Abstract
BACKGROUND: The aim of this study was to evaluate the clinical efficacy of APC gene promoter methylation in serum as a biomarker for breast cancer (BC) diagnosis. METHODS: Two reviewers systematically searched online resources to identify the publications relevant to APC gene promoter methylation and BC. The data of true positive, false positive, false negative, and true negative were extracted from each included study and pooled for diagnostic sensitivity, specificity, and summary receiver operating characteristic curve. RESULTS: Twelve studies finally fulfilled the inclusion criteria and were included in this meta-analysis. The diagnostic sensitivity, specificity, positive and negative likelihood ratio, diagnostic odds ratio, and area under the receiver operating characteristic curve were 0.20 (95% confidence interval [CI] 0.17-0.23), 0.96 (95% CI 0.93-0.97), 3.69 (95% CI 1.60-8.50), 0.83 (95% CI 0.75-0.92), 4.58 (95% CI 1.85-11.37) and 0.80, respectively. A Deeks' funnel plot and Egger's line regression test (t = 1.43, P = 0.18) indicated no publication bias was present. CONCLUSION: Because of low sensitivity, APC gene promoter methylation in serum was not suitable for BC screening. However, as specificity was very high, detection of serum APC gene promoter methylation could be used as tool to confirm BC.