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Assessment of Ki67 in Breast Cancer: Recommendations from the International Ki67 in Breast Cancer Working Group
Open accessAbstract
Ki67 immunohistochemistry (IHC), commonly used as a proliferation marker in breast cancer, has limited value for treatment decisions due to questionable analytical validity. The International Ki67 in Breast Cancer Working Group (IKWG) consensus meeting, held in October 2019, assessed the current evidence for Ki67 IHC analytical validity and clinical utility in breast cancer, including the series of scoring studies the IKWG conducted on centrally stained tissues. Consensus observations and recommendations are: 1) as for estrogen receptor and HER2 testing, preanalytical handling considerations are critical; 2) a standardized visual scoring method has been established and is recommended for adoption; 3) participation in and evaluation of quality assurance and quality control programs is recommended to maintain analytical validity; and 4) the IKWG accepted that Ki67 IHC as a prognostic marker in breast cancer has clinical validity but concluded that clinical utility is evident only for prognosis estimation in anatomically favorable estrogen receptor-positive and HER2-negative patients to identify those who do not need adjuvant chemotherapy. In this T1-2, N0-1 patient group, the IKWG consensus is that Ki67 5% or less, or 30% or more, can be used to estimate prognosis. In conclusion, analytical validity of Ki67 IHC can be reached with careful attention to preanalytical issues and calibrated standardized visual scoring. Currently, clinical utility of Ki67 IHC in breast cancer care remains limited to prognosis assessment in stage I or II breast cancer. Further development of automated scoring might help to overcome some current limitations.
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Gerdes, J., Lemke, H., Baisch, H., Wacker, H. H., Schwab, U., & Stein, H. (1984) · The Journal of Immunology · doi:10.4049/jimmunol.133.4.1710 · Cited by 4,173
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Geiss, G. K., Bumgarner, R. E., Birditt, B., Dahl, T., Dowidar, N., Dunaway, D. L., Fell, H. P., Ferree, S., George, R. D., Grogan, T., et al. (2008) · Nature Biotechnology · doi:10.1038/nbt1385 · Cited by 2,066
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Self-citationEarly breast cancer: ESMO Clinical Practice Guidelines for diagnosis, treatment and follow-up
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Self-citationKi-67: more than a proliferation marker
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Molecular biology in breast cancer: Intrinsic subtypes and signaling pathways
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Cancer across the tree of life: cooperation and cheating in multicellularity
Aktipis, C. A., Boddy, A. M., Jansen, G., Hibner, U., Hochberg, M. E., Maley, C. C., & Wilkinson, G. S. (2015) · Philosophical Transactions of the Royal Society B: Biological Sciences · doi:10.1098/rstb.2014.0219 · Cited by 466
Metadata
- Authors
- Dowsett, M., Nielsen, T. O., A'Hern, R., Bartlett, J., Coombes, R. C., Cuzick, J., Ellis, M., Henry, N. L., Hugh, J. C., Lively, T., McShane, L., Paik, S., Penault-Llorca, F., Prudkin, L., Regan, M., Salter, J., Sotiriou, C., Smith, I. E., Viale, G., Zujewski, J. A., & Hayes, D. F.
- Venue
- JNCI Journal of the National Cancer Institute
- Publisher
- Oxford University Press (OUP)
- Published
- 2011-09-29
- Volume
- 103
- Issue
- 22
- Pages
- 1656-1664
- ISSN
- 0027-8874 (ISSN-L)
- 1460-2105
- OpenAlex
- W2150134401
- Cited by
- 1,977
- References
- 2
- FWCI
- 34.45
- Type
- journal article
- Language
- en
- Open access
- bronze
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- Dowsett, M., Nielsen, T. O., A'Hern, R., Bartlett, J., Coombes, R. C., Cuzick, J., Ellis, M., Henry, N. L., Hugh, J. C., Lively, T., McShane, L., Paik, S., Penault-Llorca, F., Prudkin, L., Regan, M., Salter, J., Sotiriou, C., Smith, I. E., Viale, G., . . . Hayes, D. F. (2011). Assessment of Ki67 in Breast Cancer: Recommendations from the International Ki67 in Breast Cancer Working Group. JNCI Journal of the National Cancer Institute. https://doi.org/10.1093/jnci/djr393
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Bibliographic data: Semantic Scholar, OpenAlex, Crossref.
Contains information from the Semantic Scholar Academic Graph Datasets, made available under the ODC Attribution License (ODC-BY 1.0).
Semantic Scholar’s data is described in: Kinney, R., et al. (2023). The Semantic Scholar Open Data Platform. arXiv:2301.10140.