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Next-Generation Sequencing in 305 Consecutive Patients: Clinical Outcomes and Management Changes
William Davis1, Gabriel Makar1, Pallav Mehta2
1Cooper Medical School of Rowan University, Camden, NJ.
Purpose:
Next-generation sequencing (NGS) is increasingly used to identify actionable mutations for oncology treatment. We examined the results and use of NGS assays at our institution.
Patients And Methods:
We retrospectively reviewed the medical records of 305 consecutive patients who had NGS testing of tumor samples from March 2014 to April 2017. NGS was performed by FoundationOne.
Results:
Of the 305 tissue samples sent to FoundationOne, 189 reports were potentially usable. Of these reports, 76 (40.21%) demonstrated an aberration targetable by on-label therapies and 126 (66.67%) by off-label therapies, and 170 (89.94%) revealed actionable aberrations via all potential avenues, including clinical trials; 21 of these 189 potentially usable reports (11.1%) yielded a change in management, including use of on-label therapies (n = 7), use of off-label therapies (n = 6), enrollment in a clinical trial (n = 6), and discontinuation of a medication with a predicted poor response (n = 3; one report was used twice). For the six patients with off-label use, median duration of treatment was 46 days and discontinued after death (n = 3) or progression (n = 3).
Conclusion:
Only a minority of NGS assay results (6.9% percent of all tests ordered and 11.1% of useable tests) resulted in a management change. A small minority of patients started off-label therapy on the basis of NSG assay results and overall had poor responses to off-label treatment. Although in theory NGS assays may improve oncologic outcomes, the results of our initial 305 patients showed low clinical utility.
Insights
Next-generation sequencing (NGS) identified actionable mutations in cancer patients, but few results led to treatment changes. The study found low clinical utility for NGS assays in guiding oncology treatment decisions.
Area of Science:
- Oncology
- Genomics
- Molecular Diagnostics
Background:
- Next-generation sequencing (NGS) is a powerful tool for identifying genetic alterations in tumors.
- Its application in clinical oncology aims to personalize treatment strategies based on actionable mutations.
Purpose of the Study:
- To evaluate the clinical utility and impact of next-generation sequencing (NGS) assays in guiding cancer treatment decisions.
- To assess the rate of actionable mutations identified and subsequent changes in patient management.
Main Methods:
- Retrospective review of medical records for 305 patients undergoing tumor NGS testing.
- Analysis of FoundationOne assay results for actionable mutations and their influence on treatment plans.
Main Results:
- Of 189 usable NGS reports, 40.2% had on-label, 66.7% off-label, and 89.9% actionable aberrations (including clinical trials).
- Only 11.1% of usable tests resulted in a management change, with limited success in off-label therapy.
- A minority of patients (6.9% of all tests) experienced a management change.
Conclusions:
- Despite identifying actionable mutations, NGS assays showed low clinical utility in this cohort.
- Management changes based on NGS results were infrequent and off-label treatments yielded poor responses.
- Further research is needed to optimize the integration of NGS into routine oncology care.
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