Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients
Authors
Inho Kim ; Youngil Koh ; Sung-Soo Yoon ; Seonyang Park ; Byoung Kook Kim ; Dae-Young Kim ; Jung-Hee Lee ; Kyoo-Hyung Lee ; June-Won Cheong ; Hong-Kee Lee ; Sung-Hyun Kim ; Hyuk Kim ; Young Don Joo ; Sang-Min Lee ; Jong-Ho Won ; Sung-Kyu Park ; Dae-Sik Hong ; Se-Hyung Kim ; Sang Kyun Sohn ; Chul-Soo Kim ; Eunkyung Park ; Min Kyoung Kim ; Moo Rim Park ; Je-Hwan Lee ; Yoo Hong Min
Citation
AMERICAN JOURNAL OF HEMATOLOGY, Vol.88(1) : 10-15, 2013
We performed a phase II trial to evaluate the efficacy and safety of the modified fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) regimen in elderly acute myeloid leukemia (AML) patients. Elderly (≥60 years) AML patients who had not previously received chemotherapy were enrolled in the study. Patients received two consecutive cycles of m-FLAI chemotherapy as an induction. The m-FLAI regimen comprised fludarabine (25 mg/m(2) , days 1-4), cytarabine (1,000 mg/m(2) , days 1-4), and attenuated-dose idarubicin (5 mg/m(2) , days 1-3). The primary end point was complete remission (CR) rate. Secondary end points were overall survival (OS), event-free survival (EFS), and treatment-related mortality (TRM). There were 108 patients (median age 68.4 years, M:F = 64:44) enrolled in the study. CR was achieved in 56.5% of patients, and the TRM rate was 21.3%. Median OS and median EFS were 10.2 and 6.6 months, respectively. The mortality at 30 and 60 days was 15 and 21%, respectively. Performance status and comorbidity did not have prognostic value in this patient cohort. Bone marrow expression of CD117 was associated with increased EFS and OS. m-FLAI is an effective induction regimen for previously untreated AML in elderly patients. In addition, bone-marrow CD117 expression is an independent favorable prognostic factor in elderly AML patients. (ClinicalTrials.gov number, NCT01247493).