An International Ki67 Reproducibility Study
In breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67's value. A working group was assembled to devise a strategy to harmonize Ki67 ana...
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| Published in | JNCI : Journal of the National Cancer Institute Vol. 105; no. 24; pp. 1897 - 1906 |
|---|---|
| Main Authors | , , , , , , , , , , , , , , , , , |
| Format | Journal Article |
| Language | English |
| Published |
Cary, NC
Oxford University Press
18.12.2013
Oxford Publishing Limited (England) |
| Subjects | |
| Online Access | Get full text |
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| Abstract | In breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67's value. A working group was assembled to devise a strategy to harmonize Ki67 analysis and increase scoring concordance. Toward that goal, we conducted a Ki67 reproducibility study.
Eight laboratories received 100 breast cancer cases arranged into 1-mm core tissue microarrays-one set stained by the participating laboratory and one set stained by the central laboratory, both using antibody MIB-1. Each laboratory scored Ki67 as percentage of positively stained invasive tumor cells using its own method. Six laboratories repeated scoring of 50 locally stained cases on 3 different days. Sources of variation were analyzed using random effects models with log2-transformed measurements. Reproducibility was quantified by intraclass correlation coefficient (ICC), and the approximate two-sided 95% confidence intervals (CIs) for the true intraclass correlation coefficients in these experiments were provided.
Intralaboratory reproducibility was high (ICC = 0.94; 95% CI = 0.93 to 0.97). Interlaboratory reproducibility was only moderate (central staining: ICC = 0.71, 95% CI = 0.47 to 0.78; local staining: ICC = 0.59, 95% CI = 0.37 to 0.68). Geometric mean of Ki67 values for each laboratory across the 100 cases ranged 7.1% to 23.9% with central staining and 6.1% to 30.1% with local staining. Factors contributing to interlaboratory discordance included tumor region selection, counting method, and subjective assessment of staining positivity. Formal counting methods gave more consistent results than visual estimation.
Substantial variability in Ki67 scoring was observed among some of the world's most experienced laboratories. Ki67 values and cutoffs for clinical decision-making cannot be transferred between laboratories without standardizing scoring methodology because analytical validity is limited. |
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| AbstractList | In breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67's value. A working group was assembled to devise a strategy to harmonize Ki67 analysis and increase scoring concordance. Toward that goal, we conducted a Ki67 reproducibility study.
Eight laboratories received 100 breast cancer cases arranged into 1-mm core tissue microarrays-one set stained by the participating laboratory and one set stained by the central laboratory, both using antibody MIB-1. Each laboratory scored Ki67 as percentage of positively stained invasive tumor cells using its own method. Six laboratories repeated scoring of 50 locally stained cases on 3 different days. Sources of variation were analyzed using random effects models with log2-transformed measurements. Reproducibility was quantified by intraclass correlation coefficient (ICC), and the approximate two-sided 95% confidence intervals (CIs) for the true intraclass correlation coefficients in these experiments were provided.
Intralaboratory reproducibility was high (ICC = 0.94; 95% CI = 0.93 to 0.97). Interlaboratory reproducibility was only moderate (central staining: ICC = 0.71, 95% CI = 0.47 to 0.78; local staining: ICC = 0.59, 95% CI = 0.37 to 0.68). Geometric mean of Ki67 values for each laboratory across the 100 cases ranged 7.1% to 23.9% with central staining and 6.1% to 30.1% with local staining. Factors contributing to interlaboratory discordance included tumor region selection, counting method, and subjective assessment of staining positivity. Formal counting methods gave more consistent results than visual estimation.
Substantial variability in Ki67 scoring was observed among some of the world's most experienced laboratories. Ki67 values and cutoffs for clinical decision-making cannot be transferred between laboratories without standardizing scoring methodology because analytical validity is limited. BACKGROUNDIn breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67's value. A working group was assembled to devise a strategy to harmonize Ki67 analysis and increase scoring concordance. Toward that goal, we conducted a Ki67 reproducibility study.METHODSEight laboratories received 100 breast cancer cases arranged into 1-mm core tissue microarrays-one set stained by the participating laboratory and one set stained by the central laboratory, both using antibody MIB-1. Each laboratory scored Ki67 as percentage of positively stained invasive tumor cells using its own method. Six laboratories repeated scoring of 50 locally stained cases on 3 different days. Sources of variation were analyzed using random effects models with log2-transformed measurements. Reproducibility was quantified by intraclass correlation coefficient (ICC), and the approximate two-sided 95% confidence intervals (CIs) for the true intraclass correlation coefficients in these experiments were provided.RESULTSIntralaboratory reproducibility was high (ICC = 0.94; 95% CI = 0.93 to 0.97). Interlaboratory reproducibility was only moderate (central staining: ICC = 0.71, 95% CI = 0.47 to 0.78; local staining: ICC = 0.59, 95% CI = 0.37 to 0.68). Geometric mean of Ki67 values for each laboratory across the 100 cases ranged 7.1% to 23.9% with central staining and 6.1% to 30.1% with local staining. Factors contributing to interlaboratory discordance included tumor region selection, counting method, and subjective assessment of staining positivity. Formal counting methods gave more consistent results than visual estimation.CONCLUSIONSSubstantial variability in Ki67 scoring was observed among some of the world's most experienced laboratories. Ki67 values and cutoffs for clinical decision-making cannot be transferred between laboratories without standardizing scoring methodology because analytical validity is limited. In breast cancer, immunohistochemical assessment of proliferation using the marker Ki67 has potential use in both research and clinical management. However, lack of consistency across laboratories has limited Ki67's value. A working group was assembled to devise a strategy to harmonize Ki67 analysis and increase scoring concordance. Toward that goal, we conducted a Ki67 reproducibility study. Eight laboratories received 100 breast cancer cases arranged into 1-mm core tissue microarrays-one set stained by the participating laboratory and one set stained by the central laboratory, both using antibody MIB-1. Each laboratory scored Ki67 as percentage of positively stained invasive tumor cells using its own method. Six laboratories repeated scoring of 50 locally stained cases on 3 different days. Sources of variation were analyzed using random effects models with log2-transformed measurements. Reproducibility was quantified by intraclass correlation coefficient (ICC), and the approximate two-sided 95% confidence intervals (CIs) for the true intraclass correlation coefficients in these experiments were provided. Intralaboratory reproducibility was high (ICC = 0.94; 95% CI = 0.93 to 0.97). Interlaboratory reproducibility was only moderate (central staining: ICC = 0.71, 95% CI = 0.47 to 0.78; local staining: ICC = 0.59, 95% CI = 0.37 to 0.68). Geometric mean of Ki67 values for each laboratory across the 100 cases ranged 7.1% to 23.9% with central staining and 6.1% to 30.1% with local staining. Factors contributing to interlaboratory discordance included tumor region selection, counting method, and subjective assessment of staining positivity. Formal counting methods gave more consistent results than visual estimation. Substantial variability in Ki67 scoring was observed among some of the world's most experienced laboratories. Ki67 values and cutoffs for clinical decision-making cannot be transferred between laboratories without standardizing scoring methodology because analytical validity is limited. |
| Author | PENAULT-LLORCA, Frédérique HAYES, Daniel F BARTLETT, John M. S GOWN, Allen M PIPER, Tammy VIALE, Giuseppe ENOS, Rebecca A SYMMANS, W. Fraser DONGXIA GAO HUGH, Judith C DOWSETT, Mitch NIELSEN, Torsten O LEUNG, Samuel C. Y MASTROPASQUA, Mauro G McSHANE, Lisa M POLLEY, Mei-Yin C MEHL, Erika ZABAGLO, Lila A |
| Author_xml | – sequence: 1 givenname: Mei-Yin C surname: POLLEY fullname: POLLEY, Mei-Yin C organization: Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, United States – sequence: 2 givenname: Samuel C. Y surname: LEUNG fullname: LEUNG, Samuel C. Y organization: Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 3 givenname: Allen M surname: GOWN fullname: GOWN, Allen M organization: PhenoPath Laboratories, Seattle, WA, United States – sequence: 4 givenname: W. Fraser surname: SYMMANS fullname: SYMMANS, W. Fraser organization: Department of Pathology, MD Anderson Cancer Center, Houston, TX, United States – sequence: 5 givenname: Tammy surname: PIPER fullname: PIPER, Tammy organization: Edinburgh Cancer Research Centre, Western General Hospital, Edinburgh, United Kingdom – sequence: 6 givenname: Erika surname: MEHL fullname: MEHL, Erika organization: Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 7 givenname: Rebecca A surname: ENOS fullname: ENOS, Rebecca A organization: The EMMES Corporation, Rockville, MD, United States – sequence: 8 givenname: Daniel F surname: HAYES fullname: HAYES, Daniel F organization: Breast Oncology Program, University of Michigan Comprehensive Cancer Center, Ann Arbor, MI, United States – sequence: 9 givenname: Mitch surname: DOWSETT fullname: DOWSETT, Mitch organization: Academic Department of Biochemistry, Royal Marsden Hospital, London, United Kingdom – sequence: 10 givenname: Torsten O surname: NIELSEN fullname: NIELSEN, Torsten O organization: Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 11 givenname: Lisa M surname: McSHANE fullname: McSHANE, Lisa M organization: Biometric Research Branch, Division of Cancer Treatment and Diagnosis, National Cancer Institute, Bethesda, MD, United States – sequence: 12 surname: DONGXIA GAO fullname: DONGXIA GAO organization: Pathology and Laboratory Medicine, University of British Columbia, Vancouver, British Columbia, Canada – sequence: 13 givenname: Judith C surname: HUGH fullname: HUGH, Judith C organization: Department of Laboratory Medicine and Pathology, University of Alberta, Alberta, Canada – sequence: 14 givenname: Mauro G surname: MASTROPASQUA fullname: MASTROPASQUA, Mauro G organization: Division of Pathology and Laboratory Medicine, European Institute of Oncology, Milan, Italy – sequence: 15 givenname: Giuseppe surname: VIALE fullname: VIALE, Giuseppe organization: Division of Pathology and Laboratory Medicine, European Institute of Oncology, and University of Milan, Milan, Italy – sequence: 16 givenname: Lila A surname: ZABAGLO fullname: ZABAGLO, Lila A organization: Breakthrough Breast Cancer Research Centre, The Institute of Cancer Research, London, United Kingdom – sequence: 17 givenname: Frédérique surname: PENAULT-LLORCA fullname: PENAULT-LLORCA, Frédérique organization: Department of Pathology, Centre Jean Perrin, Clermont-Ferrand, France – sequence: 18 givenname: John M. S surname: BARTLETT fullname: BARTLETT, John M. S organization: Transformative Pathology, Ontario Institute for Cancer Research, Toronto, Ontario, Canada |
| BackLink | http://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=28150249$$DView record in Pascal Francis https://www.ncbi.nlm.nih.gov/pubmed/24203987$$D View this record in MEDLINE/PubMed |
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| CODEN | JNCIEQ |
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| References | Viale ( key 20170520235959_CIT0004) 2008; 26 Harris ( key 20170520235959_CIT0010) 2007; 25 Remes ( key 20170520235959_CIT0030) 2012; 36 Tang ( key 20170520235959_CIT0031) 2012; 36 Carlson ( key 20170520235959_CIT0018) 2011; 9 Konsti ( key 20170520235959_CIT0026) 2011; 25 Rabe-Hesketh ( key 20170520235959_CIT0013) 2008 Bates ( key 20170520235959_CIT0017) 2011 Dowsett ( key 20170520235959_CIT0001) 2011; 103 Kirkegaard ( key 20170520235959_CIT0022) 2006; 48 Murray ( key 20170520235959_CIT0008) 2009; 114 Freedman ( key 20170520235959_CIT0007) 2010; 119 Bland ( key 20170520235959_CIT0012) 1986; 1 R Foundation for Statistical Computing ( key 20170520235959_CIT0016) 2011 Stuart-Harris ( key 20170520235959_CIT0023) 2008; 17 Simon ( key 20170520235959_CIT0020) 2009; 101 Adsay ( key 20170520235959_CIT0029) 2012; 36 Goldhirsch ( key 20170520235959_CIT0002) 2011; 22 Cappelleri ( key 20170520235959_CIT0015) 2003; 22 Gudlaugsson ( key 20170520235959_CIT0028) 2012; 61 Galea ( key 20170520235959_CIT0011) 1992; 22(3) Dowsett ( key 20170520235959_CIT0005) 2005; 23 Ellis ( key 20170520235959_CIT0006) 2011; 29 Teutsch ( key 20170520235959_CIT0019) 2009; 11 Yerushalmi ( key 20170520235959_CIT0003) 2010; 11 Varga ( key 20170520235959_CIT0021) 2012; 7 Hadfield ( key 20170520235959_CIT0014) 2010; 33 Urruticoechea ( key 20170520235959_CIT0024) 2005; 23 Fasanella ( key 20170520235959_CIT0025) 2011; 6 Smith ( key 20170520235959_CIT0009) 2007; 25 Laurinavicius ( key 20170520235959_CIT0027) 2012; 35 |
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| SubjectTerms | Biological and medical sciences Biomarkers, Tumor - analysis Breast cancer Breast Neoplasms - immunology Correlation analysis Female Humans Immunohistochemistry International Cooperation Ki-67 Antigen - analysis Laboratories Laboratories - standards Medical sciences Observer Variation Proteins Reproducibility of Results Standardization Tissue Array Analysis - standards Tumors |
| Title | An International Ki67 Reproducibility Study |
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