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., Ozcan M., Ozcebe O., Bayik M., ...Daha Fazla

LEUKEMIA RESEARCH, cilt.35, sa.3, ss.340-345, 2011 (SCI-Expanded) identifier identifier identifier

  • Yayın Türü: Makale / Tam Makale
  • Cilt numarası: 35 Sayı: 3
  • Basım Tarihi: 2011
  • Doi Numarası: 10.1016/j.leukres.2010.07.005
  • Dergi Adı: LEUKEMIA RESEARCH
  • Derginin Tarandığı İndeksler: Science Citation Index Expanded (SCI-EXPANDED), Scopus
  • Sayfa Sayıları: ss.340-345
  • Anahtar Kelimeler: Granulocyte colony-stimulating factor, Acute myeloid leukemia, Induction, Survival, ACUTE MYELOGENOUS LEUKEMIA, PLACEBO-CONTROLLED TRIAL, SOUTHWEST-ONCOLOGY-GROUP, ELDERLY-PATIENTS, DOUBLE-BLIND, ADULT PATIENTS, GROWTH-FACTORS, G-CSF, FEBRILE NEUTROPENIA, PROGNOSTIC-FACTORS
  • Çukurova Üniversitesi Adresli: Evet

Özet

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. (C) 2010 Elsevier Ltd. All rights reserved.