Little is known about the clinical significance of interleukin (IL)-18, a novel immunoregulatory cytokine, in acute myeloid leukemia (AML). Using reverse transcriptase polymerase chain reaction (RT-PCR) analysis, levels of IL-18 mRNA were assessed in bone marrow mononuclear cells (BMMC) from 47 adult patients with de novo or CR AML in order to explore the clinical significance of IL-18. The relationship between expression levels and the established prognostic factors such as age, cytogenetic aberrations, CD34 expression and FAB subtypes was investigated. Either disease status, age or CD34 expression were found to significantly correlate with the expression of IL-18. With respect to FAB cytotypes, expression of IL-18 gene in M4/M5 (n=15) was statistically higher than that in other subtypes (n=32, P<0.001). Moreover, a significant difference in IL-18 gene expression was obtained between the high risk group and the intermediate risk group (0.5627 versus 0.3111, P=0.038). In addition, a relationship between IL-18 expression of BMMC and initial white blood cell (WBC) was clearly demonstrated by a statistical analysis (r=0.806, P<0.001). These observations suggest that IL-18 gene over-expression might reflect the convergence of several important unfavorable prognostic factors in AML.