Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method

PurposeRecommendations from the National Health Commission of China (NHCC) and the International Ki67 Working Group (IKWG) were issued to guide immunohistochemistry (IHC)-based Ki67 scoring for breast cancer patients in daily clinical practice. They were evaluated in this multi-institutional study a...

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Main Authors: Yin Wang, Jiarui Zou, Qinghua Cao, Guihong Dai, Panhong Fan, Xue Gong, Jinyan Jiang, Yanqing Kong, Chao Liu, Chunhui Liu, Chenjia Lu, Meiren Li, Zhiqiang Lang, Yang Lin, Yan Peng, Haiyan Shi, Yuhuan Wang, Jiu Wang, Bichen Xie, Bing Yang, Guohua Yu, Cuiping Zhang, Hengming Zhang, Luting Zhou, Zilan Zhang, Zhenli Zhu, Junmei Hao
Format: Article
Language:English
Published: Frontiers Media S.A. 2025-01-01
Series:Frontiers in Oncology
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Online Access:https://www.frontiersin.org/articles/10.3389/fonc.2024.1510273/full
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author Yin Wang
Jiarui Zou
Qinghua Cao
Guihong Dai
Panhong Fan
Xue Gong
Jinyan Jiang
Yanqing Kong
Chao Liu
Chunhui Liu
Chenjia Lu
Meiren Li
Zhiqiang Lang
Yang Lin
Yan Peng
Haiyan Shi
Yuhuan Wang
Jiu Wang
Bichen Xie
Bing Yang
Guohua Yu
Cuiping Zhang
Hengming Zhang
Luting Zhou
Zilan Zhang
Zhenli Zhu
Junmei Hao
author_facet Yin Wang
Jiarui Zou
Qinghua Cao
Guihong Dai
Panhong Fan
Xue Gong
Jinyan Jiang
Yanqing Kong
Chao Liu
Chunhui Liu
Chenjia Lu
Meiren Li
Zhiqiang Lang
Yang Lin
Yan Peng
Haiyan Shi
Yuhuan Wang
Jiu Wang
Bichen Xie
Bing Yang
Guohua Yu
Cuiping Zhang
Hengming Zhang
Luting Zhou
Zilan Zhang
Zhenli Zhu
Junmei Hao
author_sort Yin Wang
collection DOAJ
description PurposeRecommendations from the National Health Commission of China (NHCC) and the International Ki67 Working Group (IKWG) were issued to guide immunohistochemistry (IHC)-based Ki67 scoring for breast cancer patients in daily clinical practice. They were evaluated in this multi-institutional study alongside the results from the Quantitative Dot Blot (QDB) method.MethodsThree alternative adjacent sections from 40 primary ER+ breast cancer resection blocks were randomly assigned a number from 1 to 120 for Ki67 staining and reviewed by 21 pathologists, while the other three alternative sections were sent for QDB analysis of Ki67 protein levels. Ki67 scores were grouped by 5/30% (IKWG), 10/30% (NHCC) and 20/30% (NHCC appendix 9, NHCCa9), respectively while QDB results were grouped by C5–C95 of 2.31 nmol/g defined in previous study as low-, equivocal-, and high-risk groups.ResultsThe overall Intraclass Correlation Coefficient (ICC) was 0.785 for IHC evaluations from 21 pathologists, with Fleiss Kappa values of 0.555, 0.628, and 0.480 when Ki67 scores were grouped by guidance from IKWG, NHCC, and NHCCa9, respectively. In comparison, the ICC and Fleiss kappa values for the QDB analysis were 0.939 and 0.831, respectively. When IHC and QDB results were cross-referenced, more specimens were grouped as high-risk by QDB than IHC, and NHCCa9 led to the highest percentage of disagreement between the two methods.ConclusionThe IKWG recommendation was harder to achieve categorized agreement among pathologists than the NHCC recommendation, yet it led to the best agreement with the QDB to define the low-risk group. The QDB method offers significantly improved consistency compared to the current IHC-based Ki67 assessment.
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spelling doaj-art-4fc2feb8d3fa4f80a7481bbcf7bb20652025-01-27T09:46:07ZengFrontiers Media S.A.Frontiers in Oncology2234-943X2025-01-011410.3389/fonc.2024.15102731510273Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot methodYin Wang0Jiarui Zou1Qinghua Cao2Guihong Dai3Panhong Fan4Xue Gong5Jinyan Jiang6Yanqing Kong7Chao Liu8Chunhui Liu9Chenjia Lu10Meiren Li11Zhiqiang Lang12Yang Lin13Yan Peng14Haiyan Shi15Yuhuan Wang16Jiu Wang17Bichen Xie18Bing Yang19Guohua Yu20Cuiping Zhang21Hengming Zhang22Luting Zhou23Zilan Zhang24Zhenli Zhu25Junmei Hao26Department of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaDepartment of Pathology, Hangzhou Red Cross Hospital, Hangzhou, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaDepartment of Pathology, The Affiliated Taizhou People’s Hospital of Nanjing Medical University, Taizhou School of Clinical Medicine, Nanjing Medical University, Taizhou, ChinaDepartment of Pathology, Henan Provincial People’s Hospital, Zhengzhou, ChinaDepartment of Pathology, Qinghai University Affiliated Hospital, Xining, ChinaDepartment of Pathology, Chenzhou No. 1 People Hospital, Chenzhou, ChinaDepartment of Pathology, Shenzhen Maternity and Child Healthcare Hospital, Shenzhen, ChinaDepartment of Pathology, Guangdong Provincial People’s Hospital (Guangdong Academy of Medical Sciences), Southern Medical University, Guangzhou, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaDepartment of Pathology, The People’s Hospital of LongHua, Shenzhen, China0Department of Pathology, Jiujiang University Affiliated Hospital, Jiujiang, China1Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, China2Department of Health statistics, School of Public Health, Binzhou Medical University, Yantai, China3Department of Pathology, The Third Affiliated Hospital of Soochow University/Changzhou First People’s Hospital, Changzhou, China4Department of Pathology, Guangdong Hospital of Integrated Traditional Chinese and Western Medicine, Guangzhou, China5Department of Pathology, People’s Hospital of Xinjiang Uygur Autonomous Region, Urymqi, China2Department of Health statistics, School of Public Health, Binzhou Medical University, Yantai, China6Department of Pathology, Affiliated Hospital of Jiangnan University, Wuxi, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China1Department of Pathology, Affiliated Yantai Yuhuangding Hospital, Qingdao University, Yantai, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, China7Department of Pathology, Weifang People’s Hospital, Weifang, China8Department of Pathology, Ruijin Hospital, Shanghai Jiaotong University School of Medicine, Shanghai, China9Department of Pathology, Northern Jiangsu People’s Hospital, Yangzhou, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaDepartment of Pathology, Yantai Affiliated Hospital of Binzhou Medical University, Yantai, ChinaPurposeRecommendations from the National Health Commission of China (NHCC) and the International Ki67 Working Group (IKWG) were issued to guide immunohistochemistry (IHC)-based Ki67 scoring for breast cancer patients in daily clinical practice. They were evaluated in this multi-institutional study alongside the results from the Quantitative Dot Blot (QDB) method.MethodsThree alternative adjacent sections from 40 primary ER+ breast cancer resection blocks were randomly assigned a number from 1 to 120 for Ki67 staining and reviewed by 21 pathologists, while the other three alternative sections were sent for QDB analysis of Ki67 protein levels. Ki67 scores were grouped by 5/30% (IKWG), 10/30% (NHCC) and 20/30% (NHCC appendix 9, NHCCa9), respectively while QDB results were grouped by C5–C95 of 2.31 nmol/g defined in previous study as low-, equivocal-, and high-risk groups.ResultsThe overall Intraclass Correlation Coefficient (ICC) was 0.785 for IHC evaluations from 21 pathologists, with Fleiss Kappa values of 0.555, 0.628, and 0.480 when Ki67 scores were grouped by guidance from IKWG, NHCC, and NHCCa9, respectively. In comparison, the ICC and Fleiss kappa values for the QDB analysis were 0.939 and 0.831, respectively. When IHC and QDB results were cross-referenced, more specimens were grouped as high-risk by QDB than IHC, and NHCCa9 led to the highest percentage of disagreement between the two methods.ConclusionThe IKWG recommendation was harder to achieve categorized agreement among pathologists than the NHCC recommendation, yet it led to the best agreement with the QDB to define the low-risk group. The QDB method offers significantly improved consistency compared to the current IHC-based Ki67 assessment.https://www.frontiersin.org/articles/10.3389/fonc.2024.1510273/fullbreast cancerKi67QDBIHCIKWGNHCC
spellingShingle Yin Wang
Jiarui Zou
Qinghua Cao
Guihong Dai
Panhong Fan
Xue Gong
Jinyan Jiang
Yanqing Kong
Chao Liu
Chunhui Liu
Chenjia Lu
Meiren Li
Zhiqiang Lang
Yang Lin
Yan Peng
Haiyan Shi
Yuhuan Wang
Jiu Wang
Bichen Xie
Bing Yang
Guohua Yu
Cuiping Zhang
Hengming Zhang
Luting Zhou
Zilan Zhang
Zhenli Zhu
Junmei Hao
Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
Frontiers in Oncology
breast cancer
Ki67
QDB
IHC
IKWG
NHCC
title Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
title_full Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
title_fullStr Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
title_full_unstemmed Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
title_short Multi-institutional evaluation comparing guidance from International Ki67 Working Group vs National Health Commission of China on immunohistochemistry-based Ki67 assessment alongside the Quantitative Dot Blot method
title_sort multi institutional evaluation comparing guidance from international ki67 working group vs national health commission of china on immunohistochemistry based ki67 assessment alongside the quantitative dot blot method
topic breast cancer
Ki67
QDB
IHC
IKWG
NHCC
url https://www.frontiersin.org/articles/10.3389/fonc.2024.1510273/full
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