Analytical validation of a standardised scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections
| Autor: | Giuseppe Viale, Zuzana Kos, Allen M Gown, John M. S. Bartlett, Samuel C Y Leung, Andrew Dodson, Dongxia Gao, Frédérique Penault-Llorca, Jane Starczynski, Roberto Salgado, Mauro G. Mastropasqua, Sharon Nofech-Mozes, C. Kent Osborne, Signe Borgquist, Mitch Dowsett, Bert van der Vegt, Torsten O. Nielsen, Takuya Moriya, Takashi Sakatani, Tammy Piper, Carolina Gutierrez, Tomoharu Sugie, Anita Bane, Martin C. Chang, Susan Fineberg, Cornelia M Focke, Lila Zabaglo, Anna Ehinger, Lisa M. McShane, Sunil Badve, Daniel F. Hayes, Judith Hugh, Anne-Vibeke Lænkholm, Indu Arun |
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| Přispěvatelé: | Damage and Repair in Cancer Development and Cancer Treatment (DARE) |
| Jazyk: | angličtina |
| Rok vydání: | 2019 |
| Předmět: |
0301 basic medicine
medicine.medical_specialty Histology interobserver variability Proliferation index Intraclass correlation Concordance Breast Neoplasms Pathology and Forensic Medicine 03 medical and health sciences 0302 clinical medicine Breast cancer interobserver reproducibility scoring protocol analytical validity REPRODUCIBILITY External quality assessment Biomarkers Tumor Humans Medicine KI-67 EXPRESSION METAANALYSIS Observer Variation Protocol (science) PROLIFERATION INDEX Reproducibility Pathology Clinical ENDOCRINE THERAPY business.industry Reproducibility of Results General Medicine CHEMOTHERAPY medicine.disease PREDICTIVE-VALUE Confidence interval PROGNOSTIC VALUE PATHOLOGY Ki-67 Antigen 030104 developmental biology ANTIBODY 030220 oncology & carcinogenesis immunohistochemistry Female pathology Radiology business Ki67 |
| Zdroj: | Histopathology, 75(2), 225-235. Wiley Leung, S C Y, Nielsen, T O, Zabaglo, L A, Arun, I, Badve, S S, Bane, A L, Bartlett, J M S, Borgquist, S, Chang, M C, Dodson, A, Ehinger, A, Fineberg, S, Focke, C M, Gao, D, Gown, A M, Gutierrez, C, Hugh, J C, Kos, Z, Lænkholm, A, Mastropasqua, M G, Moriya, T, Nofech-mozes, S, Osborne, C K, Penault-llorca, F M, Piper, T, Sakatani, T, Salgado, R, Starczynski, J, Sugie, T, Vegt, B, Viale, G, Hayes, D F, Mcshane, L M & Dowsett, M 2019, ' Analytical validation of a standardised scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections: an international multicentre collaboration ', Histopathology . https://doi.org/10.1111/his.13880 Leung, S C Y, Nielsen, T O, Zabaglo, L A, Arun, I, Badve, S S, Bane, A L, Bartlett, J M S, Borgquist, S, Chang, M C, Dodson, A, Ehinger, A, Fineberg, S, Focke, C M, Gao, D, Gown, A M, Gutierrez, C, Hugh, J C, Kos, Z, Lænkholm, A V, Mastropasqua, M G, Moriya, T, Nofech-Mozes, S, Osborne, C K, Penault-Llorca, F M, Piper, T, Sakatani, T, Salgado, R, Starczynski, J, Sugie, T, van der Vegt, B, Viale, G, Hayes, D F, McShane, L M, Dowsett, M & on behalf of the International Ki67 in Breast Cancer Working Group of the Breast International Group and North American Breast Cancer Group (BIG-NABCG) 2019, ' Analytical validation of a standardised scoring protocol for Ki67 immunohistochemistry on breast cancer excision whole sections : an international multicentre collaboration ', Histopathology, vol. 75, no. 2, pp. 225-235 . https://doi.org/10.1111/his.13880 |
| ISSN: | 0309-0167 |
| Popis: | 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. |
| Databáze: | OpenAIRE |
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