Cancer Care Ontario Guideline Recommendations for Hormone Receptor Testing in Breast Cancer

Clinical Oncology

Volumn 24, Issue 10, 2012, Pages 684-696

  Nofech Mozes, S ^a   Vella, E T ^b   Dhesy Thind, S ^b   Hanna, W M ^a  

^a SUNNYBROOK RESEARCH INSTITUTE   (Canada)

^b MCMASTER UNIVERSITY   (Canada)

Author keywords

Breast cancer; Hormone receptors; Immunohistochemistry; Oestrogen; Practice guideline; Quality assurance

Indexed keywords

ANTIBODY; ANTIGEN; ESTROGEN RECEPTOR; PROGESTERONE RECEPTOR; REAGENT;

ANTIBODY DETECTION; ANTIGEN RETRIEVAL; ARTICLE; BREAST CANCER; CANCER CARE ONTARIO GUIDELINE; CLINICAL DECISION MAKING; CORE BIOPSY NEEDLE; DIAGNOSTIC ACCURACY; DIAGNOSTIC TEST; EXTERNAL VALIDITY; FROZEN SECTION; HORMONE RECEPTOR TESTING; HUMAN; IMAGE ANALYSIS; IMMUNOHISTOCHEMISTRY; INTERNAL VALIDITY; LABORATORY AUTOMATION; NEEDLE BIOPSY; PRACTICE GUIDELINE; PRIORITY JOURNAL; PROTEIN EXPRESSION; QUALITY CONTROL; STANDARD; STORAGE; TISSUE MICROARRAY;

BREAST NEOPLASMS; FEMALE; HUMANS; IMMUNOHISTOCHEMISTRY; NEOPLASMS, HORMONE-DEPENDENT; ONTARIO; RECEPTORS, ESTROGEN; RECEPTORS, PROGESTERONE; TUMOR MARKERS, BIOLOGICAL;

EID: 84868302829     PISSN: 09366555     EISSN: 14332981     Source Type: Journal    
DOI: 10.1016/j.clon.2012.04.005     Document Type: Article

References (168)

1. Government of Newfoundland and Labrador. Commission of inquiry on hormone receptor testing, volume 1: investigations and findings [Internet]. St. John's, Newfoundland and Labrador: The Honourable Margaret A. Cameron, Commissioner; 2009. Available at: http://www.releases.gov.nl.ca/releases/2009/health/Volume1_Investigation_and_Findings.pdf.
2. Hammond M.E.H., Hayes D.F., 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(6):907-922.
3. Hammond M.E.H., Hayes D.F., 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. J Clin Oncol 2010, 28(16):2784-2795.
4. Hammond M.E.H., Hayes D.F., 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, 134(7):e48-e72.
5. Nofech-Mozes S., Vella E.T., Dhesy-Thind S., et al. Systematic review on hormone receptor testing in breast cancer. Appl Immunohistochem Mol Morphol 2012, 20(3):214-263.
6. Browman G.P., Levine M.N., Mohide E.A., et al. The practice guidelines development cycle: a conceptual tool for practice guidelines development and implementation. J Clin Oncol 1995, 13:502-512. Comment in: Ann Oncol 2002;13(9):1507-1509; author reply 1509.
7. Browman G.P., Newman T.E., Mohide E.A., et al. Progress of clinical oncology guidelines development using the Practice Guidelines Development Cycle: the role of practitioner feedback. J Clin Oncol 1998, 16(3):1226-1231.
8. Allred D., Bryant J., Land S., et al. Estrogen receptor expression as a predictive marker of the effectiveness of tamoxifen in the treatment of DCIS: findings from NSABP protocol B-24. Breast Cancer Res Treat 2002, 78(Suppl. 1):36.
9. Shelley W, McCready D, Holloway C, Trudeau M, Sinclair S, Breast Cancer Disease Site Group. Management of ductal carcinoma in situ of the breast: a clinical practice guideline, 2006. Available at: http://www.cancercare.on.ca/common/pages/UserFile.aspx%3FfileId=34090.
10. Alberts S.R., Ingle J.N., Roche P.R., et al. Comparison of estrogen receptor determinations by a biochemical ligand-binding assay and immunohistochemical staining with monoclonal antibody ER1D5 in females with lymph node positive breast carcinoma entered on two prospective clinical trials. Cancer 1996, 78(4):764-772.
11. Andersen J., Thorpe S.M., Rose C., Christensen I., Rasmussen B.B., Poulsen H.S. Estrogen receptor in primary breast cancer estimated in paraffin-embedded tissue. A study of its usefulness compared to dextran-coated charcoal assay. Acta Oncol 1991, 30(6):685-690.
12. Barnes D.M., Harris W.H., Smith P., Millis R.R., Rubens R.D. Immunohistochemical determination of oestrogen receptor: comparison of different methods of assessment of staining and correlation with clinical outcome of breast cancer patients. Br J Cancer 1996, 74(9):1445-1451.
13. Biesterfeld S., Schroder W., Steinhagen G., et al. Simultaneous immunohistochemical and biochemical hormone receptor assessment in breast cancer provides complementary prognostic information. Anticancer Res 1997, 17(6D):4723-4729.
14. Cheang M.C., Treaba D.O., Speers C.H., et al. Immunohistochemical detection using the new rabbit monoclonal antibody SP1 of estrogen receptor in breast cancer is superior to mouse monoclonal antibody 1D5 in predicting survival. J Clin Oncol 2006, 24(36):5637-5644.
15. Chebil G., Bendahl P.O., Idvall I., Ferno M. Comparison of immunohistochemical and biochemical assay of steroid receptors in primary breast cancer - clinical associations and reasons for discrepancies. Acta Oncol 2003, 42(7):719-725.
16. de Mascarel I., Soubeyran I., Macgrogan G., et al. Immunohistochemical analysis of estrogen receptors in 938 breast carcinomas. Concordance with biochemical assay and prognostic significance. Appl Immunohistochem 1995, 3(4):222-231.
17. Elledge R.M., Green S., Pugh R., et al. Estrogen receptor (ER) and progesterone receptor (PgR), by ligand-binding assay compared with ER, PgR and pS2, by immuno-histochemistry in predicting response to tamoxifen in metastatic breast cancer: a Southwest Oncology Group Study. Int J Cancer 2000, 89(2):111-117.
18. Esteban J.M., Ahn C., Battifora H., Felder B. Quantitative immunohistochemical assay for hormonal receptors: technical aspects and biological significance. J Cell Biochem 1994, 19(Suppl.):138-145.
19. Ferno M., Andersson C., Fallenius G., Idvall I. Oestrogen receptor analysis of paraffin sections and cytosol samples of primary breast cancer in relation to outcome after adjuvant tamoxifen treatment. The South Sweden Breast Cancer Group. Acta Oncol 1996, 35(1):17-22.
20. Fisher E.R., Anderson S., Dean S., et al. Solving the dilemma of the immunohistochemical and other methods used for scoring estrogen receptor and progesterone receptor in patients with invasive breast carcinoma. Cancer 2005, 103(1):164-173.
21. Grabau D.A., Thorpe S.M., Knoop A., et al. Immunohistochemical assessment of oestrogen and progesterone receptors: correlations with the DCC method and clinical outcome in primary breast cancer patients. Breast 2000, 9(4):208-217.
22. Harvey J.M., Clark G.M., Osborne C.K., Allred D.C. Estrogen receptor status by immunohistochemistry is superior to the ligand-binding assay for predicting response to adjuvant endocrine therapy in breast cancer. J Clin Oncol 1999, 17(5):1474-1481.
23. Horii R., Akiyama F., Ito Y., Iwase T. Assessment of hormone receptor status in breast cancer. Pathol Int 2007, 57(12):784-790.
24. Iwase H., Zhang Z., Omoto Y., et al. Clinical significance of the expression of estrogen receptors alpha and beta for endocrine therapy of breast cancer. Cancer Chemother Pharmacol 2003, 52(Suppl.):8.
25. Macgrogan G., Soubeyran I., de M.I., et al. Immunohistochemical detection of progesterone receptors in breast invasive ductal carcinomas. A correlative study of 942 cases. Appl Immunohistochem 1996, 4(4):219-227.
26. Mohsin S.K., Weiss H., Havighurst T., et al. Progesterone receptor by immunohistochemistry and clinical outcome in breast cancer: a validation study. Mod Pathol 2004, 17(12):1545-1554.
27. Ogawa Y., Moriya T., Kato Y., et al. Immunohistochemical assessment for estrogen receptor and progesterone receptor status in breast cancer: analysis for a cut-off point as the predictor for endocrine therapy. Breast Cancer 2004, 11(3):267-275.
28. Pertschuk L.P., Feldman J.G., Kim Y.D., et al. Estrogen receptor immunocytochemistry in paraffin embedded tissues with ER1D5 predicts breast cancer endocrine response more accurately than H222Sp gamma in frozen sections or cytosol-based ligand-binding assays. Cancer 1996, 77(12):2514-2519.
29. Regan M.M., Viale G., Mastropasqua M.G., et al. Re-evaluating adjuvant breast cancer trials: assessing hormone receptor status by immunohistochemical versus extraction assays. J Natl Cancer Inst 2006, 98(21):1571-1581.
30. Thomson C.S., Twelves C.J., Mallon E.A., Leake R.E. Adjuvant ovarian ablation vs CMF chemotherapy in premenopausal breast cancer patients: trial update and impact of immunohistochemical assessment of ER status. Breast 2002, 11(5):419-429.
31. Younes M., Laucirica R., Miller C.C., Brown R.W. The prognostic value of estrogen receptor immunocytochemistry (ERICA) in breast cancer does not depend on the immunostaining intensity. Breast Dis 1996, 9(3):157-170.
32. Anania G., Bazzocchi M., Di L.C., et al. Percutaneous large core needle biopsy versus surgical biopsy in the diagnosis of breast lesions. Int Surg 1997, 82(1):52-55.
33. Arens N., Bleyl U., Hildenbrand R. HER2/neu, p53, Ki67, and hormone receptors do not change during neoadjuvant chemotherapy in breast cancer. Virchows Archiv 2005, 446(5):489-496.
34. Badoual C., Maruani A., Ghorra C., Lebas P., Avigdor S., Michenet P. Pathological prognostic factors of invasive breast carcinoma in ultrasound-guided large core biopsies-correlation with subsequent surgical excisions. Breast 2005, 14(1):22-27.
35. Burge C.N., Chang H.R., Apple S.K. Do the histologic features and results of breast cancer biomarker studies differ between core biopsy and surgical excision specimens?. Breast 2006, 15(2):167-172.
36. Cahill R.A., Walsh D., Landers R.J., Watson R.G. Preoperative profiling of symptomatic breast cancer by diagnostic core biopsy. Ann Surg Oncol 2006, 13(1):45-51.
37. Cavaliere A., Sidoni A., Scheibel M., et al. Biopathologic profile of breast cancer core biopsy: is it always a valid method?. Cancer Lett 2005, 218(1):117-121.
38. Connor C.S., Tawfik O.W., Joyce A.J., Davis M.K., Mayo M.S., Jewell W.R. A comparison of prognostic tumor markers obtained on image-guided breast biopsies and final surgical specimens. Am J Surg 2002, 184(4):322-324.
39. Douglas-Jones A.G., Collett N., Morgan J.M., Jasani B. Comparison of core oestrogen receptor (ER) assay with excised tumour: intratumoral distribution of ER in breast carcinoma. J Clin Pathol 2001, 54(12):951-955.
40. Hodi Z., Chakrabarti J., Lee A.H., et al. The reliability of assessment of oestrogen receptor expression on needle core biopsy specimens of invasive carcinomas of the breast. J Clin Pathol 2007, 60(3):299-302.
41. Jacobs T.W., Siziopikou K.P., Prioleau J.E., et al. Do prognostic marker studies on core needle biopsy specimens of breast carcinoma accurately reflect the marker status of the tumor?. Mod Pathol 1998, 11(3):259-264.
42. Mann G.B., Fahey V.D., Feleppa F., Buchanan M.R. Reliance on hormone receptor assays of surgical specimens may compromise outcome in patients with breast cancer. J Clin Oncol 2005, 23(22):5148-5154.
43. Sarakbi W.A., Salhab M., Thomas V., Mokbel K. Is preoperative core biopsy accurate in determining the hormone receptor status in women with invasive breast cancer?. Int Semin Surg Oncol 2005, 2. Article 15.
44. Smyczek-Gargya B., Krainick U., Muller-Schimpfle M., et al. Large-core needle biopsy for diagnosis and treatment of breast lesions. Arch Gynecol Obstet 2002, 266(4):198-200.
45. Sutela A., Vanninen R., Sudah M., et al. Surgical specimen can be replaced by core samples in assessment of ER, PR and HER-2 for invasive breast cancer. Acta Oncol 2008, 47(1):38-46.
46. Taucher S., Rudas M., Gnant M., et al. Sequential steroid hormone receptor measurements in primary breast cancer with and without intervening primary chemotherapy. Endocr Relat Cancer 2003, 10(1):91-98.
47. Usami S., Moriya T., Amari M., et al. Reliability of prognostic factors in breast carcinoma determined by core needle biopsy. Jpn J Clin Oncol 2007, 37(4):250-255.
48. Wood B., Junckerstorff R., Sterrett G., Frost F., Harvey J., Robbins P. A comparison of immunohistochemical staining for oestrogen receptor, progesterone receptor and HER-2 in breast core biopsies and subsequent excisions. Pathology 2007, 39(4):391-395.
49. Zidan A., Brown J.S.C., Peston D., Shousha S. Oestrogen and progesterone receptor assessment in core biopsy specimens of breast carcinoma. J Clin Pathol 1997, 50(1):27-29.
50. Camp R.L., Charette L.A., Rimm D.L. Validation of tissue microarray technology in breast carcinoma. Lab Invest 2000, 80(12):1943-1949.
51. Gillett C.E., Springall R.J., Barnes D.M., Hanby A.M. Multiple tissue core arrays in histopathology research: a validation study. J Pathol 2000, 192(4):549-553.
52. Henriksen K.L., Rasmussen B.B., Lykkesfeldt A.E., Moller S., Ejlertsen B., Mouridsen H.T. Semi-quantitative scoring of potentially predictive markers for endocrine treatment of breast cancer: a comparison between whole sections and tissue microarrays. J Clin Pathol 2007, 60(4):397-404.
53. Parker R.L., Huntsman D.G., Lesack D.W., 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, 117(5):723-728.
54. Sapino A., Marchio C., Senetta R., et al. Routine assessment of prognostic factors in breast cancer using a multicore tissue microarray procedure. Virchows Archiv 2006, 449(3):288-296.
55. Torhorst J., Bucher C., Kononen J., et al. Tissue microarrays for rapid linking of molecular changes to clinical endpoints. Am J Pathol 2001, 159(6):2249-2256.
56. Zhang D., Salto-Tellez M., Putti T.C., Do E., Koay E.S. Reliability of tissue microarrays in detecting protein expression and gene amplification in breast cancer. Mod Pathol 2003, 16(1):79-84.
57. Moeder C.B., Giltnane J.M., Harigopal M., et al. Quantitative justification of the change from 10% to 30% for human epidermal growth factor receptor 2 scoring in the American Society of Clinical Oncology/College of American Pathologists guidelines: tumor heterogeneity in breast cancer and its implications for tissue microarray-based assessment of outcome. J Clin Oncol 2007, 25(34):5418-5425.
58. Quraishi I., Rishi M., Feldman M., Wargovich M.J., Weber B. Clinical validation of breast cancer biomarkers using tissue microarray technology. Appl Immunohistochem Mol Morphol 2007, 15(1):45-49.
59. Bajetta E., Celio L., Di L.A., et al. Effects of short-term pre-operative tamoxifen on steroid receptor and Ki-67 expression in primary breast cancer: an immunocytochemical study. Int J Oncol 1998, 12(4):853-858.
60. Briffod M., Hacene K., Le D.V. Immunohistochemistry on cell blocks from fine-needle cytopunctures of primary breast carcinomas and lymph node metastases. Mod Pathol 2000, 13(8):841-850.
61. Cano G., Milanezi F., Leitao D., Ricardo S., Brito M.J., Schmitt F.C. Estimation of hormone receptor status in fine-needle aspirates and paraffin-embedded sections from breast cancer using the novel rabbit monoclonal antibodies SP1 and SP2. Diagn Cytopathol 2003, 29(4):207-211.
62. Jayaram G., Elsayed E.M. Cytologic evaluation of prognostic markers in breast carcinoma. Acta Cytol 2005, 49(6):605-610.
63. Klorin G., Keren R. Prognostic markers in histologic and cytologic specimens of breast cancer. Anal Quant Cytol Histol 2003, 25(5):297-302.
64. Konofaos P., Kontzoglou K., Georgoulakis J., et al. The role of ThinPrep cytology in the evaluation of estrogen and progesterone receptor content of breast tumors. Surg Oncol 2006, 15(4):257-266.
65. Leung S.W., Bedard Y.C. Estrogen and progesterone receptor contents in ThinPrep-processed fine-needle aspirates of breast. Am J Clin Pathol 1999, 112(1):50-56.
66. Makris A., Allred D.C., Powles T.J., et al. Cytological evaluation of biological prognostic markers from primary breast carcinomas. Breast Cancer Res Treat 1997, 44(1):65-74.
67. Nizzoli R., Bozzetti C., Naldi N., et al. Comparison of the results of immunocytochemical assays for biologic variables on preoperative fine-needle aspirates and on surgical specimens of primary breast carcinomas. Cancer 2000, 90(1):61-66.
68. Pinder S.E., Wencyk P.M., Naylor H.E., et al. The assessment of multiple variables on breast carcinoma fine needle aspiration (FNA) cytology specimens: method, preliminary results and prognostic associations. Cytopathology 1995, 6(5):316-324.
69. Schmitt F.C., Bento M.J., Amendoeira I. Estimation of estrogen receptor content in fine-needle aspirates from breast cancer using the monoclonal antibody 1D5 and microwave oven processing: correlation with paraffin embedded and frozen sections determinations. Diagn Cytopathol 1995, 13(4):347-351.
70. Sianesi M., Bozzetti C., Del R.P., Nizzoli R., Cascinu S. Primary breast carcinoma: immunocytochemical and immunohistochemical evaluation of biological parameters. Chir Ital 2000, 52(6):643-645.
71. Suthipintawong C., Leong A.S., Chan K.W., Vinyuvat S. Immunostaining of estrogen receptor, progesterone receptor, MIB1 antigen, and c-erbB-2 oncoprotein in cytologic specimens: a simplified method with formalin fixation. Diagn Cytopathol 1997, 17(2):127-133.
72. Tafjord S., Bohler P.J., Risberg B., Torlakovic E. Estrogen and progesterone hormone receptor status in breast carcinoma: comparison of immunocytochemistry and immunohistochemistry. Diagn Cytopathol 2002, 26(3):137-141.
73. Vesoulis Z., Rajappannair L., Define L., et al. Quantitative image analysis of estrogen receptors in breast fine needle aspiration biopsies. Anal Quant Cytol Histol 2004, 26(6):323-330.
74. Zoppi J.A., Rotundo A.V., Sundblad A.S. Correlation of immunocytochemical and immunohistochemical determination of estrogen and progesterone receptors in breast cancer. Acta Cytol 2002, 46(2):337-340.
75. Makris A., Powles T.J., Allred D.C., et al. Quantitative changes in cytological molecular markers during primary medical treatment of breast cancer: a pilot study. Breast Cancer Res Treat 1999, 53(1):51-59.
76. Andersen J., Thorpe S.M., King W.J., et al. The prognostic value of immunohistochemical estrogen receptor analysis in paraffin-embedded and frozen sections versus that of steroid-binding assays. Eur J Cancer 1990, 26(4):442-449.
77. Cavaliere A., Bellezza G., Ferri I., Vitali R., Sidoni A. Computer-assisted immunocytochemical determination of breast cancer steroid receptors. Frozen sections vs paraffin sections. Breast 2001, 11(6):476-483.
78. Elias J.M., Margiotta M., Sexton T.R., Heimann A. Immunohistochemical detection of sex steroid receptors in breast cancer using routine paraffin sections: comparison with frozen sections and enzyme immunoassay. J Cell Biochem Suppl 1994, 19:126-133.
79. Fee M., Tobin B., Magee H., Harrison M., Gorey T., Dervan P.A. Comparison of oestrogen receptor assessment in frozen and paraffin sections. Pathol Res Pract 1996, 192(9):919-924.
80. Goulding H., Pinder S., Cannon P., et al. A new immunohistochemical antibody for the assessment of estrogen receptor status on routine formalin-fixed tissue samples. Hum Pathol 1995, 26(3):291-294.
81. Ibarra G.R., Sananes C., Podeley G., Azcurra J., Scordo D. Estrogen receptor immunohistochemistry in formalin-fixed, paraffin-embedded breast tumor tissue: enhanced sensitivity using a monoclonal antibody cocktail. Appl Immunohistochem Mol Morphol 1995, 3(3):202-208.
82. Masood S., Dee S., Goldstein J.D. Immunocytochemical analysis of progesterone receptors in breast cancer. Am J Clin Pathol 1991, 96(1):59-63.
83. Masood S., Lu L., Rodenroth N. Potential value of estrogen receptor immunocytochemical assay in formalin-fixed breast tumors. Mod Pathol 1990, 3(6):724-728.
84. Miller R.T., Hapke M.R., Greene G.L. Immunocytochemical assay for estrogen receptor with monoclonal antibody D753P gamma in routinely processed formaldehyde-fixed breast tissue. Comparison with frozen section assay and with monoclonal antibody H222. Cancer 1993, 71(11):3541-3546.
85. Muller-Holzner E., Zeimet A.G., Daxenbichler G., Marth C., Muller L.C., Dapunt O. Progesterone receptors in routinely paraffin-embedded primary breast carcinomas and lymph node metastases. Breast Cancer Res Treat 1993, 25(1):47-55.
86. Nedergaard L., Haerslev T., Jacobsen G.K. Immunohistochemical study of estrogen receptors in primary breast carcinomas and their lymph node metastases including comparison of two monoclonal antibodies. APMIS 1995, 103(1):20-24.
87. Ozzello L., DeRosa C., Habif D.V., Greene G.L. An immunohistochemical evaluation of progesterone receptor in frozen sections, paraffin sections, and cytologic imprints of breast carcinomas. Cancer 1991, 67(2):455-462.
88. Paterson D.A., Reid C.P., Anderson T.J., Hawkins R.A. Assessment of oestrogen receptor content of breast carcinoma by immunohistochemical techniques on fixed and frozen tissue and by biochemical ligand binding assay. J Clin Pathol 1990, 43(1):46-51.
89. Raymond W.A., Leong A.S. Oestrogen receptor staining of paraffin-embedded breast carcinomas following short fixation in formalin: a comparison with cytosolic and frozen section receptor analyses. J Pathol 1990, 160(4):295-303.
90. Scharl A., Vierbuchen M., Conradt B., Moll W., Wurz H., Bolte A. Immunohistochemical detection of progesterone receptor in formalin-fixed and paraffin-embedded breast cancer tissue using a monoclonal antibody. Arch Gynecol Obstet 1990, 247(2):63-71.
91. Snead D.R., Bell J.A., Dixon A.R., et al. Methodology of immunohistological detection of oestrogen receptor in human breast carcinoma in formalin-fixed, paraffin-embedded tissue: a comparison with frozen section methodology. Histopathology 1993, 23(3):233-238.
92. Stylianodou A., Papadimitriou C.S. Immunohistochemical demonstration of estrogen receptors on routine paraffin sections of breast carcinomas: a comparison with frozen sections and an enzyme immunoassay. Oncology 1992, 49(1):15-21.
93. von Boguslawsky B.K. Immunohistochemical detection of progesterone receptors in paraffin sections. A novel method using microwave oven pretreatment. APMIS 1994, 102(9):641-646.
94. von Wasielewski W.R., Mengel M., Nolte M., Werner M. Influence of fixation, antibody clones, and signal amplification on steroid receptor analysis. Breast J 1998, 4(1):33-40.
95. von Wasielewski W.R., Mengel M., Wiese B., Rudiger T., Muller-Hermelink H.K., Kreipe H. Tissue array technology for testing interlaboratory and interobserver reproducibility of immunohistochemical estrogen receptor analysis in a large multicenter trial. Am J Clin Pathol 2002, 118(5):675-682.
96. Goldstein N.S., Ferkowicz M., Odish E., Mani A., Hastah F. Minimum formalin fixation time for consistent estrogen receptor immunohistochemical staining of invasive breast carcinoma. Am J Clin Pathol 2003, 120(1):86-92.
97. Jensen V., Ladekarl M. Immunohistochemical quantitation of oestrogen receptors and proliferative activity in oestrogen receptor positive breast cancer. J Clin Pathol 1995, 48(5):429-432.
98. Hanna W., O'Malley F., Barnes P. Updated recommendations from the Canadian National Consensus Meeting on HER2/neu testing in breast cancer. Curr Oncol 2007, 14:149-153.
99. Arber D.A. Effect of prolonged formalin fixation on the immunohistochemical reactivity of breast markers. Appl Immunohistochem Mol Morphol 2002, 10(2):183-186.
100. DiVito K.A., Charette L.A., Rimm D.L., Camp R.L. Long-term preservation of antigenicity on tissue microarrays. Lab Invest 2004, 84(8):1071-1078.
101. Fergenbaum J.H., Garcia-Closas M., Hewitt S.M., Lissowska J., Sakoda L.C., Sherman M.E. Loss of antigenicity in stored sections of breast cancer tissue microarrays. Cancer Epidemiol Biomarkers Prev 2004, 13(4):667-672.
102. Mirlacher M., Kasper M., Storz M., et al. Influence of slide aging on results of translational research studies using immunohistochemistry. Mod Pathol 2004, 17(11):1414-1420.
103. Blind C., Koepenik A., Pacyna-Gengelbach M., et al. Antigenicity testing by immunohistochemistry after tissue oxidation. J Clin Pathol 2008, 61(1):79-83.
104. Bromley C.M., Palechek P.L., Benda J.A. Preservation of estrogen receptor in paraffin sections. J Histotechnol 1994, 17(2):115-118.
105. Balaton A.J., Mathieu M.C., Le D.V. Optimization of heat-induced epitope retrieval for estrogen receptor determination by immunohistochemistry on paraffin sections. Results of a multicentric comparative study. Appl Immunohistochem 1996, 4(4):259-263.
106. Bier B., Bankfalvi A., Grote L., et al. Wet autoclave pretreatment for immunohistochemical demonstration of oestrogen receptors in routinely processed breast carcinoma tissue. Histochem J 1995, 27(2):148-154.
107. Frost A.R., Sparks D., Grizzle W.E. Methods of antigen recovery vary in their usefulness in unmasking specific antigens in immunohistochemistry. Appl Immunohistochem Mol Morphol 2000, 8(3):236-243.
108. Huang Z., Zhu W., Meng Y., Xia H. Development of new rabbit monoclonal antibody to progesterone receptor (Clone SP2): no heat pretreatment but effective for paraffin section immunohistochemistry. Appl Immunohistochem Mol Morphol 2006, 14(2):229-233.
109. Huang Z., Zhu W., Szekeres G., Xia H. Development of new rabbit monoclonal antibody to estrogen receptor: immunohistochemical assessment on formalin-fixed, paraffin-embedded tissue sections. Appl Immunohistochem Mol Morphol 2005, 13(1):91-95.
110. Mote P.A., Leary J.A., Clarke C.L. Immunohistochemical detection of progesterone receptors in archival breast cancer. Biotech Histochem 1998, 73(3):117-127.
111. Neves J.I., Begnami M.D., Arias V., Santos G.C. Antigen retrieval methods and estrogen receptor immunoexpression using 1D5 antibody: a comparative study. Int J Surg Pathol 2005, 13(4):353-357.
112. Rossi S., Laurino L., Furlanetto A., et al. Rabbit monoclonal antibodies: a comparative study between a novel category of immunoreagents and the corresponding mouse monoclonal antibodies. Am J Clin Pathol 2005, 124(2):295-302.
113. Vassallo J., Pinto G.A., Alvarenga J.M., Zeferino L.C., Chagas C.A., Metze K. Comparison of immunoexpression of 2 antibodies for estrogen receptors (1D5 and 6F11) in breast carcinomas using different antigen retrieval and detection methods. Appl Immunohistochem Mol Morphol 2004, 12(2):177-182.
114. Cohen C., Unger E.R., Sgoutas D., Bradley N., Chenggis M. Automated immunohistochemical estrogen receptor in fixed embedded breast carcinomas. Am J Clin Pathol 1991, 95(3):335-339.
115. Goldstein N.S., Hunter S., Forbes S., Odish E., Tehrani M. Estrogen receptor antibody incubation time and extent of immunoreactivity in invasive carcinoma of the breast: the importance of optimizing antibody avidity. Appl Immunohistochem Mol Morphol 2007, 15(2):203-207.
116. Sumiyoshi Y., Shirakusa T., Yamashita Y., Maekawa T., Sakai T., Kikuchi M. Highly sensitive immunohistological study for detection of estrogen receptor in human breast cancer. J Surg Oncol 2001, 76(1):13-18.
117. Biesterfeld S., Kraus H.L., Reineke T., Muys L., Mihalcea A.M., Rudlowski C. Analysis of the reliability of manual and automated immunohistochemical staining procedures. A pilot study. Anal Quant Cytol Histol 2003, 25(2):90-96.
118. Navani S., Bhaduri A.S. High incidence of oestrogen receptor negative progesterone receptor positive phenotype in Indian breast cancer: fact or fiction?. Indian J Pathol Microbiol 2005, 48(2):199-201.
119. Regitnig P., Reiner A., Dinges H.P., et al. Quality assurance for detection of estrogen and progesterone receptors by immunohistochemistry in Austrian pathology laboratories. Virchows Archiv 2002, 441(4):328-334.
120. Aziz D.C. Quantitation of estrogen and progesterone receptors by immunocytochemical and image analyses. Am J Clin Pathol 1992, 98(1):105-111.
121. Baddoura F.K., Cohen C., Unger E.R., DeRose P.B., Chenggis M. Image analysis for quantitation of estrogen receptor in formalin-fixed paraffin-embedded sections of breast carcinoma. Mod Pathol 1991, 4(1):91-95.
122. Ballouk F., Boguniewicz A., Ross J.S., Jennings T.A. Image analysis quantification in hormone receptor assay of mucinous carcinoma of the breast. Comparison with biochemical analysis. Anal Quant Cytol Histol 1995, 17(3):151-156.
123. Bejar J., Sabo E., Misselevich I., Eldar S., Boss J.H. Comparative study of computer-assisted image analysis and light-microscopically determined estrogen receptor status of breast carcinomas. Arch Pathol Lab Med 1998, 122(4):346-352.
124. Camp R.L., Chung G.G., Rimm D.L. Automated subcellular localization and quantification of protein expression in tissue microarrays. Nat Med 2002, 8(11):1323-1327.
125. Charalambous D., Kitchen P.R., Stillwell R.G., Smart P.J., Rode J. A comparison between radioligand and immunohistochemical assay of hormone receptors in primary breast cancer. Aust N Z J Surg 1993, 63(8):637-641.
126. Chung G.G., Zerkowski M.P., Ghosh S., Camp R.L., Rimm D.L. Quantitative analysis of estrogen receptor heterogeneity in breast cancer. Lab Invest 2007, 87(7):662-669.
127. Diaz L.K., Sahin A., Sneige N. Interobserver agreement for estrogen receptor immunohistochemical analysis in breast cancer: a comparison of manual and computer-assisted scoring methods. Ann Diagn Pathol 2004, 8(1):23-27.
128. Gibney E.M., Lawson D., DeRose P.B., Cotsonis G.A., Cohen C. Image cytometric progesterone receptor quantitation: comparison with visual semiquantitation and cytosolic assay. Appl Immunohistochem 1998, 6(2):62-68.
129. Gokhale S., Rosen D., Sneige N., et al. Assessment of two automated imaging systems in evaluating estrogen receptor status in breast carcinoma. Appl Immunohistochem Mol Morphol 2007, 15(4):451-455.
130. Gorczyca W., Davidian M., Gherson J., Ashikari R., Darzynkiewicz Z., Melamed M.R. Laser scanning cytometry quantification of estrogen receptors in breast cancer. Anal Quant Cytol Histol 1998, 20(6):470-476.
131. Hatanaka Y., Hashizume K., Nitta K., Kato T., Itoh I., Tani Y. Cytometrical image analysis for immunohistochemical hormone receptor status in breast carcinomas. Pathol Int 2003, 53(10):693-699.
132. Hendricks J.B., Wilkinson E.J. Comparison of two antibodies for evaluation of estrogen receptors in paraffin-embedded tumors. Mod Pathol 1993, 6(6):765-770.
133. Kohlberger P.D., Breitenecker F., Kaider A., et al. Modified true-color computer-assisted image analysis versus subjective scoring of estrogen receptor expression in breast cancer: a comparison. Anticancer Res 1999, 19(3B):2189-2193.
134. Kostopoulos S, Cavouras D, Daskalakis A, et al. Colour-texture based image analysis method for assessing the hormone receptors status in breast tissue sections. Proceedings of the 29th Annual International Conference of the IEEE Engineering in Medicine and Biology Society, 23-26 August, 2007, Lyon, France.
135. Layfield L.J., Saria E.A., Conlon D.H., Kerns B.J. Estrogen and progesterone receptor status determined by the Ventana ES 320 automated immunohistochemical stainer and the CAS 200 image analyzer in 236 early-stage breast carcinomas: prognostic significance. J Surg Oncol 1996, 61(3):177-184.
136. Lehr H.A., Mankoff D.A., Corwin D., Santeusanio G., Gown A.M. Application of photoshop-based image analysis to quantification of hormone receptor expression in breast cancer. J Histochem Cytochem 1997, 45(11):1559-1565.
137. Lockwood C.A., Ricciardelli C., Raymond W.A., Seshadri R., McCaul K., Horsfall D.J. A simple index using video image analysis to predict disease outcome in primary breast cancer. Int J Cancer 1999, 84(3):203-208.
138. McCabe A., Dolled-Filhart M., Camp R.L., Rimm D.L. Automated quantitative analysis (AQUA) of in situ protein expression, antibody concentration, and prognosis. J Natl Cancer Inst 2005, 97(24):1808-1815.
139. Mofidi R., Walsh R., Ridgway P.F., et al. Objective measurement of breast cancer oestrogen receptor status through digital image analysis. Eur J Surg Oncol 2003, 29(1):20-24.
140. Peterson L.M., Mankoff D.A., Lawton T., et al. Quantitative imaging of estrogen receptor expression in breast cancer with PET and 18F-fluoroestradiol. J Nucl Med 2008, 49(3):367-374.
141. Rothmann C., Barshack I., Gil A., Goldberg I., Kopolovic J., Malik Z. Potential use of spectral image analysis for the quantitative evaluation of estrogen receptors in breast cancer. Histol Histopathol 2000, 15(4):1051-1057.
142. Sharangpani G.M., Joshi A.S., Porter K., et al. Semi-automated imaging system to quantitate estrogen and progesterone receptor immunoreactivity in human breast cancer. J Microsc 2007, 226(3):244-255.
143. Sherman M.E., Rimm D.L., Yang X.R., et al. Variation in breast cancer hormone receptor and HER2 levels by etiologic factors: a population-based analysis. Int J Cancer 2007, 121(5):1079-1085.
144. Cowen P.N., Teasdale J., Jackson P., Reid B.J. Oestrogen receptor in breast cancer: prognostic studies using a new immunohistochemical assay. Histopathology 1990, 17(4):319-325.
145. Dowsett M., Allred C., Knox J., et al. Relationship between quantitative estrogen and progesterone receptor expression and human epidermal growth factor receptor 2 (HER-2) status with recurrence in the Arimidex, Tamoxifen, Alone or in Combination trial. J Clin Oncol 2008, 26(7):1059-1065.
146. Stendahl M., Ryden L., Nordenskjold B., Jonsson P.E., Landberg G., Jirstrom K. High progesterone receptor expression correlates to the effect of adjuvant tamoxifen in premenopausal breast cancer patients. Clin Cancer Res 2006, 12(15):4614-4618.
147. Viale G., Regan M.M., 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(25):3846-3852.
148. Yamashita H., Yando Y., Nishio M., et al. Immunohistochemical evaluation of hormone receptor status for predicting response to endocrine therapy in metastatic breast cancer. Breast Cancer 2006, 13(1):74-83.
149. Arihiro K., Umemura S., Kurosumi M., et al. Comparison of evaluations for hormone receptors in breast carcinoma using two manual and three automated immunohistochemical assays. Am J Clin Pathol 2007, 127(3):356-365.
150. Jalava P., Kuopio T., Huovinen R., Laine J., Collan Y. Immunohistochemical staining of estrogen and progesterone receptors: aspects for evaluating positivity and defining the cutpoints. Anticancer Res 2005, 25(3c):2535-2542.
151. Rhodes A., Jasani B., Barnes D.M., Bobrow L.G., Miller K.D. Reliability of immunohistochemical demonstration of oestrogen receptors in routine practice: interlaboratory variance in the sensitivity of detection and evaluation of scoring systems. J Clin Pathol 2000, 53(2):125-130.
152. Fitzgibbons P.L., Murphy D.A., Hammond M.E.H., Allred D.C., Valenstein P.N. Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays. Arch Pathol Lab Med 2010, 134(6):930-935.
153. Terry J., Torlakovic E.E., 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(5):375-382.
154. Rhodes A., Jasani B., Balaton A.J., Barnes D.M., Miller K.D. Frequency of oestrogen and progesterone receptor positivity by immunohistochemical analysis in 7016 breast carcinomas: correlation with patient age, assay sensitivity, threshold value, and mammographic screening. J Clin Pathol 2000, 53(9):688-696.
155. Chang J.C., Makris A., Gutierrez M.C., et al. Gene expression patterns in formalin-fixed, paraffin-embedded core biopsies predict docetaxel chemosensitivity in breast cancer patients. Breast Cancer Res Treat 2008, 108(2):233-240.
156. Cobleigh M.A., Tabesh B., Bitterman P., et al. Tumor gene expression and prognosis in breast cancer patients with 10 or more positive lymph nodes. Clin Cancer Res 2005, 11(24 Pt 1):8623-8631.
157. Cronin M., Pho M., Dutta D., et al. Measurement of gene expression in archival paraffin-embedded tissues: development and performance of a 92-gene reverse transcriptase-polymerase chain reaction assay. Am J Pathol 2004, 164(1):35-42.
158. Cronin M., Sangli C., Liu M.L., et al. Analytical validation of the Oncotype DX genomic diagnostic test for recurrence prognosis and therapeutic response prediction in node-negative, estrogen receptor-positive breast cancer. Clin Chem 2007, 53(6):1084-1091.
159. Esteva F.J., Sahin A.A., Cristofanilli M., et al. Prognostic role of a multigene reverse transcriptase-PCR assay in patients with node-negative breast cancer not receiving adjuvant systemic therapy. Clin Cancer Res 2005, 11(9):3315-3319.
160. Fan C., Oh D.S., Wessels L., et al. Concordance among gene-expression-based predictors for breast cancer. New Engl J Med 2006, 355(6):560-569.
161. Gianni L., Zambetti M., Clark K., et al. Gene expression profiles in paraffin-embedded core biopsy tissue predict response to chemotherapy in women with locally advanced breast cancer. J Clin Oncol 2005, 23(29):7265-7277.
162. Habel L.A., Shak S., Jacobs M.K., et al. A population-based study of tumor gene expression and risk of breast cancer death among lymph node-negative patients. Breast Cancer Res 2006, 8(3):R25.
163. Loi S., Haibe-Kains B., Desmedt C., et al. Definition of clinically distinct molecular subtypes in estrogen receptor-positive breast carcinomas through genomic grade. J Clin Oncol 2007, 25(10):1239-1246. Erratum in: J Clin Oncol 2007;25(24):3790.
164. Mina L., Soule S.E., Badve S., et al. Predicting response to primary chemotherapy: gene expression profiling of paraffin-embedded core biopsy tissue. Breast Cancer Res Treat 2007, 103(2):197-208.
165. Paik S., Shak S., Tang G., et al. A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer. New Engl J Med 2004, 351(27):2817-2826.
166. Paik S., Tang G., Shak S., et al. Gene expression and benefit of chemotherapy in women with node-negative, estrogen receptor-positive breast cancer. J Clin Oncol 2006, 24(23):3726-3734.
167. Smith D.D., Saetrom P., Snove O., et al. Meta-analysis of breast cancer microarray studies in conjunction with conserved cis-elements suggest patterns for coordinate regulation. BMC Bioinformatics 2008, 9:63.
168. Wolf I., Ben-Baruch N., Shapira-Frommer R., et al. Association between standard clinical and pathologic characteristics and the 21-gene recurrence score in breast cancer patients: a population-based study. Cancer 2008, 112(4):731-736.