TEST:

Ki-67 IHC MIB-1 pharmDx

Manual Ki-67 hotspot assessment is subjective, leading to grading variability. Algorithm-based assessment enhances reproducibility, though this occasionally leads to tumor upgrading, highlighting the need for standardization and further validation.

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.

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.

Our results offer crucial reference value for clinical diagnostic assistance.

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.

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.

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.

P=N/A; Active, not recruiting --> Completed

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.

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 .

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.

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.