Chonnam Med J.  2011 Aug;47(2):80-84. 10.4068/cmj.2011.47.2.80.

Prospective Randomization Trial of G-CSF-Primed Induction Regimen versus Standard Regimen in Patients with AML

• Lee YJ
• Moon JH
• Kim JG
• Chae YS
• Kang BW
• Lee SJ
• Choi JY
• Shin HC
• Seo JW
• Sohn SK

• KMID: 2048789
• DOI: http://doi.org/10.4068/cmj.2011.47.2.80

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.

Keyword

Acute myeloid leukemia; Cytarabine; Granulocyte colony-stimulating factor; Induction of remission

MeSH Terms

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
Cytarabine
Granulocyte Colony-Stimulating Factor
Idarubicin
Intercellular Signaling Peptides and Proteins

Figure

• 

  FIG. 1 Overall survival and event-free survival in the IA and IAG groups. IA: cytarabine plus idarubicin chemotherapy, IAG: G-CSF-primed cytarabine plus idarubicin chemotherapy. (A) The 3-year overall survival rate was 64.7±11.6% for the IA group and 45.6±13.6% for the IAG group. (B) The 3-year event-free survival rate was 64.7±11.6% for the IA group and 37.6±13.5% for the IAG group.

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