© 1999 by Oxford University Press
Journal of the National Cancer Institute, Vol. 91, No. 3, 271-278,
February 3, 1999
© 1999 Oxford University Press
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Immunologic Proliferation Marker Ki-S2 as Prognostic Indicator for Lymph Node-Negative Breast Cancer
Affiliations of authors: P. Rudolph, H.-J. Heidebrecht, H. Bolte, V. Ratjen, P. Parwaresch, Department of Pathology and Lymph Node Registry, German Association of Pathologists, University of Kiel, Germany; P. Alm, B. Baldetorp, M. Fernö, H. Olsson, South Swedish Breast Cancer Group, Departments of Pathology and Oncology, University Hospital, Lund, Sweden.
Correspondence to: Pierre Rudolph, M.D., Department of Pathology, University of Kiel, Michaelisstr. 11, 24105 Kiel, Germany (e-mail: prudolph{at}path.uni-kiel.de).
BACKGROUND: Proper treatment of lymph node-negative breast cancer depends on an accurate prognosis. To improve prognostic models for this disease, we evaluated whether an immunohistochemical marker for proliferating cells, Ki-S2 (a monoclonal antibody that binds to a 100-kd nuclear protein expressed in S, G2, and M phases of the cell cycle), is an accurate indicator of prognosis. METHODS: We studied 371 Swedish women with lymph node-negative breast cancer; the median follow-up time was 95 months. The fraction of tumor cells in S phase was assessed by flow cytometry, and tumor cell proliferation was measured immunohistochemically with the monoclonal antibodies Ki-S2 and Ki-S5 (directed against the nuclear antigen Ki-67). A combined prognostic index was calculated on the basis of the S-phase fraction, progesterone receptor content, and tumor size. RESULTS: In multivariate analyses that did or did not (263 and 332 observations, respectively) include the S-phase fraction and the combined prognostic index, the Ki-S2 labeling index (percentage of antibody-stained tumor cell nuclei) emerged as the most statistically significant predictor of overall survival, disease-specific survival, and disease-free survival (all two-sided P<.0001). In the risk group defined by a Ki-S2 labeling index of 10% or less, life expectancy was not statistically significantly different from that of age-matched women without breast cancer, whereas the group with a high Ki-S2 labeling index had an increased risk of mortality of up to 20-fold. CONCLUSIONS: Cellular proliferation is a major determinant of the biologic behavior of breast cancer. Prognosis is apparently best indicated by the percentage of cells in S through M phases of the cell cycle. Measurement of the Ki-S2 labeling index of a tumor sample may improve a clinician's ability to make an accurate prognosis and to identify patients with a low risk of recurrence who may not need adjuvant therapy.
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