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Background <p>Antibody–drug conjugates (ADC) improved&#xa0;survival in patients with HER2-positive MBC. To date,&#xa0;there&#xa0;is&#xa0; no prognostic biomarker in routine practice for these patients. HER2-ECD is associated with poor prognosis but has not yet been studied&#xa0;in patients receiving ADC.</p> Methods <p>This monocentric retrospective study&#xa0;assessed in HER2-positive MBC patients shows the prognostic value on OS&#xa0;and PFS&#xa0;of (1) baseline HER2-ECD and CA15-3 and (2) HER2-ECD and CA15-3 after 3&#xa0;months of treatment with TDM-1. At baseline, patients were divided according to the median value of HER2-ECD and CA15-3 from study population. For&#xa0;kinetic assessments, we compared survival outcomes according to the evolution of HER2-ECD and CA15-3 (stable/decrease vs increase).</p> Results <p>40 patients were included. For both biomarkers, baseline&#xa0;values were not prognostic for OS neither PFS. Patients with stable or decrease HER2-ECD at 3&#xa0;months had a significantly longer OS (median 43 versus 15.3&#xa0;months, <i>p</i> &lt; 0.0001) and PFS (median 9.4 versus 2.9&#xa0;months, <i>p</i> = 0.0018) than patients with decrease, confirmed in multivariate analysis (<i>p</i> = 0.004 for OS and &lt; 0.0001 for PFS). In contrast, CA15-3 kinetic was only prognostic for PFS (median 9.6 versus 4.9&#xa0;months, <i>p</i> = 0.019), confirmed in multivariate analysis (<i>p</i> = 0.008).</p> Conclusion <p>In this retrospective cohort,&#xa0;HER2-ECD kinetic&#xa0;was a prognostic biomarker for OS and PFS in patients with an HER2-positive MBC treated with TDM-1.</p>

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Prognostic value of circulating HER2 extracellular domain in patients with HER2-positive metastatic breast carcinoma treated with TDM-1 (trastuzumab emtansine)

  • 期刊论文

  • 发表日期：

    2025年8月3日

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  • Roman Vion,
  • Céline Calbrix,
  • Anca Berghian,
  • Emilie Lévêque,
  • Maxime Fontanilles,
  • Cédric Paquin,
  • Philippe Ruminy,
  • Jean Rouvet,
  • Marianne Leheurteur,
  • Nathalie Olympios,
  • Vinciane Rainville,
  • Frédéric Di Fiore,
  • Florian Clatot

摘要

Background

Antibody–drug conjugates (ADC) improved survival in patients with HER2-positive MBC. To date, there is  no prognostic biomarker in routine practice for these patients. HER2-ECD is associated with poor prognosis but has not yet been studied in patients receiving ADC.

Methods

This monocentric retrospective study assessed in HER2-positive MBC patients shows the prognostic value on OS and PFS of (1) baseline HER2-ECD and CA15-3 and (2) HER2-ECD and CA15-3 after 3 months of treatment with TDM-1. At baseline, patients were divided according to the median value of HER2-ECD and CA15-3 from study population. For kinetic assessments, we compared survival outcomes according to the evolution of HER2-ECD and CA15-3 (stable/decrease vs increase).

Results

40 patients were included. For both biomarkers, baseline values were not prognostic for OS neither PFS. Patients with stable or decrease HER2-ECD at 3 months had a significantly longer OS (median 43 versus 15.3 months, p < 0.0001) and PFS (median 9.4 versus 2.9 months, p = 0.0018) than patients with decrease, confirmed in multivariate analysis (p = 0.004 for OS and < 0.0001 for PFS). In contrast, CA15-3 kinetic was only prognostic for PFS (median 9.6 versus 4.9 months, p = 0.019), confirmed in multivariate analysis (p = 0.008).

Conclusion

In this retrospective cohort, HER2-ECD kinetic was a prognostic biomarker for OS and PFS in patients with an HER2-positive MBC treated with TDM-1.