Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab
We conducted a retrospective evaluation of the IMCL-9815 study to examine the association of human papillomavirus (HPV) and p16 protein expression status with outcomes in patients with oropharyngeal carcinoma (OPC) receiving radiotherapy (RT) plus cetuximab or RT alone. In the IMCL-9815 study, patie...
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| Veröffentlicht in: | Journal of clinical oncology 2016-04, Vol.34 (12), p.1300-1308 |
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| creator | Rosenthal, David I Harari, Paul M Giralt, Jordi Bell, Diana Raben, David Liu, Joyce Schulten, Jeltje Ang, Kian K Bonner, James A |
| description | We conducted a retrospective evaluation of the IMCL-9815 study to examine the association of human papillomavirus (HPV) and p16 protein expression status with outcomes in patients with oropharyngeal carcinoma (OPC) receiving radiotherapy (RT) plus cetuximab or RT alone.
In the IMCL-9815 study, patients were randomly allocated to receive RT plus weekly cetuximab or RT alone. A subpopulation of patients with p16-evaluable OPC was retrospectively evaluated on the basis of locoregional control (LRC), overall survival (OS), and progression-free survival (PFS). Evaluable samples from patients with p16-positive OPC were also tested for HPV DNA.
Tumor p16 status was evaluable in 182 patients with OPC enrolled in the IMCL-9815 study; 41% were p16 positive. When treated with RT alone or RT plus cetuximab, p16-positive patients had a longer OS than p16-negative patients (hazard ratio, 0.40; 95% CI, 0.21 to 0.74 and hazard ratio, 0.16; 95% CI, 0.07 to 0.36, respectively). The addition of cetuximab to RT increased LRC, OS, and PFS in both patients with p16-positive OPC and those with p16-negative disease. Interaction tests for LRC, OS, and PFS did not demonstrate any significant interaction between p16 status and treatment effect (P = .087, .085, and .253, respectively). Similar trends were observed when patients with p16-positive/HPV-positive OPC (n = 49) and those with p16-positive/HPV-negative OPC (n = 14) were compared.
p16 status was strongly prognostic for patients with OPC. The data suggest that the addition of cetuximab to RT improved clinical outcomes regardless of p16 or HPV status versus RT alone. |
| doi_str_mv | 10.1200/JCO.2015.62.5970 |
| format | Article |
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In the IMCL-9815 study, patients were randomly allocated to receive RT plus weekly cetuximab or RT alone. A subpopulation of patients with p16-evaluable OPC was retrospectively evaluated on the basis of locoregional control (LRC), overall survival (OS), and progression-free survival (PFS). Evaluable samples from patients with p16-positive OPC were also tested for HPV DNA.
Tumor p16 status was evaluable in 182 patients with OPC enrolled in the IMCL-9815 study; 41% were p16 positive. When treated with RT alone or RT plus cetuximab, p16-positive patients had a longer OS than p16-negative patients (hazard ratio, 0.40; 95% CI, 0.21 to 0.74 and hazard ratio, 0.16; 95% CI, 0.07 to 0.36, respectively). The addition of cetuximab to RT increased LRC, OS, and PFS in both patients with p16-positive OPC and those with p16-negative disease. Interaction tests for LRC, OS, and PFS did not demonstrate any significant interaction between p16 status and treatment effect (P = .087, .085, and .253, respectively). Similar trends were observed when patients with p16-positive/HPV-positive OPC (n = 49) and those with p16-positive/HPV-negative OPC (n = 14) were compared.
p16 status was strongly prognostic for patients with OPC. The data suggest that the addition of cetuximab to RT improved clinical outcomes regardless of p16 or HPV status versus RT alone.</description><identifier>ISSN: 0732-183X</identifier><identifier>EISSN: 1527-7755</identifier><identifier>DOI: 10.1200/JCO.2015.62.5970</identifier><identifier>PMID: 26712222</identifier><language>eng</language><publisher>United States: American Society of Clinical Oncology</publisher><subject>Aged ; Antineoplastic Agents - adverse effects ; Antineoplastic Agents - therapeutic use ; Biomarkers, Tumor - analysis ; Carcinoma, Squamous Cell - chemistry ; Carcinoma, Squamous Cell - mortality ; Carcinoma, Squamous Cell - pathology ; Carcinoma, Squamous Cell - therapy ; Carcinoma, Squamous Cell - virology ; Cetuximab - adverse effects ; Cetuximab - therapeutic use ; Chemoradiotherapy - adverse effects ; Clinical Trials, Phase III as Topic ; Cyclin-Dependent Kinase Inhibitor p16 - analysis ; Disease-Free Survival ; DNA, Viral - genetics ; Female ; Head and Neck Neoplasms - chemistry ; Head and Neck Neoplasms - mortality ; Head and Neck Neoplasms - pathology ; Head and Neck Neoplasms - therapy ; Head and Neck Neoplasms - virology ; Human Papillomavirus DNA Tests ; Humans ; Immunohistochemistry ; Kaplan-Meier Estimate ; Male ; Middle Aged ; ORIGINAL REPORTS ; Oropharyngeal Neoplasms - chemistry ; Oropharyngeal Neoplasms - mortality ; Oropharyngeal Neoplasms - pathology ; Oropharyngeal Neoplasms - therapy ; Oropharyngeal Neoplasms - virology ; Papillomaviridae - genetics ; Papillomaviridae - isolation & purification ; Predictive Value of Tests ; Proportional Hazards Models ; Randomized Controlled Trials as Topic ; Retrospective Studies ; Squamous Cell Carcinoma of Head and Neck ; Time Factors ; Treatment Outcome</subject><ispartof>Journal of clinical oncology, 2016-04, Vol.34 (12), p.1300-1308</ispartof><rights>2015 by American Society of Clinical Oncology.</rights><rights>2015 by American Society of Clinical Oncology 2015 American Society of Clinical Oncology</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c443t-aceebf8ad1c9ec913181ca52117f0a5e286121cb097c9a1ba5bf58898cba4c393</citedby><cites>FETCH-LOGICAL-c443t-aceebf8ad1c9ec913181ca52117f0a5e286121cb097c9a1ba5bf58898cba4c393</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>230,314,780,784,885,3729,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26712222$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rosenthal, David I</creatorcontrib><creatorcontrib>Harari, Paul M</creatorcontrib><creatorcontrib>Giralt, Jordi</creatorcontrib><creatorcontrib>Bell, Diana</creatorcontrib><creatorcontrib>Raben, David</creatorcontrib><creatorcontrib>Liu, Joyce</creatorcontrib><creatorcontrib>Schulten, Jeltje</creatorcontrib><creatorcontrib>Ang, Kian K</creatorcontrib><creatorcontrib>Bonner, James A</creatorcontrib><title>Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab</title><title>Journal of clinical oncology</title><addtitle>J Clin Oncol</addtitle><description>We conducted a retrospective evaluation of the IMCL-9815 study to examine the association of human papillomavirus (HPV) and p16 protein expression status with outcomes in patients with oropharyngeal carcinoma (OPC) receiving radiotherapy (RT) plus cetuximab or RT alone.
In the IMCL-9815 study, patients were randomly allocated to receive RT plus weekly cetuximab or RT alone. A subpopulation of patients with p16-evaluable OPC was retrospectively evaluated on the basis of locoregional control (LRC), overall survival (OS), and progression-free survival (PFS). Evaluable samples from patients with p16-positive OPC were also tested for HPV DNA.
Tumor p16 status was evaluable in 182 patients with OPC enrolled in the IMCL-9815 study; 41% were p16 positive. When treated with RT alone or RT plus cetuximab, p16-positive patients had a longer OS than p16-negative patients (hazard ratio, 0.40; 95% CI, 0.21 to 0.74 and hazard ratio, 0.16; 95% CI, 0.07 to 0.36, respectively). The addition of cetuximab to RT increased LRC, OS, and PFS in both patients with p16-positive OPC and those with p16-negative disease. Interaction tests for LRC, OS, and PFS did not demonstrate any significant interaction between p16 status and treatment effect (P = .087, .085, and .253, respectively). Similar trends were observed when patients with p16-positive/HPV-positive OPC (n = 49) and those with p16-positive/HPV-negative OPC (n = 14) were compared.
p16 status was strongly prognostic for patients with OPC. The data suggest that the addition of cetuximab to RT improved clinical outcomes regardless of p16 or HPV status versus RT alone.</description><subject>Aged</subject><subject>Antineoplastic Agents - adverse effects</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biomarkers, Tumor - analysis</subject><subject>Carcinoma, Squamous Cell - chemistry</subject><subject>Carcinoma, Squamous Cell - mortality</subject><subject>Carcinoma, Squamous Cell - pathology</subject><subject>Carcinoma, Squamous Cell - therapy</subject><subject>Carcinoma, Squamous Cell - virology</subject><subject>Cetuximab - adverse effects</subject><subject>Cetuximab - therapeutic use</subject><subject>Chemoradiotherapy - adverse effects</subject><subject>Clinical Trials, Phase III as Topic</subject><subject>Cyclin-Dependent Kinase Inhibitor p16 - analysis</subject><subject>Disease-Free Survival</subject><subject>DNA, Viral - genetics</subject><subject>Female</subject><subject>Head and Neck Neoplasms - chemistry</subject><subject>Head and Neck Neoplasms - mortality</subject><subject>Head and Neck Neoplasms - pathology</subject><subject>Head and Neck Neoplasms - therapy</subject><subject>Head and Neck Neoplasms - virology</subject><subject>Human Papillomavirus DNA Tests</subject><subject>Humans</subject><subject>Immunohistochemistry</subject><subject>Kaplan-Meier Estimate</subject><subject>Male</subject><subject>Middle Aged</subject><subject>ORIGINAL REPORTS</subject><subject>Oropharyngeal Neoplasms - chemistry</subject><subject>Oropharyngeal Neoplasms - mortality</subject><subject>Oropharyngeal Neoplasms - pathology</subject><subject>Oropharyngeal Neoplasms - therapy</subject><subject>Oropharyngeal Neoplasms - virology</subject><subject>Papillomaviridae - genetics</subject><subject>Papillomaviridae - isolation & purification</subject><subject>Predictive Value of Tests</subject><subject>Proportional Hazards Models</subject><subject>Randomized Controlled Trials as Topic</subject><subject>Retrospective Studies</subject><subject>Squamous Cell Carcinoma of Head and Neck</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><issn>0732-183X</issn><issn>1527-7755</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2016</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNpVksFv0zAUxgMCbWVw54R85JJiO3WcXJCqCGhRodM2BDfrxXFaQ2JntlPR_x5nLRP4Ytl-7_d9ev6S5DXBc0Ixfve52s4pJmye0zkrOX6azAijPOWcsWfJDPOMpqTIflwmL7z_iTFZFBm7SC5pzgmNa_bkYum9lRqCtgbZFq3GHgy6hkF3ne3hoN3oEZgGDSRHtwFCPH7XYY-2Y5C2Vx5pg8JeofWXapOWBWHoeg8-ntdrdKN22gd3gt85DR1qrYv0oJUJZ9DGSutioTXQdUe0bA5gpGrQ1tlhD-5odir23d6P0NsoXqmuQxU4qU30N1me1FcKmgebX5X8FaUUhIh44N9Ao22scTAcTzfRwrTbMURaGH_rHuqXyfMWOq9enfer5NvHD3fVKt1sP62r5SaVi0UWUpBK1W0BDZGlkiXJSEEkMEoIbzEwRYucUCJrXHJZAqmB1S0rirKQNSxkVmZXyfsTdxjrXjUyzsFBJwYXTbijsKDF_y9G78XOHgTDHDPOI-DtGeDs_ah8EL32Mg4FjIrzEYTHP8hyTictfCqVznrvVPsoQ7CY8iNifsSUH5FTMeUntrz5195jw9_AZH8AeSnGNg</recordid><startdate>20160420</startdate><enddate>20160420</enddate><creator>Rosenthal, David I</creator><creator>Harari, Paul M</creator><creator>Giralt, Jordi</creator><creator>Bell, Diana</creator><creator>Raben, David</creator><creator>Liu, Joyce</creator><creator>Schulten, Jeltje</creator><creator>Ang, Kian K</creator><creator>Bonner, James A</creator><general>American Society of Clinical Oncology</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20160420</creationdate><title>Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab</title><author>Rosenthal, David I ; Harari, Paul M ; Giralt, Jordi ; Bell, Diana ; Raben, David ; Liu, Joyce ; Schulten, Jeltje ; Ang, Kian K ; Bonner, James A</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c443t-aceebf8ad1c9ec913181ca52117f0a5e286121cb097c9a1ba5bf58898cba4c393</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2016</creationdate><topic>Aged</topic><topic>Antineoplastic Agents - adverse effects</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Biomarkers, Tumor - analysis</topic><topic>Carcinoma, Squamous Cell - chemistry</topic><topic>Carcinoma, Squamous Cell - mortality</topic><topic>Carcinoma, Squamous Cell - pathology</topic><topic>Carcinoma, Squamous Cell - therapy</topic><topic>Carcinoma, Squamous Cell - virology</topic><topic>Cetuximab - adverse effects</topic><topic>Cetuximab - therapeutic use</topic><topic>Chemoradiotherapy - adverse effects</topic><topic>Clinical Trials, Phase III as Topic</topic><topic>Cyclin-Dependent Kinase Inhibitor p16 - analysis</topic><topic>Disease-Free Survival</topic><topic>DNA, Viral - genetics</topic><topic>Female</topic><topic>Head and Neck Neoplasms - chemistry</topic><topic>Head and Neck Neoplasms - mortality</topic><topic>Head and Neck Neoplasms - pathology</topic><topic>Head and Neck Neoplasms - therapy</topic><topic>Head and Neck Neoplasms - virology</topic><topic>Human Papillomavirus DNA Tests</topic><topic>Humans</topic><topic>Immunohistochemistry</topic><topic>Kaplan-Meier Estimate</topic><topic>Male</topic><topic>Middle Aged</topic><topic>ORIGINAL REPORTS</topic><topic>Oropharyngeal Neoplasms - chemistry</topic><topic>Oropharyngeal Neoplasms - mortality</topic><topic>Oropharyngeal Neoplasms - pathology</topic><topic>Oropharyngeal Neoplasms - therapy</topic><topic>Oropharyngeal Neoplasms - virology</topic><topic>Papillomaviridae - genetics</topic><topic>Papillomaviridae - isolation & purification</topic><topic>Predictive Value of Tests</topic><topic>Proportional Hazards Models</topic><topic>Randomized Controlled Trials as Topic</topic><topic>Retrospective Studies</topic><topic>Squamous Cell Carcinoma of Head and Neck</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Rosenthal, David I</creatorcontrib><creatorcontrib>Harari, Paul M</creatorcontrib><creatorcontrib>Giralt, Jordi</creatorcontrib><creatorcontrib>Bell, Diana</creatorcontrib><creatorcontrib>Raben, David</creatorcontrib><creatorcontrib>Liu, Joyce</creatorcontrib><creatorcontrib>Schulten, Jeltje</creatorcontrib><creatorcontrib>Ang, Kian K</creatorcontrib><creatorcontrib>Bonner, James A</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>Journal of clinical oncology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rosenthal, David I</au><au>Harari, Paul M</au><au>Giralt, Jordi</au><au>Bell, Diana</au><au>Raben, David</au><au>Liu, Joyce</au><au>Schulten, Jeltje</au><au>Ang, Kian K</au><au>Bonner, James A</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab</atitle><jtitle>Journal of clinical oncology</jtitle><addtitle>J Clin Oncol</addtitle><date>2016-04-20</date><risdate>2016</risdate><volume>34</volume><issue>12</issue><spage>1300</spage><epage>1308</epage><pages>1300-1308</pages><issn>0732-183X</issn><eissn>1527-7755</eissn><abstract>We conducted a retrospective evaluation of the IMCL-9815 study to examine the association of human papillomavirus (HPV) and p16 protein expression status with outcomes in patients with oropharyngeal carcinoma (OPC) receiving radiotherapy (RT) plus cetuximab or RT alone.
In the IMCL-9815 study, patients were randomly allocated to receive RT plus weekly cetuximab or RT alone. A subpopulation of patients with p16-evaluable OPC was retrospectively evaluated on the basis of locoregional control (LRC), overall survival (OS), and progression-free survival (PFS). Evaluable samples from patients with p16-positive OPC were also tested for HPV DNA.
Tumor p16 status was evaluable in 182 patients with OPC enrolled in the IMCL-9815 study; 41% were p16 positive. When treated with RT alone or RT plus cetuximab, p16-positive patients had a longer OS than p16-negative patients (hazard ratio, 0.40; 95% CI, 0.21 to 0.74 and hazard ratio, 0.16; 95% CI, 0.07 to 0.36, respectively). The addition of cetuximab to RT increased LRC, OS, and PFS in both patients with p16-positive OPC and those with p16-negative disease. Interaction tests for LRC, OS, and PFS did not demonstrate any significant interaction between p16 status and treatment effect (P = .087, .085, and .253, respectively). Similar trends were observed when patients with p16-positive/HPV-positive OPC (n = 49) and those with p16-positive/HPV-negative OPC (n = 14) were compared.
p16 status was strongly prognostic for patients with OPC. The data suggest that the addition of cetuximab to RT improved clinical outcomes regardless of p16 or HPV status versus RT alone.</abstract><cop>United States</cop><pub>American Society of Clinical Oncology</pub><pmid>26712222</pmid><doi>10.1200/JCO.2015.62.5970</doi><tpages>9</tpages><oa>free_for_read</oa></addata></record> |
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| ispartof | Journal of clinical oncology, 2016-04, Vol.34 (12), p.1300-1308 |
| issn | 0732-183X 1527-7755 |
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| source | MEDLINE; American Society of Clinical Oncology Online Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Alma/SFX Local Collection |
| subjects | Aged Antineoplastic Agents - adverse effects Antineoplastic Agents - therapeutic use Biomarkers, Tumor - analysis Carcinoma, Squamous Cell - chemistry Carcinoma, Squamous Cell - mortality Carcinoma, Squamous Cell - pathology Carcinoma, Squamous Cell - therapy Carcinoma, Squamous Cell - virology Cetuximab - adverse effects Cetuximab - therapeutic use Chemoradiotherapy - adverse effects Clinical Trials, Phase III as Topic Cyclin-Dependent Kinase Inhibitor p16 - analysis Disease-Free Survival DNA, Viral - genetics Female Head and Neck Neoplasms - chemistry Head and Neck Neoplasms - mortality Head and Neck Neoplasms - pathology Head and Neck Neoplasms - therapy Head and Neck Neoplasms - virology Human Papillomavirus DNA Tests Humans Immunohistochemistry Kaplan-Meier Estimate Male Middle Aged ORIGINAL REPORTS Oropharyngeal Neoplasms - chemistry Oropharyngeal Neoplasms - mortality Oropharyngeal Neoplasms - pathology Oropharyngeal Neoplasms - therapy Oropharyngeal Neoplasms - virology Papillomaviridae - genetics Papillomaviridae - isolation & purification Predictive Value of Tests Proportional Hazards Models Randomized Controlled Trials as Topic Retrospective Studies Squamous Cell Carcinoma of Head and Neck Time Factors Treatment Outcome |
| title | Association of Human Papillomavirus and p16 Status With Outcomes in the IMCL-9815 Phase III Registration Trial for Patients With Locoregionally Advanced Oropharyngeal Squamous Cell Carcinoma of the Head and Neck Treated With Radiotherapy With or Without Cetuximab |
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