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An international Ki67 reproducibility study.

Mei-Yin C Polley1, Samuel C Y Leung, Lisa M McShane

  • 1Affiliations of authors: Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD (MCP, LMM); Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada (SCYL, DG, EM, TON); Department of Laboratory Medicine and Pathology, University of Alberta, Alberta, Canada (JCH); Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy (MGM); Division of Pathology and Laboratory Medicine, European Institute of Oncology, and University of Milan, Milan, Italy (GV); Breakthrough Breast Cancer Research Centre, The Institute of Cancer Research, London, United Kingdom (LAZ); Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, and Université d'Auvergne, France (FP-L); Transformative Pathology, Ontario Institute for Cancer Research, Toronto, Ontario, Canada (JMSB); PhenoPath Laboratories, Seattle, WA (AMG); Department of Pathology, MD Anderson Cancer Center, Houston, TX (WFS); Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, United Kingdom (TP); The EMMES Corporation, Rockville, MD (RAE); Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI (DFH); Academic Department of Biochemistry, Royal Marsden Hospital, London, United Kingdom (MD); on behalf of the International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group.

Journal of the National Cancer Institute
|November 9, 2013
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Summary
This summary is machine-generated.

This study found moderate reproducibility in Ki67 breast cancer scoring between laboratories, highlighting the need for standardized methods. Harmonizing Ki67 analysis is crucial for reliable clinical decision-making.

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Area of Science:

  • Oncology
  • Pathology
  • Biostatistics

Background:

  • Immunohistochemical Ki67 assessment is vital for breast cancer research and clinical management.
  • Inconsistent Ki67 scoring across laboratories limits its clinical utility.
  • A working group aimed to harmonize Ki67 analysis and improve scoring concordance.

Purpose of the Study:

  • To evaluate the reproducibility of Ki67 scoring among experienced breast cancer laboratories.
  • To identify factors contributing to variability in Ki67 assessment.

Main Methods:

  • Eight laboratories scored 100 breast cancer cases using tissue microarrays.
  • Both centrally and locally stained samples were analyzed.
  • Intraclass correlation coefficients (ICC) quantified reproducibility, with random effects models analyzing sources of variation.

Main Results:

  • High intralaboratory reproducibility (ICC=0.94) was observed.
  • Moderate interlaboratory reproducibility was found (central staining ICC=0.71, local staining ICC=0.59).
  • Tumor region selection, counting methods, and subjective assessment contributed to discordance; formal counting improved consistency.

Conclusions:

  • Significant Ki67 scoring variability exists even among expert laboratories.
  • Standardizing Ki67 scoring methodology is essential for analytical validity and reliable clinical decision-making.
  • Current Ki67 values and cutoffs are not directly transferable between laboratories.