The predictive role of Ki67 in pathological complete response (pCR) and invasive disease-free survival (IDFS) in HER2-positive breast cancer: a bi-centric retrospective cohort study of 244 cases - Summary - MDSpire

The predictive role of Ki67 in pathological complete response (pCR) and invasive disease-free survival (IDFS) in HER2-positive breast cancer: a bi-centric retrospective cohort study of 244 cases

  • By

  • Laura Weydandt

  • Saida Agabejli

  • Massimiliano Lia

  • Pauline Wimberger

  • Bahriye Aktas

  • Theresa Link

  • May 2, 2026

  • 0 min

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Objective:

To examine the prognostic potential of Ki67 on the rate of pathological complete response (pCR) and invasive disease-free survival (IDFS) in early HER2-positive breast cancer and to test specific suggested Ki67 cut-offs.

Key Findings:
  • Ki67 showed no significant association with pCR or IDFS in the studied cohort, suggesting it may not be a reliable biomarker.
  • The previously suggested Ki67 cut-offs did not demonstrate predictive value for treatment outcomes, indicating a need for alternative biomarkers.
  • More reliable predictive factors should guide therapeutic decisions in HER2-positive breast cancer.
Interpretation:

The findings indicate that Ki67 is not a reliable biomarker for predicting treatment response or survival outcomes in early HER2-positive breast cancer, challenging its use in clinical decision-making and highlighting the need for alternative biomarkers.

Limitations:
  • Retrospective design may introduce bias.
  • Data derived from only two centers may limit generalizability.
  • Potential confounding factors not fully accounted for despite statistical adjustments.
  • Retrospective data collection may impact data quality.
Conclusion:

Ki67 should not be used to guide therapeutic decisions in routine practice for HER2-positive breast cancer, emphasizing the need for more reliable predictive factors.

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