Primary Clinical Research of FA Regimen as Consolidation Therapy for Patients with Acute Myeloid Leukemia

Abstract 4380

In our study, 28 patients with AML treated in our department between 2004 and 2009 under complete remission, median age of 54 years (range 23–77) were consolidated with FA regimen which included fludarabine 30mg/m² (days 1–3) and Ara-C 2g/m² (days 1–3). Ara-C were administered as a continuous sequential infusion 4 hours later when the application of fludarabine had been over. Another 14 AML patients with matched conditions treated with high dose Ara-C (HDAra-C, 3g/m², q12h×3d) were designated as controls. Event-free survival of both 2 groups of these patients were analysed.

Overall, 14 patients (50%) achieved continuous complete remission for more than 2 years. There is no statistically significant differences between FA group and HDAra-C group (P=0.214>0.05) in CCR. Patients aged >60 years also had no statistically significant differences compared to the patients aged <60 years in CCR. Seven patients relapsed after this treatment in a median survival of 11 months. Two of the relapsed patients had karyotype abnormalities and all of them had a markedly elevated WBC count at diagnosis.

The main toxicity was myelosuppression. WBC count and platelet count reached the lowest (about 0.8×10^⁹/L and 2.0×10^⁹/L) 6–13 days after the begining of the regimen. Median recovery time for granulocyte (≥1.0×10^⁹/L) and platelet (≥20×10^⁹/L) was 12 and 13 days, respectively. Fever(>38°C) caused by granulopenia occurred in 21 patients, recovered to normal for a median time of 5 days (range, 2–23). Heart, liver and enteric toxicity were negligible. There were no significant differences in hematologic toxicity or nonhematologic toxicity between the FA and HDAra-C group. The average hospitalization was about 20 days.

The FA is effective and safe as consolidation regimen in AML with acceptable toxicity and is not associated with an increased incidence of infections compared to conventional HDAra-C regimen.