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Michael J Humphries



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    FP07 - Pathology (ID 109)

    • Event: WCLC 2020
    • Type: Posters (Featured)
    • Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
    • Presentations: 1
    • Moderators:
    • Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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      FP07.15 - Real-world ALK Testing Trends and Patterns in Patients with Advanced NSCLC in the United States (ID 3333)

      00:00 - 00:00  |  Author(s): Michael J Humphries

      • Abstract
      • Slides

      Introduction

      Patients whose lung cancers harbor anaplastic lymphoma kinase (ALK) rearrangements are sensitive to treatment with ALK tyrosine kinase inhibitors (TKIs). Several treatment guidelines recommend molecular testing to identify ALK-positive patients who are eligible for ALK TKI therapy. This study assessed real-world ALK testing patterns among community practices in the United States in patients with advanced non-small cell lung cancer (NSCLC) and explored treatments received prior to receiving test results in patients with ALK-positive NSCLC.

      Methods

      This retrospective analysis used data extracted from the Flatiron Health electronic health record-derived deidentified database. Patients ≥ 18 years old with a diagnosis of advanced NSCLC (clinical stage IIIB or IV as determined by pathologic and radiologic findings) and ≥ 2 clinic visits within the Flatiron Network between 01/01/2011 and 12/31/2019 were included.

      Results

      Overall, 60,025 patients with advanced NSCLC were identified, including 41,496 patients with non-squamous cell carcinoma and 15,291 patients with squamous cell carcinoma. Between 2011 and 2019, 36,691 (61.1%) patients with advanced NSCLC were ever tested for ALK by various diagnostic tests. Of these, 1,042 patients were ALK-positive. In patients with advanced NSCLC, ALK testing rates increased from 33.1% in 2011 to 73.0% in 2019. Considering histological subtype, ALK testing rates increased from 41.6% in 2011 to 81.6% in 2019 in patients with non-squamous cell carcinoma and from 13.6% in 2011 to 50.4% in 2019 in patients with squamous cell carcinoma. The proportion of ALK testing conducted by fluorescence in situ hybridization (FISH) declined from 68.3% in 2011 to 32.1% in 2019, while the use of next-generation sequencing (NGS) increased from < 1% in 2011 to 52.2% in 2019. Overall, tissue samples were most commonly used for testing (85.1%), followed by blood samples (13.5%), and the use of blood samples for ‘liquid biopsy’ increased from < 1% in 2011 to 28.2% in 2019. Among 983 patients who tested ALK-positive with a non-missing test result date, 24.7% of patients initiated therapy before receiving their first ALK-positive test results, with immuno-oncology (IO) therapies the most common treatments initiated since 2017. Among those who tested ALK-positive, the proportion of patients who started IO therapies before receiving ALK test results increased from 4.8% in 2016 to 17.8% in 2019. Median time from diagnosis of advanced NSCLC to first ALK-positive result date was 23 days. This included a laboratory turnaround time of 9 days from the date specimens were received by the laboratory to the test report date.

      Conclusion

      Over time, ALK testing rates have increased, reaching over 70.0% since 2017. There was increased use of NGS and a concurrent decrease in the use of FISH as the primary testing method. Despite this increase, over a quarter of patients with advanced NSCLC were not tested for ALK, indicating that many patients are not receiving recommended biomarker testing. Furthermore, 24.7% of patients who tested ALK-positive initiated therapy before receipt of ALK test results, which indicates that treatment decisions are sometimes being made in the absence of recommended biomarker data.

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