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Analytical Comparison of Commonly Used Laboratory-Developed Tests for the Assessment of Ki-67 in Breast Carcinoma With an FDA-Approved Benchmark. (PubMed, Mod Pathol)
Commonly used IHC assays for Ki-67 assessment in breast cancer can significantly vary. Pathologists should be aware of variables that may impact Ki-67 interpretation and look to standardize biomarker assessments for early breast cancer patient care.
FDA event • Journal
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Ki-67 IHC MIB-1 pharmDx
1year
Comparative Analysis of the Oncotype DX Breast Recurrence Score® assay for Neoadjuvant Letrozole/Abemaciclib versus Chemotherapy in Stage II-III, Ki67≥20%, HR+/HER2- Breast Cancer: Insights from the GEICAM/CARABELA Trial (SABCS 2024)
Neoadjuvant let/abema and CT varied in efficacy by Recurrence Score®. Let/abema achieved higher CCCA rates in RS≤25 patients, accompanied by significant ER and PgR mRNA suppression, highlighting its efficacy in less biologically aggressive subtypes and suggesting it might replace the need for CT. Surgery-RS result was higher in the let/abema arm than in CT and correlated inversely with surgery ER and PgR levels, indicating deeper ER signaling suppression.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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HER-2 negative
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Ki-67 IHC MIB-1 pharmDx • Oncotype DX Breast Recurrence Score®Test
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Verzenio (abemaciclib) • letrozole
1year
Journal
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Ki-67 IHC MIB-1 pharmDx
over1year
Evaluating Ki67 and Oncotype DX Breast Recurrence Score during neoadjuvant treatment with letrozole/abemaciclib or chemotherapy in patients with highly proliferative HR+/HER2- breast cancer participating in the GEICAM CARABELA trial. (ASCO 2024)
Highly proliferative tumors Ki67 (≥40%) or those with high Recurrence Score (>25) exhibited higher rates of RCB 0-I when treated with chemotherapy, than when treated with letrozole/abemaciclib. This suggests that relying solely on letrozole/abemaciclib as systemic treatment for these tumors may be insufficient.
Clinical
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HER-2 (Human epidermal growth factor receptor 2)
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HER-2 negative
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Ki-67 IHC MIB-1 pharmDx • Oncotype DX Breast Recurrence Score®Test
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Verzenio (abemaciclib) • letrozole
over1year
Non-basal subtype defined by FOXC1 expression as an independent predictor of capecitabine efficacy in the triple negative breast cancer GEICAM/2003-11_CIBOMA/2004-01 trial. (ASCO 2024)
In the CIBOMA TNBC trial, the non-BLBC definition by a single biomarker (FOXC1 Veresca) provided prognostic and predictive value of cap benefit after (neo)adjuvant CT, corroborating our previous findings by PAM50 and IHC non-BLBC subtyping. This is a pragmatic option to effectively apply findings from this trial in the real-world setting.
Clinical
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FOXC1 (Forkhead Box C1)
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Prosigna™ Breast Cancer Prognostic Gene Signature Assay • Ki-67 IHC MIB-1 pharmDx
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capecitabine
almost2years
Development of a flow cytometric panel to assess prognostic biomarkers in fine needle aspirates of canine cutaneous or subcutaneous mast cell tumors. (PubMed, Front Vet Sci)
In conclusion, FNA samples of canine MCTs can often yield adequate cell numbers for FC analysis, and a multicolor FC panel was developed that can detect Ki-67 in canine mast cells. This would permit further studies into the potential use of this panel for canine cutaneous and subcutaneous MCT prognostication purposes.
Journal
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KIT (KIT proto-oncogene, receptor tyrosine kinase)
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Ki-67 IHC MIB-1 pharmDx
almost3years
Trial completion
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HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor) • PGR (Progesterone receptor) • IGF1 (Insulin-like growth factor 1) • IR (Insulin receptor) • CRP (C-reactive protein) • LEP (Leptin)
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Ki-67 IHC MIB-1 pharmDx
almost3years
Deep Learning-Based, Fully Automated Analysis of Whole Slide Images Can Detect Invasive Breast Carcinoma and Count Ki-67 Easily and Precisely (USCAP 2023)
Recently, cyclin-dependent kinases 4/6 inhibitor called abemaciclib, has been approved for high risk patients after surgery, together with Ki-67 IHC MIB-1 pharmDx(Dako Omnis) for the patient selection... Here, we have created a fully automated software to analyze Ki-67, which includes DL-based algorithm to detect invasive BC nest and count a large amount of cells quickly. It has probed to have concordant result with experienced breast pathologists, although the prognostic value needs to be confirmed. As the software tend to have lower value than pathologists, we have to pay attention to the cut-off value .
HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
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Ki-67 IHC MIB-1 pharmDx
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Verzenio (abemaciclib)
almost3years
Digital Quantitation of Ki-67 in Uveal Melanomas (USCAP 2023)
Digital evaluation of Ki-67 appears to play an independent role in the progression of UM. This objective method is a promising tool for better prognostic stratification of UM patients.
BAP1 (BRCA1 Associated Protein 1) • PRAME (Preferentially Expressed Antigen In Melanoma)
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PRAME expression
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Anti-PRAME (EPR 20330) Rabbit Monoclonal Primary Antibody • Ki-67 IHC MIB-1 pharmDx
almost3years
Ki-67 Expression in Invasive Carcinomas of the Breast: Does Scoring Method Impact Abemaciclib Eligibility? (USCAP 2023)
UNWT and WT trend toward better interobserver variability compared to the EST. Count differences between pathologists that would have led to treatment difference were minimized using the WT protocol; however, this was not statistically significant when sorted by specimen type. Overall, our study suggests that further refinement in Ki67% scoring is advisable to reduce clinically significant manual score variation.
HER-2 (Human epidermal growth factor receptor 2)
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HR positive • HER-2 negative • HR positive + HER-2 negative
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Ki-67 IHC MIB-1 pharmDx
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Verzenio (abemaciclib)
almost3years
Ki-67 Evaluation in HR+/HER2- Node-Positive High Risk Early Breast Cancer on Patients Eligible for Abemaciclib Using Artificial Intelligence (USCAP 2023)
In our cohort, PharmDx clone is not superior to MIB1 stain and either of the clones can be used in the clinical laboratory to direct therapy with Abemaciclib. Considering the weak staining of Ki-67 (1+) increases the final score and consequently the number of eligible patients for Abemaciclib, the benefit from treatment is unclear. Validation of different clones in the clinical laboratories is warranted.
Clinical
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HER-2 (Human epidermal growth factor receptor 2) • PGR (Progesterone receptor)
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HER-2 negative
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Ki-67 IHC MIB-1 pharmDx
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Verzenio (abemaciclib)
almost3years
Ki-67 Expression in Invasive carcinomas of the Breast: Does Specimen Type and Manual vs Automated Counting Impact Abemaciclib Eligibility? (USCAP 2023)
There was no statistical difference in mean Ki67% between CNB, RES, and LN specimens using the weighted Ki67 scoring protocol; however, 9 patients in our cohort (18%) would have treatment changes based on which specimen was chosen for analysis and 13 (25%) whether manual or automated counting was performed. To ensure reproducible eligibility assessment, further refinement in scoring Ki67% is needed.
HER-2 (Human epidermal growth factor receptor 2) • ER (Estrogen receptor)
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ER positive • HR positive • HER-2 negative • HR positive + HER-2 negative
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Ki-67 IHC MIB-1 pharmDx
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Verzenio (abemaciclib)