Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients
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, Korean Society of Hematology AML/MDS working party, 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, Korean Society of Hematology AML/MDS working party
Abstract
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).
Copyright © 2012 Wiley Periodicals, Inc.
Source: PubMed