Randomized phase-II trial evaluating induction therapy with idarubicin and etoposide plus sequential or concurrent azacitidine and maintenance therapy with azacitidine View Full Text


Ontology type: schema:ScholarlyArticle     


Article Info

DATE

2019-02-06

AUTHORS

R. F. Schlenk, D. Weber, W. Herr, G. Wulf, H. R. Salih, H. G. Derigs, A. Kuendgen, M. Ringhoffer, B. Hertenstein, U. M. Martens, M. Grießhammer, H. Bernhard, J. Krauter, M. Girschikofsky, D. Wolf, E. Lange, J. Westermann, E. Koller, S. Kremers, M. Wattad, M. Heuser, F. Thol, G. Göhring, D. Haase, V. Teleanu, V. Gaidzik, A. Benner, K. Döhner, A. Ganser, P. Paschka, H. Döhner

ABSTRACT

The aim of this randomized phase-II study was to evaluate the effect of substituting cytarabine by azacitidine in intensive induction therapy of patients with acute myeloid leukemia (AML). Patients were randomized to four induction schedules for two cycles: STANDARD (idarubicin, cytarabine, etoposide); and azacitidine given prior (PRIOR), concurrently (CONCURRENT), or after (AFTER) therapy with idarubicin and etoposide. Consolidation therapy consisted of allogeneic hematopoietic-cell transplantation or three courses of high-dose cytarabine followed by 2-year maintenance therapy with azacitidine in the azacitidine-arms. AML with CBFB-MYH11, RUNX1-RUNX1T1, mutated NPM1, and FLT3-ITD were excluded and accrued to genotype-specific trials. The primary end point was response to induction therapy. The statistical design was based on an optimal two-stage design applied for each arm separately. During the first stage, 104 patients (median age 62.6, range 18-82 years) were randomized; the study arms PRIOR and CONCURRENT were terminated early due to inefficacy. After randomization of 268 patients, all azacitidine-containing arms showed inferior response rates compared to STANDARD. Event-free and overall survival were significantly inferior in the azacitidine-containing arms compared to the standard arm (p < 0.001 and p = 0.03, respectively). The data from this trial do not support the substitution of cytarabine by azacitidine in intensive induction therapy. More... »

PAGES

1-11

References to SciGraph publications

Identifiers

URI

http://scigraph.springernature.com/pub.10.1038/s41375-019-0395-y

DOI

http://dx.doi.org/10.1038/s41375-019-0395-y

DIMENSIONS

https://app.dimensions.ai/details/publication/pub.1111950346

PUBMED

https://www.ncbi.nlm.nih.gov/pubmed/30728457


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