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Ki-67 Testing in Breast Cancer: Assessing Variability With Scoring Methods and Specimen Types and the Potential
Therese Bocklage1, Virgilius Cornea1, Caylin Hickey1
1Departments of Pathology and Laboratory Medicine.
Summary
This study highlights significant variation in Ki-67 scoring for abemaciclib eligibility. Refined Ki-67 assessment methods are crucial to reduce variability and ensure accurate patient selection for ER-positive/HER2-negative breast cancer treatment.
Area of Science:
- Oncology
- Pathology
- Biomarker Analysis
Background:
- Abemaciclib is approved for ER-positive/HER2-negative breast cancer with Ki-67 ≥20%.
- Lack of standardized guidelines for Ki-67 testing and scoring methods creates ambiguity.
- Patient eligibility for abemaciclib therapy may be impacted by scoring variability.
Purpose of the Study:
- To evaluate the variability of Ki-67 expression across different specimen types and scoring methods.
- To compare manual Ki-67 scoring techniques (estimated, unweighted, weighted) with quantitative image analysis (QIA).
- To assess the impact of scoring variations on determining eligibility for abemaciclib therapy.
Main Methods:
- Comprehensive analysis of breast specimens from 50 patients eligible for abemaciclib.
- Three pathologists performed blinded reviews using estimated (EST), unweighted (UNW), and weighted (WT) manual scoring methods.
- Quantitative image analysis (QIA) using the HALO platform was employed for comparison.
- Evaluation of Ki-67 expression in core needle biopsy (CNB), resection (RES), and axillary lymph node metastasis (ALN) specimens.
Main Results:
- Average Ki-67 expression varied by scoring method: EST (14.68%), UNW (14.46%), WT (14.15%), and QIA (11.15%).
- The weighted (WT) method demonstrated lower interobserver variability (ICC1=0.959) compared to EST (ICC1=0.922) and UNW (ICC1=0.949).
- Treatment eligibility based on Ki-67 ≥20% ranged from 24% (QIA) to 40% (EST), indicating significant discrepancies.
- No statistically significant difference in Ki-67 expression was found among CNB, RES, and ALN specimens.
Conclusions:
- Significant clinical variation exists in Ki-67 scoring for abemaciclib eligibility.
- The weighted scoring method and QIA show potential for reducing interobserver variability.
- Further refinement of Ki-67 scoring methodologies is essential to ensure accurate patient selection for targeted breast cancer therapies.
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