An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer

Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc
David L RimmMitch Dowsett

Abstract

The nuclear proliferation biomarker Ki67 has potential prognostic, predictive, and monitoring roles in breast cancer. Unacceptable between-laboratory variability has limited its clinical value. The International Ki67 in Breast Cancer Working Group investigated whether Ki67 immunohistochemistry can be analytically validated and standardized across laboratories using automated machine-based scoring. Sets of pre-stained core-cut biopsy sections of 30 breast tumors were circulated to 14 laboratories for scanning and automated assessment of the average and maximum percentage of tumor cells positive for Ki67. Seven unique scanners and 10 software platforms were involved in this study. Pre-specified analyses included evaluation of reproducibility between all laboratories (primary) as well as among those using scanners from a single vendor (secondary). The primary reproducibility metric was intraclass correlation coefficient between laboratories, with success considered to be intraclass correlation coefficient >0.80. Intraclass correlation coefficient for automated average scores across 16 operators was 0.83 (95% credible interval: 0.73-0.91) and intraclass correlation coefficient for maximum scores across 10 operators was 0.63 (95% cr...Continue Reading

References

Feb 16, 2010·The Lancet Oncology·Rinat YerushalmiKaren A Gelmon
Oct 1, 2011·Journal of the National Cancer Institute·Mitch DowsettUNKNOWN International Ki-67 in Breast Cancer Working Group
Jul 13, 2012·Scientific Reports·Stephan WienertFrederick Klauschen
Mar 1, 2013·Diagnostic Pathology·Stephan WienertFrederick Klauschen
Nov 6, 2013·Laboratory Investigation; a Journal of Technical Methods and Pathology·Jason R BrownDavid L Rimm
Nov 10, 2013·Journal of the National Cancer Institute·Mei-Yin C PolleyUNKNOWN International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group
Dec 17, 2014·Clinical Cancer Research : an Official Journal of the American Association for Cancer Research·Frederick KlauschenGunter von Minckwitz
Feb 24, 2015·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Mei-Yin C PolleyTorsten O Nielsen
Feb 10, 2016·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Lyndsay N HarrisUNKNOWN American Society of Clinical Oncology

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Citations

Feb 16, 2019·The Journal of Pathology. Clinical Research·Robert PellUNKNOWN UK National Cancer Research Institute (NCRI) Cellular-Molecular Pathology (CM-Path) quality assurance working group
Jan 14, 2020·Journal of Clinical Oncology : Official Journal of the American Society of Clinical Oncology·Kimberly H AllisonAntonio C Wolff
May 30, 2020·Advances in Anatomic Pathology·Toby C Cornish
Dec 5, 2019·Journal of Clinical Pathology·Yeh-Han WangChih-Yi Hsu
Aug 16, 2019·European Radiology Experimental·Alberto Stefano TagliaficoNehmat Houssami
Mar 5, 2020·Journal of Internal Medicine·B AcsJ Hartman
Apr 25, 2019·Histopathology·Samuel C Y LeungUNKNOWN International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group (
Jun 24, 2020·Breast Cancer Research and Treatment·Stephanie RobertsonJohan Hartman
Apr 29, 2020·The Breast Journal·Martin C Chang, Miralem Mrkonjic
Jun 20, 2019·Frontiers in Oncology·Nawale HajjajiJacques Bonneterre
Aug 3, 2020·Modern Pathology : an Official Journal of the United States and Canadian Academy of Pathology, Inc·Swikrity Upadhyay BaskotaRohit Bhargava
Dec 29, 2020·Journal of the National Cancer Institute·Torsten O NielsenDaniel F Hayes
Dec 29, 2020·Journal of the National Cancer Institute·Jorge S Reis-Filho, Nancy E Davidson
Feb 10, 2021·Applied Immunohistochemistry & Molecular Morphology : AIMM·Regan Fulton
Apr 26, 2021·The American Journal of Pathology·Arvydas LaurinaviciusRichard Levenson

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Methods Mentioned

BETA
biopsy
biopsies

Software Mentioned

Virtuoso
Ariol
Excel
CellVigene
lme4
Definiens Tissue Studio
Brightfield ToolBox
R
Aperio ePathology
Aperio

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