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Background  A novel fusion gene of echinoderm microtubule-associated protein-like 4 ( EML4 ) and anaplastic lymphoma kinase ( ALK ) has been recently identified in non-small-cell lung cancers (NSCLCs). Patients with the  EML4-ALK  fusion gene demonstrate unique clinicopathological and physiological characteristics. Here we present a meta-analysis of large-scale studies to evaluate the clinicopathological characteristics of NSCLC patients harboring the  EML4-ALK  fusion gene.    Methods  Both English and Chinese databases were systematically used to search the materials of the clinicopathological characteristics of patients with NSCLC harboring the  EML4-ALK  fusion gene. Pooled relative risk (RR) estimates and the 95% confidence intervals (95% CI) were calculated with the fixed or random effect model. Publication bias and chi-square test were also calculated.    Results  27 retrospective studies were included in our meta-analysis. These studies included a total of 6950 patients. The incidence rate of  EML4-ALK  fusion in NSCLC patients was found to be 6.8% (472/6950). The correlation of the  EML4-ALK  fusion gene and clinicopathological characteristics of NSCLC patients demonstrated a significant difference in smoking status, histological types, stage, and ethnic characteristics. The positive rate of the  EML4-ALK  fusion gene expression in females were slightly higher than that in males, but not significantly ( P  = 0.52). In addition, the  EML4-ALK  fusion gene was mutually exclusive of the  EGFR  and  KRAS  mutation genes ( P  = 0.00).    Conclusion  Our pooled analysis revealed that the  EML4-ALK  fusion gene was observed predominantly in adenocarcinoma, non-smoking and NSCLC patients, especially those diagnosed in the advanced clinical stage of NSCLC. Additionally, the  EML4-ALK  fusion gene was exclusive of the  EGFR  and  KRAS  mutation genes. We surmise that IHC assay is a valuable tool for the prescreening of patients with  ALK  fusion gene in clinical practice, and FISH assay can be performed as a confirmation method. These insights might be helpful in guiding the appropriate molecular target therapy for NSCLC.

Clinicopathological Characteristics of Patients with Non-Small-Cell Lung Cancer Who Harbor EML4-ALK Fusion Gene: A Meta-Analysis