A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck†
Identifieur interne : 000072 ( Pmc/Checkpoint ); précédent : 000071; suivant : 000073A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck†
Auteurs : T. Y. Seiwert [États-Unis] ; J. Fayette ; D. Cupissol [France] ; J. M. Del Campo [Espagne] ; P. M. Clement [Belgique] ; R. Hitt [Espagne] ; M. Degardin [France] ; W. Zhang [République populaire de Chine] ; A. Blackman [États-Unis] ; E. Ehrnrooth [Danemark] ; E. E. W. Cohen [États-Unis]Source :
- Annals of Oncology [ 0923-7534 ] ; 2014.
Abstract
Afatinib, an oral irreversible ErbB family blocker, showed comparable activity to cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma in this phase II trial. Further, sequential EGFR/ErbB treatment provided sustained clinical benefit in some patients, suggesting a lack of cross-resistance.
Url:
DOI: 10.1093/annonc/mdu216
PubMed: 24928832
PubMed Central: 4143093
Affiliations:
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<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck<sup><xref ref-type="author-notes" rid="mdu216_AN1">†</xref></sup></title><author><name sortKey="Seiwert, T Y" sort="Seiwert, T Y" uniqKey="Seiwert T" first="T. Y." last="Seiwert">T. Y. Seiwert</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af1"><addr-line>Department of Medicine</addr-line>,<institution>University of Chicago Medical Centre</institution>,<addr-line>Chicago</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fayette, J" sort="Fayette, J" uniqKey="Fayette J" first="J." last="Fayette">J. Fayette</name><affiliation><nlm:aff id="mdu216_af2"><addr-line>Department of Medicine</addr-line>,<institution>Université de Lyon</institution>,<addr-line>Lyon</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cupissol, D" sort="Cupissol, D" uniqKey="Cupissol D" first="D." last="Cupissol">D. Cupissol</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af3"><institution>Institut du Cancer de Montpellier Val d'Aurelle</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Del Campo, J M" sort="Del Campo, J M" uniqKey="Del Campo J" first="J. M." last="Del Campo">J. M. Del Campo</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af4"><addr-line>Department of Medical Oncology</addr-line>,<institution>Hospital Universitario Vall d'Hebron</institution>,<addr-line>Barcelona</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clement, P M" sort="Clement, P M" uniqKey="Clement P" first="P. M." last="Clement">P. M. Clement</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af5"><addr-line>Division of Oncology</addr-line>,<institution>KU Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hitt, R" sort="Hitt, R" uniqKey="Hitt R" first="R." last="Hitt">R. Hitt</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af6"><addr-line>Centro Integral Oncológico Clara Campal (CIOCC), Madrid</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Degardin, M" sort="Degardin, M" uniqKey="Degardin M" first="M." last="Degardin">M. Degardin</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af7"><institution>Centre Oscar Lambret</institution>,<addr-line>Lille</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, W" sort="Zhang, W" uniqKey="Zhang W" first="W." last="Zhang">W. Zhang</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af8"><institution>Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd</institution>,<addr-line>Shanghai</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Blackman, A" sort="Blackman, A" uniqKey="Blackman A" first="A." last="Blackman">A. Blackman</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af9"><institution>Boehringer Ingelheim Pharmaceuticals, Inc.</institution>,<addr-line>Ridgefield</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ehrnrooth, E" sort="Ehrnrooth, E" uniqKey="Ehrnrooth E" first="E." last="Ehrnrooth">E. Ehrnrooth</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af10"><institution>Boehringer Ingelheim</institution><addr-line>Danmark A/S</addr-line>,<country>Copenhagen, Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea></wicri:regionArea></affiliation></author><author><name sortKey="Cohen, E E W" sort="Cohen, E E W" uniqKey="Cohen E" first="E. E. W." last="Cohen">E. E. W. Cohen</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af11"><addr-line>Department of Medicine</addr-line>,<institution>University of California San Diego Moores Cancer Center</institution>,<addr-line>La Jolla</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">PMC</idno><idno type="pmid">24928832</idno><idno type="pmc">4143093</idno><idno type="url">http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4143093</idno><idno type="RBID">PMC:4143093</idno><idno type="doi">10.1093/annonc/mdu216</idno><date when="2014">2014</date><idno type="wicri:Area/Pmc/Corpus">000302</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Corpus" wicri:corpus="PMC">000302</idno><idno type="wicri:Area/Pmc/Curation">000302</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Curation">000302</idno><idno type="wicri:Area/Pmc/Checkpoint">000072</idno><idno type="wicri:explorRef" wicri:stream="Pmc" wicri:step="Checkpoint">000072</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a" type="main">A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck<sup><xref ref-type="author-notes" rid="mdu216_AN1">†</xref></sup></title><author><name sortKey="Seiwert, T Y" sort="Seiwert, T Y" uniqKey="Seiwert T" first="T. Y." last="Seiwert">T. Y. Seiwert</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af1"><addr-line>Department of Medicine</addr-line>,<institution>University of Chicago Medical Centre</institution>,<addr-line>Chicago</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Fayette, J" sort="Fayette, J" uniqKey="Fayette J" first="J." last="Fayette">J. Fayette</name><affiliation><nlm:aff id="mdu216_af2"><addr-line>Department of Medicine</addr-line>,<institution>Université de Lyon</institution>,<addr-line>Lyon</addr-line></nlm:aff></affiliation></author><author><name sortKey="Cupissol, D" sort="Cupissol, D" uniqKey="Cupissol D" first="D." last="Cupissol">D. Cupissol</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af3"><institution>Institut du Cancer de Montpellier Val d'Aurelle</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Del Campo, J M" sort="Del Campo, J M" uniqKey="Del Campo J" first="J. M." last="Del Campo">J. M. Del Campo</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af4"><addr-line>Department of Medical Oncology</addr-line>,<institution>Hospital Universitario Vall d'Hebron</institution>,<addr-line>Barcelona</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Clement, P M" sort="Clement, P M" uniqKey="Clement P" first="P. M." last="Clement">P. M. Clement</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af5"><addr-line>Division of Oncology</addr-line>,<institution>KU Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></nlm:aff><country xml:lang="fr">Belgique</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Hitt, R" sort="Hitt, R" uniqKey="Hitt R" first="R." last="Hitt">R. Hitt</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af6"><addr-line>Centro Integral Oncológico Clara Campal (CIOCC), Madrid</addr-line>,<country>Spain</country></nlm:aff><country xml:lang="fr">Espagne</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Degardin, M" sort="Degardin, M" uniqKey="Degardin M" first="M." last="Degardin">M. Degardin</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af7"><institution>Centre Oscar Lambret</institution>,<addr-line>Lille</addr-line>,<country>France</country></nlm:aff><country xml:lang="fr">France</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Zhang, W" sort="Zhang, W" uniqKey="Zhang W" first="W." last="Zhang">W. Zhang</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af8"><institution>Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd</institution>,<addr-line>Shanghai</addr-line>,<country>China</country></nlm:aff><country xml:lang="fr">République populaire de Chine</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Blackman, A" sort="Blackman, A" uniqKey="Blackman A" first="A." last="Blackman">A. Blackman</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af9"><institution>Boehringer Ingelheim Pharmaceuticals, Inc.</institution>,<addr-line>Ridgefield</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author><author><name sortKey="Ehrnrooth, E" sort="Ehrnrooth, E" uniqKey="Ehrnrooth E" first="E." last="Ehrnrooth">E. Ehrnrooth</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af10"><institution>Boehringer Ingelheim</institution><addr-line>Danmark A/S</addr-line>,<country>Copenhagen, Denmark</country></nlm:aff><country xml:lang="fr">Danemark</country><wicri:regionArea></wicri:regionArea></affiliation></author><author><name sortKey="Cohen, E E W" sort="Cohen, E E W" uniqKey="Cohen E" first="E. E. W." last="Cohen">E. E. W. Cohen</name><affiliation wicri:level="1"><nlm:aff id="mdu216_af11"><addr-line>Department of Medicine</addr-line>,<institution>University of California San Diego Moores Cancer Center</institution>,<addr-line>La Jolla</addr-line>,<country>USA</country></nlm:aff><country xml:lang="fr">États-Unis</country><wicri:regionArea># see nlm:aff country strict</wicri:regionArea></affiliation></author></analytic><series><title level="j">Annals of Oncology</title><idno type="ISSN">0923-7534</idno><idno type="eISSN">1569-8041</idno><imprint><date when="2014">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en"><p>Afatinib, an oral irreversible ErbB family blocker, showed comparable activity to cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma in this phase II trial. Further, sequential EGFR/ErbB treatment provided sustained clinical benefit in some patients, suggesting a lack of cross-resistance.</p></div></front><back><div1 type="bibliography"><listBibl><biblStruct><analytic><author><name sortKey="Ferlay, J" uniqKey="Ferlay J">J Ferlay</name></author><author><name sortKey="Shin, Hr" uniqKey="Shin H">HR Shin</name></author><author><name sortKey="Bray, F" uniqKey="Bray F">F Bray</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Seiwert, Ty" uniqKey="Seiwert T">TY Seiwert</name></author><author><name sortKey="Salama, Jk" uniqKey="Salama J">JK Salama</name></author><author><name sortKey="Vokes, Ee" uniqKey="Vokes E">EE Vokes</name></author></analytic></biblStruct><biblStruct><analytic><author><name sortKey="Gold, Ka" uniqKey="Gold K">KA Gold</name></author><author><name sortKey="Lee, Hy" uniqKey="Lee H">HY Lee</name></author><author><name sortKey="Kim, Es" uniqKey="Kim E">ES 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<front><journal-meta><journal-id journal-id-type="nlm-ta">Ann Oncol</journal-id><journal-id journal-id-type="iso-abbrev">Ann. Oncol</journal-id><journal-id journal-id-type="publisher-id">annonc</journal-id><journal-id journal-id-type="hwp">annonc</journal-id><journal-title-group><journal-title>Annals of Oncology</journal-title></journal-title-group><issn pub-type="ppub">0923-7534</issn><issn pub-type="epub">1569-8041</issn><publisher><publisher-name>Oxford University Press</publisher-name></publisher></journal-meta><article-meta><article-id pub-id-type="pmid">24928832</article-id><article-id pub-id-type="pmc">4143093</article-id><article-id pub-id-type="doi">10.1093/annonc/mdu216</article-id><article-id pub-id-type="publisher-id">mdu216</article-id><article-categories><subj-group subj-group-type="heading"><subject>Original Articles</subject><subj-group subj-group-type="overline"><subject>Head and Neck Tumors</subject></subj-group></subj-group><series-title>Editor's choice</series-title></article-categories><title-group><article-title>A randomized, phase II study of afatinib versus cetuximab in metastatic or recurrent squamous cell carcinoma of the head and neck<sup><xref ref-type="author-notes" rid="mdu216_AN1">†</xref></sup></article-title></title-group><contrib-group><contrib contrib-type="author"><name><surname>Seiwert</surname><given-names>T. Y.</given-names></name><xref ref-type="aff" rid="mdu216_af1">1</xref><xref ref-type="corresp" rid="mdu216_cor1">*</xref></contrib><contrib contrib-type="author"><name><surname>Fayette</surname><given-names>J.</given-names></name><xref ref-type="aff" rid="mdu216_af2">2</xref></contrib><contrib contrib-type="author"><name><surname>Cupissol</surname><given-names>D.</given-names></name><xref ref-type="aff" rid="mdu216_af3">3</xref></contrib><contrib contrib-type="author"><name><surname>del Campo</surname><given-names>J. M.</given-names></name><xref ref-type="aff" rid="mdu216_af4">4</xref></contrib><contrib contrib-type="author"><name><surname>Clement</surname><given-names>P. M.</given-names></name><xref ref-type="aff" rid="mdu216_af5">5</xref></contrib><contrib contrib-type="author"><name><surname>Hitt</surname><given-names>R.</given-names></name><xref ref-type="aff" rid="mdu216_af6">6</xref></contrib><contrib contrib-type="author"><name><surname>Degardin</surname><given-names>M.</given-names></name><xref ref-type="aff" rid="mdu216_af7">7</xref></contrib><contrib contrib-type="author"><name><surname>Zhang</surname><given-names>W.</given-names></name><xref ref-type="aff" rid="mdu216_af8">8</xref></contrib><contrib contrib-type="author"><name><surname>Blackman</surname><given-names>A.</given-names></name><xref ref-type="aff" rid="mdu216_af9">9</xref></contrib><contrib contrib-type="author"><name><surname>Ehrnrooth</surname><given-names>E.</given-names></name><xref ref-type="aff" rid="mdu216_af10">10</xref></contrib><contrib contrib-type="author"><name><surname>Cohen</surname><given-names>E. E. W.</given-names></name><xref ref-type="aff" rid="mdu216_af11">11</xref></contrib><aff id="mdu216_af1"><label>1</label><addr-line>Department of Medicine</addr-line>,<institution>University of Chicago Medical Centre</institution>,<addr-line>Chicago</addr-line>,<country>USA</country></aff><aff id="mdu216_af2"><label>2</label><addr-line>Department of Medicine</addr-line>,<institution>Université de Lyon</institution>,<addr-line>Lyon</addr-line></aff><aff id="mdu216_af3"><label>3</label><institution>Institut du Cancer de Montpellier Val d'Aurelle</institution>,<addr-line>Montpellier</addr-line>,<country>France</country></aff><aff id="mdu216_af4"><label>4</label><addr-line>Department of Medical Oncology</addr-line>,<institution>Hospital Universitario Vall d'Hebron</institution>,<addr-line>Barcelona</addr-line>,<country>Spain</country></aff><aff id="mdu216_af5"><label>5</label><addr-line>Division of Oncology</addr-line>,<institution>KU Leuven</institution>,<addr-line>Leuven</addr-line>,<country>Belgium</country></aff><aff id="mdu216_af6"><label>6</label><addr-line>Centro Integral Oncológico Clara Campal (CIOCC), Madrid</addr-line>,<country>Spain</country></aff><aff id="mdu216_af7"><label>7</label><institution>Centre Oscar Lambret</institution>,<addr-line>Lille</addr-line>,<country>France</country></aff><aff id="mdu216_af8"><label>8</label><institution>Boehringer Ingelheim Shanghai Pharmaceuticals Co., Ltd</institution>,<addr-line>Shanghai</addr-line>,<country>China</country></aff><aff id="mdu216_af9"><label>9</label><institution>Boehringer Ingelheim Pharmaceuticals, Inc.</institution>,<addr-line>Ridgefield</addr-line>,<country>USA</country></aff><aff id="mdu216_af10"><label>10</label><institution>Boehringer Ingelheim</institution><addr-line>Danmark A/S</addr-line>,<country>Copenhagen, Denmark</country></aff><aff id="mdu216_af11"><label>11</label><addr-line>Department of Medicine</addr-line>,<institution>University of California San Diego Moores Cancer Center</institution>,<addr-line>La Jolla</addr-line>,<country>USA</country></aff></contrib-group><author-notes><corresp id="mdu216_cor1"><label>*</label><italic>Correspondence to:</italic> Dr Tanguy Y. Seiwert, Section of Hematology/Oncology, University of Chicago Medical Center, 5841 South Maryland Avenue, MC2115, Chicago, IL 60637, USA. Tel: +1-773-702-2452; Fax: +<fax>1-773-702-3002</fax>; E-mail: <email>tseiwert@medicine.bsd.uchicago.edu</email></corresp><fn id="mdu216_AN1"><label>†</label><p>List of where and when the study has been presented in part elsewhere: Previously presented at the 46th Annual Meeting of American Society of Clinical Oncology, 4–8 June 2010, Chicago, IL, USA; the 3rd Trends in Head & Neck Oncology (THNO), 3–5 November 2011, Rome, Italy; the Multidisciplinary Head and Neck Cancer Symposium, 26–28 January 2012, Phoenix, Arizona, USA; the European Conference on Head and Neck Oncology (EHNS), 18–21 April 2012, Poznan, Poland; the 10th Annual Meeting of the Japanese Society of Medical Oncology, 26–28 July 2012, Osaka, Japan and the 49th American Society of Clinical Oncology, May 31–June 4 2013, Chicago, IL, USA.</p></fn></author-notes><pub-date pub-type="ppub"><month>9</month><year>2014</year></pub-date><pub-date pub-type="epub"><day>13</day><month>6</month><year>2014</year></pub-date><pub-date pub-type="pmc-release"><day>13</day><month>6</month><year>2014</year></pub-date><pmc-comment> PMC Release delay is 0 months and 0 days and was based on the
<volume>25</volume><issue>9</issue><fpage>1813</fpage><lpage>1820</lpage><history><date date-type="received"><day>3</day><month>4</month><year>2014</year></date><date date-type="rev-recd"><day>1</day><month>6</month><year>2014</year></date><date date-type="accepted"><day>4</day><month>6</month><year>2014</year></date></history><permissions><copyright-statement>© The Author 2014. Published by Oxford University Press on behalf of the European Society for Medical Oncology.</copyright-statement><copyright-year>2014</copyright-year><license license-type="creative-commons" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/"><license-p>This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License (<ext-link ext-link-type="uri" xlink:href="http://creativecommons.org/licenses/by-nc/4.0/">http://creativecommons.org/licenses/by-nc/4.0/</ext-link>), which permits non-commercial re-use, distribution, and reproduction in any medium, provided the original work is properly cited. For commercial re-use, please contact journals.permissions@oup.com</license-p></license></permissions><self-uri content-type="pdf" xlink:type="simple" xlink:href="mdu216.pdf"></self-uri><abstract abstract-type="precis"><p>Afatinib, an oral irreversible ErbB family blocker, showed comparable activity to cetuximab in patients with recurrent/metastatic head and neck squamous cell carcinoma in this phase II trial. Further, sequential EGFR/ErbB treatment provided sustained clinical benefit in some patients, suggesting a lack of cross-resistance.</p></abstract><abstract><sec><title>Background</title><p>Afatinib is an oral, irreversible ErbB family blocker that has shown activity in epidermal growth factor receptor (EGFR)-mutated lung cancer. We hypothesized that the agent would have greater antitumor activity compared with cetuximab in recurrent or metastatic (R/M) head and neck squamous cell carcinoma (HNSCC) patients, whose disease has progressed after platinum-containing therapy.</p></sec><sec><title>Patients and methods</title><p>An open-label, randomized, phase II trial was conducted in 43 centers; 124 patients were randomized (1 : 1) to either afatinib (50 mg/day) or cetuximab (250 mg/m<sup>2</sup>/week) until disease progression or intolerable adverse events (AEs) (stage I), with optional crossover (stage II). The primary end point was tumor shrinkage before crossover assessed by investigator (IR) and independent central review (ICR).</p></sec><sec><title>Results</title><p>A total of 121 patients were treated (61 afatinib, 60 cetuximab) and 68 crossed over to stage II (32 and 36 respectively). In stage I, mean tumor shrinkage by IR/ICR was 10.4%/16.6% with afatinib and 5.4%/10.1% with cetuximab (<italic>P</italic> = 0.46/0.30). Objective response rate was 16.1%/8.1% with afatinib and 6.5%/9.7% with cetuximab (IR/ICR). Comparable disease control rates were observed with afatinib (50%) and cetuximab (56.5%) by IR; similar results were seen by ICR. Most common grade ≥3 drug-related AEs (DRAEs) were rash/acne (18% versus 8.3%), diarrhea (14.8% versus 0%), and stomatitis/mucositis (11.5% versus 0%) with afatinib and cetuximab, respectively. Patients with DRAEs leading to treatment discontinuation were 23% with afatinib and 5% with cetuximab. In stage II, disease control rate (IR/ICR) was 38.9%/33.3% with afatinib and 18.8%/18.8% with cetuximab.</p></sec><sec><title>Conclusion</title><p>Afatinib showed antitumor activity comparable to cetuximab in R/M HNSCC in this exploratory phase II trial, although more patients on afatinib discontinued treatment due to AEs. Sequential EGFR/ErbB treatment with afatinib and cetuximab provided sustained clinical benefit in patients after crossover, suggesting a lack of cross-resistance.</p></sec></abstract><kwd-group><kwd>afatinib</kwd><kwd>cetuximab</kwd><kwd>recurrent HNSCC</kwd><kwd>metastatic HNSCC</kwd><kwd>EGFR inhibitor therapy</kwd></kwd-group></article-meta></front></pmc><affiliations><list><country><li>Belgique</li><li>Danemark</li><li>Espagne</li><li>France</li><li>République populaire de Chine</li><li>États-Unis</li></country></list><tree><noCountry><name sortKey="Fayette, J" sort="Fayette, J" uniqKey="Fayette J" first="J." last="Fayette">J. Fayette</name></noCountry><country name="États-Unis"><noRegion><name sortKey="Seiwert, T Y" sort="Seiwert, T Y" uniqKey="Seiwert T" first="T. Y." last="Seiwert">T. Y. Seiwert</name></noRegion><name sortKey="Blackman, A" sort="Blackman, A" uniqKey="Blackman A" first="A." last="Blackman">A. Blackman</name><name sortKey="Cohen, E E W" sort="Cohen, E E W" uniqKey="Cohen E" first="E. E. W." last="Cohen">E. E. W. Cohen</name></country><country name="France"><noRegion><name sortKey="Cupissol, D" sort="Cupissol, D" uniqKey="Cupissol D" first="D." last="Cupissol">D. Cupissol</name></noRegion><name sortKey="Degardin, M" sort="Degardin, M" uniqKey="Degardin M" first="M." last="Degardin">M. Degardin</name></country><country name="Espagne"><noRegion><name sortKey="Del Campo, J M" sort="Del Campo, J M" uniqKey="Del Campo J" first="J. M." last="Del Campo">J. M. Del Campo</name></noRegion><name sortKey="Hitt, R" sort="Hitt, R" uniqKey="Hitt R" first="R." last="Hitt">R. Hitt</name></country><country name="Belgique"><noRegion><name sortKey="Clement, P M" sort="Clement, P M" uniqKey="Clement P" first="P. M." last="Clement">P. M. Clement</name></noRegion></country><country name="République populaire de Chine"><noRegion><name sortKey="Zhang, W" sort="Zhang, W" uniqKey="Zhang W" first="W." last="Zhang">W. Zhang</name></noRegion></country><country name="Danemark"><noRegion><name sortKey="Ehrnrooth, E" sort="Ehrnrooth, E" uniqKey="Ehrnrooth E" first="E." last="Ehrnrooth">E. Ehrnrooth</name></noRegion></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
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