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: Meral Beksac, Ridvan Ali, Tulay Ozcelik, Muhit Ozcan, Osman Ozcebe, Mahmut Bayik, Semra Paydas, Yahya Buyukasik, Osman Ilhan, Fahir Ozkalemkas, Gunhan Gurman, Akin Uysal, Hamdi Akan, Ender Akcaglayan Soydan, Ahmet Tunali
• Journal: Leukemia research (Leuk Res) Vol. 35 Issue 3 Pg. 340-5 (Mar 2011) ISSN: 1873-5835 [Electronic] England
• PMID: 20673585 (Publication Type: Clinical Trial, Phase III, Journal Article, Multicenter Study, Randomized Controlled Trial, Research Support, Non-U.S. Gov't)
• Copyright: Copyright © 2010 Elsevier Ltd. All rights reserved.

Chemical References

• Granulocyte Colony-Stimulating Factor

Topics

• Adolescent
• Adult
• Aged
• Drug Resistance, Neoplasm (drug effects)
• Female
• Granulocyte Colony-Stimulating Factor (therapeutic use)
• Humans
• Leukemia, Myeloid, Acute (drug therapy, pathology)
• Male
• Middle Aged
• Neoplasm Recurrence, Local (drug therapy, pathology)
• Neutropenia (drug therapy)
• Remission Induction
• Survival Rate
• Time Factors
• Treatment Outcome
• Young Adult