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.

Abstract

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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