Fludarabine, cytarabine, and attenuated-dose idarubicin (m-FLAI) combination therapy for elderly acute myeloid leukemia patients.
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).
Department of Internal Medicine, Seoul National University Hospital, Seoul National University College of Medicine, Korea.
Inho
I
Kim
Youngil
Y
Koh
Sung-Soo
SS
Yoon
Seonyang
S
Park
Byoung Kook
BK
Kim
Dae-Young
DY
Kim
Jung-Hee
JH
Lee
Kyoo-Hyung
KH
Lee
June-Won
JW
Cheong
Hong-Kee
HK
Lee
Sung-Hyun
SH
Kim
Hyuk
H
Kim
Young Don
YD
Joo
Sang-Min
SM
Lee
Jong-Ho
JH
Won
Sung-Kyu
SK
Park
Dae-Sik
DS
Hong
Se-Hyung
SH
Kim
Sang Kyun
SK
Sohn
Chul-Soo
CS
Kim
Eunkyung
E
Park
Min Kyoung
MK
Kim
Moo Rim
MR
Park
Je-Hwan
JH
Lee
Yoo Hong
YH
Min
D000368:Aged; D000369:Aged, 80 and over; D000971:Antineoplastic Combined Chemotherapy Protocols / Q000008:administration & dosage* / Q000009:adverse effects; D001853:Bone Marrow / Q000378:metabolism*; D015331:Cohort Studies; D003561:Cytarabine / Q000008:administration & dosage / Q000009:adverse effects; D018572:Disease-Free Survival; D005260:Female; D015973:Gene Expression Regulation, Leukemic; D006801:Humans; D015255:Idarubicin / Q000008:administration & dosage / Q000009:adverse effects; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy / Q000378:metabolism / Q000401:mortality; D008297:Male; D008875:Middle Aged; D019009:Proto-Oncogene Proteins c-kit / Q000096:biosynthesis*; D015996:Survival Rate; D013997:Time Factors; D014740:Vidarabine / Q000008:administration & dosage / Q000009:adverse effects / Q000031:analogs & derivatives
D003561:Cytarabine; D019009:Proto-Oncogene Proteins c-kit; D014740:Vidarabine; C024352:fludarabine; D015255:Idarubicin