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Background   KRAS  mutations negatively affect outcome after treatment with cetuximab in metastatic colorectal cancer (mCRC) patients. As only 20% of  KRAS  wild type (WT) patients respond to cetuximab it is possible that other mutations, constitutively activating the EGFR pathway, are present in the non-responding  KRAS  WT patients. We retrospectively analyzed objective tumor response rate, (ORR) progression-free (PFS) and overall survival (OS) with respect to the mutational status of  KRAS ,  BRAF ,  PIK3CA  and PTEN expression in mCRC patients treated with a cetuximab-based regimen.    Methods  67 mCRC patients were enrolled onto the study. DNA was extracted from paraffin-embedded sections derived from primary or metastatic lesions. Exon 2 of  KRAS  and exon 15 of  BRAF  were analyzed by direct sequencing,  PIK3CA  was evaluated by pyrosequencing and PTEN expression by immunohistochemistry.    Results   BRAF  and  PIK3CA  mutations were independently associated with worse PFS ( p  = 0.006 and  p  = 0.028, respectively) and OS ( p  = 0.008 and  p  = 0.029, respectively). No differences in clinical outcome were found between patients who were positive or negative for PTEN expression. Conversely, patients negative for  KRAS ,  BRAF  and  PIK3CA  mutations were characterized by significantly better ORR, PFS and OS than patients with at least one of these mutations.    Conclusions   BRAF  and  PIK3CA  mutations would seem to be independent predictors of anti-EGFR therapy effectiveness and could be taken into consideration during treatment decision making.

Predictive role of multiple gene alterations in response to cetuximab in metastatic colorectal cancer: A single center study