Patients ≥ 60 years of age with non-promyelocytic AML were centrally randomized up-front in a 9:1 assignment to study specific arms of the German AML cooperative Group (AMLCG) or the East German Study Group Hematology and Oncology (OSHO) compared to a CSA (suppl. Figure S1 ). The AMLCG study arm randomized TAD (ara-C 100 mg/m2/d continuous infusion (CI) d1-2 followed by 30-min IV infusion BID d 3–8, daunorubicin 60 mg/m2/d IV d 3–5 and 6-thioguanine 100 mg/m2/d p.o. BID d 3–9) followed by HAM (ara-C 1 g/m2/d IV BID d 1–3 and mitoxantrone 10 mg/m2/d IV d 3–5) versus two courses of HAM ± G-CSF, with the second induction course only applied in case of blast persistence. One course of TAD was given as consolidation followed by maintenance chemotherapy over three years [21 (link)]. The OSHO AML04 study included ara-C 1 g/m2/d BID IV d 1 + 3 + 5 + 7 and mitoxantrone 10 mg/m2/d IV d 1 – 3 for one or two induction courses and ara-C 500 mg/m2 BID 1 h IV d 1 + 3 + 5 in combination with mitoxantrone 10 mg/m2/d IV d 1 + 2 as consolidation twice. Pegfilgrastim 6 mg s.c. was given on day 10 of induction and on day 8 of consolidation. Allogeneic related or unrelated HSCT following non-myeloablative conditioning was considered after CR. The CSA consisted of one or two induction cycles of ara-C 100 mg/m2/d CI d 1–7 and daunorubicin 60 mg/m2/d IV d 3, 4, 5 (3 + 7 regimen) followed by two courses of ara-C 1 g/m2/d BID IV d 1 + 3 + 5 as consolidation [20 (link)]. Detailed information on therapies of the study groups and CSA are given in suppl. Figure 1. Cytogenetic and molecular risk was determined as previously described [22 (link)].
Inclusion criteria contained all consecutive AML (de novo, secondary, and therapy related, except APL) diagnosed in the study period. Exclusion criteria included inability of the patient to understand the study and give informed consent, non AML-related renal insufficiency, liver insufficiency, cardiac insufficiency NYHA III + IV, concurrent acute myocardial infarction, and uncontrolled infection such as pneumonia with hypoxia or septic shock.
The study was approved by the Institutional Review Board (IRB) of the University of Leipzig, registered at clinicaltrials.gov (NCT01497002 and NCT00266136) and the approval notified to IRBs of the participating centers. Patients had given written informed consent prior to study enrollment and randomization.
Inclusion criteria contained all consecutive AML (de novo, secondary, and therapy related, except APL) diagnosed in the study period. Exclusion criteria included inability of the patient to understand the study and give informed consent, non AML-related renal insufficiency, liver insufficiency, cardiac insufficiency NYHA III + IV, concurrent acute myocardial infarction, and uncontrolled infection such as pneumonia with hypoxia or septic shock.
The study was approved by the Institutional Review Board (IRB) of the University of Leipzig, registered at clinicaltrials.gov (NCT01497002 and NCT00266136) and the approval notified to IRBs of the participating centers. Patients had given written informed consent prior to study enrollment and randomization.
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