Dataset Information

External quality assessment (EQA) program for the immunohistochemical detection of ER, PR and Ki-67 in breast cancer: results of an interlaboratory reproducibility ring study in China.

ABSTRACT:

Background

An External Quality Assessment (EQA) program was developed to investigate the status of estrogen receptor (ER), progesterone receptor (PR), and Ki-67 immunohistochemical (IHC) detection in breast cancer and to evaluate the reproducibility of staining and interpretation in 44 pathology laboratories in China.

Methods

This program was implemented through three specific steps. In study I, three revising centres defined the reference value for 11 sections. In study II, 41 participating centres (PC) stained and interpreted 11 sections by their own daily practice IHC protocols. In study III, all cases received second interpretation opinions.

Results

The stained slides of 44 laboratories were up to the interpretation standard. The overall interpretation concordance rate of this study was over 90%. A perfect agreement was reached among the PCs for the cases with ER+ and PR+ >?50% and Ki-67?>?30%, whereas a moderate agreement was observed for intermediate categories. After second interpretations, the misclassification rates for ER were reduced by 12.20%, for PR were reduced by 17.07%, and for Ki-67 were reduced by 4.88%. Up to 31 PCs observed a benefit from the second opinion strategy.

Conclusions

This project is the first EQA study performed on a national scale for assessment of ER, PR and Ki-67 status by IHC in China. In the whole IHC evaluation process, the intermediate categories were less reproducible than those with high expression rates. Second opinions can significantly improve the diagnostic agreement of pathologists' interpretations.

SUBMITTER: Pu T

PROVIDER: S-EPMC6805628 | biostudies-literature | 2019 Oct

REPOSITORIES: biostudies-literature

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Publications

External quality assessment (EQA) program for the immunohistochemical detection of ER, PR and Ki-67 in breast cancer: results of an interlaboratory reproducibility ring study in China.

Pu Tianjie T Shui Ruohong R Shi Jie J Liang Zhiyong Z Yang Wentao W Bu Hong H Li Qin Q Zhang Zhang Z

BMC cancer 20191022 1

<h4>Background</h4>An External Quality Assessment (EQA) program was developed to investigate the status of estrogen receptor (ER), progesterone receptor (PR), and Ki-67 immunohistochemical (IHC) detection in breast cancer and to evaluate the reproducibility of staining and interpretation in 44 pathology laboratories in China.<h4>Methods</h4>This program was implemented through three specific steps. In study I, three revising centres defined the reference value for 11 sections. In study II, 41 pa ...[more]

PMID: 31640622

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Project description:Ki-67 is considered as one of prime biomarkers to reflect cell proliferation and immunohistochemical Ki-67 staining has been widely applied in clinical pathology. To solve the widespread controversy whether Ki-67 reactivity significantly predicts clinical prognosis of bladder carcinoma (BC), we performed a comprehensive meta-analysis by combining results from different literature. A comprehensive search was conducted in the Chinese databases of WanFang, China National Knowledge Infrastructure and Chinese VIP as well as English databases of PubMed, ISI web of science, EMBASE, Science Direct, and Wiley online library. Independent studies linking Ki-67 to cancer-specific survival (CSS), disease-free survival (DFS), overall survival (OS), progression-free survival (PFS), and recurrence-free survival (RFS) were included in our meta-analysis. With the cut-off values literature provided, hazard ratio (HR) values between the survival distributions were extracted and later combined with STATA 12.0. In total, 76 studies (n?=?13,053 patients) were eligible for the meta-analysis. It was indicated in either univariate or multivariate analysis for survival that high Ki-67 reactivity significantly predicted poor prognosis. In the univariate analysis, the combined HR for CSS, DFS, OS, PFS, and RFS were 2.588 (95% confidence interval [CI]: 1.623-4.127, P?<?0.001), 2.697 (95%CI: 1.874-3.883, P?<?0.001), 2.649 (95%CI: 1.632-4.300, P?<?0.001), 3.506 (95%CI: 2.231-5.508, P?<?0.001), and 1.792 (95%CI: 1.409-2.279, P?<?0.001), respectively. The pooled HR of multivariate analysis for CSS, DFS, OS, PFS, and RFS were 1.868 (95%CI: 1.343-2.597, P?<?0.001), 2.626 (95%CI: 2.089-3.301, P?<?0.001), 1.104 (95%CI: 1.008-1.209, P?=?0.032), 1.518 (95%CI: 1.299-1.773, P?<?0.001), and 1.294 (95%CI: 1.203-1.392, P?<?0.001), respectively. Subgroup analysis of univariate analysis by origin showed that Ki-67 reactivity significantly correlated with all 5 clinical outcome in Asian and European-American patients (P?<?0.05). For multivariate analysis, however, the pooled results were only significant for DFS, OS, and RFS in Asian patients, for CSS, DFS, PFS, and RFS in European-American patients (P?<?0.05). In the subgroup with low cut-off value (<20%), our meta-analysis indicated that high Ki-67 reactivity was significantly correlated with worsened CSS, DFS, OS, PFS, and RFS on univariate analysis (P?<?0.05). For multivariate analysis, the meta-analysis of literature with low cut-off value (<20%) demonstrated that high Ki-67 reactivity predicted shorter DFS, PFS, and RFS in BC patients (P?<?0.05). In the subgroup analysis of high cut-off value (?20%), our meta-analysis indicated that high Ki-67 reactivity, in either univariate or multivariate analysis, significantly correlated with all five clinical outcomes in BC patients (P?<?0.05). The meta-analysis indicates that high Ki-67 reactivity significantly correlates with deteriorated clinical outcomes in BC patients and that Ki-67 can be considered as an independent indicator for the prognosis by the meta-analyses of multivariate analysis.

Dataset Information

External quality assessment (EQA) program for the immunohistochemical detection of ER, PR and Ki-67 in breast cancer: results of an interlaboratory reproducibility ring study in China.

Background

Methods

Results

Conclusions

Publications

External quality assessment (EQA) program for the immunohistochemical detection of ER, PR and Ki-67 in breast cancer: results of an interlaboratory reproducibility ring study in China.

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