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.