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Background <p>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.</p> Objectives <p>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.</p> Design <p>We analyzed eligibility and inclusion in targeted therapy trials among all cancer patients treated at Poitiers University Hospital who underwent routine NGS.</p> Methods <p>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.</p> Results <p>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%.</p> Conclusion <p>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.</p>

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

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2025年10月29日

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  • Mathieu Faigner,
  • Lucie Karayan-Tapon,
  • Ulrich Cortes,
  • Birama Ndiaye,
  • Marine Martel,
  • Pierre Rivet,
  • Jade Duche,
  • Nicolas Isambert,
  • David Tougeron,
  • Camille Evrard

摘要

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.