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Interpretive Handbook

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Test 89027:
Ki-67(MIB-1), Quantitative Immunohistochemistry, Automated

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

Ki-67(MIB-1 clone) is a monoclonal antibody that reacts with cells undergoing DNA synthesis by binding to the Ki-67 antigen, a marker known to be expressed only in proliferating cells. By measuring the amount of tumor cells expressing Ki-67, an estimate of DNA synthesis can be determined. Studies suggest that Ki-67(MIB-1) analysis of paraffin-embedded tissue specimens may provide useful prognostic information in various tumor types.

Useful For Suggests clinical disorders or settings where the test may be helpful

Determining proliferation of tumor cells in paraffin-embedded tissue blocks from patients diagnosed with breast or prostate carcinoma

Interpretation Provides information to assist in interpretation of the test results

Results will be reported as a percentage of tumor cells staining positive for Ki-67(MIB-1). Quantitative Ki-67(MIB-1) results should be interpreted within the clinical context for which the test was ordered. 

 

The scoring method using the Automated Cellular Imaging System III (ACIS  III) was developed and validated in the Molecular Anatomic Pathology Laboratory, Department of Laboratory Medicine and Pathology, Mayo Clinic (see Method Description).

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The paraffin block analyzed must be representative of the patient's tumor.

 

Test results should be interpreted in the context of clinical findings and other laboratory data.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Varies by tumor type; values reported from 0% to 100%

Clinical References Provides recommendations for further in-depth reading of a clinical nature

Prostate Cancer:

1. Cheng L, Pisansky TM, Sebo TJ, et al: Cell proliferation in prostate cancer patients with lymph node metastasis: a marker for progression. Clin Cancer Res 1999;5:2820-2823

2. Sebo TJ, Cheville JC, Riehle DL, et al: Perineural invasion and MIB-one positivity in addition to Gleason score are significant preoperative predictors of progression after radical retropubic prostatectomy for prostate cancer. Am J Surg Pathol 2002;26(4):431-439

3. Pollack A, DeSilvio M, Khor LY, et al: Ki-67 staining is a strong predictor of distant metastasis and mortality for men with prostate cancer treated with radiotherapy plus androgen deprivation: Radiation Therapy Oncology Group Trial 92-02. J Clin Oncol 2004;22:2133-2140

4. Berney DM, Gopalan A, Kudahetti S, et al: Ki-67 and outcome in clinically localized prostate cancer: analysis of conservatively treated prostate cancer patients from the Trans-Atlantic Prostate Group study. Br J Cancer 2009 Mar 24;100(6):888-893

 

Breast Cancer:

1. Urruticoechea A, Smith IE, Dowsett M. Proliferation marker Ki-67 in early breast cancer. J Clin Oncol 2005 Oct 1;23(28):7212-7220

2. de Azambuja E, Cardoso F, de Castro G Jr, et al: Ki-67 as prognostic marker in early breast cancer: a meta-analysis of published studies involving 12,155 patients. Br J Cancer 2007 May 21;96(10):1504-1513