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J. Pluenneke



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    Poster Display session (Friday) (ID 65)

    • Event: ELCC 2018
    • Type: Poster Display session
    • Track:
    • Presentations: 1
    • Moderators:
    • Coordinates: 4/13/2018, 12:30 - 13:00, Hall 1
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      147P - Clinical testing of ctDNA from NSCLC patients using A 17-gene liquid biopsy mutation panel (ID 590)

      12:30 - 13:00  |  Author(s): J. Pluenneke

      • Abstract
      • Slides

      Background:
      The Oncotype SEQ® Liquid Select™ assay is a next-generation sequencing gene panel assay performed as a laboratory-developed test in a central CLIA-certified laboratory by Genomic Health, Inc. Oncotype SEQ® detects clinically relevant genomic alterations in 17 genes using ctDNA isolated from blood plasma. Here we summarize genomic findings from patients (pts) tested after commercial launch of Oncotype SEQ® in June 2016.

      Methods:
      126 NSCLC pts from 17 community cancer centers in the US were tested with Oncotype SEQ® in routine clinical care. Proprietary technologies and bioinformatics tools were used to identify actionable genomic variants, which were reported to pts’ medical records.

      Results:
      Tested NSCLC pts were stages IV (124), III (1) and II (1). Diagnoses were adenocarcinoma (94), squamous cell carcinoma (19), other (11), or unknown primary (2). Mean age (range) was 69 y (44–90 y), 64% were ≥65 y, 16% were >80 y. 56% were female. Results were reported for 112 (89%) pts. 135 gene variants were detected in 72/112 (64%) pts across 12 genes. 66% of identified variants were SNV, 5% indels, 27% CNV, and 2% fusions. 39 pts had 1 variant, 19 had 2, and 14 had ≥3. In nonsquamous NSCLC, 91/117 (78%) reported variants were SNV/indel/fusions and 26/117 (22%) were CNV; in squamous tumors, these were 7/16 (44%) and 9/16 (56%), respectively. Clinically actionable variants specified in FDA drug labels or in NCCN guidelines for NSCLC were reported for 42/112 (38%) pts in EGFR (13 variants), ALK (3), KRAS (21), MET (7), BRAF (2), and ERBB2 (1). These were observed at allele fractions as low as 0.12% for KRAS G12D and ranging from 0.26% to 22% for EGFR E746_A750del (n = 4). Other reported variants were potentially actionable, either specified in FDA labels of drugs approved for other tumor types, associated with active therapeutic clinical trials in NSCLC, or represented possible germline variants warranting genetic counseling.

      Conclusions:
      Oncotype SEQ® sensitively identifies gene variants that are important to inform optimal management decisions for pts with advanced-stage NSCLC. A retrospective review of medical records to examine concurrent tissue testing, treatments received, and clinical outcomes is ongoing and will be presented.

      Clinical trial identification:
      N/A

      Legal entity responsible for the study:
      Genomic Health, Inc.

      Funding:
      Genomic Health, Inc.

      Disclosure:
      D.A. Eberhard, J. Bennett, D. Davison, C. Hammond, A. Petty, J. Pluenneke, A. Dei Rossi, G. Alexander, D. Paragas, M. Lopatin: Employment and stock ownership: Genomic Health.

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