Hematotoxicity of induction and consolidation therapy.

<p>The time from start of chemotherapy until regeneration of leukocytes >1,000/µl, neutrophils >500/µl and plateletes >20,000/µl (transfusion independent) is shown. A: induction therapy, B: consolidation therapy.</p

CONSORT statement.

<p>The patient flow through this dose finding pilot trial is shown.</p

Outcome of the entire trial population.

<p>A: overall survival, B: event-free survival.</p

Outline of induction and consolidation therapy.

<p>Patients were randomised between 37.5 mg/sqm (dose level 1) and 75 mg/sqm (dose level 2) of azacitidine administered before each cycle of chemotherapy. Patients received 1–2 cycles of induction chemotherapy (‘7+3’) and responding patients received 2 cycles of consolidation therapy (intermediate-dose cytarabine).</p

Listing of all severe adverse events and adverse events grade 3 or 4.

<p>The highest CTCAE grade of each event is listed. Hematotoxicity was not listed as adverse event unless persisting >42 days with grade IV after start of the last chemotherapy cycle without evidence of persisting leukemia.</p><p>Abbreviations: AZA, 5-azacitidine; CTCAE, common terminology criteria for adverse events; SAE, serious adverse event.</p>a<p>In patient 7, both SAEs were documented with a fatal outcome.</p

Patient characteristics and outcome of the 12 patients included into the trial.

<p>Abbreviations: ASXL1, additional sex combs like 1; AZA, 5-azacitidine; BM, bone marrow; CR, complete remission; FLT3, fms-like tyrosine kinase 3; IDH, isocitrate dehydrogenase; ITD, internal tandem duplication; NPM1, Nucleophosmin 1; PS, ECOG performance status; TET2, ten-eleven translocation 2.</p>a<p>Presence of a sole trisomy in each of two clones.</p>b<p>Mutational analysis revealed wildtype status for NPM and no FLT3-ITD. Analysis of ASXL1, DNMT3A, IDH1, IDH2 and TET2 could not be performed due to lack of material.</p>c<p>In patient 10, CR was achieved after trial termination without further therapy.</p>d<p>Relapse after achievement of CR by salvage therapy.</p