An international study to increase concordance in Ki67 scoring

Polley, Mei Yin; Leung, Samuel; Gao, Dongxia; Mastropasqua, Mauro G.; Zabaglo, Lila; Bartlett, John M.S.; McShane, Lisa M.; Enos, Rebecca A.; Badve, Sunil; Bane, Anita; Borgquist, Signe; Fineberg, Susan; Lin, Ming Gang; Gown, Allen M.; Grabau, Dorthe; Gutiérrez, Carolina; Hugh, Judith; Moriya, Takuya; Ohi, Yasuyo; Osborne, C. Kent; Penault‐Llorca, Frédérique; Piper, Tammy; Porter, Peggy L.; Sakatani, Takashi; Salgado, Roberto; Starczynski, Jane; Lænkholm, Anne‐Vibeke; Viale, Giuseppe; Dowsett, Mitch; Hayes, Daniel F.; Nielsen, Torsten O.

doi:10.1038/modpathol.2015.38

Cited by 205 publications

(156 citation statements)

References 23 publications

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“…In addition, in other studies IHC-detected Ki67 levels were associated with quantitatively assessed proliferation in first-generation genetic signatures [37][38][39]. Finally, different studies have reported a high interlaboratory variability in Ki67 scoring on breast tumors among some of the world's most experienced pathologists [40,41]. Clinical decision-making regarding treatment options in breast cancer often relies on the application of a Ki67 cutoff to classify patients into "Ki67 high" or "Ki67 low" risk groups.…”

Section: Discussionmentioning

confidence: 99%

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

Alba

Lluch²,

Ribelles

et al. 2016

The Oncologist

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Background. In the neoadjuvant setting, changes in the proliferation marker Ki67 are associated with primary endocrine treatment efficacy, but its value as a predictor of response to chemotherapy is still controversial. Patients and Methods. We analyzed 262 patients with centralized basal Ki67 immunohistochemical evaluation derived from 4 GEICAM (Spanish Breast Cancer Group) clinicaltrialsofneoadjuvant chemotherapy for breast cancer. The objective was to identify the optimal threshold for Ki67 using the receiver-operating characteristic curve method to maximize its predictive value for chemotherapy benefit. We also evaluated the predictive role of the defined Ki67 cutoffs for molecular subtypes defined by estrogen receptor (ER) and human epidermal growth factor receptor 2 (HER2). Results. A basal Ki67 cutpoint of 50% predicted pathological complete response (pCR). Patients with Ki67 .50% achieved a

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Section: Discussionmentioning

confidence: 99%

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

Alba

Lluch²,

Ribelles

et al. 2016

The Oncologist

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“…In their early multi-institutional study on Ki67 reproducibility in breast cancer, Polley et al showed that analytical validity of Ki67 LI was "unacceptably poor" [53]. Calibration using web-based tool allowed to increase concordance in reporting of Ki67 LI [61]. Despite these efforts, it is probably still too early to recommend usage of Ki67 LI for management of patients with breast cancer [53,61,62].…”

Section: Post-analytical Phase Of Ki67 LI Assessmentmentioning

confidence: 99%

“…Significant efforts were made to improve reliability of Ki67 reporting in breast cancer [39,53,61]. In their early multi-institutional study on Ki67 reproducibility in breast cancer, Polley et al showed that analytical validity of Ki67 LI was "unacceptably poor" [53].…”

Section: Post-analytical Phase Of Ki67 LI Assessmentmentioning

confidence: 99%

Tissue heterogeneity contributes to suboptimal precision of WHO 2010 scoring criteria for Ki67 labeling index in a subset of neuroendocrine neoplasms of the pancreascriteria for Ki67 labeling index in a subset of neuroendocrine neoplasms of the pancreas

Liszka¹

2016

pjp

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Reporting of Ki67 labeling index (LI) is a routine in diagnostics of neuroendocrine neoplasms of the pancreas. The aim of the study was to examine whether heterogeneity of Ki67 LI distribution in primary tumoral tissue influences precision of reporting of Ki67 LI and Ki67-LI-based grade, both established in adherence to WHO 2010 guidelines. Seventy-one samples of neuroendocrine tumours (NET) and 6 samples of neuroendocrine carcinomas (NEC) of the pancreas were taken for manual counting of Ki67 LI in 25 portions of 100 cells (2500 cells in total) in 3 hot spots an in a single area of lower proliferation rate (cold spot) in each case. Both NET and NEC showed Ki67 LI heterogeneity within primary tumour. Almost 20% of NET showed higher grade when 500 cells rather than 2000 cells were counted in hot spot area. Suboptimal choice of hot spot resulted in under-grading of approximately 20% of NET. Cold spots were constantly present in NET. Heterogeneity of Ki67 LI was also present in NEC, but it virtually never resulted in under-grading. Concept and methodology of Ki67 LI counting in neuroendocrine neoplasms of the pancreas requires clarification. Efforts aiming to improve precision of assessment of Ki67 LI are needed.

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“…Currently, there is no standardized cutoff value for Ki-67. [54][55][56] A meta-analysis of 46 studies with 12 155 patients has shown that high Ki-67 labeling correlated with increased relapse and decreased survival. However, the threshold designated as high Ki-67 labeling ranged from 3.5% to 35%.…”

Section: Ki-67mentioning

confidence: 99%

Immunohistochemical Surrogates for Molecular Classification of Breast Carcinoma: A 2015 Update

Tang¹,

Tse

2016

Archives of Pathology &Amp; Laboratory Medicine

131

109

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Context.-The pioneering works on molecular classification (MC) by Perou and Sorlie et al in the early 2000s using global gene expression profiling identified 5 intrinsic subtypes of invasive breast cancers (IBCs): luminal A, luminal B, normal breast-like, HER2-enriched, and basallike subtypes, each unique in incidence, survival, and response to therapy. Because the application of gene expression profiling in daily practice is not economical or practical at the present time, many investigators have studied the use of immunohistochemical (IHC) surrogates as a substitute for determining the MC of IBC.Objective.-To discuss the continuing efforts that have been made to develop clinically significant and readily available IHC surrogates for the MC of IBC.Data Sources.-Data were obtained from pertinent peer-reviewed English-language literature.Conclusions.-The most commonly used IHC surrogates are estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor-2 (HER2), dividing IBC into luminal, HER2, and triple-negative subtypes. The addition of Ki-67, cytokeratin 5, and epidermal growth factor receptor (EGFR) separates luminal B from luminal A subtypes, and basal-like subtype from triple-negative breast cancer. More recently, biomarkers such as androgen receptor and p53 have been shown to further stratify these molecular subtypes. Although many studies of IHC-based MC have shown clinical significance similar to gene expression profiling-defined MC, its critical limitations are: (1) a lack of standardization in terminology, (2) a lack of standardization in biomarkers used for each subtype, and (3) the lack of a uniform cutoff for each biomarker. A panel of IHC surrogates for each subtype of IBC is proposed.

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An international study to increase concordance in Ki67 scoring

Cited by 205 publications

References 23 publications

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

High Proliferation Predicts Pathological Complete Response to Neoadjuvant Chemotherapy in Early Breast Cancer

Tissue heterogeneity contributes to suboptimal precision of WHO 2010 scoring criteria for Ki67 labeling index in a subset of neuroendocrine neoplasms of the pancreascriteria for Ki67 labeling index in a subset of neuroendocrine neoplasms of the pancreas

Immunohistochemical Surrogates for Molecular Classification of Breast Carcinoma: A 2015 Update

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