{"id":1478,"date":"2016-08-03T11:56:52","date_gmt":"2016-08-03T11:56:52","guid":{"rendered":"https:\/\/www.lalpathlabs.com\/blog\/?p=1478"},"modified":"2023-10-12T10:41:23","modified_gmt":"2023-10-12T05:11:23","slug":"fish-equivocal-her2-erbb2-amplification","status":"publish","type":"post","link":"https:\/\/www.lalpathlabs.com\/blog\/fish-equivocal-her2-erbb2-amplification\/","title":{"rendered":"Fish-Equivocal HER2 (ERBB2) Amplification in Breast Cancer"},"content":{"rendered":"<p><img decoding=\"async\" loading=\"lazy\" class=\"size-large wp-image-1480 aligncenter\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/innovative-forum-1024x312.png\" alt=\"FISH-EQUIVOCAL HER2\" width=\"750\" height=\"229\" \/><\/p>\n<h2 style=\"text-align: center;\"><span style=\"color: #ff6600;\">FISH-EQUIVOCAL HER2 (ERBB2) amplification<\/span><\/h2>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1481\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/test_principle-1024x93.png\" alt=\"test_principle\" width=\"750\" height=\"68\" \/><\/p>\n<p style=\"text-align: justify;\">ERBB2 (a.k.a. HER2) testing must be requested on every primary invasive breast cancer. Additionally,\u00a0it is recommended to perform ERBB2 testing on metastatic sites, classified as stage IV, if tissue sample\u00a0is available. This is to guide decision to pursue ERBB2-targeted therapy.<\/p>\n<p style=\"text-align: justify;\">This Interpretation Guide is based on ASCO (American Society of Clinical Oncology) and CAP (College\u00a0of American Pathologists) recommendations for ERBB2 testing in <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/www.lalpathlabs.com\/breast-cancer.aspx\">breast cancer<\/a><\/span> (Wolff AC, et al.\u00a02013)*.<\/p>\n<p style=\"text-align: justify;\">It does not claim to be complete in reference to clinical usage and appraisal of results. Moreover, it\u00a0should be regarded as a practical help of ERBB2 FISH evaluation in regards to clinical decision making.<\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1483\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/useful_for-1024x90.png\" alt=\"useful_for\" width=\"750\" height=\"66\" \/><\/p>\n<p style=\"text-align: justify;\">\u2022 A prognostic indicator for patients with both node-positive or node-negative primary and\u00a0metastatic breast cancer<\/p>\n<p style=\"text-align: justify;\">\u2022 Guiding therapy, as patients with <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/www.lalpathlabs.com\/pathology-test\/fish-her-2-neu-oncogene-amplification\">HER2 amplification<\/a><\/span> may be candidates for therapies that target\u00a0the human Epidermal Growth Factor Receptor 2 (HER2) protein (e.g., trastuzumab [Herceptin],\u00a0pertuzumab, lapatinib)<\/p>\n<p style=\"text-align: justify;\">\u2022 Confirming the presence of HER2 amplification in cases with 2+ (low level) or 3+ (high level) HER2\u00a0overexpression by immunohistochemistry<\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1486\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/whats_new-1024x92.png\" alt=\"what's_new\" width=\"750\" height=\"67\" \/><\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-1487 aligncenter\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/recommendation.png\" alt=\"recommendation\" width=\"917\" height=\"824\" \/><\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1488\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/erbb2-1024x92.png\" alt=\"erbb2\" width=\"750\" height=\"67\" \/><\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"size-full wp-image-1489 aligncenter\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/breast_cancer_specimen.png\" alt=\"breast_cancer_specimen\" width=\"844\" height=\"867\" \/><\/p>\n<p style=\"text-align: justify;\">1) Using ERBB2\/CEN 17 ratio alone can be misleading in cases of gains or losses of the\u00a0centromeric region of chromosome 17. Cases with ERBB2 copy number &lt; 4.0 should be reported<br \/>\nas ERBB2-positive if ratio is \u001f 2.0.<br \/>\n2) Monosomy with low-level amplification of ERBB2.<\/p>\n<p style=\"text-align: justify;\"><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1490\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/test_details-1024x94.png\" alt=\"test_details\" width=\"750\" height=\"69\" \/><\/p>\n<p style=\"text-align: justify;\"><span style=\"color: #3366ff;\"><strong>Code:<\/strong><\/span> XX051<br \/>\n<span style=\"color: #3366ff;\"><strong>Department:<\/strong><\/span> FISH<br \/>\n<span style=\"color: #3366ff;\"><strong>Name:<\/strong><\/span> FISH-EQUIVOCAL HER2 (ERBB2) amplification<br \/>\n<span style=\"color: #3366ff;\"><strong>Specimen:<\/strong><\/span> Formalin fixed paraffin embedded tissue block \/ three 4\u03bc sections on\u00a0Poly-L-Lysine coated slides. Ship at room temperature. Clinical history\u00a0is mandatory.<br \/>\n<span style=\"color: #3366ff;\"><strong>Room temperature:<\/strong><\/span> NA<br \/>\n<span style=\"color: #3366ff;\"><strong>Refrigerated:<\/strong><\/span> NA<br \/>\n<span style=\"color: #3366ff;\"><strong>Frozen:<\/strong> <\/span>NA<br \/>\n<span style=\"color: #3366ff;\"><strong>Method:<\/strong><\/span> FISH<br \/>\n<span style=\"color: #3366ff;\"><strong>Report:<\/strong><\/span> Sample Daily by 4 pm; Report in 5 days.<br \/>\n<span style=\"color: #3366ff;\"><strong>Usage:<\/strong> <\/span>This assay is recommended ( ASCO \/ CAP guidelines 2013) in all cases\u00a0where initial HER2 test result is equivocal. Reflex testing should be\u00a0performed on the same specimen using an alternative probe like\u00a0HER2 \/ D17S122. This probe targets an area which is different from\u00a0the usual centromere probe for HER2. It is important to further identify\u00a0equivocal results as it affects treatment protocols.<\/p>\n<p><img decoding=\"async\" loading=\"lazy\" class=\"alignnone size-large wp-image-1491\" src=\"https:\/\/www.lalpathlabs.com\/blog\/wp-content\/uploads\/2016\/08\/references-1024x91.png\" alt=\"references\" width=\"750\" height=\"67\" \/><\/p>\n<p style=\"text-align: justify;\">1. Wolff AC, Hammond ME, Hicks DG, et al: Recommendations for human epidermal growth factor\u00a0receptor 2 testing in breast cancer: American Society for Clinical Oncology\/College of American<br \/>\nPathologists clinical practice guideline update. J Clin Onc 2013 Nov 1;31(31):3997-4013<\/p>\n<p style=\"text-align: justify;\">2. Perez EA, Roche PC, Jenkins RB, et al: <span style=\"color: #0000ff;\"><a style=\"color: #0000ff;\" href=\"https:\/\/www.lalpathlabs.com\/pathology-test\/fish-her-2-neu-oncogene-amplification\">HER2 testing<\/a><\/span> in patients with breast cancer: poor correlation\u00a0between weak positively by immunohistochemistry and gene amplification by fluorescence in\u00a0situ hybridization. Mayo Clin Proc 2002 Feb;77(2):148-154<\/p>\n<p style=\"text-align: justify;\">3. Romond EH, Perez EA, Bryant J, et al: Trastuzumab plus adjuvant chemotherapy for operable\u00a0HER2-positive breast cancer. N Engl J Med 2005 Oct 20;353(16):1673-1684<\/p>\n<p style=\"text-align: justify;\">4. Perez EA, Romond EH, Suman VJ, et al: Four-year follow-up of trastuzumab plus adjuvant\u00a0chemotherapy for operable human epidermal growth factor receptor 2-positive breast cancer:<br \/>\njoint analysis of data from NCCTG N9831 and NSABP B-31. J Clin Oncol 2011 Sep\u00a01;29(25):3366-3373<\/p>\n<p style=\"text-align: justify;\">5. Blumenthal GM, Scher NS, Cortazar P, et al: First FDA approval of dual anti-HER2 regimen:\u00a0pertuzumab in combination with trastuzumab and docetaxel for HER2-positive metastatic breast\u00a0cancer. Clin Cancer Res 2013 Sep 5;19(18):4911-4916<\/p>\n<p style=\"text-align: justify;\">6. Robidoux A, Tang G, Rastogi P: Lapatinib as a component of neoadjuvant therapy for HER2-positive\u00a0operable breast cancer (NSABP protocol B-41): an open-label, randomised phase 3 trial. Lancet\u00a0Oncol 2013 epub: 2013 Oct 3<\/p>\n","protected":false},"excerpt":{"rendered":"<p>FISH-EQUIVOCAL HER2 (ERBB2) amplification ERBB2 (a.k.a. HER2) testing must be requested on every primary invasive breast cancer. Additionally,\u00a0it is recommended to perform ERBB2 testing on metastatic sites, classified as stage IV, if tissue sample\u00a0is available. This is to guide decision to pursue ERBB2-targeted therapy. This Interpretation Guide is based on ASCO (American Society of Clinical [&hellip;]<\/p>\n","protected":false},"author":6,"featured_media":9888,"comment_status":"open","ping_status":"open","sticky":false,"template":"","format":"standard","meta":{"footnotes":""},"categories":[1],"tags":[728,729,730,731,732],"acf":[],"_links":{"self":[{"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/posts\/1478"}],"collection":[{"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/posts"}],"about":[{"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/types\/post"}],"author":[{"embeddable":true,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/users\/6"}],"replies":[{"embeddable":true,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/comments?post=1478"}],"version-history":[{"count":2,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/posts\/1478\/revisions"}],"predecessor-version":[{"id":9887,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/posts\/1478\/revisions\/9887"}],"wp:featuredmedia":[{"embeddable":true,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/media\/9888"}],"wp:attachment":[{"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/media?parent=1478"}],"wp:term":[{"taxonomy":"category","embeddable":true,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/categories?post=1478"},{"taxonomy":"post_tag","embeddable":true,"href":"https:\/\/www.lalpathlabs.com\/blog\/wp-json\/wp\/v2\/tags?post=1478"}],"curies":[{"name":"wp","href":"https:\/\/api.w.org\/{rel}","templated":true}]}}