Early breast carcinoma is defined as pathological stage 1 (pT1N0M0) tumour and its incidence has recently increased possibly due to the advent of mammography based mass screening. Overall survival of these patients is in general excellent, but more than 20% of them will eventually develop distant metastasis and die. Therefore, an establishment of prognostic factors could contribute greatly to determining the algorithm for treating these patients after surgery. Histopathological prognostic factors still play pivotal roles in the management of these patients. Among these, Nottingham histological grade is considered the gold standard for determining the clinical outcome of early breast cancer patients if done in optimally processed tissue specimens by well-trained pathologists. Among these histological factors of Nottingham histological grade, mitotic index has been demonstrated to provide the most significant information as to prognosis of these patients. Attempts have been made to assess the status of tumour cell proliferation in practical, reproducible and accurate manners in the past. Among these attempts, immunohistochemical analysis of cell cycle associated nuclear antigens, especially Ki67/MIB1 labelling index in archival materials, has been reported to provide clinically inert and significant information. However, its methodologies, including processing of the specimens, and modes of interpretation should be standardised before this Ki67/MIB1 labelling index can become incorporated into routine clinical practice in the management of early breast carcinoma patients.
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