title: Prospective Randomization Trial of G-CSF-Primed Induction Regimen versus Standard Regimen in Patients with AML.
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/m(2)/24 hr, days 1-3) plus Ara-C (500 mg/m(2)/12 hr, days 4-8) with G-CSF (250 µg/m(2)/d, days 3-7) (IAG group) or standard idarubicin (12 mg/m(2)/24 hr, days 1-3) plus Ara-C (100 mg/m(2)/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 (>1×10(9)/L) and platelet recovery (>20×10(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.
authors: Department of Hematology/Oncology and Stem Cell Transplantation Unit, Kyungpook National University Hospital, Kyungpook National University School of Medicine, Daegu, Korea.
authors: Yoo Jin
authors: YJ
authors: Lee
authors: Joon Ho
authors: JH
authors: Moon
authors: Jong Gwang
authors: JG
authors: Kim
authors: Yee Soo
authors: YS
authors: Chae
authors: Byung Woog
authors: BW
authors: Kang
authors: Soo Jung
authors: SJ
authors: Lee
authors: Jun Young
authors: JY
authors: Choi
authors: Ho Chul
authors: HC
authors: Shin
authors: Jong Won
authors: JW
authors: Seo
authors: Sang Kyun
authors: SK
authors: Sohn