Fludarabine, arabinosyl cytosine and idarubicin (FLAI) for remission induction in poor-risk acute myeloid leukemia

Progress in treatment of acute myeloid leukemia (AML) is slow and treatment intensification alone has limited effects, particularly in poor-risk cases . Poor-risk cases. that are identified mainly by prior history. leukemic ce ll mass and cytogenetic abnormalities, share multiple mechanisms of drug re sistance that are responsible for treatment failure. Since Pgp-mediated res istance to anthracycline can be reduced with Idarubicin (IDA) and resistanc e to arabinosyl cytosine (AC) can be reduced with Fludarabine (FLUDA), we t ested a combination of high dose AC (2000 mg/sqm. 5 doses). FLUDA (30 mg/sq m. 5 doses) and IDA (12 mg/sqm. 3 doses) for remission induction and consol idation in 45 consecutive cases of poor-risk AML. The complete remission (C R) rate was 71% after the first course and 82% overall, with a projected 2- year survival and relapse-free survival of 44% and 50% respectively. Non-he matologic toxicity was very mild, that is very important in elderly patient s. but hemopoietic toxicity was substantial, with a time to hematologic rec overy of 3 to 4 weeks and two cases of death in CR. Peripheral blood stem c ells (PBSC) could be mobilized and collected successfully only in 11 cases. This three-drug combination is effective and has a limited non-hematologic toxicity, but FLUDA may increase the difficulty of obtaining PBSC early af ter remission induction.