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Research Article: Evaluation of the international Ki67 working group cut point recommendations for early breast cancer: comparison with 21-gene assay results in a large integrated health care system

Date Published: 2023-10-17

Introduction:
While considered an established marker of cell proliferation for decades, the potential role for Ki67 immunohistochemistry (IHC) in breast cancer management has remained unclear due largely to its high inter-observer variability and the lack of established cutoff points for clinical decisions [1]. Nonetheless, Ki67 has been used in several clinical trials (e.g., POETIC) [2]. In 2021, it was FDA approved as a companion diagnostic for selection of high-risk patients for treatment with CDK4/6 inhibitors, although…

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