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

Beksac M., Ali R., Ozcelik T., ÖZCAN M., Ozcebe O., BAYIK M. M., ...More

Leukemia Research, vol.35, no.3, pp.340-345, 2011 (SCI-Expanded) identifier identifier

  • Publication Type: Article / Article
  • Volume: 35 Issue: 3
  • Publication Date: 2011
  • Doi Number: 10.1016/j.leukres.2010.07.005
  • Journal Name: Leukemia Research
  • Journal Indexes: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Page Numbers: pp.340-345
  • Keywords: Acute myeloid leukemia, Granulocyte colony-stimulating factor, Induction, Survival
  • Lokman Hekim University Affiliated: Yes

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. © 2010 Elsevier Ltd.