title: 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.
abstract: 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.
authors.affiliation: Department of Hematology and Bone Marrow Transplantation, University of Ankara, Ankara, Turkey. meral.beksac@medicine.ankara.edu.tr
authors.forename: Meral
authors.initials: M
authors.lastname: Beksac
authors.forename: Ridvan
authors.initials: R
authors.lastname: Ali
authors.forename: Tulay
authors.initials: T
authors.lastname: Ozcelik
authors.forename: Muhit
authors.initials: M
authors.lastname: Ozcan
authors.forename: Osman
authors.initials: O
authors.lastname: Ozcebe
authors.forename: Mahmut
authors.initials: M
authors.lastname: Bayik
authors.forename: Semra
authors.initials: S
authors.lastname: Paydas
authors.forename: Yahya
authors.initials: Y
authors.lastname: Buyukasik
authors.forename: Osman
authors.initials: O
authors.lastname: Ilhan
authors.forename: Fahir
authors.initials: F
authors.lastname: Ozkalemkas
authors.forename: Gunhan
authors.initials: G
authors.lastname: Gurman
authors.forename: Akin
authors.initials: A
authors.lastname: Uysal
authors.forename: Hamdi
authors.initials: H
authors.lastname: Akan
authors.forename: Ender Akcaglayan
authors.initials: EA
authors.lastname: Soydan
authors.forename: Ahmet
authors.initials: A
authors.lastname: Tunali
mesh_terms: 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
chemical_list: D016179:Granulocyte Colony-Stimulating Factor