Ki-67 immunostaining in human breast tumors and its relationship to prognosis

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Abstract
Ki‐67 labeling was quantified in 37 nonmalignant breast tissues and in 63 breast carcinomas by counting ten random high‐power fields each in three section planes (RC) or by evaluation of the area with the highest labeling density (HDC). Both procedures proved to be highly correlated (rs = 0.94). Ki‐67‐positive fractions of the nonmalignant tissues (mean, 2.1% for RC and 4.1% for HDC) were significantly lower as compared with the carcinomas (mean, 14.5% for RC and 17.5% for HDC). In carcinomas the Ki‐67 labeling was significantly associated with pT stage, axillary lymph node status, and tumor grading and inversely related to progesterone receptor status. Using the medians of both counting methods (12% for RC and 17% for HDC) as cutoff points, significantly different curves for overall and disease‐free survival (median follow‐up, 37 months) were obtained. However, Cox multivariate analysis failed to demonstrate an independent effect of Ki‐67 labeling. In contrast, Ki‐67 reactivity seems to be of independent prognostic value if a higher cutoff level was selected.

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