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Background  The anaplastic lymphoma kinase ( ALK ) gene is frequently involved in translocations that lead to gene fusions in a variety of human malignancies, including lymphoma and lung cancer. Fusion partners of  ALK  include  NPM ,  EML4 ,  TPM3 ,  ATIC ,  TFG ,  CARS , and  CLTC . Characterization of ALK fusion patterns and their resulting clinicopathological profiles could be of great benefit in better understanding the biology of lung cancer.    Results  RACE-coupled PCR sequencing was used to assess  ALK  fusions in a cohort of 103 non-small cell lung carcinoma (NSCLC) patients. Within this cohort, the  EML4 - ALK  fusion gene was identified in 12 tumors (11.6%). Further analysis revealed that  EML4 - ALK  was present at a frequency of 16.13% (10/62) in patients with adenocarcinomas, 19.23% (10/52) in never-smokers, and 42.80% (9/21) in patients with adenocarcinomas lacking  EGFR  and  KRAS  mutations. The  EML4 - ALK  fusion was associated with non-smokers ( P  = 0.03), younger age of onset ( P  = 0.03), and adenocarcinomas without  EGFR / KRAS  mutations ( P  = 0.04). A trend towards improved survival was observed for patients with the  EML4 - ALK  fusion, although it was not statistically significant ( P  = 0.20). Concurrent deletion in  EGFR  exon 19 and fusion of  EML4 - ALK  was identified for the first time in a Chinese female patient with an adenocarcinoma. Analysis of ALK expression revealed that ALK mRNA levels were higher in tumors positive for the  EML - ALK  fusion than in negative tumors (normalized intensity of 21.99 vs. 0.45, respectively;  P  = 0.0018). However, expression of EML4 did not differ between the groups.    Conclusions  The  EML4 - ALK  fusion gene was present at a high frequency in Chinese NSCLC patients, particularly in those with adenocarcinomas lacking  EGFR / KRAS  mutations. The  EML4 - ALK  fusion appears to be tightly associated with ALK mRNA expression levels. RACE-coupled PCR sequencing is a highly sensitive method that could be used clinically for the identification of  EML4 - ALK -positive patients.

Fusion of EML4 and ALK is associated with development of lung adenocarcinomas lacking EGFR and KRAS mutations and is correlated with ALK expression