Abstract

BackgroundThe Ki67 labeling index (LI) is regarded as a significant prognostic marker in ER-positive/HER2-negative breast cancer patients. The expression of PgR has recently been identified as another prognostic marker. In the present study, we investigated the prognostic utilities and most suitable cut-off values for Ki67 and PgR, and evaluated the relationship between Ki67 LI and PgR expression in ER-positive/HER2-negative breast cancer.Patients and methodsIn the present study, 177 consecutive Japanese women with ER-positive/HER2-negative invasive carcinoma of no special type who were treated between 2000 and 2001 were enrolled. Recurrence-free survival (RFS) and cancer-specific survival (CSS) were analyzed according to Ki67 LI and PgR expression, and significant cut-off values for selecting patients with a poor prognosis were evaluated.ResultsThe cut-off values for Ki67 LI as a prognostic marker plotted against P values showed bimodal peaks at 10% and 30%. Among the cut-off points examined for the PgR status, 20% PgR positivity was the most significant for predicting survival differences (RFS: P = 0.0003; CSS: P < 0.0001). A multivariate analysis showed that PgR (≥20%) was an independent prognostic marker (RFS: P = 0.0092; CSS: P = 0.00014). Furthermore, in the intermediate risk group with Ki67 LI of 10–30%, the low PgR <20% group had a markedly poorer prognosis for RFS and CSS (RFS: P < 0.0001; CSS: P < 0.0001).ConclusionsThe expression of PgR is a potent prognostic indicator for evaluating the long-term prognosis of ER-positive/HER2-negative breast cancer, and the most suitable cut-off value was found to be 20%. Furthermore, the PgR status is a powerful method for selecting patients with a poor prognosis among ER-positive/HER2-negative patients at intermediate risk, as assessed using Ki67 LI.

Highlights

  • The Ki67 labeling index (LI) is regarded as a significant prognostic marker in Estrogen receptor (ER)-positive/Human epidermal growth factor receptor 2 (HER2)-negative breast cancer patients

  • The cut-off values for Ki67 LI as a prognostic marker plotted against P values showed bimodal peaks at 10% and 30%

  • A multivariate analysis showed that Progesterone receptor (PgR) (≥20%) was an independent prognostic marker (RFS: P = 0.0092; cancer-specific survival (CSS): P = 0.00014)

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Summary

Introduction

The Ki67 labeling index (LI) is regarded as a significant prognostic marker in ER-positive/HER2-negative breast cancer patients. Prat et al reported that an empiric cut-off of more than 20% of PgR-positive tumor cells was statistically proven to be significant for predicting survival differences within luminal-type breast cancer defined by their molecular classification. They concluded that the new definition of the luminal A-like type was ER-positive/HER2negative/Ki67 LI less than 14%/PgR more than 20% [18]. PgR may be a useful indicator for classifying ER-positive/HER2-negative breast cancer between the luminal A-like subtype and B-like subtype [19]

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