PittsburghV1, Main, Exploration, bibRecord, 005544

Erlotinib, Erlotinib-Sulindac versus Placebo: A Randomized, Double-Blind, Placebo-Controlled Window Trial in Operable Head and Neck Cancer

Identifieur interne : 005544 ( Main/Exploration ); précédent : 005543; suivant : 005545

Erlotinib, Erlotinib-Sulindac versus Placebo: A Randomized, Double-Blind, Placebo-Controlled Window Trial in Operable Head and Neck Cancer

Auteurs : Neil D. Gross [États-Unis] ; Julie E. Bauman [États-Unis] ; William E. Gooding [États-Unis] ; William Denq [États-Unis] ; Sufi M. Thomas [États-Unis] ; LIN WANG [États-Unis] ; Simion Chiosea [États-Unis] ; Brian L. Hood [États-Unis] ; Melanie S. Flint [États-Unis] ; MAI SUN [États-Unis] ; Thomas P. Conrads [États-Unis] ; Robert L. Ferris [États-Unis] ; Jonas T. Johnson [États-Unis] ; SEUNGWON KIM [États-Unis] ; Athanassios Argiris [États-Unis] ; Lori Wirth [États-Unis] ; Marina N. Nikiforova [États-Unis] ; Jill M. Siegfried [États-Unis] ; Jennifer R. Grandis [États-Unis]

Source :

Clinical cancer research : (Print) [ 1078-0432 ] ; 2014.

RBID : Pascal:14-0167478

Descripteurs français

KwdFr :
- Adulte, Adulte d'âge moyen, Analyse sur puce à tissus, Carcinome épidermoïde (anatomopathologie), Carcinome épidermoïde (métabolisme), Carcinome épidermoïde (traitement médicamenteux), Chlorhydrate d'erlotinib, Femelle, Humains, Marqueurs biologiques tumoraux (métabolisme), Mâle, Méthode en double aveugle, Pronostic, Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Quinazolines (administration et posologie), Récepteur du facteur de croissance épidermique (antagonistes et inhibiteurs), Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Sulindac (administration et posologie), Techniques immunoenzymatiques, Tumeurs de la tête et du cou (anatomopathologie), Tumeurs de la tête et du cou (métabolisme), Tumeurs de la tête et du cou (traitement médicamenteux), Études de cohortes, Études de suivi.
MESH :
- administration et posologie : Quinazolines, Sulindac.
- anatomopathologie : Carcinome épidermoïde, Tumeurs de la tête et du cou.
- antagonistes et inhibiteurs : Récepteur du facteur de croissance épidermique.
- métabolisme : Carcinome épidermoïde, Marqueurs biologiques tumoraux, Tumeurs de la tête et du cou.
- traitement médicamenteux : Carcinome épidermoïde, Tumeurs de la tête et du cou.
- usage thérapeutique : Protocoles de polychimiothérapie antinéoplasique.
Pascal (Inist)
- Adulte, Adulte d'âge moyen, Analyse sur puce à tissus, Chlorhydrate d'erlotinib, Erlotinib, Femelle, Humains, Mâle, Méthode en double aveugle, Pronostic, Stade de la tumeur, Sujet âgé, Sujet âgé de 80 ans ou plus, Sulindac, Etude comparative, Placebo, Randomisation, Etude double insu, Essai clinique, Cancer de la tête et du cou, Anticancéreux, Techniques immunoenzymatiques, Études de cohortes, Études de suivi.

English descriptors

KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Antineoplastic agent, Biomarkers, Tumor (metabolism), Carcinoma, Squamous Cell (drug therapy), Carcinoma, Squamous Cell (metabolism), Carcinoma, Squamous Cell (pathology), Clinical trial, Cohort Studies, Comparative study, Double blind study, Double-Blind Method, Erlotinib, Erlotinib Hydrochloride, Female, Follow-Up Studies, Head and Neck Neoplasms (drug therapy), Head and Neck Neoplasms (metabolism), Head and Neck Neoplasms (pathology), Head and neck cancer, Humans, Immunoenzyme Techniques, Male, Middle Aged, Neoplasm Staging, Placebo, Prognosis, Quinazolines (administration & dosage), Randomization, Receptor, Epidermal Growth Factor (antagonists & inhibitors), Sulindac, Sulindac (administration & dosage), Tissue Array Analysis.
MESH :
- chemical , administration & dosage : Quinazolines, Sulindac.
- chemical , antagonists & inhibitors : Receptor, Epidermal Growth Factor.
- chemical , metabolism : Biomarkers, Tumor.
- drug therapy : Carcinoma, Squamous Cell, Head and Neck Neoplasms.
- metabolism : Carcinoma, Squamous Cell, Head and Neck Neoplasms.
- pathology : Carcinoma, Squamous Cell, Head and Neck Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols.
- Adult, Aged, Aged, 80 and over, Cohort Studies, Double-Blind Method, Erlotinib Hydrochloride, Female, Follow-Up Studies, Humans, Immunoenzyme Techniques, Male, Middle Aged, Neoplasm Staging, Prognosis, Tissue Array Analysis.

Abstract

Purpose: The EGF receptor (EGFR) and COX2 pathways are upregulated in head and neck squamous cell carcinoma (HNSCC). Preclinical models indicate synergistic antitumor activity from dual blockade. We conducted a randomized, double-blind, placebo-controlled window trial of erlotinib, an EGFR inhibitor; erlotinib plus sulindac, a nonselective COX inhibitor; versus placebo. Experimental Design: Patients with untreated, operable stage II-IVb HNSCC were randomized 5:5:3 to erlotinib, erlotinib-sulindac, or placebo. Tumor specimens were collected before and after seven to 14 days of treatment. The primary endpoint was change in Ki67 proliferation index. We hypothesized an ordering effect in Ki67 reduction: erlotinib-sulindac > erlotinib > placebo. We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX2 signaling intermediates. Results: From 2005-2009, 47 patients were randomized for the target 39 evaluable patients. Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation. Ki67 was significantly decreased by erlotinib or erlotinib-sulindac (omnibus comparison, two-sided Kruskal-Wallis, P = 0.04). Wilcoxon pairwise contrasts confirmed greater Ki67 effect in both erlotinib groups (erlotinib-sulindac vs. placebo, P = 0.043; erlotinib vs. placebo, P = 0.027). There was a significant trend in ordering of Ki67 reduction: erlotinib-sulindac > erlotinib > placebo (two-sided exact Jonckheere-Terpstra, P = 0.0185). Low baseline pSrc correlated with greater Ki67 reduction (R² = 0.312, P = 0.024). Conclusions: Brief treatment with erlotinib significantly decreased proliferation in HNSCC, with additive effect from sulindac. Efficacy studies of dual EGFR-COX inhibition are justified. pSrc is a potential resistance biomarker for anti-EGFR therapy, and warrants investigation as a molecular target. Cancer.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4104657

Affiliations:

Le document en format XML

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<author><name sortKey="Nikiforova, Marina N" sort="Nikiforova, Marina N" uniqKey="Nikiforova M" first="Marina N." last="Nikiforova">Marina N. Nikiforova</name>
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<author><name sortKey="Grandis, Jennifer R" sort="Grandis, Jennifer R" uniqKey="Grandis J" first="Jennifer R." last="Grandis">Jennifer R. Grandis</name>
<affiliation wicri:level="4"><inist:fA14 i1="05"><s1>Department of Otolaryngology, University of Pittsburgh</s1>
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</affiliation>
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</affiliation>
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<author><name sortKey="Mai Sun" sort="Mai Sun" uniqKey="Mai Sun" last="Mai Sun">MAI SUN</name>
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<author><name sortKey="Conrads, Thomas P" sort="Conrads, Thomas P" uniqKey="Conrads T" first="Thomas P." last="Conrads">Thomas P. Conrads</name>
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<author><name sortKey="Ferris, Robert L" sort="Ferris, Robert L" uniqKey="Ferris R" first="Robert L." last="Ferris">Robert L. Ferris</name>
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<author><name sortKey="Johnson, Jonas T" sort="Johnson, Jonas T" uniqKey="Johnson J" first="Jonas T." last="Johnson">Jonas T. Johnson</name>
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<author><name sortKey="Seungwon Kim" sort="Seungwon Kim" uniqKey="Seungwon Kim" last="Seungwon Kim">SEUNGWON KIM</name>
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<s2>Pittsburgh, Pennsylvania</s2>
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<term>Analyse sur puce à tissus</term>
<term>Chlorhydrate d'erlotinib</term>
<term>Erlotinib</term>
<term>Femelle</term>
<term>Humains</term>
<term>Mâle</term>
<term>Méthode en double aveugle</term>
<term>Pronostic</term>
<term>Stade de la tumeur</term>
<term>Sujet âgé</term>
<term>Sujet âgé de 80 ans ou plus</term>
<term>Sulindac</term>
<term>Etude comparative</term>
<term>Placebo</term>
<term>Randomisation</term>
<term>Etude double insu</term>
<term>Essai clinique</term>
<term>Cancer de la tête et du cou</term>
<term>Anticancéreux</term>
<term>Techniques immunoenzymatiques</term>
<term>Études de cohortes</term>
<term>Études de suivi</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: The EGF receptor (EGFR) and COX2 pathways are upregulated in head and neck squamous cell carcinoma (HNSCC). Preclinical models indicate synergistic antitumor activity from dual blockade. We conducted a randomized, double-blind, placebo-controlled window trial of erlotinib, an EGFR inhibitor; erlotinib plus sulindac, a nonselective COX inhibitor; versus placebo. Experimental Design: Patients with untreated, operable stage II-IVb HNSCC were randomized 5:5:3 to erlotinib, erlotinib-sulindac, or placebo. Tumor specimens were collected before and after seven to 14 days of treatment. The primary endpoint was change in Ki67 proliferation index. We hypothesized an ordering effect in Ki67 reduction: erlotinib-sulindac > erlotinib > placebo. We evaluated tissue microarrays by immunohistochemistry for pharmacodynamic modulation of EGFR and COX2 signaling intermediates. Results: From 2005-2009, 47 patients were randomized for the target 39 evaluable patients. Thirty-four tumor pairs were of sufficient quality to assess biomarker modulation. Ki67 was significantly decreased by erlotinib or erlotinib-sulindac (omnibus comparison, two-sided Kruskal-Wallis, P = 0.04). Wilcoxon pairwise contrasts confirmed greater Ki67 effect in both erlotinib groups (erlotinib-sulindac vs. placebo, P = 0.043; erlotinib vs. placebo, P = 0.027). There was a significant trend in ordering of Ki67 reduction: erlotinib-sulindac > erlotinib > placebo (two-sided exact Jonckheere-Terpstra, P = 0.0185). Low baseline pSrc correlated with greater Ki67 reduction (R<sup>2</sup>
 = 0.312, P = 0.024). Conclusions: Brief treatment with erlotinib significantly decreased proliferation in HNSCC, with additive effect from sulindac. Efficacy studies of dual EGFR-COX inhibition are justified. pSrc is a potential resistance biomarker for anti-EGFR therapy, and warrants investigation as a molecular target. Cancer.</div>
</front>
</TEI>
<affiliations><list><country><li>États-Unis</li>
</country>
<region><li>Kansas</li>
<li>Massachusetts</li>
<li>Minnesota</li>
<li>Oregon</li>
<li>Pennsylvanie</li>
<li>Texas</li>
<li>Virginie</li>
</region>
<settlement><li>Pittsburgh</li>
</settlement>
<orgName><li>Université de Pittsburgh</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Oregon"><name sortKey="Gross, Neil D" sort="Gross, Neil D" uniqKey="Gross N" first="Neil D." last="Gross">Neil D. Gross</name>
</region>
<name sortKey="Argiris, Athanassios" sort="Argiris, Athanassios" uniqKey="Argiris A" first="Athanassios" last="Argiris">Athanassios Argiris</name>
<name sortKey="Argiris, Athanassios" sort="Argiris, Athanassios" uniqKey="Argiris A" first="Athanassios" last="Argiris">Athanassios Argiris</name>
<name sortKey="Bauman, Julie E" sort="Bauman, Julie E" uniqKey="Bauman J" first="Julie E." last="Bauman">Julie E. Bauman</name>
<name sortKey="Chiosea, Simion" sort="Chiosea, Simion" uniqKey="Chiosea S" first="Simion" last="Chiosea">Simion Chiosea</name>
<name sortKey="Chiosea, Simion" sort="Chiosea, Simion" uniqKey="Chiosea S" first="Simion" last="Chiosea">Simion Chiosea</name>
<name sortKey="Conrads, Thomas P" sort="Conrads, Thomas P" uniqKey="Conrads T" first="Thomas P." last="Conrads">Thomas P. Conrads</name>
<name sortKey="Conrads, Thomas P" sort="Conrads, Thomas P" uniqKey="Conrads T" first="Thomas P." last="Conrads">Thomas P. Conrads</name>
<name sortKey="Denq, William" sort="Denq, William" uniqKey="Denq W" first="William" last="Denq">William Denq</name>
<name sortKey="Ferris, Robert L" sort="Ferris, Robert L" uniqKey="Ferris R" first="Robert L." last="Ferris">Robert L. Ferris</name>
<name sortKey="Flint, Melanie S" sort="Flint, Melanie S" uniqKey="Flint M" first="Melanie S." last="Flint">Melanie S. Flint</name>
<name sortKey="Gooding, William E" sort="Gooding, William E" uniqKey="Gooding W" first="William E." last="Gooding">William E. Gooding</name>
<name sortKey="Grandis, Jennifer R" sort="Grandis, Jennifer R" uniqKey="Grandis J" first="Jennifer R." last="Grandis">Jennifer R. Grandis</name>
<name sortKey="Hood, Brian L" sort="Hood, Brian L" uniqKey="Hood B" first="Brian L." last="Hood">Brian L. Hood</name>
<name sortKey="Hood, Brian L" sort="Hood, Brian L" uniqKey="Hood B" first="Brian L." last="Hood">Brian L. Hood</name>
<name sortKey="Johnson, Jonas T" sort="Johnson, Jonas T" uniqKey="Johnson J" first="Jonas T." last="Johnson">Jonas T. Johnson</name>
<name sortKey="Lin Wang" sort="Lin Wang" uniqKey="Lin Wang" last="Lin Wang">LIN WANG</name>
<name sortKey="Mai Sun" sort="Mai Sun" uniqKey="Mai Sun" last="Mai Sun">MAI SUN</name>
<name sortKey="Nikiforova, Marina N" sort="Nikiforova, Marina N" uniqKey="Nikiforova M" first="Marina N." last="Nikiforova">Marina N. Nikiforova</name>
<name sortKey="Seungwon Kim" sort="Seungwon Kim" uniqKey="Seungwon Kim" last="Seungwon Kim">SEUNGWON KIM</name>
<name sortKey="Siegfried, Jill M" sort="Siegfried, Jill M" uniqKey="Siegfried J" first="Jill M." last="Siegfried">Jill M. Siegfried</name>
<name sortKey="Siegfried, Jill M" sort="Siegfried, Jill M" uniqKey="Siegfried J" first="Jill M." last="Siegfried">Jill M. Siegfried</name>
<name sortKey="Thomas, Sufi M" sort="Thomas, Sufi M" uniqKey="Thomas S" first="Sufi M." last="Thomas">Sufi M. Thomas</name>
<name sortKey="Thomas, Sufi M" sort="Thomas, Sufi M" uniqKey="Thomas S" first="Sufi M." last="Thomas">Sufi M. Thomas</name>
<name sortKey="Wirth, Lori" sort="Wirth, Lori" uniqKey="Wirth L" first="Lori" last="Wirth">Lori Wirth</name>
</country>
</tree>
</affiliations>
</record>

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Erlotinib, Erlotinib-Sulindac versus Placebo: A Randomized, Double-Blind, Placebo-Controlled Window Trial in Operable Head and Neck Cancer

Erlotinib, Erlotinib-Sulindac versus Placebo: A Randomized, Double-Blind, Placebo-Controlled Window Trial in Operable Head and Neck Cancer

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