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  P1.09 - Pathology (Not CME Accredited Session) (ID 941)

  • Event: WCLC 2018
  • Type: Poster Viewing in the Exhibit Hall
  • Track:
  • Presentations: 1
  • Moderators:
  • Coordinates: 9/24/2018, 16:45 - 18:00, Exhibit Hall

  • 26524

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    P1.09-23 - Effect of Plasma Input on the Clinical Sensitivity of a Real-Time PCR Assay for the Detection Of EGFR Mutation in Plasma ctDNA From NSCLC Patients (ID 12256)

    16:45 - 18:00  |  Author(s): Qingtao Song
    • Abstract
    • Slides

    Background
    

    Plasma based EGFR mutation testing is a less invasive and feasible testing option for patients with advanced non-small cell lung cancer (NSCLC) when traditional tissue biopsy testing is challenging. A fast and sensitive real-time PCR method has been developed for the detection of EGFR mutations in plasma circulating tumor DNA (ctDNA). To define the effect of plasma input on the clinical sensitivity of the assay, clinical evaluation was conducted in the present study.

    a9ded1e5ce5d75814730bb4caaf49419 Method
    

    A total of 203 patients with advanced NSCLC were recruited who provided plasma and matched tumor tissue samples, 109 of whom providing samples had adequate plasma for both 2 mL and 4 mL plasma testing, and the rest providing 2 mL plasma samples. ctDNA was isolated and tested for the presence of EGFR mutation by the AmoyDx Super-ARMS EGFR Mutation Detection Kit (Super-ARMS EGFR). Tumor tissue DNA was isolated and tested for EGFR mutation by AmoyDx ARMS EGFR Mutation Detection Kit (ARMS EGFR). Clinical sensitivity and specificity of ctDNA testing were analyzed by using tumor tissue testing as a reference.

    4c3880bb027f159e801041b1021e88e8 Result
    

    In pairs of tumor biopsy and plasma samples, the sensitivity, specificity and overall concordance of EGFR mutation status determined in 4 mL of plasma by Super-ARMS EGFR test and matched tissue samples were 82.0% [50/61], 100% [48/48], and 89.9% [98/109] (N=109), respectively. These rates were much higher than those of mutation status determined in 2 mL of plasma and matched tissue samples (65.55% [78/119], 97.62% [82/84] and 78.82% [160/203], N=203).

    8eea62084ca7e541d918e823422bd82e Conclusion
    

    Super-ARMS EGFR assay is a highly reliable and sensitive method for the detection of EGFR mutation in lung cancer plasma ctDNA samples. Plasma samples of 4 mL volume is more appropriate for ctDNA EGFR mutation assessment than determination in 2 mL volume of plasma.

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