Work

Impact of next-generation sequencing on routine clinical practice and patient inclusion in molecularly targeted clinical trials: a retrospective cohort analysis

Year: 2025

Type: article

Abstract: BACKGROUND: High-throughput sequencing has advanced biomarker identification, enabling more targeted cancer treatment. Various gene panels are used to screen for actionable genomic alterations for clinical practice and trial inclusion. OBJECTIVES: We aimed to determine the proportion of cancer patients with a targetable molecular tumor alteration and their inclusion in related trials using a routine panel, and to compare these proportions with results from a larger panel combined with molecular tumor board (MTB) discussion. DESIGN: We analyzed eligibility and inclusion in targeted therapy trials among all cancer patients treated at Poitiers University Hospital who underwent routine NGS. METHODS: Clinical trials were identified via the French National Cancer Institute (INCa) and ClinicalTrials.gov databases. Inclusion rates were also assessed for patients analyzed with the broader FoundationOne CDx® (FO) panel. RESULTS: Among 1456 patients, 835 targetable mutations were identified: KRAS 43.6%, BRAF 19.0%, and PIK3CA 10.8%. Of 179 patients eligible for a dedicated trial, 19 were enrolled (10.6%), mostly at Poitiers University Hospital (84.2%) and predominantly melanoma patients (11/19). For 78.8% of non-included eligible patients, reasons were undocumented. FO analysis increased actionable alteration detection from 34.0% to 64.0%, with trial inclusion rising from 12.0% to 16.0%. CONCLUSION: Although a substantial fraction of patients harbored actionable alterations, trial inclusion remained low at our center. Improving access requires better physician awareness of available clinical trials to optimize patient enrollment.

Source: Clinical & Translational Oncology

DOI: 10.1007/s12094-025-04086-7