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<meta name="keywords" content="CN077999, braf, egfr, erbb2, kras, nras, panitumumab response, sign or symptom, vectibix response, autosomal dominant, autosomal recessive, birth defects, chromosomal disease, chromosome, clinical features, clinical findings, clinical genetics, clinical recommendations, clinvar, congenital chromosomal disease, consumer genetic resources, cytogenetic location, disease characteristics, disease definitions, disease descriptions, disease ontology, disease synonyms, disease vocabulary, dysmorphology, entrez, familial disease, gene, gene-disease relationship, genereviews, genetic disease, genetic disorder, genetic terminology, genetic testing registry, genetics home reference, genomic disease, gtr, hereditary disease, heritable disease, hpo, human phenotype ontology, inherited disease, management guidelines, maternal inheritance, medgen, medical genetics, medical subject headings, mesh, mitochondrial inheritance, mode of inheritance, national center for biotechnology information, national institutes of health, national library of medicine, ncbi, nih, nlm, omim, ordo, orphanet, paternal inheritance, phenome, position statements, professional practice guidelines, rare disease, reference sequence, refseq, snomed ct, syndrome, undiagnosed diseases, x-linked recessive" /><meta name="description" content="Panitumumab is a monoclonal antibody used for the treatment of metastatic colorectal cancer (mCRC). Panitumumab is an epidermal growth factor receptor (EGFR) antagonist, which works by blocking the growth of cancer cells. It is administered every 14 days as an intravenous (IV) infusion, often with chemotherapy. Panitumumab is approved for first-line therapy with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. The location of the primary tumor correlates whether an individual with mCRC is likely respond to anti-EGFR therapy. Individuals with left-sided tumors are more likely to respond well to anti-EGFR therapy and have a better prognosis. Individuals with right-sided tumors have a worse prognosis and respond poorly to anti-EGFR therapy. However, only the genetic variation status of the tumor, and not the location of the tumor, is discussed in the FDA drug label’s dosing recommendations. Resistance to panitumumab is associated with specific RAS mutations. The RAS is a family of oncogenes that includes the KRAS and NRAS genes. When mutated, these genes have the ability to transform normal cells into cancerous cells by providing a continual growth stimulus to cells. The KRAS mutations are particularly common, being detectable in 40% of metastatic colorectal tumors. The KRAS mutations often lead to constitutive activation of the EGFR and are associated with resistance to anti-EGFR drugs such as panitumumab. Mutations in NRAS and another gene, BRAF, have also been associated with poor response to anti-EGFR therapy. The 2017 FDA-approved label states that panitumumab is indicated for wild-type RAS (no mutations in either KRAS or NRAS) mCRC. The label states that an FDA-approved test must be used to confirm the absence of RAS mutations before starting panitumumab, and that panitumumab is not indicated for the treatment of individuals with colorectal cancer with RAS mutations (in either NRAS or KRAS), or when the RAS genetic variation status is unknown. Similarly, the 2015 Update from the American Society of Clinical Oncology (ASCO) states that anti-EGFR therapy should only be considered for the treatment of individuals whose tumor is determined to not have variations detected after extended RAS testing. The 2020 National Comprehensive Cancer Network (NCCN) guideline also strongly recommends KRAS/NRAS genotyping of tumor tissue in all individuals with mCRC. In addition, the guideline states the V600E mutation in the BRAF gene makes a response to panitumumab highly unlikely, unless given with a BRAF inhibitor." /><meta name="robots" content="index,nofollow,noarchive" />
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<!--
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||
UID=450471
|
||
ConceptID=CN077999
|
||
-->
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<!--imgCountBooks = 0--><h1 class="medgenTitle"><div class="MedGenTitleText">Panitumumab response</div></h1><div class="aux"><div class="resc"><dl class="rprtid"><dt>MedGen UID: </dt><dd>450471</dd><dt><span class="dotprefix"> •</span>Concept ID: </dt><dd><a href="/medgen/docs/help/#sources" target="_blank" title="Concept Unique Identifier assigned by MedGen (starting with CN) for terms that cannot be identified in NLM's Unified Medical Language system (UMLS) Click for more information."><span class="highlight" style="background-color:">CN077999</span></a></dd><dt><span class="dotprefix"> •</span></dt><dd>Sign or Symptom</dd></dl></div></div><table class="medgenTable"><tbody><tr><td>Synonym:</td>
|
||
<td>Vectibix response</td></tr>
|
||
<tr><td>Drug:</td>
|
||
<td>
|
||
<div class="divPopper rprt" id="drug_168099"><div><strong>Panitumumab</strong><div class="aux"><div class="resc"><dl class="rprtid"><dt>MedGen UID: </dt><dd>168099</dd><dt><span class="dotprefix"> •</span>Concept ID: </dt><dd><a href="/medgen/docs/help/#sources" target="_blank" title="Concept Unique Identifier from NLM's Unified Medical Language system (UMLS) Click for more information.">C0879427</a></dd><dt><span class="dotprefix"> •</span></dt><dd>Amino Acid, Peptide, or Protein</dd></dl></div></div></div>
|
||
<div class="spaceAbove">A human IgG2kappa monoclonal antibody specific for the epidermal growth factor receptor (EGFR). Monoclonal antibody E7.6.3 binds to the EGFR, blocking the binding of epidermal growth factor and transforming growth factor alpha to EGFR-expressing cancer cells and ultimately inhibiting EGFR-dependent cell activation and proliferation. (NCI) [from NCI]</div></div>
|
||
<div class="hangingIndent"><a title="click for more information" class="jig-ncbipopper" href="#drug_168099" data-jigconfig="hasArrow: true, openEvent: 'click', closeEvent: 'mouseout', openAnimation: 'fadeIn', closeAnimation: 'fadeOut', triggerPosition: 'center right', destPosition: 'center left', arrowDirection: 'left'">Panitumumab</a></div></td></tr>
|
||
<tr><td colspan="2" class="small"> </td></tr><tr><td><a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#target-gene-loc">Genes (locations):<img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a><div class="display-none" id="target-gene-loc">
|
||
Gene(s) directly associated with<br />
|
||
this condition or phenotype.</div></td>
|
||
<td><a target="_blank" title="BRAF - ID: 673 - NCBI Gene" href="/gene/673" class="medgenPMinfo">BRAF</a> (7q34); <a target="_blank" title="EGFR - ID: 1956 - NCBI Gene" href="/gene/1956" class="medgenPMinfo">EGFR</a> (7p11.2); <a target="_blank" title="ERBB2 - ID: 2064 - NCBI Gene" href="/gene/2064" class="medgenPMinfo">ERBB2</a> (17q12); <a target="_blank" title="KRAS - ID: 3845 - NCBI Gene" href="/gene/3845" class="medgenPMinfo">KRAS</a> (12p12.1); <a target="_blank" title="NRAS - ID: 4893 - NCBI Gene" href="/gene/4893" class="medgenPMinfo">NRAS</a> (1p13.2)</td></tr>
|
||
</tbody></table></div><div class="rprt-body jig-ncbiinpagenav" data-jigconfig="smoothScroll: false, gotoTopLink: true, gotoTopLinkText: '', gotoTopLinkAttrs: {'title': 'Go to the top of the page'},allHeadingLevels: ['h1'], topOfPageTOC: true, tocId: 'my-toc'"><div id="rprt-tabs-1" class="rprt-tab"><div id="tb-termsProp-1"><div class="leftCol mgCol"><div>
|
||
<div class="portlet mgSection" id="ID_100">
|
||
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Definition">Definition</h1><a sid="100" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
|
||
<div class="portlet_content ln">Panitumumab is a monoclonal antibody used for the treatment of metastatic colorectal cancer (mCRC). Panitumumab is an epidermal growth factor receptor (EGFR) antagonist, which works by blocking the growth of cancer cells. It is administered every 14 days as an intravenous (IV) infusion, often with chemotherapy. Panitumumab is approved for first-line therapy with folinic acid, fluorouracil, and oxaliplatin (FOLFOX) and as monotherapy following disease progression after prior treatment with fluoropyrimidine-, oxaliplatin-, and irinotecan-containing chemotherapy. The location of the primary tumor correlates whether an individual with mCRC is likely respond to anti-EGFR therapy. Individuals with left-sided tumors are more likely to respond well to anti-EGFR therapy and have a better prognosis. Individuals with right-sided tumors have a worse prognosis and respond poorly to anti-EGFR therapy. However, only the genetic variation status of the tumor, and not the location of the tumor, is discussed in the FDA drug label’s dosing recommendations. Resistance to panitumumab is associated with specific RAS mutations. The RAS is a family of oncogenes that includes the KRAS and NRAS genes. When mutated, these genes have the ability to transform normal cells into cancerous cells by providing a continual growth stimulus to cells. The KRAS mutations are particularly common, being detectable in 40% of metastatic colorectal tumors. The KRAS mutations often lead to constitutive activation of the EGFR and are associated with resistance to anti-EGFR drugs such as panitumumab. Mutations in NRAS and another gene, BRAF, have also been associated with poor response to anti-EGFR therapy. The 2017 FDA-approved label states that panitumumab is indicated for wild-type RAS (no mutations in either KRAS or NRAS) mCRC. The label states that an FDA-approved test must be used to confirm the absence of RAS mutations before starting panitumumab, and that panitumumab is not indicated for the treatment of individuals with colorectal cancer with RAS mutations (in either NRAS or KRAS), or when the RAS genetic variation status is unknown. Similarly, the 2015 Update from the American Society of Clinical Oncology (ASCO) states that anti-EGFR therapy should only be considered for the treatment of individuals whose tumor is determined to not have variations detected after extended RAS testing. The 2020 National Comprehensive Cancer Network (NCCN) guideline also strongly recommends KRAS/NRAS genotyping of tumor tissue in all individuals with mCRC. In addition, the guideline states the V600E mutation in the BRAF gene makes a response to panitumumab highly unlikely, unless given with a BRAF inhibitor. [from <a title="Medical Genetics Summaries" href="https://www.ncbi.nlm.nih.gov/books/NBK61999" class="defSource" target="_blank">Medical Genetics Summaries</a>]</div>
|
||
</div>
|
||
|
||
<div class="portlet mgSection" id="ID_105">
|
||
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Professional_guidelines">Professional guidelines</h1><a sid="105" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
|
||
<div class="portlet_content ln"><h3 class="subhead">PubMed<a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#guidelinesHelpPM"><img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a></h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/30920626">Systemic treatment of advanced esophageal squamous cell carcinoma: chemotherapy, molecular-targeting therapy and immunotherapy.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Hirano H,
|
||
Kato K</span><br />
|
||
<span class="medgenPMjournal">Jpn J Clin Oncol</span>
|
||
2019 May 1;49(5):412-420.
|
||
doi: 10.1093/jjco/hyz034.
|
||
<span class="bold">PMID: </span><a href="/pubmed/30920626" target="_blank">30920626</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/27977573">The efficacy and safety of panitumumab plus irrinotecan-based chemotherapy in the treatment of metastatic colorectal cancer: A meta-analysis.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Chen Q,
|
||
Cheng M,
|
||
Wang Z,
|
||
Zhao S</span><br />
|
||
<span class="medgenPMjournal">Medicine (Baltimore)</span>
|
||
2016 Dec;95(50):e5284.
|
||
doi: 10.1097/MD.0000000000005284.
|
||
<span class="bold">PMID: </span><a href="/pubmed/27977573" target="_blank">27977573</a><a href="/pmc/articles/PMC5268019" target="_blank" class="PubMedFree">Free PMC Article</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/26572750">Pharmacokinetic and pharmacodynamic evaluation of panitumumab in the treatment of colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Lo L,
|
||
Patel D,
|
||
Townsend AR,
|
||
Price TJ</span><br />
|
||
<span class="medgenPMjournal">Expert Opin Drug Metab Toxicol</span>
|
||
2015;11(12):1907-24.
|
||
Epub 2015 Nov 16
|
||
doi: 10.1517/17425255.2015.1112787.
|
||
<span class="bold">PMID: </span><a href="/pubmed/26572750" target="_blank">26572750</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=(panitumumab%20response)%20AND%20(%22english%20and%20humans%22%5BFilter%5D)%20AND%20(%20(%22practice%20guideline%22%5BFilter%5D)%20OR%20(practice*%5Btitl%5D%20AND%20(guideline%5Btitl%5D%20OR%20parameter%5Btitl%5D%20OR%20resource%5Btitl%5D%20OR%20bulletin%5Btitl%5D%20OR%20best%5Btitl%5D))%20OR%20(genetic*%5Btitl%5D%20AND%20(evaluation%5Btitl%5D%20OR%20counseling%5Btitl%5D%20OR%20screening%5Btitl%5D%20OR%20test*%5Btitl%5D))%20OR%20(clinical%5Btitl%5D%20AND%20((expert%5Btitl%5D%20AND%20consensus%5Btitl%5D)%20OR%20utility%5Btitl%5D%20OR%20guideline*%5Btitl%5D))%20OR%20(management%5Btitl%5D%20AND%20(clinical%5Btitl%5D%20OR%20diagnos*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20pain%5Btitl%5D%20OR%20surveillance%5Btitl%5D%20OR%20emergency%5Btitl%5D%20OR%20guideline*%5Btitl%5D%20OR%20therap*))%20OR%20(treatment%5Btitl%5D%20AND%20((evaluation%5Btitl%5D%20AND%20diagnosis%5Btitl%5D)%20OR%20(assessment%5Btitl%5D%20AND%20prevention%5Btitl%5D)%20OR%20therap*))%20OR%20(Diagnos*%5Btitl%5D%20AND%20(prenatal%5Btitl%5D%20OR%20treatment%5Btitl%5D%20OR%20follow-up%5Btitl%5D%20OR%20statement%5Btitl%5D%20OR%20criteria%5Btitl%5D%20OR%20newborn%5Btitl%5D%20OR%20differential%5Btitl%5D%20OR%20neonatal%5Btitl%5D%20OR%20neonate%5Btitl%5D))%20OR%20(guideline*%5Btitl%5D%20AND%20(pharmacogenetic*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20evidence-based%5Btitl%5D%20OR%20consensus%5Btitl%5D%20OR%20(technical%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20(molecular%5Btitl%5D%20AND%20testing%5Btitl%5D)))%20OR%20(risk%5Btitl%5D%20AND%20assessment%5Btitl%5D)%20OR%20(recommendation*%5Btitl%5D%20AND%20(statement%5Btitl%5D%20OR%20Evidence-based%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(care%20AND%20((Patient%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20primary%5Btitl%5D%20OR%20psychosocial%5Btitl%5D))%20OR%20(Health%5Btitl%5D%20AND%20supervision%5Btitl%5D)%20OR%20(statement%5Btitl%5D%20AND%20(policy%5Btitl%5D%20OR%20position%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(pharmacogenetics%5Btitl%5D%20AND%20(Dosing%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20genotype*%5Btitl%5D%20OR%20drug*%5Btitl%5D))%20OR%20(Chemotherapy%5Btitl%5D%20AND%20decision*%5Btitl%5D)%20OR%20(screening%5Btitl%5D%20AND%20(newborn%5Btitl%5D%20OR%20neonat*%5Btitl%5D%20OR%20detection%5Btitl%5D%20OR%20diagnos*%5Btitl%5D))%20OR%20(criteria%5Btitl%5D%20OR%20genotype*%5Btitl%5D)%20)%20NOT%20(%22Case%20reports%22%5BPublication%20type%5D%20OR%20%22clinical%20study%22%5BPublication%20Type%5D%20OR%20%22randomized%20controlled%20trial%22%5BPublication%20Type%5D)" title="PubMed search">See all (90)</a></div><h3 class="subhead">Curated<a class="help jig-ncbi-popper" data-jig="ncbipopper" href="#guidelinesHelpCurated"><img class="pulldown" src="//static.pubmed.gov/portal/portal3rc.fcgi/4223267/img/4204968" /></a></h3><h3 class="nl vspace"><a href="https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf" target="_blank">NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Colon Cancer, 2024</a></h3>
|
||
<h3 class="nl vspace"><a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2" target="_blank">DailyMed Drug Label, VECTIBIX- panitumumab solution 2021</a></h3>
|
||
<h3 class="nl vspace"><a href="https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2" target="_blank">DailyMed Drug Label, panitumumab, 2021</a></h3>
|
||
</div>
|
||
</div>
|
||
<div class="display-none help-popup" id="guidelinesHelpPM">These guidelines are articles in PubMed that match specific search criteria developed by MedGen to capture the most relevant practice guidelines. This list may not be comprehensive and may include broader topics as well. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div><div class="display-none help-popup" id="guidelinesHelpCurated">These guidelines are manually curated by the MedGen team
|
||
to supplement articles available in PubMed. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div>
|
||
<div class="portlet mgSection" id="ID_103">
|
||
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Recent_clinical_studies">Recent clinical studies</h1><a sid="103" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
|
||
<div class="portlet_content ln"><h3 class="subhead">Etiology</h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/19001320">Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Di Nicolantonio F,
|
||
Martini M,
|
||
Molinari F,
|
||
Sartore-Bianchi A,
|
||
Arena S,
|
||
Saletti P,
|
||
De Dosso S,
|
||
Mazzucchelli L,
|
||
Frattini M,
|
||
Siena S,
|
||
Bardelli A</span><br />
|
||
<span class="medgenPMjournal">J Clin Oncol</span>
|
||
2008 Dec 10;26(35):5705-12.
|
||
Epub 2008 Nov 10
|
||
doi: 10.1200/JCO.2008.18.0786.
|
||
<span class="bold">PMID: </span><a href="/pubmed/19001320" target="_blank">19001320</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Panitumumab%20response%22%20AND%20Etiology%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (1)</a></div><h3 class="subhead">Diagnosis</h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/19001320">Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Di Nicolantonio F,
|
||
Martini M,
|
||
Molinari F,
|
||
Sartore-Bianchi A,
|
||
Arena S,
|
||
Saletti P,
|
||
De Dosso S,
|
||
Mazzucchelli L,
|
||
Frattini M,
|
||
Siena S,
|
||
Bardelli A</span><br />
|
||
<span class="medgenPMjournal">J Clin Oncol</span>
|
||
2008 Dec 10;26(35):5705-12.
|
||
Epub 2008 Nov 10
|
||
doi: 10.1200/JCO.2008.18.0786.
|
||
<span class="bold">PMID: </span><a href="/pubmed/19001320" target="_blank">19001320</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Panitumumab%20response%22%20AND%20Diagnosis%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (1)</a></div><h3 class="subhead">Therapy</h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/24780353">Influence of epidermal growth factor receptor expression on the cetuximab and panitumumab response rates of head and neck carcinoma cells.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Hartmann S,
|
||
Seher A,
|
||
Brands RC,
|
||
Linz C,
|
||
Lessner G,
|
||
Böhm H,
|
||
Kübler AC,
|
||
Müller-Richter UD</span><br />
|
||
<span class="medgenPMjournal">J Craniomaxillofac Surg</span>
|
||
2014 Oct;42(7):1322-8.
|
||
Epub 2014 Apr 2
|
||
doi: 10.1016/j.jcms.2014.03.018.
|
||
<span class="bold">PMID: </span><a href="/pubmed/24780353" target="_blank">24780353</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/22210091">Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Wadlow RC,
|
||
Hezel AF,
|
||
Abrams TA,
|
||
Blaszkowsky LS,
|
||
Fuchs CS,
|
||
Kulke MH,
|
||
Kwak EL,
|
||
Meyerhardt JA,
|
||
Ryan DP,
|
||
Szymonifka J,
|
||
Wolpin BM,
|
||
Zhu AX,
|
||
Clark JW</span><br />
|
||
<span class="medgenPMjournal">Oncologist</span>
|
||
2012;17(1):14.
|
||
Epub 2011 Dec 30
|
||
doi: 10.1634/theoncologist.2011-0452.
|
||
<span class="bold">PMID: </span><a href="/pubmed/22210091" target="_blank">22210091</a><a href="/pmc/articles/PMC3267814" target="_blank" class="PubMedFree">Free PMC Article</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/19001320">Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Di Nicolantonio F,
|
||
Martini M,
|
||
Molinari F,
|
||
Sartore-Bianchi A,
|
||
Arena S,
|
||
Saletti P,
|
||
De Dosso S,
|
||
Mazzucchelli L,
|
||
Frattini M,
|
||
Siena S,
|
||
Bardelli A</span><br />
|
||
<span class="medgenPMjournal">J Clin Oncol</span>
|
||
2008 Dec 10;26(35):5705-12.
|
||
Epub 2008 Nov 10
|
||
doi: 10.1200/JCO.2008.18.0786.
|
||
<span class="bold">PMID: </span><a href="/pubmed/19001320" target="_blank">19001320</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Panitumumab%20response%22%20AND%20Therapy%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (3)</a></div><h3 class="subhead">Prognosis</h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/22210091">Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Wadlow RC,
|
||
Hezel AF,
|
||
Abrams TA,
|
||
Blaszkowsky LS,
|
||
Fuchs CS,
|
||
Kulke MH,
|
||
Kwak EL,
|
||
Meyerhardt JA,
|
||
Ryan DP,
|
||
Szymonifka J,
|
||
Wolpin BM,
|
||
Zhu AX,
|
||
Clark JW</span><br />
|
||
<span class="medgenPMjournal">Oncologist</span>
|
||
2012;17(1):14.
|
||
Epub 2011 Dec 30
|
||
doi: 10.1634/theoncologist.2011-0452.
|
||
<span class="bold">PMID: </span><a href="/pubmed/22210091" target="_blank">22210091</a><a href="/pmc/articles/PMC3267814" target="_blank" class="PubMedFree">Free PMC Article</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/19001320">Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Di Nicolantonio F,
|
||
Martini M,
|
||
Molinari F,
|
||
Sartore-Bianchi A,
|
||
Arena S,
|
||
Saletti P,
|
||
De Dosso S,
|
||
Mazzucchelli L,
|
||
Frattini M,
|
||
Siena S,
|
||
Bardelli A</span><br />
|
||
<span class="medgenPMjournal">J Clin Oncol</span>
|
||
2008 Dec 10;26(35):5705-12.
|
||
Epub 2008 Nov 10
|
||
doi: 10.1200/JCO.2008.18.0786.
|
||
<span class="bold">PMID: </span><a href="/pubmed/19001320" target="_blank">19001320</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Panitumumab%20response%22%20AND%20Prognosis%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (2)</a></div><h3 class="subhead">Clinical prediction guides</h3>
|
||
<div class="nl"><a target="_blank" href="/pubmed/22210091">Panitumumab in patients with KRAS wild-type colorectal cancer after progression on cetuximab.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Wadlow RC,
|
||
Hezel AF,
|
||
Abrams TA,
|
||
Blaszkowsky LS,
|
||
Fuchs CS,
|
||
Kulke MH,
|
||
Kwak EL,
|
||
Meyerhardt JA,
|
||
Ryan DP,
|
||
Szymonifka J,
|
||
Wolpin BM,
|
||
Zhu AX,
|
||
Clark JW</span><br />
|
||
<span class="medgenPMjournal">Oncologist</span>
|
||
2012;17(1):14.
|
||
Epub 2011 Dec 30
|
||
doi: 10.1634/theoncologist.2011-0452.
|
||
<span class="bold">PMID: </span><a href="/pubmed/22210091" target="_blank">22210091</a><a href="/pmc/articles/PMC3267814" target="_blank" class="PubMedFree">Free PMC Article</a></div>
|
||
|
||
<div class="nl"><a target="_blank" href="/pubmed/19001320">Wild-type BRAF is required for response to panitumumab or cetuximab in metastatic colorectal cancer.</a></div>
|
||
<div class="portlet_content ln"><span class="medgenPMauthor">Di Nicolantonio F,
|
||
Martini M,
|
||
Molinari F,
|
||
Sartore-Bianchi A,
|
||
Arena S,
|
||
Saletti P,
|
||
De Dosso S,
|
||
Mazzucchelli L,
|
||
Frattini M,
|
||
Siena S,
|
||
Bardelli A</span><br />
|
||
<span class="medgenPMjournal">J Clin Oncol</span>
|
||
2008 Dec 10;26(35):5705-12.
|
||
Epub 2008 Nov 10
|
||
doi: 10.1200/JCO.2008.18.0786.
|
||
<span class="bold">PMID: </span><a href="/pubmed/19001320" target="_blank">19001320</a></div>
|
||
<div><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=%22Panitumumab%20response%22%20AND%20Clinical%20prediction%20guides%2Fbroad%5Bfilter%5D%20%20AND%20%22english%20and%20humans%22%5Bfilter%5D%20NOT%20comment%5BPTYP%5D%20NOT%20letter%5BPTYP%5D" title="PubMed search">See all (2)</a></div></div>
|
||
</div>
|
||
|
||
<div class="portlet mgSection" id="ID_120">
|
||
<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Therapeutic_recommendations">Therapeutic recommendations</h1><a sid="120" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
|
||
<div class="portlet_content ln" id="therapeutic"><strong>From <a href="https://www.ncbi.nlm.nih.gov/books/NBK564800" target="_blank">Medical Genetics Summaries</a></strong><br /><div id="TheraputicContent"><div class="divPopper rprt" id="panitumumab_REF_1" style="display: none;">1. VECTIBIX- panitumumab solution [package insert]. Thousand Oaks, CA: AmGen; 2017. Available from: <a href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2" target="_blank">https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2</a></div><div class="divPopper rprt" id="panitumumab_REF_2" style="display: none;">2. Allegra C.J., Rumble R.B., Hamilton S.R., Mangu P.B., et al. Extended RAS Gene Mutation Testing in Metastatic Colorectal Carcinoma to Predict Response to Anti-Epidermal Growth Factor Receptor Monoclonal Antibody Therapy: American Society of Clinical Oncology Provisional Clinical Opinion Update 2015. J Clin Oncol. 2016;34(2):179–85.</div><div class="divPopper rprt" id="panitumumab_REF_23" style="display: none;">23. Chiorean E.G., Nandakumar G., Fadelu T., Temin S., et al. Treatment of Patients With Late-Stage Colorectal Cancer: ASCO Resource-Stratified Guideline. JCO Glob Oncol. 2020;6:414–438.</div><div class="divPopper rprt" id="panitumumab_REF_3" style="display: none;">3. <i>NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines). Colon Cancer: NCCN Guidelines. Version 4.2020</i>. 15 June 2020 2020]; Available from: <a href="https://www.nccn.org/guidelines/category_1#colon" target="_blank">https://www.nccn.org/guidelines/category_1#colon</a>.</div><p><b>This section contains excerpted</b>
|
||
<sup>1</sup>
|
||
<b>information on gene-based dosing recommendations. Neither this section nor other parts of this review contain the complete recommendations from the sources.</b>
|
||
</p><p><b>2017 Statement from the US Food and Drug Administration (FDA):</b>
|
||
</p><p>Prior to initiation of treatment with panitumumab, assess RAS mutational status in colorectal tumors and confirm the absence of a RAS mutation. Information on FDA-approved tests for the detection of KRAS mutations in individuals with metastatic colorectal cancer is available at: http://www.fda.gov/CompanionDiagnostics.</p><p>[…]</p><p>Panitumumab is not indicated for the treatment of individuals with colorectal cancer that harbor somatic mutations in exon 2 (codons 12 and 13), exon 3 (codons 59 and 61), and exon 4 (codons 117 and 146) of either KRAS or NRAS and hereafter is referred to as “RAS”.</p><p><b>Please review the complete therapeutic recommendations that are located here:</b>
|
||
(<a title="click for more information" class="jig-ncbipopper s_TOP" href="#panitumumab_REF_1" data-jigconfig="hasArrow: true, openEvent: 'click', closeEvent: 'mouseout', openAnimation: 'fadeIn', closeAnimation: 'fadeOut', triggerPosition: 'center right', destPosition: 'center left', arrowDirection: 'left'">1</a>)</p><p>2015 Provisional Clinical Opinion from the American Society of Clinical Oncology (ASCO) and 2020 Late-Stage Colorectal Cancer ASCO Resource-Stratified Guidelines All individuals with metastatic colorectal cancer who are candidates for anti-EGFR antibody therapy should have their tumor tested in a Clinical Laboratory Improvement Amendments–certified laboratory for mutations in both KRAS and NRAS exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146). The weight of current evidence indicates that anti-EGFR monoclonal antibody therapy should only be considered for treatment of individuals whose tumor is determined to not have mutations detected after such extended RAS testing.</p><p><b>What’s New and Different?</b>
|
||
</p><p>In addition to testing for mutations in KRAS exon 2 (codons 12 and 13) as recommended previously, before treatment with anti-EGFR antibody therapy, individuals with mCRC should have their tumor tested for mutations in:</p><ul><li>KRAS exons 3 (codons 59 and 61) and 4 (codons 117 and 146)</li><li>NRAS exons 2 (codons 12 and 13), 3 (codons 59 and 61), and 4 (codons 117 and 146)</li></ul><p>Targeted therapies such as anti-VEGF and anti-EGFR agents may be added to doublet chemotherapies in maximal settings. […] If molecular testing results for <i>RAS</i> (<i>KRAS/NRAS</i>) are available, this guideline provides recommendations according to the status of these markers. In maximal (-resource) settings, for individuals with left-sided colon cancer and known <i>KRAS/NRAS</i> wild type (WT) molecular status, anti-EGFR antibodies such as cetuximab or panitumumab may be added to chemotherapy doublet, with a moderate-strength recommendation. However, individuals with right-sided colon cancer and <i>RAS</i> WT status should not be offered treatment with anti-EGFR antibodies in the first-line setting. Anti-EGFR therapies have increased response rates and conversion from unresectable to resectable metastatic disease when added to chemotherapy with FOLFOC or FOLFIRI for individuals with <i>RAS</i> wildtype, but more recent data suggest that debenit with anti-EGFR therapies seems to be limited to individuals whose primary tumors are left-sided.</p><p><b>Please review the complete therapeutic recommendations that are located here: (</b>
|
||
<b>2</b>
|
||
<b>, </b>
|
||
<b>23</b>
|
||
<b>)</b>
|
||
</p><h2>2020 Clinical Practice Guidelines in Oncology: Colon Cancer, from the National Comprehensive Cancer Network (NCCN)</h2><p><b>Version 4.2020 – Discussion update in progress.</b>
|
||
</p><p>A sizable body of literature has shown that tumors with a mutation in codon 12 or 13 of exon 2 of the <i>KRAS</i> gene are essentially insensitive to cetuximab or panitumumab therapy. More recent evidence shows mutations in <i>KRAS</i> outside of exon 2 and mutations in <i>NRAS</i> are also predictive for a lack of benefit to cetuximab and panitumumab.</p><p>The panel therefore strongly recommends <i>RAS</i> (<i>KRAS/NRAS)</i> genotyping of tumor tissue (either primary tumor or metastasis) in all individuals with metastatic colorectal cancer. Individuals with known <i>KRAS</i> or <i>NRAS</i> mutations should not be treated with either cetuximab or panitumumab, either alone or in combination with other anticancer agents, because they have virtually no chance of benefit and the exposure to toxicity and expense cannot be justified. It is implied throughout the guidelines that NCCN recommendations involving cetuximab or panitumumab relate only to individuals with disease characterized by <i>KRAS/NRAS</i> wild-type genes. ASCO released a Provisional Clinical Opinion Update on extended <i>RAS</i> testing in individuals with metastatic colorectal cancer that is consistent with the NCCN panel’s recommendations. A guideline on molecular biomarkers for colorectal cancer developed by the ASCP, CAP, AMP and ASCO also recommends <i>RAS</i> testing consistent with the NCCN recommendations.</p><p>The recommendation for KRAS/NRAS testing, at this point, is not meant to indicate a preference regarding regimen selection in the first-line setting. Rather, this early establishment of KRAS/NRAS status is appropriate to plan for the treatment continuum, so that the information may be obtained in a non- time–sensitive manner and the individual and provider can discuss the implications of a KRAS/NRAS mutation, if present, while other treatment options still exist. Note that because anti-EGFR agents have no role in the management of stage I, II, or III disease, KRAS/NRAS genotyping of colorectal cancers at these earlier stages is not recommended. […] The NCCN Colon/Rectal Cancer Panel believes that <i>RAS</i> mutation status should be determined at diagnosis of stage IV disease. Individuals with any known <i>RAS</i> mutation should not be treated with either cetuximab or panitumumab.</p><p><i>KRAS</i> mutations are early events in colorectal cancer formation, and therefore a very tight correlation exists between mutation status in the primary tumor and the metastases. For this reason, <i>KRAS/NRAS</i> genotyping can be performed on archived specimens of either the primary tumor or a metastasis. Fresh biopsies should not be obtained solely for the purpose of <i>KRAS/NRAS</i> genotyping unless an archived specimen from either the primary tumor or a metastasis is unavailable.</p><p>Approximately 5% to 9% of colorectal cancers are characterized by a specific mutation in the <i>BRAF</i> gene (V600E). <i>BRAF</i> mutations are, for all practical purposes, limited to tumors that do not have <i>KRAS</i> exon 2 mutations. Activation of the protein product of the non-mutated <i>BRAF</i> gene occurs downstream of the activated KRAS protein in the EGFR pathway. The mutated BRAF protein product is believed to be constitutively active, thereby putatively bypassing inhibition of EGFR by cetuximab or panitumumab.</p><p>The panel recommends that <i>KRAS</i>, <i>NRAS</i>, and <i>BRAF</i> gene testing be performed only in laboratories that are certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA-88) as qualified to perform highly complex molecular pathology testing. No specific testing methodology is recommended.</p><p><b>Please review the complete therapeutic recommendations that are located here:(</b>
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<b>3</b>
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||
<b>)</b>
|
||
</p><p><sup>1</sup>
|
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|
||
The FDA labels specific drug formulations. We have substituted the generic names for any drug labels in this excerpt. The FDA may not have labeled all formulations containing the generic drug.</p></div></div>
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</div></div></div></div></div></div></div>
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<div class="supplemental col three_col last">
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<h2 class="offscreen_noflow">Supplemental Content</h2>
|
||
|
||
<div>
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|
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<!-- MedGen supplemental column starts here -->
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<div class="rightCol mgCol">
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<div class="portlet mgSection" id="ID_113">
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<div class="portlet_head mgSectionHead ui-widget-header"><h1 class="nl" id="Table_of_contents">Table of contents</h1><a sid="113" href="#" class="portlet_shutter" title="Show/hide content"></a></div>
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||
<div class="portlet_content ln"><ul><li><a href="/gtr/tests?term=CN077999%5bDISCUI%5d&filter=method%3A1%5F3" target="_blank">Immunohistochemistry (1)</a></li>
|
||
<li><a href="/gtr/tests?term=CN077999%5bDISCUI%5d&filter=method%3A2%5F30" target="_blank">RNA analysis (1)</a></li>
|
||
<li><a href="/gtr/tests?term=CN077999%5bDISCUI%5d&filter=method%3A2%5F7" target="_blank">Sequence analysis of the entire coding region (1)</a></li>
|
||
<li><a href="/gtr/tests?term=CN077999%5bDISCUI%5d&filter=method%3A2%5F19" target="_blank">Targeted variant analysis (1)</a></li>
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<li class="portletSeeAll portletSeeAllPad"><total><a href="/gtr/tests?term=CN077999%5bDISCUI%5d" target="_blank">See all (2)</a></total></li>
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|
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<div class="portlet_content ln"><ul><li><a href="https://www.pharmgkb.org/chemical/PA162373091" target="_blank">PharmGKB</a></li><li><a href="https://clinicaltrials.gov/search?cond=Panitumumab%20response" target="_blank">ClinicalTrials.gov</a></li></ul></div>
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<div class="portlet_content ln"><ul class="a_poppers"><li><a target="_blank" href="https://pubmed.ncbi.nlm.nih.gov/?term=(panitumumab%20response)%20AND%20(%22english%20and%20humans%22%5BFilter%5D)%20AND%20(%20(%22practice%20guideline%22%5BFilter%5D)%20OR%20(practice*%5Btitl%5D%20AND%20(guideline%5Btitl%5D%20OR%20parameter%5Btitl%5D%20OR%20resource%5Btitl%5D%20OR%20bulletin%5Btitl%5D%20OR%20best%5Btitl%5D))%20OR%20(genetic*%5Btitl%5D%20AND%20(evaluation%5Btitl%5D%20OR%20counseling%5Btitl%5D%20OR%20screening%5Btitl%5D%20OR%20test*%5Btitl%5D))%20OR%20(clinical%5Btitl%5D%20AND%20((expert%5Btitl%5D%20AND%20consensus%5Btitl%5D)%20OR%20utility%5Btitl%5D%20OR%20guideline*%5Btitl%5D))%20OR%20(management%5Btitl%5D%20AND%20(clinical%5Btitl%5D%20OR%20diagnos*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20pain%5Btitl%5D%20OR%20surveillance%5Btitl%5D%20OR%20emergency%5Btitl%5D%20OR%20guideline*%5Btitl%5D%20OR%20therap*))%20OR%20(treatment%5Btitl%5D%20AND%20((evaluation%5Btitl%5D%20AND%20diagnosis%5Btitl%5D)%20OR%20(assessment%5Btitl%5D%20AND%20prevention%5Btitl%5D)%20OR%20therap*))%20OR%20(Diagnos*%5Btitl%5D%20AND%20(prenatal%5Btitl%5D%20OR%20treatment%5Btitl%5D%20OR%20follow-up%5Btitl%5D%20OR%20statement%5Btitl%5D%20OR%20criteria%5Btitl%5D%20OR%20newborn%5Btitl%5D%20OR%20differential%5Btitl%5D%20OR%20neonatal%5Btitl%5D%20OR%20neonate%5Btitl%5D))%20OR%20(guideline*%5Btitl%5D%20AND%20(pharmacogenetic*%5Btitl%5D%20OR%20recommendation%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20evidence-based%5Btitl%5D%20OR%20consensus%5Btitl%5D%20OR%20(technical%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20(molecular%5Btitl%5D%20AND%20testing%5Btitl%5D)))%20OR%20(risk%5Btitl%5D%20AND%20assessment%5Btitl%5D)%20OR%20(recommendation*%5Btitl%5D%20AND%20(statement%5Btitl%5D%20OR%20Evidence-based%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(care%20AND%20((Patient%5Btitl%5D%20AND%20standard*%5Btitl%5D)%20OR%20primary%5Btitl%5D%20OR%20psychosocial%5Btitl%5D))%20OR%20(Health%5Btitl%5D%20AND%20supervision%5Btitl%5D)%20OR%20(statement%5Btitl%5D%20AND%20(policy%5Btitl%5D%20OR%20position%5Btitl%5D%20OR%20Consensus%5Btitl%5D))%20OR%20(pharmacogenetics%5Btitl%5D%20AND%20(Dosing%5Btitl%5D%20OR%20therap*%5Btitl%5D%20OR%20genotype*%5Btitl%5D%20OR%20drug*%5Btitl%5D))%20OR%20(Chemotherapy%5Btitl%5D%20AND%20decision*%5Btitl%5D)%20OR%20(screening%5Btitl%5D%20AND%20(newborn%5Btitl%5D%20OR%20neonat*%5Btitl%5D%20OR%20detection%5Btitl%5D%20OR%20diagnos*%5Btitl%5D))%20OR%20(criteria%5Btitl%5D%20OR%20genotype*%5Btitl%5D)%20)%20NOT%20(%22Case%20reports%22%5BPublication%20type%5D%20OR%20%22clinical%20study%22%5BPublication%20Type%5D%20OR%20%22randomized%20controlled%20trial%22%5BPublication%20Type%5D)" title="PubMed search">PubMed</a><div class="help-popup">See practice and clinical guidelines in PubMed. The search results may include broader topics and may not capture all published guidelines. See the <a href="/medgen/docs/faq/" title="Frequently asked questions" target="_blank">FAQ</a> for details.</div></li></ul><h3 class="subhead">Curated</h3><ul class="a_poppers"><li><a target="_blank" href="https://www.nccn.org/professionals/physician_gls/pdf/colon.pdf">NCCN, 2024</a><div>NCCN Clinical Practice Guidelines in Oncology (NCCN Guidelines®) Colon Cancer, 2024</div></li><li><a target="_blank" href="https://dailymed.nlm.nih.gov/dailymed/drugInfo.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2">DailyMed Drug Label, 2021</a><div>DailyMed Drug Label, VECTIBIX- panitumumab solution 2021</div></li><li><a target="_blank" href="https://dailymed.nlm.nih.gov/dailymed/lookup.cfm?setid=e0fa4bca-f245-4d92-ae29-b0c630a315c2">DailyMed Drug Label, 2021</a><div>DailyMed Drug Label, panitumumab, 2021</div></li></ul></div>
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<div class="portlet_content ln"><ul><li><a href="https://vsearch.nlm.nih.gov/vivisimo/cgi-bin/query-meta?v:project=medlineplus&query=Panitumumab%20response" target="_blank">MedlinePlus</a></li></ul></div>
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<a href="/books/NBK564800" ref="ncbi_uid=&discoId=gtr_reviews&linkpos=1&linkpostotal=3" target="_blank">Medical Genetics Summaries</a>
|
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|
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<a href="/pubmed/clinical?term=Panitumumab%20response" ref="ncbi_uid=&discoId=gtr_reviews&linkpos=2&linkpostotal=3" target="_blank">PubMed Clinical Queries</a>
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<a href="/pubmed?term=Panitumumab%20response%20AND%20humans[mesh]%20AND%20review[publication%20type]" ref="ncbi_uid=&discoId=gtr_reviews&linkpos=3&linkpostotal=3" target="_blank">Reviews in PubMed</a>
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<a class="brieflinkpopperctrl" href="/gene?LinkName=medgen_gene_diseases&from_uid=450471" ref="log$=recordlinks">Gene</a>
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