Skip to main content
Top
Published in: Cancer Cell International 1/2019

Open Access 01-12-2019 | Fluorescence in Situ Hybridization | Primary research

Suboptimal concordance in testing and retesting results of triple-negative breast carcinoma cases among laboratories: one institution experience

Authors: Jose De Jesus, Marilin Rosa

Published in: Cancer Cell International | Issue 1/2019

Login to get access

Abstract

Background

Triple-negative breast carcinoma (TNBC) patients do not benefit from hormone- or human epidermal growth factor receptor 2- (HER2-) targeted therapies. Accurate testing is pivotal for these patients.

Methods

TNBC cases that were retested at our institution during a 3-year period were evaluated for concordance rates in estrogen (ER) and progesterone (PR) receptor and HER2 results.

Results

We found 19 (22%) discrepancies (13 major/6 minor) among 86 cases. Minor discrepancies were in HER2 changes by immunohistochemistry, and all cases were demonstrated to be negative by and dual in situ hybridization. All major discrepancies were in ER/PR expression changes. In only 2 cases the treatment changed based on repeated results and/or patient history.

Conclusions

Discrepancies in prognostic/predictive testing continue to be frequent despite rigorous regulations. However, since for the majority of patients in our setting, the treatment plan did not change, reflex retesting for TNBC has been deemed unnecessary in our institution.
Literature
1.
go back to reference Diaz LK, Sneige N. Estrogen receptor analysis for breast cancer: current issues and keys to increasing testing accuracy. Adv Anat Pathol. 2005;121:10–9 (Epub 2004/12/23).CrossRef Diaz LK, Sneige N. Estrogen receptor analysis for breast cancer: current issues and keys to increasing testing accuracy. Adv Anat Pathol. 2005;121:10–9 (Epub 2004/12/23).CrossRef
2.
go back to reference Gown AM. Current issues in ER and HER2 testing by IHC in breast cancer. Mod Pathol. 2008;21(Suppl 2):S8–s15 (Epub 2008/06/24).CrossRef Gown AM. Current issues in ER and HER2 testing by IHC in breast cancer. Mod Pathol. 2008;21(Suppl 2):S8–s15 (Epub 2008/06/24).CrossRef
3.
go back to reference Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008;268:1275–81.CrossRef Liedtke C, Mazouni C, Hess KR, et al. Response to neoadjuvant therapy and long-term survival in patients with triple-negative breast cancer. J Clin Oncol. 2008;268:1275–81.CrossRef
4.
go back to reference Schmadeka R, Harmon BE, Singh M. Triple-negative breast carcinoma: current and emerging concepts. Am J Clin Pathol. 2014;1414:462–77.CrossRef Schmadeka R, Harmon BE, Singh M. Triple-negative breast carcinoma: current and emerging concepts. Am J Clin Pathol. 2014;1414:462–77.CrossRef
5.
go back to reference Boichuk S, Galembikova A, Sitenkov A, et al. Establishment and characterization of a triple negative basallike breast cancer cell line with multidrug resistance. Oncol Lett. 2017;144:5039–45.CrossRef Boichuk S, Galembikova A, Sitenkov A, et al. Establishment and characterization of a triple negative basallike breast cancer cell line with multidrug resistance. Oncol Lett. 2017;144:5039–45.CrossRef
6.
go back to reference Shao F, Sun H, Deng C-X. Potential therapeutic targets of triple-negative breast cancer based on its intrinsic subtype. Oncotarget. 2017;842:73329. Shao F, Sun H, Deng C-X. Potential therapeutic targets of triple-negative breast cancer based on its intrinsic subtype. Oncotarget. 2017;842:73329.
7.
go back to reference Carey LA, Dees EC, Sawyer L, et al. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007;138:2329–34.CrossRef Carey LA, Dees EC, Sawyer L, et al. The triple negative paradox: primary tumor chemosensitivity of breast cancer subtypes. Clin Cancer Res. 2007;138:2329–34.CrossRef
8.
go back to reference Precht LM, Lowe KA, Atwood M, Beatty JD. Neoadjuvant chemotherapy of breast cancer: tumor markers as predictors of pathologic response, recurrence, and survival. Breast J. 2010;164:362–8. Precht LM, Lowe KA, Atwood M, Beatty JD. Neoadjuvant chemotherapy of breast cancer: tumor markers as predictors of pathologic response, recurrence, and survival. Breast J. 2010;164:362–8.
9.
go back to reference Wolff AC, Hammond MEH, Hicks DG, et al. 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. 2013;1382:241–56. Wolff AC, Hammond MEH, Hicks DG, et al. 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. 2013;1382:241–56.
10.
go back to reference Hammond MEH, 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 (unabridged version). Arch Pathol Lab Med. 2010;1347:e48–72. Hammond MEH, 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 (unabridged version). Arch Pathol Lab Med. 2010;1347:e48–72.
11.
go back to reference Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018;3620:2105–22 (Epub 2018/05/31).CrossRef Wolff AC, Hammond MEH, Allison KH, et al. Human epidermal growth factor receptor 2 testing in breast cancer: American Society of Clinical Oncology/College of American Pathologists Clinical Practice Guideline Focused Update. J Clin Oncol. 2018;3620:2105–22 (Epub 2018/05/31).CrossRef
12.
go back to reference McCullough AE, Dell’Orto P, Reinholz MM, et al. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014;1433:485–92.CrossRef McCullough AE, Dell’Orto P, Reinholz MM, et al. Central pathology laboratory review of HER2 and ER in early breast cancer: an ALTTO trial [BIG 2-06/NCCTG N063D (Alliance)] ring study. Breast Cancer Res Treat. 2014;1433:485–92.CrossRef
13.
go back to reference Layfield LJ, Goldstein N, Perkinson KR, Proia AD. Interlaboratory variation in results from immunohistochemical assessment of estrogen receptor status. Breast J. 2003;93:257–9.CrossRef Layfield LJ, Goldstein N, Perkinson KR, Proia AD. Interlaboratory variation in results from immunohistochemical assessment of estrogen receptor status. Breast J. 2003;93:257–9.CrossRef
14.
go back to reference Moatamed NA, Nanjangud G, Pucci R, et al. Effect of ischemic time, fixation time, and fixative type on HER2/neu immunohistochemical and fluorescence in situ hybridization results in breast cancer. Am J Clin Pathol. 2011;1365:754–61.CrossRef Moatamed NA, Nanjangud G, Pucci R, et al. Effect of ischemic time, fixation time, and fixative type on HER2/neu immunohistochemical and fluorescence in situ hybridization results in breast cancer. Am J Clin Pathol. 2011;1365:754–61.CrossRef
16.
go back to reference Parker RL, Huntsman DG, Lesack DW, et al. Assessment of interlaboratory variation in the immunohistochemical determination of estrogen receptor status using a breast cancer tissue microarray. Am J Clin Pathol. 2002;1175:723–8.CrossRef Parker RL, Huntsman DG, Lesack DW, et al. Assessment of interlaboratory variation in the immunohistochemical determination of estrogen receptor status using a breast cancer tissue microarray. Am J Clin Pathol. 2002;1175:723–8.CrossRef
17.
go back to reference Perez EA, Press MF, Dueck AC, et al. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013;1381:99–108.CrossRef Perez EA, Press MF, Dueck AC, et al. Immunohistochemistry and fluorescence in situ hybridization assessment of HER2 in clinical trials of adjuvant therapy for breast cancer (NCCTG N9831, BCIRG 006, and BCIRG 005). Breast Cancer Res Treat. 2013;1381:99–108.CrossRef
18.
go back to reference Paik S, Bryant J, Tan-Chiu E, et al. Real-world performance of HER2 testing—national surgical adjuvant breast and bowel project experience. J Natl Cancer Inst. 2002;9411:852–4.CrossRef Paik S, Bryant J, Tan-Chiu E, et al. Real-world performance of HER2 testing—national surgical adjuvant breast and bowel project experience. J Natl Cancer Inst. 2002;9411:852–4.CrossRef
19.
go back to reference Reddy JC, Reimann JD, Anderson SM, Klein PM. Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clin Breast Cancer. 2006;72:153–7.CrossRef Reddy JC, Reimann JD, Anderson SM, Klein PM. Concordance between central and local laboratory HER2 testing from a community-based clinical study. Clin Breast Cancer. 2006;72:153–7.CrossRef
20.
go back to reference O’Malley FP, Thomson T, Julian J, et al. HER2 testing in a population-based study of patients with metastatic breast cancer treated with trastuzumab. Arch Pathol Lab Med. 2008;1321:61–5. O’Malley FP, Thomson T, Julian J, et al. HER2 testing in a population-based study of patients with metastatic breast cancer treated with trastuzumab. Arch Pathol Lab Med. 2008;1321:61–5.
21.
go back to reference Roche PC, Suman VJ, Jenkins RB, et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002;9411:855–7.CrossRef Roche PC, Suman VJ, Jenkins RB, et al. Concordance between local and central laboratory HER2 testing in the breast intergroup trial N9831. J Natl Cancer Inst. 2002;9411:855–7.CrossRef
22.
go back to reference Rosa M, Khazai L. Comparison of HER 2 testing among laboratories: our experience with review cases retested at Moffitt Cancer Center in a two-year period. Breast J. 2018;242:139–47.CrossRef Rosa M, Khazai L. Comparison of HER 2 testing among laboratories: our experience with review cases retested at Moffitt Cancer Center in a two-year period. Breast J. 2018;242:139–47.CrossRef
23.
go back to reference Pinder SE, Campbell AF, Bartlett JM, et al. Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial. Br J Cancer. 2017;1167:859–63 (Epub 2017/02/22).CrossRef Pinder SE, Campbell AF, Bartlett JM, et al. Discrepancies in central review re-testing of patients with ER-positive and HER2-negative breast cancer in the OPTIMA prelim randomised clinical trial. Br J Cancer. 2017;1167:859–63 (Epub 2017/02/22).CrossRef
24.
go back to reference Badve SS, Baehner FL, Gray RP, et al. Estrogen- and progesterone-receptor 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;2615:2473–81 (Epub 2008/05/20).CrossRef Badve SS, Baehner FL, Gray RP, et al. Estrogen- and progesterone-receptor 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;2615:2473–81 (Epub 2008/05/20).CrossRef
25.
go back to reference Iwamoto T, Booser D, Valero V, et al. Estrogen receptor (ER) mRNA and ER-related gene expression in breast cancers that are 1% to 10% ER-positive by immunohistochemistry. J Clin Oncol. 2012;307:729–34.CrossRef Iwamoto T, Booser D, Valero V, et al. Estrogen receptor (ER) mRNA and ER-related gene expression in breast cancers that are 1% to 10% ER-positive by immunohistochemistry. J Clin Oncol. 2012;307:729–34.CrossRef
26.
go back to reference Deyarmin B, Kane JL, Valente AL, et al. Effect of ASCO/CAP guidelines for determining ER status on molecular subtype. Ann Surg Oncol. 2013;201:87–93.CrossRef Deyarmin B, Kane JL, Valente AL, et al. Effect of ASCO/CAP guidelines for determining ER status on molecular subtype. Ann Surg Oncol. 2013;201:87–93.CrossRef
27.
go back to reference Hefti MM, Hu R, Knoblauch NW, et al. Estrogen receptor negative/progesterone receptor positive breast cancer is not a reproducible subtype. Breast Cancer Res. 2013;154:R68.CrossRef Hefti MM, Hu R, Knoblauch NW, et al. Estrogen receptor negative/progesterone receptor positive breast cancer is not a reproducible subtype. Breast Cancer Res. 2013;154:R68.CrossRef
28.
go back to reference Bardou V-J, Arpino G, Elledge RM, Osborne CK, Clark GM. Progesterone receptor status significantly improves outcome prediction over estrogen receptor status alone for adjuvant endocrine therapy in two large breast cancer databases. J Clin Oncol. 2003;2110:1973–9.CrossRef Bardou V-J, Arpino G, Elledge RM, Osborne CK, Clark GM. Progesterone receptor status significantly improves outcome prediction over estrogen receptor status alone for adjuvant endocrine therapy in two large breast cancer databases. J Clin Oncol. 2003;2110:1973–9.CrossRef
29.
go back to reference Colomer R, Beltran M, Dorcas J, et al. It is not time to stop progesterone receptor testing in breast cancer. J Clin Oncol. 2005;2316:3868–9.CrossRef Colomer R, Beltran M, Dorcas J, et al. It is not time to stop progesterone receptor testing in breast cancer. J Clin Oncol. 2005;2316:3868–9.CrossRef
30.
go back to reference Fuqua SA, Cui Y, Lee AV, Osborne CK, Horwitz KB. Insights into the role of progesterone receptors in breast cancer. J Clin Oncol. 2005;234:931–2.CrossRef Fuqua SA, Cui Y, Lee AV, Osborne CK, Horwitz KB. Insights into the role of progesterone receptors in breast cancer. J Clin Oncol. 2005;234:931–2.CrossRef
31.
go back to reference Kornaga EN, Klimowicz AC, Guggisberg N, et al. Evaluation of three commercial progesterone receptor assays in a single tamoxifen-treated breast cancer cohort. Mod Pathol. 2016;2912:1492.CrossRef Kornaga EN, Klimowicz AC, Guggisberg N, et al. Evaluation of three commercial progesterone receptor assays in a single tamoxifen-treated breast cancer cohort. Mod Pathol. 2016;2912:1492.CrossRef
32.
go back to reference Knutson TP, Lange CA. Tracking progesterone receptor-mediated actions in breast cancer. Pharmacol Ther. 2014;1421:114–25.CrossRef Knutson TP, Lange CA. Tracking progesterone receptor-mediated actions in breast cancer. Pharmacol Ther. 2014;1421:114–25.CrossRef
33.
go back to reference Osborne CK, Schiff R, Arpino G, Lee AS, Hilsenbeck V. Endocrine responsiveness: understanding how progesterone receptor can be used to select endocrine therapy. Breast J. 2005;146:458–65.CrossRef Osborne CK, Schiff R, Arpino G, Lee AS, Hilsenbeck V. Endocrine responsiveness: understanding how progesterone receptor can be used to select endocrine therapy. Breast J. 2005;146:458–65.CrossRef
34.
go back to reference Ibrahim M, Dodson A, Barnett S, Fish D, Jasani B, Miller K. Potential for false-positive staining with a rabbit monoclonal antibody to progesterone receptor (SP2): findings of the UK National External Quality Assessment Scheme for Immunocytochemistry and FISH highlight the need for correct validation of antibodies on introduction to the laboratory. Am J Clin Pathol. 2008;1293:398–409 (Epub 2008/02/21).CrossRef Ibrahim M, Dodson A, Barnett S, Fish D, Jasani B, Miller K. Potential for false-positive staining with a rabbit monoclonal antibody to progesterone receptor (SP2): findings of the UK National External Quality Assessment Scheme for Immunocytochemistry and FISH highlight the need for correct validation of antibodies on introduction to the laboratory. Am J Clin Pathol. 2008;1293:398–409 (Epub 2008/02/21).CrossRef
35.
go back to reference Ciocca DR, Elledge R. Molecular markers for predicting response to tamoxifen in breast cancer patients. Endocrine. 2000;131:1–10.CrossRef Ciocca DR, Elledge R. Molecular markers for predicting response to tamoxifen in breast cancer patients. Endocrine. 2000;131:1–10.CrossRef
37.
go back to reference VandenBussche CJ, Cimino-Mathews A, Park BH, Emens LA, Tsangaris TN, Argani P. Reflex estrogen receptor/progesterone receptor/human epidermal growth factor receptor 2 (ER/PR/Her2) analysis of breast cancers in needle core biopsy specimens dramatically increases health care costs. Am J Surg Pathol. 2015;397:939–47.CrossRef VandenBussche CJ, Cimino-Mathews A, Park BH, Emens LA, Tsangaris TN, Argani P. Reflex estrogen receptor/progesterone receptor/human epidermal growth factor receptor 2 (ER/PR/Her2) analysis of breast cancers in needle core biopsy specimens dramatically increases health care costs. Am J Surg Pathol. 2015;397:939–47.CrossRef
Metadata
Title
Suboptimal concordance in testing and retesting results of triple-negative breast carcinoma cases among laboratories: one institution experience
Authors
Jose De Jesus
Marilin Rosa
Publication date
01-12-2019
Publisher
BioMed Central
Published in
Cancer Cell International / Issue 1/2019
Electronic ISSN: 1475-2867
DOI
https://doi.org/10.1186/s12935-019-0987-7

Other articles of this Issue 1/2019

Cancer Cell International 1/2019 Go to the issue
Webinar | 19-02-2024 | 17:30 (CET)

Keynote webinar | Spotlight on antibody–drug conjugates in cancer

Antibody–drug conjugates (ADCs) are novel agents that have shown promise across multiple tumor types. Explore the current landscape of ADCs in breast and lung cancer with our experts, and gain insights into the mechanism of action, key clinical trials data, existing challenges, and future directions.

Dr. Véronique Diéras
Prof. Fabrice Barlesi
Developed by: Springer Medicine