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01-01-2016 | Original Article

Assessment of the Ki67 labeling index: a Japanese validation ring study

Authors: Naoki Niikura, Takashi Sakatani, Nobuyuki Arima, Yasuyo Ohi, Naoko Honma, Naoki Kanomata, Kazuya Yoshida, Takayuki Kadoya, Kentaro Tamaki, Nobue Kumaki, Takayuki Iwamoto, Tomoharu Sugie, Takuya Moriya

Published in: Breast Cancer | Issue 1/2016

Abstract

Background

A lack of consistent methods to evaluate Ki67 expression is problematic in terms of accurately predicting prognosis in breast cancer. Accordingly, this study aimed to identify the causes of discrepancies in Ki67 labeling index measurements by different observers under different conditions using breast cancer samples.

Patients and methods

This Japanese study group compared and assessed immunohistochemical (IHC) analysis of the Ki67 labeling index when measured by different pathologists. Six pathologists (pathologists A–F) in Japan participated in this ring study. One hundred and ten surgical cases of estrogen receptor-positive and human epidermal growth factor receptor 2-negative invasive breast cancer treated in 2007 were identified from the breast cancer database of Tokai University Hospital and were included in this study.

Results

For all 6 pathologists, the Ki67 labeling index were significantly different between grade 3 and grade 1 cases and between grade 3 and grade 2 cases, whereas the index tended to be different between grade 1 and grade 2 cases. Further, the Ki67 labeling indexes measured by the 6 pathologists were strongly correlated (ρ: 0.73–0.88). The IHC scores recorded by pathologist A were in moderate to good agreement with those recorded by the others in patients with a Ki67 labeling index of <13.25 % and in those with a Ki67 labeling index of >13.25 % (κ = 0.429–0.660). The Ki67 low and high concordance rates between pathologist A and the others were 0.452–0.778 and 0.862–0.979, respectively. The most pertinent reason for discrepancy in scores seemed to be the selection of the area for counting and the quality of nuclear staining.

Conclusion

The Ki67 labeling index measured by 6 pathologists without method standardization was in fair to good agreement. We plan to undertake a second ring study, pending recommendations by the international Ki67 panel.

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Title: Assessment of the Ki67 labeling index: a Japanese validation ring study
Authors: Naoki Niikura
Takashi Sakatani
Nobuyuki Arima
Yasuyo Ohi
Naoko Honma
Naoki Kanomata
Kazuya Yoshida
Takayuki Kadoya
Kentaro Tamaki
Nobue Kumaki
Takayuki Iwamoto
Tomoharu Sugie
Takuya Moriya
Publication date: 01-01-2016
Publisher: Springer Japan
Published in: Breast Cancer / Issue 1/2016
Print ISSN: 1340-6868
Electronic ISSN: 1880-4233
DOI: https://doi.org/10.1007/s12282-014-0536-0

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Abstract

Background

Patients and methods

Results

Conclusion

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