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Analytical validati...
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Leung, Samuel CYUniversity of British Columbia
(author)
Analytical validation of a standardized scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections: an international multicenter collaboration
- Article/chapterEnglish2019
Publisher, publication year, extent ...
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2019-07-08
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Wiley,2019
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11 s.
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LIBRIS-ID:oai:lup.lub.lu.se:8558506b-5b3a-4020-895b-6c4d897a5ac9
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https://lup.lub.lu.se/record/8558506b-5b3a-4020-895b-6c4d897a5ac9URI
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https://doi.org/10.1111/his.13880DOI
Supplementary language notes
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Language:English
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Summary in:English
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Subject category:art swepub-publicationtype
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Subject category:ref swepub-contenttype
Notes
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Aims: The nuclear proliferation marker Ki67 assayed by immunohistochemistry has multiple potential uses in breast cancer, but an unacceptable level of interlaboratory variability has hampered its clinical utility. The International Ki67 in Breast Cancer Working Group has undertaken a systematic programme to determine whether Ki67 measurement can be analytically validated and standardised among laboratories. This study addresses whether acceptable scoring reproducibility can be achieved on excision whole sections.Methods and results: Adjacent sections from 30 primary ER+ breast cancers were centrally stained for Ki67 and sections were circulated among 23 pathologists in 12 countries. All pathologists scored Ki67 by two methods: (i) global: four fields of 100 tumour cells each were selected to reflect observed heterogeneity in nuclear staining; (ii) hot‐spot: the field with highest apparent Ki67 index was selected and up to 500 cells scored. The intraclass correlation coefficient (ICC) for the global method [confidence interval (CI) = 0.87; 95% CI = 0.799–0.93] marginally met the prespecified success criterion (lower 95% CI ≥ 0.8), while the ICC for the hot‐spot method (0.83; 95% CI = 0.74–0.90) did not. Visually, interobserver concordance in location of selected hot‐spots varies between cases. The median times for scoring were 9 and 6 min for global and hot‐spot methods, respectively.Conclusions: The global scoring method demonstrates adequate reproducibility to warrant next steps towards evaluation for technical and clinical validity in appropriate cohorts of cases. The time taken for scoring by either method is practical using counting software we are making publicly available. Establishment of external quality assessment schemes is likely to improve the reproducibility between laboratories further.
Subject headings and genre
Added entries (persons, corporate bodies, meetings, titles ...)
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Nielsen, TorstenUniversity of British Columbia
(author)
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Zabaglo, Lila AInstitute of Cancer Research London
(author)
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Arun, InduTata Medical Centre, Kolkata
(author)
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Badve, Sunil SIndiana University
(author)
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Bane, Anita LMcMaster University
(author)
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Bartlett, JohnOntario Institute for Cancer Research,Western General Hospital
(author)
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Borgquist, SigneLund University,Lunds universitet,Bröstcancer - prevention & intervention,Forskargrupper vid Lunds universitet,Breast cancer prevention & intervention,Lund University Research Groups(Swepub:lu)ront-sbo
(author)
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Chang, Martin CUniversity of Vermont
(author)
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Dodson, ARoyal Marsden Hospital, London
(author)
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Ehinger, AnnaLund University,Lunds universitet,Individuell Bröstcancerbehandling,Forskargrupper vid Lunds universitet,Personalized Breast Cancer Treatment,Lund University Research Groups,Skåne University Hospital(Swepub:lu)pat-amm
(author)
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Fineberg, SusanUniversity of Vermont Medical Center (UVM)
(author)
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Focke, CorneliaDietrich-Bonhoeffer-Klinikum
(author)
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Gao, DongxiaUniversity of British Columbia
(author)
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Gown, Allen MPhenoPath Laboratories
(author)
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Gutierrez, CarolinaBaylor College of Medicine
(author)
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Hugh, Judith CUniversity of Alberta
(author)
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Kos, ZuzanaThe Ottawa Hospital,University of Ottawa
(author)
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Laenkholm, Anne VibekeUniversity College Zealand,Slagelse Hospital
(author)
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Mastropasqua, Mauro GEuropean Institute of Oncology
(author)
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Moriya, TakuyaKawasaki Medical School
(author)
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Nofech-Mozes, SharonUniversity of Toronto,Sunnybrook Health Sciences Centre
(author)
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Osborne, C KentBaylor College of Medicine
(author)
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Penault-Llorca, Frédérique MUniversity of Auvergne
(author)
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Piper, TammyWestern General Hospital
(author)
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Sakatani, TakashiNippon Medical School
(author)
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Salgado, RobertoUniversity of Antwerp,Peter MacCallum Cancer Centre
(author)
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Starczynski, JaneBirmingham Heartlands Hospital
(author)
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Sugie, TomoharuKansai Medical University
(author)
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van der Vegt, BertUniversity Medical Center Groningen
(author)
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Viale, GiuseppeUniversity of Milan,European Institute of Oncology
(author)
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Hayes, DanielUniversity of Michigan
(author)
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McShane, Lisa MNational Cancer Institute, NCI
(author)
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Dowsett, MitchInstitute of Cancer Research London
(author)
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University of British ColumbiaInstitute of Cancer Research London
(creator_code:org_t)
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In:Histopathology: Wiley75:2, s. 225-2350309-01671365-2559
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Leung, Samuel CY
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Nielsen, Torsten
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Zabaglo, Lila A
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Arun, Indu
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Badve, Sunil S
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Bane, Anita L
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Bartlett, John
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Borgquist, Signe
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Chang, Martin C
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Dodson, A
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Ehinger, Anna
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Fineberg, Susan
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Focke, Cornelia
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Gao, Dongxia
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Gown, Allen M
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Gutierrez, Carol ...
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Hugh, Judith C
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Kos, Zuzana
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Laenkholm, Anne ...
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Mastropasqua, Ma ...
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Moriya, Takuya
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Nofech-Mozes, Sh ...
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Osborne, C Kent
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Penault-Llorca, ...
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Piper, Tammy
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Sakatani, Takash ...
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Salgado, Roberto
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Starczynski, Jan ...
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Sugie, Tomoharu
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van der Vegt, Be ...
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Viale, Giuseppe
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Hayes, Daniel
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McShane, Lisa M
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Dowsett, Mitch
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Histopathology
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Lund University