Short and long term effects of granulocyte colony-stimulating factor during induction therapy in acute myeloid leukemia patients younger than 65: results of a randomized multicenter phase III trial.
This prospective multicenter phase III clinical trial was designed to assess efficacy and safety of G-CSF as an adjunct to de novo AML remission induction therapy (www.clinicaltrials.gov. NCT00820976). Patients' characteristics were similar in both arms. G-CSF improved severity and duration of leukopenia. Three-year OS were similar (25.6 ± 5.1% vs. 31.8 ± 5.6%) in both arms except for patients with myeloblastic features. Significant factors for better survival were the use of G-CSF (p=0.049), female sex (p=0.05) and single induction cycle (p<0.001) in multivariate analysis. Female patients performed better than male patients. Better survival obtained among female AML patients needs to be validated within the context of cytogenetic analysis.
Beksac
Meral
M
Department of Hematology and Bone Marrow Transplantation, University of Ankara, Ankara, Turkey. meral.beksac@medicine.ankara.edu.tr
Ali
Ridvan
R
Ozcelik
Tulay
T
Ozcan
Muhit
M
Ozcebe
Osman
O
Bayik
Mahmut
M
Paydas
Semra
S
Buyukasik
Yahya
Y
Ilhan
Osman
O
Ozkalemkas
Fahir
F
Gurman
Gunhan
G
Uysal
Akin
A
Akan
Hamdi
H
Soydan
Ender Akcaglayan
EA
Tunali
Ahmet
A
D000293:Adolescent; D000328:Adult; D000368:Aged; D019008:Drug Resistance, Neoplasm / Q000187:drug effects*; D005260:Female; D016179:Granulocyte Colony-Stimulating Factor / Q000627:therapeutic use*; D006801:Humans; D015470:Leukemia, Myeloid, Acute / Q000188:drug therapy* / Q000473:pathology; D008297:Male; D008875:Middle Aged; D009364:Neoplasm Recurrence, Local / Q000188:drug therapy* / Q000473:pathology; D009503:Neutropenia / Q000188:drug therapy; D012074:Remission Induction; D015996:Survival Rate; D013997:Time Factors; D016896:Treatment Outcome; D055815:Young Adult
D016179:Granulocyte Colony-Stimulating Factor