ABSTRACT: Epidemiological studies have been conducted to investigate the association between the FOXP3 promoter polymorphisms, rs3761549 and rs3761548, and the risk of cancer. However, the results from these studies have been controversial. In order to obtain a more precise conclusion of this association, the present meta-analysis was performed. The odds ratio (OR) and 95% confidence interval (95% CI) values were used to assess any correlations between the data. Overall, the rs3761549 (C>T) and rs3761548 (C>A) polymorphisms of the FOXP3 gene were not associated with the cancer risk in an Asian population. In the subgroup analyses based on cancer type, no significant associations were identified between these two polymorphisms and breast cancer. However, the results altered when the analyses were restricted to hepatocellular carcinoma (HCC) and non-small cell lung cancer (NSCLC) (for rs3761549: TT+CT vs. CC OR, 0.52, 95% CI, 0.38-0.72; TC vs. CC OR, 0.25, 95% CI, 0.16-0.39; T vs. C OR, 0.76, 95% CI, 0.59-0.97. For rs3761548: AA vs. AC+CC OR, 3.20, 95% CI 1.76-5.81; AA+AC vs. CC OR, 2.56, 95% CI, 1.75-3.76; AA vs. CC OR, 4.41, 95% CI, 2.36-8.25; AC vs. CC OR, 2.15, 95% CI, 1.42-3.25; A vs. C OR, 2.32, 95% CI, 1.74-3.10). The present meta-analysis indicates that the FOXP3 rs3761549 (C>T) and rs3761548 (C>A) polymorphisms are not associated with the risk of breast cancer, but with the risk of HCC and NSCLC. Therefore, a study with a larger sample size is required to further evaluate this association.