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. 2016 Jun;157(2):363-371.
doi: 10.1007/s10549-016-3817-9. Epub 2016 May 7.

Optimal Ki67 cut-off for luminal breast cancer prognostic evaluation: a large case series study with a long-term follow-up

Sara Bustreo  1 , Simona Osella-Abate  2 , Paola Cassoni  2 , Michela Donadio  1 , Mario Airoldi  3 , Fulvia Pedani  3 , Mauro Papotti  4 , Anna Sapino  2   5 , Isabella Castellano  6
Affiliations

Optimal Ki67 cut-off for luminal breast cancer prognostic evaluation: a large case series study with a long-term follow-up

Sara Bustreo et al. Breast Cancer Res Treat. 2016 Jun.

Abstract

Although Ki67 index suffers from poor reproducibility, it is one of the most important prognostic markers used by oncologists to select the treatment of estrogen receptor (ER) positive breast cancer patients. In this study, we aim to establish the optimal Ki67 cut-offs for stratifying patient prognosis and to create a comprehensive prognostic index for clinical applications. A mono-institutional cohort of 1.577 human epidermal growth factor receptor 2 negative/ER+ breast cancer patients having complete clinical, histological, and follow-up data was collected. The 14 and 20 % Ki67 cut-offs were correlated to disease-free interval (DFI) and disease-specific survival (DSS). To create a comprehensive prognostic index, we used independent variables selected by uni/multivariate analyses. In terms of DFI and DSS, patients bearing tumors with Ki67 < 14 % proliferation index did not differ from those with Ki67 values between 14 and 20 %. Patients with tumor with Ki67 > 20 % showed the poorest prognosis. Moreover, to tumor size, the number of metastatic lymph nodes and Ki67 > 20 % was given a score value, varying depending on definite cut-offs and used to create a prognostic index, which was applied to the population. Patients with a prognostic index ≥3 were characterized by significant risk of relapse [DFI: Hazard Ratio (HR) = 4.74, p < 0.001] and death (DSS: HR = 5.03, p < 0.001). We confirm that the 20 % Ki67 cut-off is the best to stratify high-risk patients in luminal breast cancers, and we suggest to integrate it with other prognostic factors, to better stratify patients at risk of adverse outcome.

Keywords: Ki67 cut-offs; Luminal breast cancer; Prognostic index; Relapse.

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Figures

Fig. 1
Fig. 1
DFI and DSS in low, intermediate, and high Ki67 patients
Fig. 2
Fig. 2
DFI and DSS in patients stratified on the basis of good (<3) or poor (≥3) score
Fig. 3
Fig. 3
DFI and DSS in patients with good score (<3) stratified on the basis of therapy
Fig. 4
Fig. 4
DFI and DSS in patients with poor score (≥3) stratified on the basis of therapy
See this image and copyright information in PMC

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