FLAIE (fludarabine, cytarabine, idarubicin, and etoposide), a four drug induction chemotherapy for adult acute myeloid leukemia: A single center experience

The target of this pilot study was to evaluate the complete remission (CR) rate and the safety profile of a four drug induction chemotherapy regimen (FLAIE) in previously untreated AML. Fifty consecutive patients were included between 2003 and 2005. All were younger than 65 years (median age of 51 years). FLAIE included: fludarabine (25 mg/m2), cytarabine (2 g/m 2), and etoposide (100 mg/m2) on days 1-5, idarubicin (6 mg/m2) on days 1, 3, and 5. Patients were evaluated for response rate, treatment-related adverse events, overall survival (OS), and disease-free survival (DFS). After FLAIE, CR occurred in 64% of patients (32/50); three patients (6%) achieved a partial remission and 15 (30%) were nonresponders. There was only one induction death (2%). Infections occurred in 29/50 patients (58%). Grade II-III WHO oral mucositis was reported in 11 patients (22%). Median time to neutrophil (>1 × 109/l) and platelet (>50 × 109/l) recovery was 24 and 26 days, respectively. Supportive therapy consisted of a median of 13 packed red cell units and 9 platelets units. The probability of 1-year OS and DFS were 68% and 48%. The FLAIE regimen appeared to have acceptable toxicity, but these results suggest that the addition of etoposide to FLAI scheme does not improve CR rate of FLAI alone.