloid leukemia (AML) or high-risk myelodysplastic syndrome to test whether increasingly intensive chemotherapies assigned at study-entry and analyzed on an intent-to-treat basis improved outcomes. In total, 1529 subjects <60 years were randomized to receive: (1) a first course of induction therapy with high-dose cytarabine and mitoxantrone (HAM) or with standard-dose cytarabine, daunorubicin and 6-thioguanine (TAD) followed by a second course of HAM; (2) granulocyte-colony stimulating factor (G-CSF) or no G-CSF before induction and consolidation courses; and (3) high-dose therapy and an autotransplant or maintenance chemotherapy. In total, 1846 subjects. 60 years were randomized to receive: (1) a first induction course of HAM or TAD and second induction course of HAM (if they had bone marrow blasts >= 5% after the first course); and (2) G-CSF or no G-CSF as above. Median follow-up was 7.4 years (range, 1 day to 14.7 years). Five-year event-free survivals (EFSs) for subjects receiving a first induction course of HAM vs TAD were 17% (95% confidence interval, 15, 18%) vs 16% (95% confidence interval 14, 18%; P = 0.719). Five-year EFSs for subjects randomized to receive or not receive G-CSF were 19% (95% confidence interval 16, 21%) vs 16% (95% confidence interval 14, 19%; P = 0.266). Five-year relapse-free survivals (RFSs) for subjects <60 years receiving an autotransplant vs maintenance therapy were 43% (95% confidence interval 40, 47%) vs 40 (95% confidence interval 35, 44%; P = 0.535). Many subjects never achieved pre-specified landmarks and consequently did not receive their assigned therapies. These data indicate the limited impact of more intensive therapies on outcomes of adults with AML. Moreover, none of the more intensive therapies we tested improved 5-year EFS, RFS or any other outcomes.

Item Type: Journal Article
Creators:
CreatorsEmailORCIDORCID Put Code
Krug, U.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Berdel, W. E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Gale, R. P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haferlach, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schnittger, S.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Mueller-Tidow, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Braess, J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Spiekermann, K.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Staib, P.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Beelen, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Serve, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Schliemann, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Stelljes, M.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Balleisen, L.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Maschmeyer, G.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Grueneisen, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Eimermacher, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Giagounidis, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Rasche, H.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hehlmann, R.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Lengfelder, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Thiel, E.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Reichle, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Aul, C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Ludwig, W-DUNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Kern, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Haferlach, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Koepcke, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Goerlich, D.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Sauerland, M. C.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Heinecke, A.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Woermann, B. J.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Hiddemann, W.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
Buechner, T.UNSPECIFIEDUNSPECIFIEDUNSPECIFIED
URN: urn:nbn:de:hbz:38-274700
DOI: 10.1038/leu.2016.25
Journal or Publication Title: Leukemia
Volume: 30
Number: 6
Page Range: S. 1230 - 1237
Date: 2016
Publisher: NATURE PUBLISHING GROUP
Place of Publication: LONDON
ISSN: 1476-5551
Language: English
Faculty: Unspecified
Divisions: Unspecified
Subjects: no entry
Uncontrolled Keywords:
KeywordsLanguage
BONE-MARROW-TRANSPLANTATION; STEM-CELL TRANSPLANTATION; ACUTE MYELOGENOUS LEUKEMIA; COLONY-STIMULATING FACTOR; HIGH-DOSE CYTARABINE; 1ST REMISSION; POSTREMISSION THERAPY; CHEMOTHERAPY; TRIAL; RECOMMENDATIONSMultiple languages
Oncology; HematologyMultiple languages
Refereed: Yes
URI: http://kups.ub.uni-koeln.de/id/eprint/27470

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