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Background <p>Circulating tumor DNA (ctDNA) has emerged as a promising noninvasive biomarker for monitoring minimal residual disease (MRD) and predicting recurrence in early-stage breast cancer (EBC). Despite growing interest, the prognostic impact of ctDNA detection in this setting remains to be fully elucidated.</p> Methods <p>A systematic review and meta-analysis were conducted on prospective studies assessing the association between ctDNA positivity and outcomes in early or locally advanced non-metastatic breast cancer. Databases including PubMed and the Cochrane Library were systematically searched. Studies were included if they reported hazard ratios (HRs) for disease-free survival (DFS) and/or overall survival (OS) according to ctDNA status. Pooled HRs were calculated using random-effects models; heterogeneity was evaluated with the <i>I</i><sup>2</sup> statistic.</p> Results <p>Eighteen studies comprising 1670 patients were included. ctDNA positivity was significantly associated with shorter DFS (pooled HR 6.92, 95% CI 3.64–13.13; <i>p</i> &lt; 0.0001; <i>I</i><sup>2</sup> = 79.7%). This association held across subtypes and timepoints, including post-surgical and longitudinal assessments. In the neoadjuvant setting, ctDNA positivity was associated with increased recurrence risk (HR 6.06, 95% CI 2.85–12.87; <i>p</i> &lt; 0.0001), while in the adjuvant setting, it was an even stronger predictor of relapse (HR 14.76, 95% CI 1.11–197.02; <i>p</i> = 0.042). In a combined early-stage setting, ctDNA positivity correlated with significantly worse DFS (HR 6.55, 95% CI 1.41–30.39; <i>p</i> = 0.017). A non-significant trend was observed for worse OS (HR 3.91, 95% CI 0.78–19.72; <i>p</i> = 0.098).</p> Conclusions <p>ctDNA positivity is a robust prognostic biomarker for recurrence in early breast cancer. Its integration into post-treatment surveillance and interventional trials may enable risk-adapted strategies and early therapeutic intervention. </p>

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Prognostic significance of circulating tumor DNA in early breast cancer: a systematic review and meta-analysis

  • 期刊论文

  • 发表日期：

    2026年2月23日

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  • L. Sisca,
  • M. G. Polito,
  • M. Silletta,
  • A. La Cesa,
  • R. Scafetta,
  • M. Donato,
  • C. M. Gullotta,
  • A. Guarino,
  • G. Barnini,
  • E. Speziale,
  • R. Troiano,
  • S. Foderaro,
  • M. Iuliani,
  • S. Simonetti,
  • S. Cavalieri,
  • S. Calagna,
  • A. Cortellini,
  • B. Vincenzi,
  • G. Tonini,
  • F. Pantano

摘要

Background

Circulating tumor DNA (ctDNA) has emerged as a promising noninvasive biomarker for monitoring minimal residual disease (MRD) and predicting recurrence in early-stage breast cancer (EBC). Despite growing interest, the prognostic impact of ctDNA detection in this setting remains to be fully elucidated.

Methods

A systematic review and meta-analysis were conducted on prospective studies assessing the association between ctDNA positivity and outcomes in early or locally advanced non-metastatic breast cancer. Databases including PubMed and the Cochrane Library were systematically searched. Studies were included if they reported hazard ratios (HRs) for disease-free survival (DFS) and/or overall survival (OS) according to ctDNA status. Pooled HRs were calculated using random-effects models; heterogeneity was evaluated with the I2 statistic.

Results

Eighteen studies comprising 1670 patients were included. ctDNA positivity was significantly associated with shorter DFS (pooled HR 6.92, 95% CI 3.64–13.13; p < 0.0001; I2 = 79.7%). This association held across subtypes and timepoints, including post-surgical and longitudinal assessments. In the neoadjuvant setting, ctDNA positivity was associated with increased recurrence risk (HR 6.06, 95% CI 2.85–12.87; p < 0.0001), while in the adjuvant setting, it was an even stronger predictor of relapse (HR 14.76, 95% CI 1.11–197.02; p = 0.042). In a combined early-stage setting, ctDNA positivity correlated with significantly worse DFS (HR 6.55, 95% CI 1.41–30.39; p = 0.017). A non-significant trend was observed for worse OS (HR 3.91, 95% CI 0.78–19.72; p = 0.098).

Conclusions

ctDNA positivity is a robust prognostic biomarker for recurrence in early breast cancer. Its integration into post-treatment surveillance and interventional trials may enable risk-adapted strategies and early therapeutic intervention.