Hướng dẫn của Hiệp hội Y tế Lâm sàng Hoa Kỳ/Trường Cao đẳng Bác sĩ chuyên khoa Hoa Kỳ về Kiểm tra Hóa mô miễn dịch của Thụ thể Estrogen và Progesterone trong Ung thư Vú (Phiên bản đầy đủ)
Tóm tắt
Mục đích.—Phát triển hướng dẫn để cải thiện độ chính xác của xét nghiệm hóa mô miễn dịch (IHC) thụ thể estrogen (ER) và thụ thể progesterone (PgR) trong ung thư vú và khả năng sử dụng của các thụ thể này như là các dấu ấn tiên lượng.
Phương pháp.—Hiệp hội Y tế Lâm sàng Hoa Kỳ và Trường Cao đẳng Bác sĩ chuyên khoa Hoa Kỳ đã triệu tập một Ban Chuyên gia Quốc tế, tiến hành một đánh giá hệ thống và đánh giá tài liệu khoa học với sự hợp tác của tổ chức Cancer Care Ontario và phát triển khuyến nghị cho hoạt động IHC ER/PgR tối ưu.
Kết quả.—Có đến 20% của các xác định IHC hiện tại về xét nghiệm ER và PgR trên toàn thế giới có thể không chính xác (âm tính giả hoặc dương tính giả). Phần lớn các vấn đề với xét nghiệm đã xảy ra do sự thay đổi trong các biến số tiền phân tích, ngưỡng dương tính, và tiêu chí diễn giải.
Khuyến nghị.—Ban đề nghị rằng trạng thái ER và PgR nên được xác định trên tất cả các trường hợp ung thư vú xâm lấn và các tái phát ung thư vú. Một thuật toán xét nghiệm phụ thuộc vào hiệu suất thí nghiệm chính xác, dễ tái tạo được đề xuất. Các yếu tố để giảm đáng tin cậy sự biến đổi của phép thử được chỉ ra. Người ta khuyến cáo rằng các xét nghiệm ER và PgR được coi là dương tính nếu có ít nhất 1% hạt nhân khối u dương tính trong mẫu thử nghiệm với sự hiện diện của phản ứng dự kiến của các đối chứng nội tại (các yếu tố biểu bì bình thường) và các đối chứng ngoài. Sự vắng mặt của lợi ích từ điều trị nội tiết đối với phụ nữ có các trường hợp ung thư vú xâm lấn ER âm tính đã được xác nhận trong các tổng quan lớn của các thử nghiệm lâm sàng ngẫu nhiên.
Từ khóa
#hóa mô miễn dịch #thụ thể estrogen #thụ thể progesterone #ung thư vú #đánh giá hệ thống #biến số tiền phân tích #thuật toán xét nghiệm.Tài liệu tham khảo
Fisher, 1981, Treatment of primary breast cancer with chemotherapy and tamoxifen., N Engl J Med, 305, 1, 10.1056/NEJM198107023050101
Fisher, 1983, Influence of tumor estrogen and progesterone receptor levels on the response to tamoxifen and chemotherapy in primary breast cancer., J Clin Oncol, 1, 227, 10.1200/JCO.1983.1.4.227
Harris, 2007, American Society of Clinical Oncology 2007 update of recommendations for the use of tumor markers in breast cancer., J Clin Oncol, 25, 5287, 10.1200/JCO.2007.14.2364
Fitzgibbons, 2000, Prognostic factors in breast cancer: College of American Pathologists Consensus Statement 1999., Arch Pathol Lab Med, 124, 966, 10.5858/2000-124-0966-PFIBC
Fleisher, 2002, Practice Guidelines and Recommendations for Use of Tumor Markers in the Clinic. Tumor Markers: Physiology, Pathobiology, Technology and Clinical Applications
Wittliff, 1987, Steroid hormone receptors., Methods in Clinical Chemistry, 767
Wittliff, 1981, Establishment of uniformity in steroid receptor determinations for protocol B-09 of the National Surgical Adjuvant Breast Project., Estrogen Receptor Assays in Breast Cancer: Laboratory Discrepancies and Quality Assurance, 27
Wittliff, 1980, Establishment of uniformity in steroid receptor analyses used in cooperative clinical trials of breast cancer treatment., Recent Results Cancer Res, 71, 198
McCormack, 2009, Sex steroids, growth factors and mammographic density: A cross-sectional study of UK postmenopausal Caucasian and Afro-Caribbean women., Breast Cancer Res, 11, R38, 10.1186/bcr2325
Murray, 2009, A randomised study of the effects of letrozole and anastrozole on oestrogen receptor positive breast cancers in postmenopausal women., Breast Cancer Res Treat, 114, 495, 10.1007/s10549-008-0027-0
Bjornstrom, 2005, Mechanisms of estrogen receptor signaling: Convergence of genomic and nongenomic actions on target genes., Mol Endocrinol, 19, 833, 10.1210/me.2004-0486
Jensen, 1967, Estrogen-receptor interactions in target tissues., Arch Anat Microsc Morphol Exp, 56, 547
McGuire, 1975, Estrogen receptors in human breast cancer., Estrogen Receptors in Human Breast Cancer, 1
Pasic, 1990, Comparison of sex steroid receptor determinations in human breast cancer by enzyme immunoassay and radioligand binding., J Clin Lab Anal, 4, 430, 10.1002/jcla.1860040608
Dowsett, 2006, Benefit from adjuvant tamoxifen therapy in primary breast cancer patients according oestrogen receptor, progesterone receptor, EGF receptor and HER2 status., Ann Oncol, 17, 818, 10.1093/annonc/mdl016
McCarty, 1985, Estrogen receptor analyses: Correlation of biochemical and immunohistochemical methods using monoclonal antireceptor antibodies., Arch Pathol Lab Med, 109, 716
Barnes, 1996, 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, 74, 1445, 10.1038/bjc.1996.563
Harvey, 1999, 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, 17, 1474, 10.1200/JCO.1999.17.5.1474
Elledge, 2000, 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, 89, 111, 10.1002/(SICI)1097-0215(20000320)89:2<111::AID-IJC2>3.0.CO;2-W
Thomson, 2002, Adjuvant ovarian ablation vs CMF chemotherapy in premenopausal breast cancer patients: Trial update and impact of immunohistochemical assessment of ER status., Breast, 11, 419, 10.1054/brst.2002.0451
Regan, 2006, Re-evaluating adjuvant breast cancer trials: Assessing hormone receptor status by immunohistochemical versus extraction assays., J Natl Cancer Inst, 98, 1571, 10.1093/jnci/djj415
Massarweh, 2008, Tamoxifen resistance in breast tumors is driven by growth factor receptor signaling with repression of classic estrogen receptor genomic function., Cancer Res, 68, 826, 10.1158/0008-5472.CAN-07-2707
Clark, 1983, Progesterone receptors as a prognostic factor in stage II breast cancer., N Engl J Med, 309, 1343, 10.1056/NEJM198312013092240
Osborne, 1979, Therapy for cancer of the breast: Current status of steroid hormone receptors., West J Med, 130, 401
Ravdin, 1992, Prognostic significance of progesterone receptor levels in estrogen receptor-positive patients with metastatic breast cancer treated with tamoxifen: Results of a prospective Southwest Oncology Group study., J Clin Oncol, 10, 1284, 10.1200/JCO.1992.10.8.1284
Horwitz, 1975, Predicting response to endocrine therapy in human breast cancer: A hypothesis., Science, 189, 726, 10.1126/science.168640
Beatson, 1896, On the treatment of inoperable cases of carcinoma of the mamma: Suggestions for a new method of treatment with illustrative cases., Lancet, 148, 104, 10.1016/S0140-6736(01)72307-0
Early Breast Cancer Trialists' Collaborative Group, 2005, Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: An overview of the randomised trials., Lancet, 365, 1687, 10.1016/S0140-6736(05)66544-0
Ellis, 2004, Treatment of metastatic breast cancer., Diseases of the Breast (ed 3), 1101
Vogel, 2006, Effects of tamoxifen vs raloxifene on the risk of developing invasive breast cancer and other disease outcomes: The NSABP Study of Tamoxifen and Raloxifene (STAR) P-2 trial., JAMA, 295, 2727, 10.1001/jama.295.23.joc60074
Visvanathan, 2009, American Society of Clinical Oncology Clinical Practice Guideline Update on the use of pharmacologic interventions including tamoxifen, raloxifene, and aromatase inhibition for breast cancer risk reduction., J Clin Oncol, 27, 3235, 10.1200/JCO.2008.20.5179
Haddow, 1944, Influence of synthetic oestrogens upon advanced malignant disease., BMJ, 2, 393, 10.1136/bmj.2.4368.393
Kennedy, 1962, Massive estrogen administration in premenopausal women with metastatic breast cancer., Cancer, 15, 641, 10.1002/1097-0142(196205/06)15:3<641::AID-CNCR2820150330>3.0.CO;2-9
Ellis, 2009, Lower-dose vs high-dose oral estradiol therapy of hormone receptor-positive, aromatase inhibitor-resistant advanced breast cancer: A phase 2 randomized study., JAMA, 302, 774, 10.1001/jama.2009.1204
Jordan, 2002, Historical perspective on hormonal therapy of advanced breast cancer., Clin Ther, 24, A3, 10.1016/S0149-2918(02)85031-7
Mauri, 2006, Survival with aromatase inhibitors and inactivators versus standard hormonal therapy in advanced breast cancer: Meta-analysis., J Natl Cancer Inst, 98, 1285, 10.1093/jnci/djj357
Winer, 2005, American Society of Clinical Oncology technology assessment on the use of aromatase inhibitors as adjuvant therapy for postmenopausal women with hormone receptor-positive breast cancer: Status report 2004., J Clin Oncol, 23, 619, 10.1200/JCO.2005.09.121
Lippman, 1984, An assessment of current achievements in the systemic management of breast cancer., Breast Cancer Res Treat, 4, 69, 10.1007/BF01806388
Anderson, 2007, Expanding priorities: Confronting chronic disease in countries with low income., N Engl J Med, 356, 209, 10.1056/NEJMp068182
Ferlay, 2004, GLOBOCAN 2002: Cancer Incidence, Mortality and Prevalence Worldwide. IARC CancerBase No. 5. version 2.0
Uy, 2007, Immuno-histochemical assay of hormone receptors in breast cancer at the Philippine General Hospital: Importance of early fixation of specimens., Philip J Surg Spec, 62, 123
Nichols, 2005, Differences in breast cancer risk factors by tumor marker subtypes among premenopausal Vietnamese and Chinese women., Cancer Epidemiol Biomarkers Prev, 14, 41, 10.1158/1055-9965.41.14.1
Tan
Adebamowo, 2008, Immunohistochemical and molecular subtypes of breast cancer in Nigeria., Breast Cancer Res Treat, 110, 183, 10.1007/s10549-007-9694-5
Mostafa
Dowsett, 2008, 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, 26, 1059, 10.1200/JCO.2007.12.9437
Wolff, 2007, American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer., J Clin Oncol, 25, 118, 10.1200/JCO.2006.09.2775
Wolff, 2007, American Society of Clinical Oncology/College of American Pathologists guideline recommendations for human epidermal growth factor receptor 2 testing in breast cancer., Arch Pathol Lab Med, 131, 18, 10.5858/2007-131-18-ASOCCO
Raam, 1981, Estrogen receptor assay: Interlaboratory and intralaboratory variations in the measurement of receptors using dextran-coated charcoal technique: A study sponsored by ECOG., Eur J Cancer, 17, 643, 10.1016/0014-2964(81)90267-X
Oxley, 1982, Precision in estrogen and progesterone receptor assays: Results of the first CAP pilot survey., Am J Clin Pathol, 78, 587
Rhodes, 2000, 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, 53, 688, 10.1136/jcp.53.9.688
Rhodes, 2000, 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, 53, 125, 10.1136/jcp.53.2.125
Francis, 2007, Frequency and reliability of oestrogen receptor, progesterone receptor and HER2 in breast carcinoma determined by immunohistochemistry in Australasia: Results of the RCPA Quality Assurance Program., J Clin Pathol, 60, 1277, 10.1136/jcp.2006.044701
Cameron, 2009, Commission of Inquiry on Hormone Receptor Testing
Seguin, Breast cancer patients to be retested in Quebec.
Canadian Cancer Society, Pathology tests related to breast cancer treatment.
Love, 2002, Oophorectomy and tamoxifen adjuvant therapy in premenopausal Vietnamese and Chinese women with operable breast cancer., J Clin Oncol, 20, 2559, 10.1200/JCO.2002.08.169
Badve, 2008, 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, 26, 2473, 10.1200/JCO.2007.13.6424
Viale, 2007, 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, 25, 3846, 10.1200/JCO.2007.11.9453
Gelber, 2009, Facilitating consensus by examining patterns of treatment effects. International Breast Cancer Study Group (IBCSG) and the Breast International Group (BIG)., Breast, 18, S2, 10.1016/S0960-9776(09)70265-6
Ibrahim, 2008, 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, 129, 398, 10.1309/2YXRLEQVPPNRWHGA
Fitzgibbons, Recommendations for validating estrogen and progesterone receptor immunohistochemistry assays., Arch Pathol Lab Med (in press)
McCarty, 1986, Use of a monoclonal anti-estrogen receptor antibody in the immunohistochemical evaluation of human tumors., Cancer Res, 46, 4244s
DeSombre, 1986, Prognostic usefulness of estrogen receptor immunocytochemical assays for human breast cancer., Cancer Res, 46, 4256s
Arpino, 2004, HER-2 amplification, HER-1 expression, and tamoxifen response in estrogen receptor-positive metastatic breast cancer: A Southwest Oncology Group study., Clin Cancer Res, 10, 5670, 10.1158/1078-0432.CCR-04-0110
Horiguchi, 2005, Co-expressed type of ER and HER2 protein as a predictive factor in determining resistance to antiestrogen therapy in patients with ER-positive and HER2-positive breast cancer., Oncol Rep, 14, 1109
Ellis, 2008, Outcome prediction for estrogen receptor-positive breast cancer based on postneoadjuvant endocrine therapy tumor characteristics., J Natl Cancer Inst, 100, 1380, 10.1093/jnci/djn309
Mohsin, 2004, Progesterone receptor by immunohistochemistry and clinical outcome in breast cancer: A validation study., Mod Pathol, 17, 1545, 10.1038/modpathol.3800229
Paik, 2004, A multigene assay to predict recurrence of tamoxifen-treated, node-negative breast cancer., N Engl J Med, 351, 2817, 10.1056/NEJMoa041588
Viale, 2008, Chemoendocrine compared with endocrine adjuvant therapies for node-negative breast cancer: Predictive value of centrally reviewed expression of estrogen and progesterone receptors—International Breast Cancer Study Group., J Clin Oncol, 26, 1404, 10.1200/JCO.2007.10.6393
Cheang, 2006, 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, 24, 5637, 10.1200/JCO.2005.05.4155
Phillips, 2007, Development of standard estrogen and progesterone receptor immunohistochemical assays for selection of patients for antihormonal therapy., Appl Immunohistochem Mol Morphol, 15, 325, 10.1097/01.pai.0000213135.16783.bc
Osborne, 1980, The value of estrogen and progesterone receptors in the treatment of breast cancer., Cancer, 46, 2884, 10.1002/1097-0142(19801215)46:12+<2884::AID-CNCR2820461429>3.0.CO;2-U
Knight, 1980, Hormone receptors in primary and advanced breast cancer., Clin Endocrinol Metab, 9, 361, 10.1016/S0300-595X(80)80038-7
Cowen, 1990, Oestrogen receptor in breast cancer: Prognostic studies using a new immunohistochemical assay., Histopathology, 17, 319, 10.1111/j.1365-2559.1990.tb00735.x
Stendahl, 2006, High progesterone receptor expression correlates to the effect of adjuvant tamoxifen in premenopausal breast cancer patients., Clin Cancer Res, 12, 4614, 10.1158/1078-0432.CCR-06-0248
Lockwood, 1999, A simple index using video image analysis to predict disease outcome in primary breast cancer., Int J Cancer, 84, 203, 10.1002/(SICI)1097-0215(19990621)84:3<203::AID-IJC1>3.0.CO;2-U
Esteban, 1994, Quantitative immunohistochemical assay for hormonal receptors: Technical aspects and biological significance., J Cell Biochem Suppl, 19, 138
Yamashita, 2006, Immunohistochemical evaluation of hormone receptor status for predicting response to endocrine therapy in metastatic breast cancer., Breast Cancer, 13, 74, 10.2325/jbcs.13.74
Jalava, 2005, Immunohistochemical staining of estrogen and progesterone receptors: Aspects for evaluating positivity and defining the cutpoints., Anticancer Res, 25, 2535
Ogawa, 2004, 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, 11, 267, 10.1007/BF02984548
Gown, 2004, Unmasking the mysteries of antigen or epitope retrieval and formalin fixation., Am J Clin Pathol, 121, 172, 10.1309/9G5FY3U3QB4R15DR
Nenci, 1976, Detection and dynamic localisation of estradiol-receptor complexes in intact target cells by immunofluorescence technique., J Steroid Biochem, 7, 505, 10.1016/0022-4731(76)90194-1
Diaz, 2005, Estrogen receptor analysis for breast cancer: Current issues and keys to increasing testing accuracy., Adv Anat Pathol, 12, 10, 10.1097/00125480-200501000-00003
Yaziji, 2008, Consensus recommendations on estrogen receptor testing in breast cancer by immunohistochemistry., Appl Immunohistochem Mol Morphol, 16, 513, 10.1097/PAI.0b013e31818a9d3a
Goldstein, 2003, Minimum formalin fixation time for consistent estrogen receptor immunohistochemical staining of invasive breast carcinoma., Am J Clin Pathol, 120, 86, 10.1309/QPHDRB00QXGMUQ9N
Scharl, 1990, Immunohistochemical detection of progesterone receptor in formalin-fixed and paraffin-embedded breast cancer tissue using a monoclonal antibody., Arch Gynecol Obstet, 247, 63, 10.1007/BF02390663
Cavaliere, 2001, Computer-assisted immunocytochemical determination of breast cancer steroid receptors: Frozen sections vs paraffin sections., Breast, 11, 476, 10.1054/brst.2001.0294
Arber, 2002, Effect of prolonged formalin fixation on the immunohistochemical reactivity of breast markers., Appl Immunohistochem Mol Morphol, 10, 183, 10.1097/00129039-200206000-00015
Ibarra, 1995, Estrogen receptor immunohistochemistry in formalin-fixed, paraffin-embedded breast tumor tissue: Enhanced sensitivity using a monoclonal antibody cocktail., Appl Immunohistochem Mol Morphol, 3, 202
Jensen, 1995, Immunohistochemical quantitation of oestrogen receptors and proliferative activity in oestrogen receptor positive breast cancer., J Clin Pathol, 48, 429, 10.1136/jcp.48.5.429
von Wasielewski, 1998, Influence of fixation, antibody clones, and signal amplification on steroid receptor analysis., Breast J, 4, 33, 10.1046/j.1524-4741.1998.410033.x
von Wasielewski, 2002, Tissue array technology for testing interlaboratory and interobserver reproducibility of immunohistochemical estrogen receptor analysis in a large multicenter trial., Am J Clin Pathol, 118, 675, 10.1309/URLK-6AVK-331U-0V5P