Fludarabine,cytarabine, and attenuated‐dose idarubicin (m‐FLAI) combination therapy for elderly acute myeloid leukemia patients |
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| Authors: | 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 for the Korean Society of Hematology AML/MDS working party |
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| Institution: | 1. Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Seoul, Korea;2. Department of Internal Medicine, Asian Medical Center, University of Ulsan College of Medicine, Seoul, Korea;3. Department of Internal Medicine, Yonsei University Severance Hospital, Seoul, Korea;4. Department of Internal Medicine, Kunkook University Hospital, Seoul, Korea;5. Department of Internal Medicine, Dong‐A University Hospital, Busan, Korea;6. Department of Internal Medicine, Ulsan University Hospital, Ulsan, Korea;7. Department of Internal Medicine, Inje University College of Medicine, Busan, Korea;8. Department of Internal Medicine, Soonchunhyang University Hospital, Seoul, Korea;9. Department of Internal Medicine, Soonchunhyang University College of Medicine, Bucheon Hospital, Bucheon, Korea;10. Department of Internal Medicine, Kyungpook University Hospital, Daegu, Korea;11. Department of Internal Medicine, Inha University Hospital, Incheon, Korea;12. Department of Internal Medicine, Chung‐Ang University Hospital, Seoul, Korea;13. Department of Internal Medicine, Yeungnam University Medical Center, Daegu, Korea;14. Department of Internal Medicine, Wonkwang University Hospital, Iksan, Korea |
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| 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/m2, days 1–4), cytarabine (1,000 mg/m2, days 1–4), and attenuated‐dose idarubicin (5 mg/m2, 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). Am. J. Hematol. 2013. © 2012 Wiley Periodicals, Inc. |
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