ReviewBreast cancer research and treatment2012
Ki-67: level of evidence and methodological considerations for its role in the clinical management of breast cancer: analytical and critical review.
Review in Breast cancer research and treatment, 2012. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 138 papers, 1 of them a synthesis that pooled it.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
138 citing papers in PubMed, 1 synthesis or guideline pooled it.
- Association of tumor-infiltrating lymphocytes with clinical outcomes in patients with triple-negative breast cancer receiving neoadjuvant chemotherapy: a systematic review and meta-analysis.Clinical & translational oncology : official publication of the Federation of Spanish Oncology Societies and of the National Cancer Institute of Mexico · 2025Pooled it
- Prognostic assessment of breast carcinoma submitted to neoadjuvant chemotherapy with pathological non-complete response.BMC cancer · 2019Trial
- Statin-induced anti-proliferative effects via cyclin D1 and p27 in a window-of-opportunity breast cancer trial.Journal of translational medicine · 2015Trial
- Trastuzumab or lapatinib with standard chemotherapy for HER2-positive breast cancer: results from the GEICAM/2006-14 trial.British journal of cancer · 2014Trial
- Randomized trial of preoperative docetaxel with or without capecitabine after 4 cycles of 5-fluorouracil– epirubicin–cyclophosphamide (FEC) in early-stage breast cancer: exploratory analyses identify Ki67 as a predictive biomarker for response to neoadjuvant chemotherapy.Breast cancer research and treatment · 2013Trial
- Trial
- Ki67 Gene Expression is Associated with Immune Cell Infiltration and Neoadjuvant Chemotherapy Response in ER+/HER2- Breast Cancer.Annals of surgical oncology · 2026Article
- Evaluating the Association of Ki-67 with Oncotype DX Recurrence Score in Early-Stage ER-Positive/HER2-Negative Breast Cancer.Cancers · 2026Article
- Time-dependent diffusion MRI for non-invasive differentiation of benign and malignant breast lesions and evaluation of proliferation index biomarkers.Breast cancer (Tokyo, Japan) · 2026Article
- Prostate-Specific Membrane Antigen (PSMA): A Potential Theranostic Biomarker in Breast Cancer.Biomedicines · 2026Article
- Clinicopathological features of breast cancer in Ukrainian women with BRCA1 c.181T>G (p.Cys61Gly) variant: a case series.Frontiers in endocrinology · 2026Article
- Study on the predictive efficacy of Ki-67, ER, and PR levels on the effectiveness of neoadjuvant chemotherapy in breast cancer.Frontiers in medicine · 2026Article
- Association of immuno-inflammatory biomarkers with response to neoadjuvant chemotherapy and prognosis in HER2-positive breast cancer: dual-center clinical evidence.Frontiers in immunology · 2026Article
- An Unusual Observation in Metastatic Neuroendocrine Neoplasm: Diffuse Pattern Hepatic [World journal of nuclear medicine · 2025Article
- Unusual Axillary Recurrence Observed in Breast Cancer With Bloody Nipple Discharge: A Case Report.Cureus · 2025Article
- The prognostic value of changes in Ki67 following neoadjuvant chemotherapy in residual triple-negative breast cancer: a Swedish nationwide registry-based study.Breast cancer research and treatment · 2025Article
- Characteristics and Prognostic Markers of Aggressive Subtypes of Thyroid Cancer: A Retrospective Study.Cancer reports (Hoboken, N.J.) · 2025Article
- Factors associated with recurrence in operable breast cancer patients undergoing surgery as the sole treatment modality.Acta cirurgica brasileira · 2025Article
- Establishment and characterization of primary epithelial cell cultures from healthy canine mammary gland tissue.Frontiers in veterinary science · 2025Article
- Article
78 more citing papers are in PubMed but not listed here.
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Authors and funding
25 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Clinicians can use biomarkers to guide therapeutic decisions in estrogen receptor positive (ER+) breast cancer. One such biomarker is cellular proliferation as evaluated by Ki-67. This biomarker has been extensively studied and is easily assayed by histopathologists but it is not currently accepted as a standard. This review focuses on its prognostic and predictive value, and on methodological considerations for its measurement and the cut-points used for treatment decision. Data describing study design, patients' characteristics, methods used and results were extracted from papers published between January 1990 and July 2010. In addition, the studies were assessed using the REMARK tool. Ki-67 is an independent prognostic factor for disease-free survival (HR 1.05-1.72) in multivariate analyses studies using samples from randomized clinical trials with secondary central analysis of the biomarker. The level of evidence (LOE) was judged to be I-B with the recently revised definition of Simon. However, standardization of the techniques and scoring methods are needed for the integration of this biomarker in everyday practice. Ki-67 was not found to be predictive for long-term follow-up after chemotherapy. Nevertheless, high KI-67 was found to be associated with immediate pathological complete response in the neoadjuvant setting, with an LOE of II-B. The REMARK score improved over time (with a range of 6-13/20 vs. 10-18/20, before and after 2005, respectively). KI-67 could be considered as a prognostic biomarker for therapeutic decision. It is assessed with a simple assay that could be standardized. However, international guidelines are needed for routine clinical use.
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