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Ki67—no evidence for its use in node-positive breast cancer

Nature Reviews Clinical Oncology volume 12, pages 296–301 (2015)Cite this article

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Abstract

The expression of Ki67 in breast cancer has been associated with the luminal B phenotype, a high risk of relapse, and likelihood of good response to neoadjuvant chemotherapy. Several guidelines propose assays to determine Ki67 expression levels to select which patients with early stage breast cancer and 1–3 positive axillary nodes should not receive adjuvant chemotherapy. We discuss why oncologists should not rely on the use of this biomarker for patients with early stage breast cancer and only 1–3 positive axillary nodes. First, Ki67 staining lacks analytical validity. Second, the performance of the biomarker for prognostic purposes is poor, with no compelling evidence to indicate that patients with oestrogen receptor (ER)-positive disease, low Ki67 expression and 1–3 positive axillary nodes have a very low risk of disease relapse. Finally, no robust evidence indicates that Ki67 staining predicts the efficacy of adjuvant chemotherapy. Overall, evidence does not support withholding adjuvant chemotherapy in patients with ER-positive, Ki67-low breast cancer and 1–3 positive nodes without risk in daily practice.

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Figure 1: Limitations in evidence for using Ki67 in node-positive breast cancers.

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Authors and Affiliations

  1. Department of Medical Oncology, Gustave Roussy Institute, 114 rue E. Vaillant, Villejuif, 94800, France

    Fabrice Andre, Monica Arnedos, Amal Ghouadni & Suzette Delaloge

  2. INSERM Unit UMR981, Gustave Roussy Institute, 114 rue E. Vaillant, Villejuif, 94800, France

    Aicha Goubar

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All authors researched data for article, reviewed and edited the manuscript before submission, made a substantial contribution to discussion of content for the article, and wrote the manuscript.

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Correspondence to Fabrice Andre.

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Andre, F., Arnedos, M., Goubar, A. et al. Ki67—no evidence for its use in node-positive breast cancer. Nat Rev Clin Oncol 12, 296–301 (2015). https://doi.org/10.1038/nrclinonc.2015.46

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