Document Detail

Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group.
MedLine Citation:
PMID:  21960707     Owner:  NLM     Status:  MEDLINE    
Uncontrolled proliferation is a hallmark of cancer. In breast cancer, immunohistochemical assessment of the proportion of cells staining for the nuclear antigen Ki67 has become the most widely used method for comparing proliferation between tumor samples. Potential uses include prognosis, prediction of relative responsiveness or resistance to chemotherapy or endocrine therapy, estimation of residual risk in patients on standard therapy and as a dynamic biomarker of treatment efficacy in samples taken before, during, and after neoadjuvant therapy, particularly neoadjuvant endocrine therapy. Increasingly, Ki67 is measured in these scenarios for clinical research, including as a primary efficacy endpoint for clinical trials, and sometimes for clinical management. At present, the enormous variation in analytical practice markedly limits the value of Ki67 in each of these contexts. On March 12, 2010, an international panel of investigators with substantial expertise in the assessment of Ki67 and in the development of biomarker guidelines was convened in London by the co-chairs of the Breast International Group and North American Breast Cancer Group Biomarker Working Party to consider evidence for potential applications. Comprehensive recommendations on preanalytical and analytical assessment, and interpretation and scoring of Ki67 were formulated based on current evidence. These recommendations are geared toward achieving a harmonized methodology, create greater between-laboratory and between-study comparability, and allow earlier valid applications of this marker in clinical practice.
Mitch Dowsett; Torsten O Nielsen; Roger A'Hern; John Bartlett; R Charles Coombes; Jack Cuzick; Matthew Ellis; N Lynn Henry; Judith C Hugh; Tracy Lively; Lisa McShane; Soon Paik; Frederique Penault-Llorca; Ljudmila Prudkin; Meredith Regan; Janine Salter; Christos Sotiriou; Ian E Smith; Giuseppe Viale; Jo Anne Zujewski; Daniel F Hayes;
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Publication Detail:
Type:  Journal Article; Practice Guideline; Research Support, Non-U.S. Gov't     Date:  2011-09-29
Journal Detail:
Title:  Journal of the National Cancer Institute     Volume:  103     ISSN:  1460-2105     ISO Abbreviation:  J. Natl. Cancer Inst.     Publication Date:  2011 Nov 
Date Detail:
Created Date:  2011-11-17     Completed Date:  2012-01-09     Revised Date:  2013-06-27    
Medline Journal Info:
Nlm Unique ID:  7503089     Medline TA:  J Natl Cancer Inst     Country:  United States    
Other Details:
Languages:  eng     Pagination:  1656-64     Citation Subset:  IM    
Department of Biochemistry, Royal Marsden Hospital and Breakthrough Breast Cancer Centre, Fulham Road, London, UK.
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MeSH Terms
Antineoplastic Agents, Hormonal / therapeutic use
Antineoplastic Combined Chemotherapy Protocols / therapeutic use*
Breast Neoplasms / chemistry*,  drug therapy*,  surgery
Chemotherapy, Adjuvant
Clinical Trials as Topic / methods
Ki-67 Antigen / analysis*
Neoadjuvant Therapy / methods
Predictive Value of Tests
Protein Array Analysis
Reproducibility of Results
Tumor Markers, Biological / analysis*
Grant Support
//Cancer Research UK
Reg. No./Substance:
0/Antineoplastic Agents, Hormonal; 0/Ki-67 Antigen; 0/Tumor Markers, Biological

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