PMID- 34875014 OWN - NLM STAT- MEDLINE DCOM- 20220608 LR - 20220712 IS - 1943-7722 (Electronic) IS - 0002-9173 (Linking) VI - 157 IP - 6 DP - 2022 Jun 7 TI - Quantitative Image Analysis as an Adjunct to Manual Scoring of ER, PgR, and HER2 in Invasive Breast Carcinoma. PG - 899-907 LID - 10.1093/ajcp/aqab206 [doi] AB - OBJECTIVES: Biomarker expression evaluation for estrogen receptor (ER), progesterone receptor (PgR), and human epidermal growth factor receptor 2 (HER2) is an essential prognostic and predictive parameter for breast cancer and critical for guiding hormonal and neoadjuvant therapy. This study compared quantitative image analysis (QIA) with pathologists' scoring for ER, PgR, and HER2. METHODS: A retrospective analysis was undertaken of 1,367 invasive breast carcinomas, including all histopathology subtypes, for which ER, PgR, and HER2 were analyzed by manual scoring and QIA. The resulting scores were compared, and in a subset of HER2 cases (n = 373, 26%), scores were correlated with available fluorescence in situ hybridization (FISH) results. RESULTS: Concordance between QIA and manual scores for ER, PgR, and HER2 was 93%, 96%, and 90%, respectively. Discordant cases had low positive scores (1%-10%) for ER (n = 33), were due to nonrepresentative region selection (eg, ductal carcinoma in situ) or tumor heterogeneity for PgR (n = 43), and were of one-step difference (negative to equivocal, equivocal to positive, or vice versa) for HER2 (n = 90). Among HER2 cases where FISH results were available, only four (1.0%) showed discordant QIA and FISH results. CONCLUSIONS: QIA is a computer-aided diagnostic support tool for pathologists. It significantly improves ER, PgR, and HER2 scoring standardization. QIA demonstrated excellent concordance with pathologists' scores. To avoid pitfalls, pathologist oversight of representative region selection is recommended. CI - (c) American Society for Clinical Pathology, 2021. All rights reserved. For permissions, please e-mail: journals.permissions@oup.com. FAU - Yousif, Mustafa AU - Yousif M AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. AD - Department of Pathology, Vanderbilt University Medical Center, Nashville, TN USA. FAU - Huang, Yiyuan AU - Huang Y AD - Department of Biostatistics, University of Michigan, Ann Arbor, MI USA. FAU - Sciallis, Andrew AU - Sciallis A AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Kleer, Celina G AU - Kleer CG AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Pang, Judy AU - Pang J AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Smola, Brian AU - Smola B AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Naik, Kalyani AU - Naik K AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - McClintock, David S AU - McClintock DS AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Zhao, Lili AU - Zhao L AUID- ORCID: 0000-0002-6366-8206 AD - Department of Biostatistics, University of Michigan, Ann Arbor, MI USA. FAU - Kunju, Lakshmi P AU - Kunju LP AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Balis, Ulysses G J AU - Balis UGJ AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. FAU - Pantanowitz, Liron AU - Pantanowitz L AD - Department of Pathology, University of Michigan Medical School, Ann Arbor, MI USA. LA - eng PT - Journal Article PL - England TA - Am J Clin Pathol JT - American journal of clinical pathology JID - 0370470 RN - 0 (Biomarkers, Tumor) RN - 0 (Receptors, Estrogen) RN - 0 (Receptors, Progesterone) RN - EC 2.7.10.1 (ERBB2 protein, human) RN - EC 2.7.10.1 (Receptor, ErbB-2) SB - IM MH - Biomarkers, Tumor/metabolism MH - *Breast Neoplasms/diagnosis MH - Female MH - Humans MH - In Situ Hybridization, Fluorescence MH - Receptor, ErbB-2/metabolism MH - Receptors, Estrogen/metabolism MH - *Receptors, Progesterone/metabolism MH - Retrospective Studies OTO - NOTNLM OT - Biomarkers OT - Digital pathology OT - Invasive breast carcinoma OT - Quantitative image analysis OT - Whole slide imaging EDAT- 2021/12/08 06:00 MHDA- 2022/06/09 06:00 CRDT- 2021/12/07 17:24 PHST- 2021/09/13 00:00 [received] PHST- 2021/11/08 00:00 [accepted] PHST- 2021/12/08 06:00 [pubmed] PHST- 2022/06/09 06:00 [medline] PHST- 2021/12/07 17:24 [entrez] AID - 6454995 [pii] AID - 10.1093/ajcp/aqab206 [doi] PST - ppublish SO - Am J Clin Pathol. 2022 Jun 7;157(6):899-907. doi: 10.1093/ajcp/aqab206.