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Purpose    PIK3CA  gene encoding a catalytic subunit of the phosphatidylinositol-3-kinase (PI3K) is mutated and/or amplified in various neoplasia, including lung cancer. Here we investigated  PIK3CA  gene alterations, the expression of core components of PI3K pathway, and evaluated their clinical importance in non-small cell lung cancer (NSCLC).    Materials and methods  Oncogenic mutations/rearrangements in  PIK3CA ,  EGFR ,  KRAS ,  HER2 ,  BRAF, AKT1  and  ALK  genes were detected in tumors from 1117 patients with NSCLC.  PIK3CA  gene copy number was examined by fluorescent  in situ  hybridization and the expression of PI3K p110 subunit alpha (PI3K p110α), p-Akt, mTOR, PTEN was determined by immunohistochemistry in  PIK3CA  mutant cases and 108 patients without  PIK3CA  mutation.    Results    PIK3CA  mutation was found in 3.9% of squamous cell carcinoma and 2.7% of adenocarcinoma. Among 34  PIK3CA  mutant cases, 17 tumors harbored concurrent  EGFR  mutations and 4 had  KRAS  mutations.  PIK3CA  mutation was significantly associated with high expression of PI3K p110α ( p <0.0001), p-Akt ( p  = 0.024) and mTOR ( p  = 0.001), but not correlated with  PIK3CA  amplification ( p  = 0.463). Patients with single  PIK3CA  mutation had shorter overall survival than those with  PIK3CA - EGFR/KRAS  co-mutation or wildtype  PIK3CA  ( p  = 0.004). A significantly worse survival was also found in patients with  PIK3CA  mutations than those without  PIK3CA  mutations in the  EGFR/KRAS  wildtype subgroup ( p  = 0.043)    Conclusions    PIK3CA  mutations frequently coexist with  EGFR/KRAS  mutations. The poor prognosis of patients with single  PIK3CA  mutation in NSCLC and the prognostic value of  PIK3CA  mutation in  EGFR/KRAS  wildtype subgroup suggest the distinct mutation status of  PIK3CA  gene should be determined for individual therapeutic strategies in NSCLC.

PIK3CA Mutations Frequently Coexist with EGFR/KRAS Mutations in Non-Small Cell Lung Cancer and Suggest Poor Prognosis in EGFR/KRAS Wildtype Subgroup