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ALK Testing Trends and Patterns Among Community Practices in the United States
Peter B Illei1, William Wong1, Ning Wu1
1Peter B. Illei, Johns Hopkins University School of Medicine, Baltimore, MD; William Wong, Laura Chu, Ravindra Gupta, and Katja Schulze, Genentech, South San Francisco; Matthew A. Gubens, University of California, San Francisco, CA; and Ning Wu, PRO Unlimited, Boca Raton, FL.
Purpose:
Targeted therapy of ALK in patients with metastatic nonsquamous non-small-cell lung cancer (NSCLC) and ALK rearrangements improves outcomes compared with chemotherapy. This study assessed real-world ALK testing patterns among community practices in the United States in patients with advanced (stage IIIB or IV) NSCLC.
Methods:
Patients age ≥ 18 years with two or more visits within the Flatiron Health electronic health record-derived database after January 2011 and diagnosed with stage IIIB or IV NSCLC through May 2017 were included in this analysis. Logistic regression was used to examine the association between demographic and clinical characteristics and testing for ALK rearrangements.
Results:
Of 31,483 patients analyzed from the database, 16,726 patients (53.1%) were tested for ALK rearrangements. ALK testing rates were 66.9% and 18.5% in patients with nonsquamous and squamous histology, respectively. Average ALK testing rates increased over time from 32.4% in 2011 to 62.1% in 2016. Fluorescent in situ hybridization was the most common ALK testing method. Agreement between fluorescent in situ hybridization and other assays ranged from 94.1% to 97.9%. Median (interquartile range) time from laboratory receipt of sample to first ALK test result was 7 (7) days; median time from advanced diagnosis to first ALK test result was 25 (29) days. Patients who were older, male, had a history of smoking, lived in non-Western US regions, and who had recurrent disease or squamous histology were less likely to be tested for ALK. Patients with Medicaid and Medicare insurance were less likely to be tested than patients with commercial insurance. Overall, 21.5% of patients initiated therapy (20.4% chemotherapy) before receiving test results.
Conclusion:
ALK testing rates have increased over time. However, certain subgroups of patients are less likely to be tested, suggesting that additional education on molecular testing is warranted.
Insights
ALK testing in advanced non-small-cell lung cancer (NSCLC) increased over time. However, certain patient groups were less likely to be tested, indicating a need for further education on molecular diagnostics for ALK rearrangements.
Area of Science:
- Oncology
- Molecular Diagnostics
- Public Health
Background:
- Targeted therapy for anaplastic lymphoma kinase (ALK) rearrangements in metastatic non-small-cell lung cancer (NSCLC) improves patient outcomes.
- Real-world data on ALK testing patterns in community practices are crucial for understanding treatment accessibility.
Purpose of the Study:
- To assess real-world ALK testing patterns in advanced (stage IIIB or IV) NSCLC patients within US community practices.
- To identify demographic and clinical factors associated with ALK testing rates.
Main Methods:
- Analysis of electronic health records from the Flatiron Health database (January 2011–May 2017).
- Inclusion of patients aged ≥18 years with stage IIIB or IV NSCLC and at least two visits.
- Logistic regression to examine associations between patient characteristics and ALK testing.
Main Results:
- Over 53% of 31,483 NSCLC patients were tested for ALK rearrangements.
- ALK testing rates varied significantly by histology (66.9% nonsquamous vs. 18.5% squamous) and increased from 32.4% in 2011 to 62.1% in 2016.
- Older age, male sex, smoking history, non-Western US region, recurrent disease, squamous histology, and certain insurance types were associated with lower testing rates. 21.5% started therapy before results.
Conclusions:
- ALK testing rates in NSCLC have improved but remain suboptimal in specific patient subgroups.
- Educational initiatives are needed to promote molecular testing for ALK rearrangements in all eligible NSCLC patients.
- Addressing disparities in ALK testing is essential for equitable application of targeted therapies.
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