ArticleModern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc2019
An international multicenter study to evaluate reproducibility of automated scoring for assessment of Ki67 in breast cancer.
Article in Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc, 2019. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 47 papers, 1 of them a synthesis that pooled it.
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Who cites it
47 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Ki67 in Breast Cancer Assay: An Ad Hoc Testing Recommendation from the Canadian Association of Pathologists Task Force.Current oncology (Toronto, Ont.) · 2023Guideline
- Next-generation osteosarcoma models for precision medicine.Communications biology · 2026Review
- Ki-67 as a treatment decision modifier in breast cancer.The oncologist · 2026Article
- Automated Assessment of Ki-67 Labeling Index Using Cell-Level Detection and Classification in Whole-Slide Images.Diagnostics (Basel, Switzerland) · 2026Article
- Evaluating the Impact of a Ki-67 Decision Support Algorithm on Pathology Residents' Scoring Accuracy.Journal of imaging informatics in medicine · 2026Article
- Integrated local and global Ki67 profiling for prognostic stratification and therapeutic guidance in high-grade neuroendocrine neoplasms: a multicenter validation study.International journal of surgery (London, England) · 2025Article
- Ki-67-Playing a key role in breast cancer but difficult to apply precisely in the real world.BMC cancer · 2025Article
- Deep learning models based on multiparametric magnetic resonance imaging and clinical parameters for identifying synchronous liver metastases from rectal cancer.BMC medical imaging · 2025Article
- High Ki67 expression, HER2 overexpression, and low progesterone receptor levels in high-grade DCIS: significant associations with clinical practice implications.Frontiers in oncology · 2025Article
- Evaluation of Ki-67 expression levels in esophageal squamous cell carcinoma using dual-energy CT quantitative parameters.Frontiers in oncology · 2025Article
- The Ki67 dilemma: investigating prognostic cut-offs and reproducibility for automated Ki67 scoring in breast cancer.Breast cancer research and treatment · 2024Article
- DREAM On, DREAM Off: A Review of the Estrogen Paradox in Luminal A Breast Cancers.Biomedicines · 2024Review
- Subspecialized breast pathologists have suboptimal interobserver agreement in Ki-67 evaluation using 20% as the cutoff.Breast cancer research and treatment · 2024Article
- Evaluation of the international Ki67 working group cut point recommendations for early breast cancer: comparison with 21-gene assay results in a large integrated health care system.Breast cancer research and treatment · 2024Article
- Use of a Novel Deep Learning Open-Source Model for Quantification of Ki-67 in Breast Cancer Patients in Pakistan: A Comparative Study between the Manual and Automated Methods.Diagnostics (Basel, Switzerland) · 2023Article
- Ki67 and breast cancer mortality in women with invasive breast cancer.JNCI cancer spectrum · 2023Article
- Ki-67, 21-Gene Recurrence Score, Endocrine Resistance, and Survival in Patients With Breast Cancer.JAMA network open · 2023Article
- Scoring Graphical Responses in TIMSS 2019 Using Artificial Neural Networks.Educational and psychological measurement · 2023Article
- The Evolution of Ki-67 and Breast Carcinoma: Past Observations, Present Directions, and Future Considerations.Cancers · 2023Review
- ERBB2 mutation is associated with sustained tumor cell proliferation after short-term preoperative endocrine therapy in early lobular breast cancer.Modern pathology : an official journal of the United States and Canadian Academy of Pathology, Inc · 2022Article
Corrections and comments
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Authors and funding
30 authors.
Funding
Abstract
The nuclear proliferation biomarker Ki67 has potential prognostic, predictive, and monitoring roles in breast cancer. Unacceptable between-laboratory variability has limited its clinical value. The International Ki67 in Breast Cancer Working Group investigated whether Ki67 immunohistochemistry can be analytically validated and standardized across laboratories using automated machine-based scoring. Sets of pre-stained core-cut biopsy sections of 30 breast tumors were circulated to 14 laboratories for scanning and automated assessment of the average and maximum percentage of tumor cells positive for Ki67. Seven unique scanners and 10 software platforms were involved in this study. Pre-specified analyses included evaluation of reproducibility between all laboratories (primary) as well as among those using scanners from a single vendor (secondary). The primary reproducibility metric was intraclass correlation coefficient between laboratories, with success considered to be intraclass correlation coefficient >0.80. Intraclass correlation coefficient for automated average scores across 16 operators was 0.83 (95% credible interval: 0.73-0.91) and intraclass correlation coefficient for maximum scores across 10 operators was 0.63 (95% credible interval: 0.44-0.80). For the laboratories using scanners from a single vendor (8 score sets), intraclass correlation coefficient for average automated scores was 0.89 (95% credible interval: 0.81-0.96), which was similar to the intraclass correlation coefficient of 0.87 (95% credible interval: 0.81-0.93) achieved using these same slides in a prior visual-reading reproducibility study. Automated machine assessment of average Ki67 has the potential to achieve between-laboratory reproducibility similar to that for a rigorously standardized pathologist-based visual assessment of Ki67. The observed intraclass correlation coefficient was worse for maximum compared to average scoring methods, suggesting that maximum score methods may be suboptimal for consistent measurement of proliferation. Automated average scoring methods show promise for assessment of Ki67 scoring, but requires further standardization and subsequent clinical validation.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.