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Evaluation of an Optimal Cut-Off Point for the Ki-67 Index as a Prognostic Factor in Primary Breast Cancer: A Retrospective Study

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Listed:
  • Rumiko Tashima
  • Reiki Nishimura
  • Tomofumi Osako
  • Yasuyuki Nishiyama
  • Yasuhiro Okumura
  • Masahiro Nakano
  • Mamiko Fujisue
  • Yasuo Toyozumi
  • Nobuyuki Arima

Abstract

The Ki-67 index is an important biomarker for indicating the proliferation of cancer cells and is considered to be an effective prognostic factor for breast cancer. However, a standard cut-off point for the Ki-67 index has not yet been established. Therefore, the aim of this retrospective study was to determine an optimal cut-off point in order to establish it as a more accurate prognostic factor. Immunohistochemical analysis of the Ki-67 index was performed on 4329 patients with primary breast cancer from August 1987 to March 2012. Out of this sample, there were 3186 consecutive cases from September 1997 with simultaneous evaluations of ER, PgR and HER2 status. Cox's proportional hazard model was used to perform univariate and multivariate analyses of the factors related to OS. The hazard ratios (HR) and the p values were then compared to determine the optimal cut-off point for the Ki-67 index. The median Ki-67 index value was 20.5% (mean value 26.2%). The univariate analysis revealed that there was a statistically significant negative correlation with DFS and OS and the multivariate analysis revealed that the Ki-67 index value was a significant factor for DFS and OS. The top seven cut-off points were then carefully chosen based on the results of the univariate analysis using the lowest p-values and the highest HR as the main selection criteria. The multivariate analysis of the factors for OS showed that the cut-off point of 20% had the highest HR in all of the cases. However, the cutoff point of 20% was only a significant factor for OS in the Luminal/HER2- subtype. There was no correlation between the Ki-67 index value and OS in any of the other subtypes. These data indicate that the optimal cut-off point of 20% is the most effective prognostic factor for Luminal/HER2- breast cancer.

Suggested Citation

  • Rumiko Tashima & Reiki Nishimura & Tomofumi Osako & Yasuyuki Nishiyama & Yasuhiro Okumura & Masahiro Nakano & Mamiko Fujisue & Yasuo Toyozumi & Nobuyuki Arima, 2015. "Evaluation of an Optimal Cut-Off Point for the Ki-67 Index as a Prognostic Factor in Primary Breast Cancer: A Retrospective Study," PLOS ONE, Public Library of Science, vol. 10(7), pages 1-10, July.
    • Handle: RePEc:plo:pone00:0119565
    DOI: 10.1371/journal.pone.0119565
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    References listed on IDEAS

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    1. Peng Gong & Yingxin Wang & Gavin Liu & Jing Zhang & Zhongyu Wang, 2013. "New Insight into Ki67 Expression at the Invasive Front in Breast Cancer," PLOS ONE, Public Library of Science, vol. 8(1), pages 1-5, January.
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    1. Yunbao Pan & Yufen Yuan & Guoshi Liu & Yongchang Wei, 2017. "P53 and Ki-67 as prognostic markers in triple-negative breast cancer patients," PLOS ONE, Public Library of Science, vol. 12(2), pages 1-13, February.

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