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Biomarker-Breast-markers.html
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<!DOCTYPE html PUBLIC "-//W3C//DTD XHTML 1.0 Transitional//EN" "http://www.w3.org/TR/xhtml1/DTD/xhtml1-transitional.dtd">
<html>
<html xmlns="http://www.w3.org/1999/xhtml">
<head>
<meta http-equiv="Content-Type" content="text/html; charset=UTF-8">
<title>Breast IHC and DISH</title>
<link rel="stylesheet" type="text/css" href="view.css" media="all">
<script type="text/javascript" src="view.js"></script>
<script>
function updateDescription (frm)
{
var Template = ""
if (frm.A01.value !== ""){
Template += "- Estrogen receptor: " + frm.A01.value + "\n";
}
if (frm.A02.value !== ""){
Template += " - Intensity: " + frm.A02.value + "\n";
}
if (frm.A03.value !== ""){
Template += " - Positive nuclei(%) : " + frm.A03.value + "\n";
}
if (frm.A04.value !== ""){
Template += "- Progesterone receptor: " + frm.A04.value + "\n";
}
if (frm.A05.value !== ""){
Template += " - Intensity: " + frm.A05.value + "\n";
}
if (frm.A06.value !== ""){
Template += " - Positive nuclei(%) : " + frm.A06.value + "\n";
}
if (frm.A07.value !== ""){
Template += "- HER2/neu oncoprotein IHC: " + frm.A07.value + "\n";
}
if (frm.A08.value !== ""){
Template += " - Score : " + frm.A08.value + "\n";
}
if (frm.A25.value !== ""){
Template += " - Percentage of Cells with Uniform Intense Staining : " + frm.A25.value + "\n";
}
if (frm.A09.value !== ""){
Template += "- HER2 DISH : " + frm.A09.value + "\n";
}
if (frm.A10.value !== ""){
Template += " - Number of tumor cell counted : " + frm.A10.value + "\n";
}
if (frm.A11.value !== ""){
Template += " - Average number of HER2 signals (black) per cell : " + frm.A11.value + "\n";
}
if (frm.A12.value !== ""){
Template += " - Average number of CEP17 signals (red) per cell : " + frm.A12.value + "\n";
}
if (frm.A13.value !== ""){
Template += " - HER2/CEP17 ratio : " + frm.A13.value + "\n";
}
if (frm.A26.value !== ""){
Template += " - Percentage of Cells with Amplified HER2 Signals : " + frm.A26.value + "\n";
}
if (document.getElementById("A14").checked || document.getElementById("A15").checked){
Template += " - Other ISH abnormalities: " + "\n";
}
if (document.getElementById("A14").checked){
Template += frm.A14.value + "\n";
}
if (document.getElementById("A15").checked){
Template += frm.A15.value + "\n";
}
if (frm.A16.value !== ""){
Template += "- Proliferation index Ki67 (%) : "+ frm.A16.value + "\n";
}
if (frm.A28.value !== ""){
Template += "\n" + "- Cold ischemia time : " + frm.A28.value + " min";
} else {
Template += "\n" + "- Cold ischemic time is uncertain." ;
}
if (frm.A28.value <= 60 && frm.A28.value !== ""){
Template += "\n" + " - Optimal (<= 60 min)." ;
}
if (frm.A28.value > 60 && frm.A28.value !== ""){
Template += "\n" + " - Prolonged intervals (> 60 min)." ;
}
if (frm.A27.value !== ""){
Template += "\n" + "- Fixation time in buffered formalin : " + frm.A27.value + " hours";
}else {
Template += "\n" + "- Formalin fixation time is uncertain." ;
}
if (frm.A27.value < 6 && frm.A27.value !== ""){
Template += "\n" + " - Inadequate fixation (<6 hours)." ;
}
if (frm.A27.value >= 6 && frm.A27.value <= 72 && frm.A27.value !== ""){
Template += "\n" + " - Optimal fixation (6-72 hours)." ;
}
if (frm.A27.value > 72 && frm.A27.value !== ""){
Template += "\n" + " - Prolonged intervals (>72 hours)." ;
}
if (frm.A28.value !== "" && frm.A28.value <= 60 && frm.A27.value >= 6 && frm.A27.value <= 72){
Template += "\n" + "- Meet requirements specified in the latest version of the ASCO/CAP guidelines." + "\n" ;
} else if (frm.A28.value == "" || frm.A27.value == ""){
Template += "\n" + "- Given the uncertain cold ischaemia time and/or uncertain fixation time, please interpret the above results with caution." + "\n" ;
} else if (frm.A28.value > 60 || frm.A27.value < 6 || frm.A27.value > 72){
Template += "\n" + "- Given the suboptimal cold ischaemia time and/or suboptimal formalin fixation time, please interpret the above results with caution." + "\n" ;
}
if (frm.A19.value !== ""){
Template += "\n" + "- Additional notes: " + "\n" + " - " + frm.A19.value + "\n";
}
if (frm.A01.value + frm.A04.value !== ""){
Template += "\n" + "Formalin-fixed paraffin embedded sections were assessed by IHC technique for ER and PR, using Novocastra ER (clone: 6F11) and Dako PR (clone: PgR636) with the Bond polymer refined detection system.";
}
if (frm.A07.value !== ""){
Template += "\n" + "Formalin-fixed paraffin embedded sections were assessed by IHC technique for HER2, using Ventana monoclonal HER2/neu (4B5) with Ventana BenchMark ULTRA multimer detection system.";
}
if (frm.A09.value !== ""){
Template += "\n" + "HER2 Dual ISH was performed on formalin-fixed paraffin embedded section with the Ventana INFORM HER2 Dual ISH DNA Probe Cocktail Assay on an automated system, and was examined by a pathologist under light microscopy."
}
if (frm.A09.value + frm.A07.value !== ""){
Template += "\n" + "\n" + "- Patients with breast cancers that are HER2 IHC 3+ or IHC 2+/ISH amplified may be eligible for several therapies that disrupt HER2 signaling pathways." + "\n" + "- Invasive breast cancers that test 'HER2-negative' (IHC 0, 1+ or 2+/ISH not-amplified) are more specifically considered ’HER2-negative for protein overexpression/gene amplification’ since non-overexpressed levels of the HER2 protein may be present in these cases." + "\n" + "- Patients with breast cancers that are HER2 IHC 1+ or IHC 2+/ISH not-amplified may be eligible for a treatment that targets non-amplified/non-overexpressed levels of HER2 expression for cytotoxic drug delivery (IHC 0 results do not result in eligibility currently).";
}
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</script>
<style>
table, th, td {
border: 1px solid silver;
border-collapse: collapse;
padding: 4px;
}
</style>
</head>
<body>
<img id="top" src="top.png" alt="">
<div id="form_container">
<div class="form_description">
<h2>
<a href=".\cap\Cancer-Protocols-2023-03-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.1.REL_CAPCP.pdf" target="_blank">
<div class="tooltip">Breast biomarkers testing
<span class="tooltiptext">click to access further explanations in the original CAP template</span>
</div>
</a></h2>
</div>
<form>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> Biomarkers assessments : </label></legend>
<p>
- Per review after 2024 CAP site inspection <br>
- Please fill in/estimate the cold ischemic time (in minutes) and formalin-fixation time (in hours).<br>
- Optimal cold ishemic time <= 60 min <br>
- Optimal formalin-fixation time 6-72 hours.
</p>
<p>
- For ER/PR, use Allred scoring for routine service.
<br>
<table>
<caption> CAP protocol (June-2021 updated):</caption>
<tr>
<td>ER assessment:</td>
<td>NEGATIVE: < 1% </td>
<td>POSITIVE: >10%; "LOW POSITIVE": 1-10% </td>
</tr>
<tr>
<td>PR assessment:</td>
<td>NEGATIVE: < 1% </td>
<td>POSITIVE: >10% </td>
</tr>
</table>
</p>
<p>
- For HER2, see <a href=".\cap\her2_breast_update_sor_2023.pdf" target="_blank">2023 ASCO guidelines</a>. <br>
- Do not report "HER2-Low" or "HER2 Ultra-Low" until further notice.<br>
- Reference for <a href=".\cap\PATHWAY anti-HER-2_neu (4B5) Rabbit Monoclonal Primary Antibody Interpretation Guide for Breast Cancer.pdf" target="_blank">4B5 antibody</a><br>
</p>
<p>
- Coming soon: BRCA1/BRCA2 genes germline variant test for patients with breast cancer (note: NOT somatic variant test).
</p>
<p>
<table border="1">
<col width="40%">
<tr>
<td rowspan="3" valign="top">
<label class="description">- <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=9" target="_blank">Estrogen recepter (ER) IHC</a> :</label>
</td>
<td>
<select class="element select large" ID="A01">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative, Internal control cells present and stain as expected">Negative, Internal control cells present and stain as expected</option>
<option value="Negative, Internal control cells absent">Negative, Internal control cells absent</option>
<option value="Negative, other (specify):">Negative, other (specify):</option>
<option value="Positive (Allred score >2)">Positive (Allred score >2)</option>
<option value="Positive (>10% positive nuclei)">Positive (>10% positive nuclei)</option>
<option value="Low Positive (1-10% positive nuclei)">Low Positive (1-10% positive nuclei)</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Intensity :</label>
<select class="element select medium" ID="A02">
<option value=""></option>
<option value="Negative (0)">Negative (0)</option>
<option value="Weak staining (1)">Weak staining (1)</option>
<option value="Moderate staining (2)">Moderate staining (2)</option>
<option value="Strong staining (3)">Strong staining (3)</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Positive nuclei (%) :</label>
<select class="element select medium" ID="A03">
<option value=""></option>
<option value="None (0)">None (0)</option>
<option value="< 1% (1)">< 1% (1)</option>
<option value="1-10% (2)">1-10% (2)</option>
<option value="11-33% (3)">11-33% (3)</option>
<option value="34-65% (4)">34-65% (4)</option>
<option value="66-100% (5)">66-100% (5)</option>
</select>
</td>
</tr>
<tr>
<td rowspan="3" valign="top">
<label class="description">- <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=9" target="_blank">Progesterone recepter (PR) IHC</a> :</label>
</td>
<td>
<select class="element select large" ID="A04">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative, Internal control cells present and stain as expected">Negative, Internal control cells present and stain as expected</option>
<option value="Negative, Internal control cells absent">Negative, Internal control cells absent</option>
<option value="Negative, other (specify):">Negative, other (specify):</option>
<option value="Positive (Allred score >2)">Positive (Allred score >2)</option>
<option value="Positive (>10% positive nuclei)">Positive (>10% positive nuclei)</option>
</select>
</td>
</tr>
<tr>
<td align="right">
<label>- Intensity :</label>
<select class="element select medium" ID="A05">
<option value=""></option>
<option value="Negative (0)">Negative (0)</option>
<option value="Weak staining (1)">Weak staining (1)</option>
<option value="Moderate staining (2)">Moderate staining (2)</option>
<option value="Strong staining (3)">Strong staining (3)</option>
</select></td>
</tr>
<tr>
<td align="right">
<label>- Positive nuclei (%) :</label>
<select class="element select medium" ID="A06">
<option value=""></option>
<option value="None (0)">None (0)</option>
<option value="< 1% (1)">< 1% (1)</option>
<option value="1-10% (2)">1-10% (2)</option>
<option value="11-33% (3)">11-33% (3)</option>
<option value="34-65% (4)">34-65% (4)</option>
<option value="66-100% (5)">66-100% (5)</option>
</select>
</td>
</tr>
<tr>
<td>
<label class="description">- <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=17" target="_blank">Ki67 Proliferation index %</a> :</label>
</td>
<td>
<input type="text" ID="A16" class="element text large" size="40">
</td>
</tr>
<tr>
<td rowspan="3" valign="top">
<label class="description">- <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=13" target="_blank">HER2/neu oncoprotein IHC</a> :</label>
Do not report "HER2-Low" or "HER2 Ultra-Low" at this moment.
</td>
<td><select class="element select large" ID="A07">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative for over-expression">Negative for over-expression</option>
<option value="Equivocal for over-expression">Equivocal for over-expression</option>
<option value="Positive for over-expression">Positive for over-expression</option>
<option value="HER2-low (IHC 1+ or IHC 2+ & DISH-)">HER2-low (IHC 1+ or IHC 2+ & DISH-)</option>
<option value="HER2-ultra-low (faint/barely perceptible and incomplete staining in <10% of tumor cells without amplification on FISH)">HER2-ultra-low (faint/barely perceptible and incomplete staining in <10% of tumor cells without amplification on FISH)</option>
</select></td>
</tr>
<tr>
<td align="right">
<label>- Score :</label>
<select class="element select medium" ID="A08">
<option value=""></option>
<option value="0 (No staining observed) (i.e. negative)">0 (No staining observed) (i.e. negative)</option>
<option value="0 (Membrane stating that is incomplete and is faint/barely perceptible and within <= 10% of
tumor cells) (i.e. negative)">0 (Membrane stating that is incomplete and is faint/barely perceptible and within <= 10% of
tumor cells) (i.e. negative)</option>
<option value="1 (Incomplete membrane staining that is faint/barely perceptible and within >10% of tumor
cells) (i.e. negative)">1 (Incomplete membrane staining that is faint/barely perceptible and within >10% of tumor
cells) (i.e. negative)</option>
<option value="2 (Weak to moderate staining within >10% of invasive tumour cells OR Complete membrane staining that is intense but within <=10% of tumor cells) (i.e. equivocal)">2 (Weak to moderate staining within >10% of invasive tumour cells OR Complete membrane staining that is intense but within <=10% of tumor cells) (i.e. equivocal)</option>
<option value="3 (Complete membrane staining that is intense and >10% of tumor cells) (i.e. positive)">3 (Complete membrane staining that is intense and >10% of tumor cells) (i.e. positive)</option>
</select></td>
</tr>
<tr>
<td align="right">
- Cells with Intense Complete Stain (%):
<input type="text" class="element text small" ID="A25" size="3"></td>
</tr>
<tr><td rowspan="7" valign="top">
<label class="description">- <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=15" target="_blank">HER2/neu oncoprotein DISH</a> :</label>
<a href=".\Biomarker-DISH-calculator.html" target="_blank">HER2 DISH calculator</a>
<!--
<br>
<a href=".\cap\her2_dish.xlsx" target="_blank">DOWNLOAD AN EXCEL FILE</a>
-->
</td>
<td><select class="element select large" ID="A09">
<option value=""></option>
<option value="Cannot be determined">Cannot be determined</option>
<option value="Negative for HER2 amplification">Negative for HER2 amplification</option>
<option value="Equivocal for HER2 amplification">Equivocal for over-expression</option>
<option value="Positive for HER2 amplification">Positive for HER2 amplification</option>
</select></td>
</tr>
<tr><td align="right">
- Number of tumor cells counted :
<input type="text" class="element text small" ID="A10" size="10"></td>
</tr>
<tr><td align="right">
- Average HER2 signals (black) per cell :
<input type="text" class="element text small" ID="A11" size="10"></td>
</tr>
<tr><td align="right">
- Average CEP17 signals (red) per cell :
<input type="text" class="element text small" ID="A12" size="10"></td>
</tr>
<tr><td align="right">
- HER2/CEP17 ratio :
<input type="text" class="element text small" ID="A13" size="10"></td>
</tr>
<tr>
<td align="right">
- Cells with Amplified Signals (%):
<input type="text" class="element text small" ID="A26" size="10"></td>
</tr>
<tr>
<td>- Other ISH abnormalities:<br>
<input class="element checkbox" type="checkbox" id="A14" value=" - Aneusomy"><label class="choice">Aneusomy</label>
<input class="element checkbox" type="checkbox" id="A15" value=" - Heterogeneous signals"><label class="choice">Heterogeneous signals</label>
</td>
</tr>
</table>
</p>
</fieldset>
</p>
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> <a href=".\cap\Cancer-Protocols-2022-06-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.0.REL_CAPCP.pdf#page=8" target="_blank">Analytical details</a> : </label></legend>
<p>
<table border="1">
<col width="40%">
<tr>
<td>
<label class="description">- Cold ischemia time (min) :</label>
</td>
<td>
<input type="text" class="element text small" ID="A28" size="3">
min
</td>
<tr>
<td>
<label class="description">- Fixation time in buffered formalin :</label>
</td>
<td>
<input type="text" class="element text small" ID="A27" size="3">
hours
</td>
</tr>
</table>
</p>
</fieldset>
</p>
<!--
<p align="center" >
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<br>
<a href=".\cap\her2_dish.xlsx" target="_blank">DOWNLOAD THE EXCEL FILE</a>
</p>
<p align="center" >
<iframe width="517" height="350" frameborder="1" scrolling="no" src="https://onedrive.live.com/embed?resid=4E150EF5229D3792%2186767&authkey=%21ADGiu7lwQ89z-xk&em=2&wdAllowInteractivity=False&AllowTyping=True&ActiveCell='Sheet1'!C4&Item='Sheet1'!A1%3AD12&wdHideGridlines=True&wdDownloadButton=True&wdInConfigurator=True"></iframe>
<br>
<a href=".\cap\PD-L1.xlsx" target="_blank">DOWNLOAD THE EXCEL FILE</a>
</p>
-->
<p>
<fieldset style="border-color:#e6e6ff;">
<legend> <label class="description"> <a href=".\cap\her2_breast_update_algorithms_2023.pdf" target="_blank">Dual probe ISH interpretation </a>: </label></legend>
- Group 1 = HER2/CEP17 ratio > or = 2.0; > or = 4.0 HER2 signals/cell<br>
- Group 2 = HER2/CEP17 ratio > or = 2.0; < 4.0 HER2 signals/cell <br>
- Group 3 = HER2/CEP17 ratio < 2.0; > or = 6.0 HER2 signals/cell <br>
- Group 4 = HER2/CEP17 ratio < 2.0; > or = 4.0 and < 6.0 HER2 signals/cell <br>
- Group 5 = HER2/CEP17 ratio < 2.0; < 4.0 HER2 signals/cell<br>
<br>
<fieldset style="border-color:#e6e6ff;">
<legend> Negative :</legend>
- Group 5;<br>
- Group 4 and concurrent IHC 0-1+ or 2+;<br>
- Group 3 and concurrent IHC 0-1+; and <br>
- Group 2 and concurrent IHC 0-1+ or 2+;<br>
<br>
</fieldset>
<fieldset style="border-color:#e6e6ff;">
<legend> Positive : </legend>
- Group 1;<br>
- Group 2 and concurrent IHC 3+;<br>
- Group 3 and concurrent IHC 2+ or 3+; and<br>
- Group 4 and concurrent IHC 3+ <br>
<br>
</fieldset>
<br>
</fieldset>
</fieldset>
</p>
<p>
Comments added in <a href=".\cap\wolff-et-al-2023-human-epidermal-growth-factor-receptor-2-testing-in-breast-cancer-asco-college-of-american.pdf" target="_blank">2023 guidelines</a>:<br><br>
Patients with breast cancers that are HER2 IHC 3+ or IHC 2+/ISH amplified may be eligible for several therapies that disrupt HER2 signaling pathways. <br><br>
Invasive breast cancers that test 'HER2-negative' (IHC 0, 1+ or 2+/ISH not-amplified) are more specifically considered 'HER2-negative for protein overexpression/gene amplification' since non-overexpressed levels of the HER2 protein may be present in these cases. <br><br>
Patients with breast cancers that are HER2 IHC 1+ or IHC 2+/ISH not-amplified may be eligible for a treatment that targets non-amplified/non-overexpressed levels of HER2 expression for cytotoxic drug delivery (IHC 0 results do not result in eligibility currently).”
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<br><br>
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<a href=".\cap\fmolb-09-834651-g001.jpg" target="_blank"><img src=".\cap\fmolb-09-834651-g001.jpg" alt="HER2 IHC" width="600"></a>
<br>
From <a href="https://doi.org/10.3389/fmolb.2022.834651" target="_blank">Venetis et al Front. Mol. Biosci. 2022.</a>
</p>
<p>
HER2-low<br>
HER2 IHC 2+ AND HER2 DISH negative OR HER2 IHC 1+<br>
Tarantino P et al. 2020<br><br>
</p>
<p>
HER2 Ultra-low<br>
It is immunohistochemically characterized by faint/barely perceptible and incomplete staining in =<10% of tumor cells without amplification on FISH. <br>
</p>
<p>
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Last upated 18-Oct-2024, based on <a href=".\cap\Cancer-Protocols-2023-03-Update\Breast Protocol Folder\Breast.Bmk_1.5.0.1.REL_CAPCP.pdf" target="_blank"> Breast Biomarkers 1.5.0.1 Mar-2023</a>.<br>
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