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Pancreatic cancer (PC) is a highly lethal malignancy, with a 5-year survival rate of 6%. Cancer gene panel testing is expected to allow selection of suitable therapeutic drugs in individual patients with PC and improve their prognosis. Although somatic mutations can be identified in formalin-fixed, paraffin-embedded samples derived from surgical specimen, the rate of surgical indication among patients with PC is only 20%. To acquire genome information with a less invasive method, we used rapid on-site evaluation (ROSE) specimens from endoscopic ultrasound-guided fine-needle aspiration. The present study aimed to retrospectively evaluate the utility of comprehensive cancer gene panel testing with ROSE specimens. DNA was extracted from preserved ROSE specimens of 26 patients diagnosed with PC between 2011 and 2017. DNA sequences of oncogenes and cancer-related genes were determined using the Ion AmpliSeq Comprehensive Caner Panel. We compared  KRAS  mutations between cancer gene panel testing by next-generation sequencing (NGS) and  KRAS  mutation analysis by polymerase chain reaction. The mean yield of DNA per extraction from ROSE specimens was 171 ng (range, 34–478 ng). On cancer gene panel testing, we noted  KRAS  mutations (92%),  TP53  mutations (50%),  CDKN2A  mutations (15%), and  SMAD4  mutations (31%). The concordance rate of  KRAS  mutations between cancer gene panel testing by NGS using ROSE specimens and  KRAS  mutation analysis by the companion diagnostics using residual materials was 81%. Among five cases of  KRAS  discordance, three showed  KRAS  mutations in cancer gene panel testing but not in  KRAS  mutation analysis. Cancer gene panel testing with ROSE specimens can help stratify unresectable PC patients without additional invasive approaches, and it can be used for therapeutic drug selection.

plos one

Usefulness of rapid on-site evaluation specimens from endoscopic ultrasound-guided fine-needle aspiration for cancer gene panel testing: A retrospective study