Clinical validity and clinical utility of Ki67 in early breast cancer

Ki67 represents an immunohistochemical nuclear localized marker that is widely used in surgical pathology. Nuclear immunoreactivity for Ki67 indicates that cells are cycling and are in G1- to S-phase. The percentage of Ki67-positive tumor cells (Ki67 index) therefore provides an estimate of the grow...

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Bibliographic Details
Published inTherapeutic Advances in Medical Oncology Vol. 14; p. 17588359221122725
Main Authors Kreipe, Hans, Harbeck, Nadia, Christgen, Matthias
Format Book Review Journal Article
LanguageEnglish
Published London, England SAGE Publications 2022
Sage Publications Ltd
SAGE Publishing
Subjects
Artificial intelligence
Breast cancer
Cell proliferation
Clinical trials
Endocrine therapy
Immunohistochemistry
Laboratories
mRNA
Pathology
Review
Tumor cells
breast cancer
Ki67
endocrine resistance
prognosis
therapy response
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Summary:Ki67 represents an immunohistochemical nuclear localized marker that is widely used in surgical pathology. Nuclear immunoreactivity for Ki67 indicates that cells are cycling and are in G1- to S-phase. The percentage of Ki67-positive tumor cells (Ki67 index) therefore provides an estimate of the growth fraction in tumor specimens. In breast cancer (BC), tumor cell proliferation rate is one of the most relevant prognostic markers and Ki67 is consequently helpful in prognostication similar to histological grading and mRNA profiling-based BC risk stratification. In BCs treated with short-term preoperative endocrine therapy, Ki67 dynamics enable distinguishing between endocrine sensitive and resistant tumors. Despite its nearly universal use in pathology laboratories worldwide, no internationally accepted consensus has yet been achieved for some methodological details related to Ki67 immunohistochemistry (IHC). Controversial issues refer to choice of IHC antibody clones, scoring methods, inter-laboratory reproducibility, and the potential value of computer-assisted imaging analysis and/or artificial intelligence for Ki67 assessment. Prospective clinical trials focusing on BC treatment have proven that Ki67, as determined by standardized central pathology assessment, is of clinical validity. Clinical utility has been demonstrated in huge observational studies.
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ISSN:1758-8359
1758-8340
1758-8359
DOI:10.1177/17588359221122725