手工半定量和自动化定量 Ki-67 增殖指数与 OncotypeDXTM 复发评分在浸润性乳腺癌中的相关性。

Correlation of manual semi-quantitative and automated quantitative Ki-67 proliferative index with OncotypeDXTM recurrence score in invasive breast carcinoma.

机构信息

Department of Pathology, The Johns Hopkins Medical Institutions, Baltimore, MD, USA.

Department of Pathology, Great Lakes Pathologists, West Allis, WI, USA.

出版信息

Breast Dis. 2022;41(1):55-65. doi: 10.3233/BD-201011.

DOI:10.3233/BD-201011

PMID:34397396

Abstract

BACKGROUND

Ki-67 immunohistochemistry (IHC) staining is a widely used cancer proliferation assay; however, its limitations could be improved with automated scoring. The OncotypeDXTM Recurrence Score (ORS), which primarily evaluates cancer proliferation genes, is a prognostic indicator for breast cancer chemotherapy response; however, it is more expensive and slower than Ki-67.

OBJECTIVE

To compare manual Ki-67 (mKi-67) with automated Ki-67 (aKi-67) algorithm results based on manually selected Ki-67 "hot spots" in breast cancer, and correlate both with ORS.

METHODS

105 invasive breast carcinoma cases from 100 patients at our institution (2011-2013) with available ORS were evaluated. Concordance was assessed via Cohen's Kappa (κ).

RESULTS

57/105 cases showed agreement between mKi-67 and aKi-67 (κ 0.31, 95% CI 0.18-0.45), with 41 cases overestimated by aKi-67. Concordance was higher when estimated on the same image (κ 0.53, 95% CI 0.37-0.69). Concordance between mKi-67 score and ORS was fair (κ 0.27, 95% CI 0.11-0.42), and concordance between aKi-67 and ORS was poor (κ 0.10, 95% CI -0.03-0.23).

CONCLUSIONS

These results highlight the limits of Ki-67 algorithms that use manual "hot spot" selection. Due to suboptimal concordance, Ki-67 is likely most useful as a complement to, rather than a surrogate for ORS, regardless of scoring method.

摘要

背景

Ki-67 免疫组化（IHC）染色是一种广泛应用于癌症增殖检测的方法；然而，其局限性可以通过自动评分来改善。OncotypeDXTM 复发评分（ORS）主要评估癌症增殖基因，是乳腺癌化疗反应的预后指标；然而，它比 Ki-67 更昂贵且速度更慢。

目的

比较乳腺癌中手动 Ki-67（mKi-67）与自动 Ki-67（aKi-67）算法结果，基于手动选择的 Ki-67“热点”，并与 ORS 相关联。

方法

评估了本机构（2011-2013 年）的 100 名患者中 105 例浸润性乳腺癌病例，这些患者均有 ORS 结果。通过 Cohen's Kappa（κ）评估一致性。

结果

57/105 例病例的 mKi-67 与 aKi-67 之间存在一致性（κ 0.31，95%CI 0.18-0.45），其中 41 例病例被 aKi-67 高估。在同一图像上进行评估时，一致性更高（κ 0.53，95%CI 0.37-0.69）。mKi-67 评分与 ORS 之间的一致性为中等（κ 0.27，95%CI 0.11-0.42），而 aKi-67 与 ORS 之间的一致性较差（κ 0.10，95%CI -0.03-0.23）。