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Yanyu Wu
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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): Yanyu Wu
- Abstract
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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P37 - Pathology - Biomarker Testing (ID 107)
- Event: WCLC 2020
- Type: Posters
- Track: Pathology, Molecular Pathology and Diagnostic Biomarkers
- Presentations: 1
- Moderators:
- Coordinates: 1/28/2021, 00:00 - 00:00, ePoster Hall
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P37.31 - Trends in the Detection of EGFR Exon 20 Insertions in Patients with NSCLC in the US (ID 3334)
00:00 - 00:00 | Author(s): Yanyu Wu
- Abstract
Introduction
Epidermal growth factor receptor exon 20 insertions (EGFRex20ins) are an uncommon subset of EGFR-activating mutations that are associated with a lack of responsiveness to tyrosine kinase inhibitor (TKI) therapy. With the clinical development of TKIs and monoclonal antibodies targeting EGFRex20ins, broad molecular profiling is needed to direct patients to these therapies. We describe real-world EGFRex20ins detection patterns in patients with advanced non-small cell lung cancer (NSCLC) in the United States.
Methods
Data were extracted from the Flatiron Health electronic health record-derived deidentified database. Patients ≥ 18 years, diagnosed with advanced NSCLC, and ≥ 2 clinic visits between 01/01/2011 and 12/31/2019 were included.
Results
A total of 60,025 patients with advanced NSCLC were identified 38,990 patients (65%) were tested for EGFR mutations, of which 326 (0.8%) harbored an EGFRex20ins; clinicopathologic characteristics of patients with an EGFRex20ins were similar to the canonical EGFR mutations. The frequency of EGFRex20ins among all NSCLC cases tested (by year of advanced diagnosis) increased from 0.6% in 2011 to 1.2% in 2019. In patients with an EGFRex20ins-positive result, the proportion of testing conducted by polymerase chain reaction (PCR) declined from 67% in 2011 to 16% in 2019, and use of next-generation sequencing (NGS) increased from 0% in 2011 to 64% in 2019. In EGFRex20ins-positive patients, tissue samples were most commonly used for testing (83%), while blood samples were also used (16%). Treatment was initiated in 26% of patients prior to confirmation of the first EGFRex20ins-positive result and in 2019, the most common treatment was immunotherapy-based (55.6%). The median time from advanced diagnosis to first EGFRex20ins result was 25 days, including a laboratory turnaround time of 10 days.
Conclusion
The detection rate of EGFRex20ins in NSCLC patients has increased, coinciding with a shift in testing methods from PCR to NGS. However, a notable proportion of patients initiated therapy before receipt of test results. With the development of EGFRex20ins targeted therapy, there is a need for early and broad biomarker testing.
