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<p>To explore whether ultra-sensitive circulating tumor DNA (ctDNA) profiling enables earlier prediction of treatment response and detection of disease progression, we applied NeXT Personal, an ultra-sensitive bespoke tumor-informed liquid biopsy platform, to profile tumor samples from the KeyLargo study, a phase II trial in which metastatic esophagogastric cancer (mEGC) patients received capecitabine, oxaliplatin, and pembrolizumab. A total of 24 patients were evaluated, and all were ctDNA-positive at baseline. ctDNA levels varied from 406,067 down to 1.5 parts per million (PPM) with a median limit of detection of 2.03 PPM. ctDNA dynamics were highly correlated with changes in tumor size (ρ = 0.59, <i>p</i> = 7.3 × 10<sup>− 9</sup>). Lack of early molecular response (50% or greater decrease in ctDNA levels at first available time point after 30 days, C2D1 or C4D1) was associated with worse overall survival (OS) (HR 4.5, 95% CI 1.2–16.7, <i>p</i> = 0.02) and progression-free survival (PFS) (HR 10.4, 95% CI 2.2–49.8, <i>p</i> = 0.003). Lack of molecular clearance of ctDNA was associated with worse OS (HR 7.1, 95% CI 1.6–31.7, <i>p</i> = 0.01) and PFS (HR 19.9, 95% CI 2.5-158.2, <i>p</i> = 0.005). Molecular progression (ctDNA increase) preceded imaging-derived progression by a median lead time of 65 days. These results suggest that ultra-sensitive liquid biopsy approaches could improve treatment decision-making for mEGC patients receiving chemotherapy and immunotherapy.</p>

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Monitoring treatment response using an ultra-sensitive ctDNA assay in advanced esophagogastric cancer patients

  • 期刊论文

  • 出版模式：

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  • 发表日期：

    2026年3月23日

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  • Andrew B. Nixon,
  • Fábio C. P. Navarro,
  • Katherine I. Zhou,
  • Charles W. Abbott,
  • Lee McDaniel,
  • Neeraja Ravi,
  • Lauren E. Howard,
  • J. Christopher Brady,
  • Yingmiao Liu,
  • Jingquan Jia,
  • Donna Niedzwiecki,
  • John H. Strickler,
  • Sean M. Boyle,
  • Richard O. Chen,
  • Hope Uronis

摘要

To explore whether ultra-sensitive circulating tumor DNA (ctDNA) profiling enables earlier prediction of treatment response and detection of disease progression, we applied NeXT Personal, an ultra-sensitive bespoke tumor-informed liquid biopsy platform, to profile tumor samples from the KeyLargo study, a phase II trial in which metastatic esophagogastric cancer (mEGC) patients received capecitabine, oxaliplatin, and pembrolizumab. A total of 24 patients were evaluated, and all were ctDNA-positive at baseline. ctDNA levels varied from 406,067 down to 1.5 parts per million (PPM) with a median limit of detection of 2.03 PPM. ctDNA dynamics were highly correlated with changes in tumor size (ρ = 0.59, p = 7.3 × 10− 9). Lack of early molecular response (50% or greater decrease in ctDNA levels at first available time point after 30 days, C2D1 or C4D1) was associated with worse overall survival (OS) (HR 4.5, 95% CI 1.2–16.7, p = 0.02) and progression-free survival (PFS) (HR 10.4, 95% CI 2.2–49.8, p = 0.003). Lack of molecular clearance of ctDNA was associated with worse OS (HR 7.1, 95% CI 1.6–31.7, p = 0.01) and PFS (HR 19.9, 95% CI 2.5-158.2, p = 0.005). Molecular progression (ctDNA increase) preceded imaging-derived progression by a median lead time of 65 days. These results suggest that ultra-sensitive liquid biopsy approaches could improve treatment decision-making for mEGC patients receiving chemotherapy and immunotherapy.