Whole tumor section quantitative image analysis maximizes between-pathologists' reproducibility for clinical immunohistochemistry-based biomarkers

Laboratory Investigation

Volumn 97, Issue 12, 2017, Pages 1508-1515

  Barnes, Michael ^a   Srinivas, Chukka ^b   Bai, Isaac ^b   Frederick, Judith ^b   Liu, Wendy ^b   Sarkar, Anindya ^b   Wang, Xiuzhong ^b   Nie, Yao ^b   Portier, Bryce ^a   Kapadia, Monesh ^a   Sertel, Olcay ^b   Little, Elizabeth ^b   Sabata, Bikash ^b   Ranger Moore, Jim ^a  

^a Roche Tissue Diagnostics   (United States)

^b Digital Pathology   (United States)

Author keywords

[No Author keywords available]

Indexed keywords

BIOLOGICAL MARKER; EPIDERMAL GROWTH FACTOR RECEPTOR 2; ESTROGEN RECEPTOR; KI 67 ANTIGEN; PROGESTERONE RECEPTOR; PROTEIN P53; TP53 PROTEIN, HUMAN; TUMOR MARKER;

ARTICLE; CLINICAL DECISION MAKING; CLINICAL STUDY; DIGITAL IMAGING; HUMAN; IMAGE ANALYSIS; IMMUNOHISTOCHEMISTRY; MORPHOLOGY; PATHOLOGIST; PRIORITY JOURNAL; QUANTITATIVE ANALYSIS; REPRODUCIBILITY; WHOLE TUMOR SECTION IMAGE ANALYSIS; BREAST TUMOR; CHEMISTRY; COMPUTER ASSISTED DIAGNOSIS; DIAGNOSTIC IMAGING; FEMALE; PROCEDURES;

BIOMARKERS, TUMOR; BREAST NEOPLASMS; FEMALE; HUMANS; IMAGE INTERPRETATION, COMPUTER-ASSISTED; IMMUNOHISTOCHEMISTRY; KI-67 ANTIGEN; TUMOR SUPPRESSOR PROTEIN P53;

EID: 85036656673     PISSN: 00236837     EISSN: 15300307     Source Type: Journal    
DOI: 10.1038/labinvest.2017.82     Document Type: Article

References (23)

1. Wolff AC, Hammond ME, Hicks DG, et al. American Society of Clinical Oncology; College of American Pathologists. Recommendations for human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists clinical practice guideline update. Arch Pathol Lab Med 2014;138:241-256.
2. Hammond ME, Hayes DF, Dowsett M, et al. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer. Arch Pathol Lab Med 2010;134:907-922.
3. Dowsett M, Nielsen TO, A'Hern R, et al. International Ki-67 in Breast Cancer Working Group. Assessment of Ki67 in breast cancer: recommendations from the International Ki67 in Breast Cancer working group. J Natl Cancer Inst 2011;103:1656-1664.
4. Ciocca DR, Elledge R. Molecular markers for predicting response to tamoxifen in breast cancer patients. Endocrine 2000;13:1-10.
5. Prichard JW. Overview of automated immunohistochemistry. Arch Pathol Lab Med 2014;138:1578-1582.
6. "Paving the way for personalized medicine: FDA's role in a new era of medical product development". US Food and Drug Adminitration, October 2013. Available at: https://www.fda.gov/downloads/science research/specialtopics/personalizedmedicine/ucm372421.pdf.
7. Fitzgibbons PL, Bradley LA, Fatheree LA, et al. Arch Pathol Lab Med 2014;138:1432-1443.
8. Terry J, Torlakovic EE, Garratt J, et al. Implementation of a Canadian external quality assurance program for breast cancer biomarkers: an initiative of Canadian Quality Control in immunohistochemistry (cIQc) and Canadian Association of Pathologists (CAP) National Standards Committee/Immunohistochemistry. Appl Immunohistochem Mol Morphol 2009;17:375-382.
9. Dyhdalo KS, Fitzgibbons PL, Goldsmith JD, et al. Laboratory compliance with the American Society of Clinical Oncology/College of American Pathologists human epidermal growth factor receptor 2 testing guidelines: a 3-year comparison of validation procedures. Arch Pathol Lab Med. 2014;138:876-884.
10. Badve SS, Baehner FL, Gray RP, et al. Estrogen- and progesteronereceptor status in ECOG 2197: comparison of immunohistochemistry by local and central laboratories and quantitative reverse transcription polymerase chain reaction by central laboratory. J Clin Oncol 2008;26: 2473-2481.
11. Gelber RD, Gelber S. International Breast Cancer Study Group; Breast International Group. Facilitating consensus by examining patterns of treatment effects. Breast 2009;18(Suppl 3):S2-S8.
12. Viale G, Regan MM, Maiorano E, et al. Prognostic and predictive value of centrally reviewed expression of estrogen and progesterone receptors in a randomized trial comparing letrozole and tamoxifen adjuvant therapy for postmenopausal early breast cancer: BIG 1-98. J Clin Oncol 2007;25:3846-3852.
13. Reisenbichler ES, Lester SC, Richardson AL, et al. Interobserver concordance in implementing the 2010 ASCO/CAP recommendations for reporting ER in breast carcinomas: a demonstration of the difficulties of consistently reporting low levels of ER expression by manual quantification. Am J Clin Pathol 2013;140:487-494.
14. Nielsen S. External quality assessment for immunohistochemistry: experiences from NordiQC. Biotech Histochem 2015;90:331-340.
15. Terrenato I, Arena V, Pizzamiglio S, et al. External Quality Assessment (EQA) program for the preanalytical and analytical immunohistochemical determination of HER2 in breast cancer: an experience on a regional scale. J Exp Clin Cancer Res 2013;32:58.
16. Torlakovic EE, Francis G, Garratt J, et al. International Ad Hoc Expert Panel. Standardization of negative controls in diagnostic immunohistochemistry: recommendations from the international ad hoc expert panel. Appl Immunohistochem Mol Morphol 2014;22: 241-252.
17. Lin F, Chen Z. Standardization of diagnostic immunohistochemistry: literature review and geisinger experience. Arch Pathol Lab Med 2014;138:1564-1577.
18. Ghaznavi F, Evans A, Madabhushi A, et al. Digital imaging in pathology: whole-slide imaging and beyond. Annu Rev Pathol 2013;8: 331-359.
19. Rexhepaj E, Brennan DJ, Holloway P, et al. Novel image analysis approach for quantifying expression of nuclear proteins assessed by immunohistochemistry: application to measurement of oestrogen and progesterone receptor levels in breast cancer. Breast Cancer Res 2008;10:R89.
20. Nassar A, Cohen C, Agersborg SS, et al. Trainable immunohistochemical HER2/neu image analysis: a multisite performance study using 260 breast tissue specimens. Arch Pathol Lab Med 2011;135: 896-902.
21. Yu KH, Zhang C, Berry GJ, et al. Predicting non-small cell lung cancer prognosis by fully automated microscopic pathology image features. Nat Commun 2016;7:12474.
22. Barnes M, Bai I, Nguyen K, et al. Pathologist agreement rates of PD-L1 tumor and immune cell quantitation using digital read, field-ofview, and whole tumor image analysis. J Thorac Oncol 2016;12: S811-S812.
23. Barnes M, Bai I, Nguyen K, et al. Pathologists' accuracy and reproducibility rates for PD-L1 immune cell quantitation using a digital pathology image analysis algorithm in urothelial carcinoma samples (abstract 2114). Mod Pathology 2017;30:523-538.