Prospective Randomization Trial of G-CSF-Primed Induction Regimen versus Standard Regimen in Patients with AML
- Author:
Yoo Jin LEE
1
;
Joon Ho MOON
;
Jong Gwang KIM
;
Yee Soo CHAE
;
Byung Woog KANG
;
Soo Jung LEE
;
Jun Young CHOI
;
Ho Chul SHIN
;
Jong Won SEO
;
Sang Kyun SOHN
Author Information
- Publication Type:Original Article
- Keywords: Acute myeloid leukemia; Cytarabine; Granulocyte colony-stimulating factor; Induction of remission
- MeSH: Blood Platelets; Cytarabine; Cytogenetics; Follow-Up Studies; Granulocyte Colony-Stimulating Factor; Humans; Idarubicin; Induction Chemotherapy; Intercellular Signaling Peptides and Proteins; Leukemia; Leukemia, Myeloid, Acute; Neutrophils; Prospective Studies; Random Allocation; Remission Induction; Survival Rate
- From:Chonnam Medical Journal 2011;47(2):80-84
- CountryRepublic of Korea
- Language:English
- Abstract: The sensitization of leukemia cells with hematopoietic growth factors can enhance the cytotoxicity of chemotherapy in acute myeloid leukemia (AML). Therefore, the current trial attempted to evaluate the efficacy of granulocyte colony-stimulating factor (G-CSF) priming in remission induction chemotherapy with an intensified dose of Ara-C for newly diagnosed AML. Patients with newly diagnosed AML were randomly assigned to receive idarubicin (12 mg/m2/24 hr, days 1-3) plus Ara-C (500 mg/m2/12 hr, days 4-8) with G-CSF (250 microg/m2/d, days 3-7) (IAG group) or standard idarubicin (12 mg/m2/24 hr, days 1-3) plus Ara-C (100 mg/m2/12 hr, days 1-7) without G-CSF (IA group). There were no significant differences in sex, age, subtype, or cytogenetic risk between the two groups. Complete remission was achieved in 15 patients (88.2%) from the IAG group and in 14 patients (82.4%) from the IA group (p=0.31). The median time to complete remission was 26 vs. 31 days (p=0.779) for the IA and IAG groups, respectively. The median time to neutrophil recovery (>1x10(9)/L) and platelet recovery (>20x10(9)/L) did not differ significantly between the two groups (26 vs. 26 days, p=0.338; 21 vs. 16 days, p=0.190, respectively). After a median follow-up of 682 days, the 3-year overall survival rate for the IA group was 64.7%, whereas that for the IAG group was 45.6% (p=0.984). No improved clinical outcomes were observed for the AML patients subjected to intensified remission induction with G-CSF priming when compared with standard induction chemotherapy.
