FLAG-IDA As First Line Induction Treatment for Children De Novo AML

Objective: The complete remission after induction therapy is very important for the prognosis of AML. Fludarabine, cytarabine, granulocyte colony-stimulating factor (G-CSF), and idarubicin (FLAG-IDA) regimen has been proven to be an effective chemotherapy for relapsed or refractory acute myeloid leukemia. The aim of this study was to evaluate complete remission rate and toxicity in children with de novo acute myeloid leukemia (none APL) who received the FLAG-IDA regimen as induction therapy.

Method: Between March 2014 and July 20015, 14 children with de novo acute myeloid leukemia (none APL) were received FLAG-IDA regimen as first line induction treatment in our center. The regimen including: Fludarabine 30 mg/(m².d), PI 0.5hr, qd, d2-6;

Ara-C 2g/(m².d), PI 3hr, d2-6; Ida (Idarubicin) mg/(m².d), PI 1hr, qd, d4-6; G-CSF 5μg/(Kg.d), s.c./i.v. qd,d1-7.

Of the 14 children, age 1-13 years old (median age 7 years old), including 2 (14.3%) children with favorable gene, 4 (28.6%) children with high risk gene. 3(21.4%) children received 1 cycle, 11 (78.6%) received 2 cycles of FLAG-IDA regimen. The CR rate and toxicity in total 25 cycles were evaluated.

Result: After 25 cycles of FLAG-IDA regimen, only 1 child (7.1%) did not get CR, 13/14 (92.9%) got CR after 1 or 2 cycles of FLAG-IDA induction treatment. In 25 FLAG-IDA cycles, the neutropenic time was from 13-43 days (mean 24.8 days). In the induction period, 2(14.3%) children suffered sepsis, 3 children (21.4%) had proven invasive fungal infection. Of 14 children, 2 children(14.3%) combined with cutaneous anaphylaxis, 2 children combined with transient fever after venous transfusion of chemicals. None obvious cardiac toxicity (arrhythmia or heart failure) was proved. One child died of ARDS in the neutropenic period after 2^nd FLAG-IDA cycle. Of 14 children, 12 children (85.7%) got continues CR with the follow up 1-19 months (median 8 months).

Discussion: Our primary study showed quite high CR rate combined with quite toxicity but can be tolerated using the FLAG-IDA regimen as first line induction treatment. Comprehensive supportive care should be given during the induction therapy. The LFS and OS need to be feedback after long time follow up.