In this trial, acute myeloid leukemia patients (pts) aged 61-80 years received MICE (mitoxantrone, etoposide and cytarabine) induction chemotherapy in combination with different schedules of granulocyte colony-stimulating factor administration. Pts in complete remission were subsequently randomized for two cycles of consolidation therapy: mini-ICE regimen (idarubicin, etoposide and cytarabine) given according to either an intravenous (i.v.) or a 'non-infusional' schedule. Among the 346 pts randomized for the second step, 331 pts received consolidation-1 and 182 consolidation-2. A total of 290 events (255 relapses, 35 deaths in first CR) have been reported. The median follow-up was 4.4 years. No significant differences were detected in terms of disease-free survival (median 9 vs 10.4 months, P ¼ 0.15, hazard ratio (HR) ¼ 1.18, 95% confidence interval (CI) 0.94-1.49) -primary end point -and survival (median 15.7 vs 17.8 months, P ¼ 0.19, HR ¼ 1.17, 95% CI 0.92-1.50). In the 'non-infusional' arm grade 3-4 vomiting (10 vs 2%; P ¼ 0.001) and diarrhea (10 vs 4%; P ¼ 0.03) were higher than in the 'i.v.' arm, whereas time to platelet recovery 420 Â 10 9 /l (median: 19 vs 23 days; P ¼ 0.02) and duration of hospitalization (mean: 15 vs 27 days; Po0.0001) was shorter. The 'noninfusional' consolidation regimen resulted in an antileukemic effect similar to the intravenous regimen, which was less myelosuppressive and associated with less hospitalization days.
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