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Ki-67 is a prognostic parameter in breast cancer patients: results of a large population-based cohort of a cancer registry

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      Abstract

      The proliferation marker Ki-67 is one of the most controversially discussed parameters for treatment decisions in breast cancer patients. The purpose of this study was to evaluate the routine use and value of Ki-67 as a prognostic marker, and to analyze the associations between Ki-67 and common histopathological parameters in the routine clinical setting. Data from the clinical cancer registry Regensburg (Bavaria, Germany) were analyzed. Within the total data pool of 4,692 female patients, who had been diagnosed between 2005 and 2011, in 3,658 cases Ki-67 was routinely determined. Thus, a total of 3,658 patients with invasive breast cancer were included in the present study and used for statistical analysis. Ki-67 expression was associated with the common histopathological parameters. The strongest correlation was found between grading and Ki-67 ( P < 0.001). In terms of survival analyses, Ki-67 was categorized into five categories (reference category Ki-67 ≤15 %) due to a nonlinear relationship to overall survival (OS). In multivariable analysis, Ki-67 was an independent prognostic parameter both for disease-free survival (DFS) (Ki-67 > 45 %, HR = 1.96, P = 0.001) as well as for OS (Ki-67: 26–35 %, HR = 1.71, P = 0.017; Ki-67: 36–45 %, HR = 2.05, P = 0.011; Ki-67 > 45 %, HR = 2.06, P = 0.002) independent of common clinical and histopathological factors. The 5-year DFS (OS) rate was 86.7 % (89.3 %) in patients with a Ki-67 value ≤15 % compared to 75.8 % (82.8 %) in patients with a Ki-67 value >45 %. Based on the data from a large cohort of a clinical cancer registry, it was demonstrated that Ki-67 is frequently determined in routine clinical work. Ki-67 expression is associated with common histopathological parameters, but is an additional independent prognostic parameter for DFS and OS in breast cancer patients. Future work should focus on standardization of Ki-67 assessment and specification of its role in treatment decisions.

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          A more accurate means of prognostication in breast cancer will improve the selection of patients for adjuvant systemic therapy. Using microarray analysis to evaluate our previously established 70-gene prognosis profile, we classified a series of 295 consecutive patients with primary breast carcinomas as having a gene-expression signature associated with either a poor prognosis or a good prognosis. All patients had stage I or II breast cancer and were younger than 53 years old; 151 had lymph-node-negative disease, and 144 had lymph-node-positive disease. We evaluated the predictive power of the prognosis profile using univariable and multivariable statistical analyses. Among the 295 patients, 180 had a poor-prognosis signature and 115 had a good-prognosis signature, and the mean (+/-SE) overall 10-year survival rates were 54.6+/-4.4 percent and 94.5+/-2.6 percent, respectively. At 10 years, the probability of remaining free of distant metastases was 50.6+/-4.5 percent in the group with a poor-prognosis signature and 85.2+/-4.3 percent in the group with a good-prognosis signature. The estimated hazard ratio for distant metastases in the group with a poor-prognosis signature, as compared with the group with the good-prognosis signature, was 5.1 (95 percent confidence interval, 2.9 to 9.0; P<0.001). This ratio remained significant when the groups were analyzed according to lymph-node status. Multivariable Cox regression analysis showed that the prognosis profile was a strong independent factor in predicting disease outcome. The gene-expression profile we studied is a more powerful predictor of the outcome of disease in young patients with breast cancer than standard systems based on clinical and histologic criteria. Copyright 2002 Massachusetts Medical Society
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            Author and article information

            Affiliations
            [ ]Department of Gynecology and Obstetrics, University of Regensburg, Caritas Krankenhaus St. Josef Regensburg, Landshuter Straße 65, 93053 Regensburg, Germany
            [ ]Tumor Center Regensburg e.V., University of Regensburg, Regensburg, Germany
            [ ]Institute of Pathology, University of Regensburg, Regensburg, Germany
            [ ]Center for Clinical Studies, University Hospital Regensburg, Regensburg, Germany
            Contributors
            +49-173-64-79-187 , elisabeth.inwald@klinik.uni-regensburg.de
            Journal
            Breast Cancer Res Treat
            Breast Cancer Res. Treat
            Breast Cancer Research and Treatment
            Springer US (Boston )
            0167-6806
            1573-7217
            16 May 2013
            16 May 2013
            June 2013
            : 139
            : 2
            : 539-552
            23674192
            3669503
            2560
            10.1007/s10549-013-2560-8
            © The Author(s) 2013

            Open AccessThis article is distributed under the terms of the Creative Commons Attribution Noncommercial License which permits any noncommercial use, distribution, and reproduction in any medium, provided the original author(s) and the source are credited.

            Categories
            Epidemiology
            Custom metadata
            © Springer Science+Business Media New York 2013

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