The Combination of Fludarabine + Citarabine + Idarubicin (Flai), Followed by Post-Remission Maintenance, is a Safe and Effective Treatment for Elderly Patients with a ml or High Risk Mds

Acute myeloid leukemia (AML) in the elderly has a dismal outcome due to both patients and disease characteristics. Fludarabine, high dose ARA-C and idarubicin combination (FLAI) has been reported to be effective in poor prognosis AML. Here we present our experience with FLAI induction regimen in patients over 60 with AML or high risk myelodysplasia (MDS) followed by post-CR maintenance (low-dose chemotherapy plus retinoids and vitamin D as differentiating agents) in patients unfit for allogeneic transplantation. Median age at diagnosis was 66 (60-78). Half (47%) of the patients were at poor prognosis for secondary/therapy related AML (26%) or MDS (21%). Thirty-seven percent of patients had an adverse karyotype. Twenty-two patients received FLAI at reduced intensity for reduced performance status. CR rate was 59%, with 5% failing because of induction death and 36% because of resistant disease. CR achievement was not affected by age or dose reduction, only by cytogenetics. The death rate in CR was 6% and the relapse rate was 60%, leading to 5-year overall and disease-free survival of 23 and 27% (median 14 and 20 months), respectively. Survival was negatively affected by adverse cytogenetics and by MDS diagnosis as compared to AML. After CR, 7 patients underwent allogeneic transplantation (median survival not reached) and 24 received a maintenance treatment (median survival 47 months). A good CR quality induced by FLAI and a benefit of the maintenance treatment may explain these fair long-term results. Our encouraging results should be confirmed in a randomized trial.