Analytical validation of a standardized scoring protocol for Ki67: phase 3 of an international multicenter collaboration
Autor: | Susan Fineberg, Jane Starczynski, Tammy Piper, Lisa M. McShane, Signe Borgquist, Martin C. Chang, Indu Arun, Andrew Dodson, Carolina Gutierrez, Dorthe Grabau, Zuzana Kos, Sharon Nofech-Mozes, Daniel F. Hayes, Giuseppe Viale, Anne Vibeke Lænkholm, Allen M Gown, Takuya Moriya, Samuel C Y Leung, C. Kent Osborne, Torsten O. Nielsen, Rebecca A. Enos, Ming-Gang Lin, Sunil Badve, Judith Hugh, Takashi Sakatani, Roberto Salgado, Lila Zabaglo, Mauro G. Mastropasqua, Anita Bane, Dongxia Gao, Frédérique Penault-Llorca, Cornelia M Focke, John M. S. Bartlett, Mitch Dowsett |
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Jazyk: | angličtina |
Rok vydání: | 2016 |
Předmět: |
0301 basic medicine
Oncology Protocol (science) medicine.medical_specialty Reproducibility business.industry Intraclass correlation medicine.disease Article 03 medical and health sciences 030104 developmental biology 0302 clinical medicine Breast cancer 030220 oncology & carcinogenesis Internal medicine External quality assessment medicine Clinical validity Credible interval Biomarker (medicine) Pharmacology (medical) Radiology Nuclear Medicine and imaging business |
Zdroj: | NPJ Breast Cancer |
ISSN: | 2374-4677 |
Popis: | Pathological analysis of the nuclear proliferation biomarker Ki67 has multiple potential roles in breast and other cancers. However, clinical utility of the immunohistochemical (IHC) assay for Ki67 immunohistochemistry has been hampered by unacceptable between-laboratory analytical variability. The International Ki67 Working Group has conducted a series of studies aiming to decrease this variability and improve the evaluation of Ki67. This study tries to assess whether acceptable performance can be achieved on prestained core-cut biopsies using a standardized scoring method. Sections from 30 primary ER+ breast cancer core biopsies were centrally stained for Ki67 and circulated among 22 laboratories in 11 countries. Each laboratory scored Ki67 using three methods: (1) global (4 fields of 100 cells each); (2) weighted global (same as global but weighted by estimated percentages of total area); and (3) hot-spot (single field of 500 cells). The intraclass correlation coefficient (ICC), a measure of interlaboratory agreement, for the unweighted global method (0.87; 95% credible interval (CI): 0.81–0.93) met the prespecified success criterion for scoring reproducibility, whereas that for the weighted global (0.87; 95% CI: 0.7999–0.93) and hot-spot methods (0.84; 95% CI: 0.77–0.92) marginally failed to do so. The unweighted global assessment of Ki67 IHC analysis on core biopsies met the prespecified criterion of success for scoring reproducibility. A few cases still showed large scoring discrepancies. Establishment of external quality assessment schemes is likely to improve the agreement between laboratories further. Additional evaluations are needed to assess staining variability and clinical validity in appropriate cohorts of samples. |
Databáze: | OpenAIRE |
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