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  P3.06 - Poster Session 3 - Prognostic and Predictive Biomarkers (ID 178)

  • Event: WCLC 2013
  • Type: Poster Session
  • Track: Biology
  • Presentations: 1
  • Moderators:
  • Coordinates: 10/30/2013, 09:30 - 16:30, Exhibit Hall, Ground Level

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    P3.06-005 - A Prospective Protocol for Simultaneous Genomic Testing in Patients with Non-Small Cell Lung Cancer (ID 993)

    09:30 - 09:30  |  Author(s): C. McGready
    • Abstract

    Background
    Molecular testing in lung cancer has dramatically evolved over the past few years with a large number of targeted therapies and associated biomarkers. This has created a demand for tissue preservation. A careful consensus for prioritization of the different assays is needed to identify the right therapy for the patient. It is necessary to have protocols available that give access to results rapidly and accurately without depleting the sample throughout the process. We have designed a prospective study to demonstrate an efficient biomarker testing workflow (EGFR, ALK and KRAS) in a real clinical setting that preserves limited, valuable clinical samples

    Methods
    This prospective study was conducted at two independent pathology laboratories (Laboratorio de Dianas Terapeuticas of Madrid, Queen’s University of Belfast). Each site performed tissue sectioning for diagnosis and molecular testing according to laboratory protocols or to the assay specific package insert. Digital pathology was used to annotate specimens. NSCLC specimens were obtained by each lab (surgical resections and small biopsies of primary and metastatic lesions), excluding cytology specimens, with the exception of cells blocks. EGFR and KRAS mutation testing was performed using the cobas[®] EGFR Mutation Test and the cobas[®] KRAS Mutation Test (both CE-IVD), using a single 5µm section per test. FISH analysis was performed using the Vysis LSI ALK probe. Figure 1

    Results
    A total of 103 cases were included. 100% of the specimens were successfully tested for EGFR mutation status. Failure rates were 1.9% for ALK and KRAS analysis. Failed DNA extraction/PCR amplification was 3.9%/2.9% for EGFR and 5.8%/12.6% for KRAS. The prevalence of molecular alterations identified in EGFR (4% and 13.2%), ALK (4% and 7.8%) and KRAS (26% and 29.4%) was somewhat similar to that described in earlier studies. ALK rearrangements were mutually exclusive with EGFR and KRAS mutations. The median turnaround time was almost identical between sites: 6-7 days for all biomarkers (EGFR range 1-12 days, ALK range 2-14 days and KRAS range 1-17 days).

    Conclusion
    We have demonstrated that it is feasible to incorporate this protocol into the routine analysis of thoracic samples. The pattern of retesting to achieve full analysis in all samples suggests that, while EGFR testing is easily achievable with a one-section approach, the analysis of KRAS and ALK may require another round of testing in a small percentage of cases. Our results thus provide a pre-analytical and analytical rationale for comprehensive genotyping in patients with NSCLC.