Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck

Background There is a need to improve the systemic treatment of advanced adenoid cystic carcinoma (ACC). Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. In this study, we evaluate sorafenib, an oral multikinase inhibitor,...

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Veröffentlicht in:Head & neck 2015-02, Vol.37 (2), p.182-187
Hauptverfasser: Thomson, David J., Silva, Priyamal, Denton, Kim, Bonington, Suzanne, Mak, Soo K., Swindell, Ric, Homer, Jarrod, Sykes, Andrew J., Lee, Lip W., Yap, Beng K., Slevin, Nicholas J.
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container_end_page 187
container_issue 2
container_start_page 182
container_title Head & neck
container_volume 37
creator Thomson, David J.
Silva, Priyamal
Denton, Kim
Bonington, Suzanne
Mak, Soo K.
Swindell, Ric
Homer, Jarrod
Sykes, Andrew J.
Lee, Lip W.
Yap, Beng K.
Slevin, Nicholas J.
description Background There is a need to improve the systemic treatment of advanced adenoid cystic carcinoma (ACC). Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. In this study, we evaluate sorafenib, an oral multikinase inhibitor, which has an attractive targeting profile for this disease. Methods In a single‐arm phase II trial, patients with unresectable locally recurrent and/or metastatic ACC were treated with sorafenib 400 mg bid. Results Twenty‐three patients, median age 51 years, were recruited from 2009 to 2011. Median progression‐free survival (PFS) and overall survival (OS) were 11.3 and 19.6 months, respectively. PFS at 6 and 12 months were 69.3% and 46.2%, respectively. Sorafenib was only reasonably well tolerated, and 13 patients (57%) experienced grade 3 toxicity. Conclusion Sorafenib showed modest activity in ACC with a 12‐month PFS of 46.2%. Sorafenib 400 mg bid was associated with significant toxicity and, taken together with limited effectiveness, cannot be enthusiastically recommended for further evaluation. © 2014 Wiley Periodicals, Inc. Head Neck 37: 182‐187, 2015
doi_str_mv 10.1002/hed.23577
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Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. In this study, we evaluate sorafenib, an oral multikinase inhibitor, which has an attractive targeting profile for this disease. Methods In a single‐arm phase II trial, patients with unresectable locally recurrent and/or metastatic ACC were treated with sorafenib 400 mg bid. Results Twenty‐three patients, median age 51 years, were recruited from 2009 to 2011. Median progression‐free survival (PFS) and overall survival (OS) were 11.3 and 19.6 months, respectively. PFS at 6 and 12 months were 69.3% and 46.2%, respectively. Sorafenib was only reasonably well tolerated, and 13 patients (57%) experienced grade 3 toxicity. Conclusion Sorafenib showed modest activity in ACC with a 12‐month PFS of 46.2%. Sorafenib 400 mg bid was associated with significant toxicity and, taken together with limited effectiveness, cannot be enthusiastically recommended for further evaluation. © 2014 Wiley Periodicals, Inc. Head Neck 37: 182‐187, 2015</description><identifier>ISSN: 1043-3074</identifier><identifier>EISSN: 1097-0347</identifier><identifier>DOI: 10.1002/hed.23577</identifier><identifier>PMID: 24346857</identifier><identifier>CODEN: HEANEE</identifier><language>eng</language><publisher>United States: Blackwell Publishing Ltd</publisher><subject>adenoid cystic carcinoma ; Adult ; Aged ; Carcinoma, Adenoid Cystic - drug therapy ; Carcinoma, Adenoid Cystic - mortality ; Disease Progression ; Female ; Humans ; Male ; Middle Aged ; Niacinamide - analogs &amp; derivatives ; Niacinamide - therapeutic use ; Phenylurea Compounds - therapeutic use ; Protein Kinase Inhibitors - therapeutic use ; Salivary Gland Neoplasms - drug therapy ; Salivary Gland Neoplasms - mortality ; sorafenib ; trial</subject><ispartof>Head &amp; neck, 2015-02, Vol.37 (2), p.182-187</ispartof><rights>2014 Wiley Periodicals, Inc.</rights><rights>2015 Wiley Periodicals, Inc.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c5627-5d8fbd5c34b21873ada857de9d6698a43cb77a1dacffde13129fa372d5e20b883</citedby><cites>FETCH-LOGICAL-c5627-5d8fbd5c34b21873ada857de9d6698a43cb77a1dacffde13129fa372d5e20b883</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1002%2Fhed.23577$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1002%2Fhed.23577$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24346857$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Thomson, David J.</creatorcontrib><creatorcontrib>Silva, Priyamal</creatorcontrib><creatorcontrib>Denton, Kim</creatorcontrib><creatorcontrib>Bonington, Suzanne</creatorcontrib><creatorcontrib>Mak, Soo K.</creatorcontrib><creatorcontrib>Swindell, Ric</creatorcontrib><creatorcontrib>Homer, Jarrod</creatorcontrib><creatorcontrib>Sykes, Andrew J.</creatorcontrib><creatorcontrib>Lee, Lip W.</creatorcontrib><creatorcontrib>Yap, Beng K.</creatorcontrib><creatorcontrib>Slevin, Nicholas J.</creatorcontrib><title>Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck</title><title>Head &amp; neck</title><addtitle>Head Neck</addtitle><description>Background There is a need to improve the systemic treatment of advanced adenoid cystic carcinoma (ACC). Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. In this study, we evaluate sorafenib, an oral multikinase inhibitor, which has an attractive targeting profile for this disease. Methods In a single‐arm phase II trial, patients with unresectable locally recurrent and/or metastatic ACC were treated with sorafenib 400 mg bid. Results Twenty‐three patients, median age 51 years, were recruited from 2009 to 2011. Median progression‐free survival (PFS) and overall survival (OS) were 11.3 and 19.6 months, respectively. PFS at 6 and 12 months were 69.3% and 46.2%, respectively. Sorafenib was only reasonably well tolerated, and 13 patients (57%) experienced grade 3 toxicity. Conclusion Sorafenib showed modest activity in ACC with a 12‐month PFS of 46.2%. Sorafenib 400 mg bid was associated with significant toxicity and, taken together with limited effectiveness, cannot be enthusiastically recommended for further evaluation. © 2014 Wiley Periodicals, Inc. Head Neck 37: 182‐187, 2015</description><subject>adenoid cystic carcinoma</subject><subject>Adult</subject><subject>Aged</subject><subject>Carcinoma, Adenoid Cystic - drug therapy</subject><subject>Carcinoma, Adenoid Cystic - mortality</subject><subject>Disease Progression</subject><subject>Female</subject><subject>Humans</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Niacinamide - analogs &amp; derivatives</subject><subject>Niacinamide - therapeutic use</subject><subject>Phenylurea Compounds - therapeutic use</subject><subject>Protein Kinase Inhibitors - therapeutic use</subject><subject>Salivary Gland Neoplasms - drug therapy</subject><subject>Salivary Gland Neoplasms - mortality</subject><subject>sorafenib</subject><subject>trial</subject><issn>1043-3074</issn><issn>1097-0347</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kMtOwzAQRS0E4lFY8APIEisWaf2KnSwRr1ZUgAQIVlgT21EMbQJ2CvTvSWnLjtWMRufembkIHVLSp4SwQeVsn_FUqQ20S0muEsKF2lz0giecKLGD9mJ8JYRwKdg22mGCC5mlahe93FUQHR6NcBs8THBT4tgEKF3tC-xrDPYTauMsjjDxnxDm3cTVjbfYzGPrDTYQjK-bKSykbeVw5cBiqC2unXnbR1slTKI7WNUeery8eDgbJuPbq9HZ6TgxqWQqSW1WFjY1XBSMZoqDhe4663IrZZ6B4KZQCqgFU5bWUU5ZXgJXzKaOkSLLeA8dL33fQ_Mxc7HVr80s1N1KTaWQacY4WVAnS8qEJsbgSv0e_LR7SlOiF0nqLkn9m2THHq0cZ8W0m67JdXQdMFgCX37i5v876eHF-doyWSp8bN33nwLCm5aKq1Q_3Vzp--vx8JlJpgX_AaR8i5c</recordid><startdate>201502</startdate><enddate>201502</enddate><creator>Thomson, David J.</creator><creator>Silva, Priyamal</creator><creator>Denton, Kim</creator><creator>Bonington, Suzanne</creator><creator>Mak, Soo K.</creator><creator>Swindell, Ric</creator><creator>Homer, Jarrod</creator><creator>Sykes, Andrew J.</creator><creator>Lee, Lip W.</creator><creator>Yap, Beng K.</creator><creator>Slevin, Nicholas J.</creator><general>Blackwell Publishing Ltd</general><general>Wiley Subscription Services, Inc</general><scope>BSCLL</scope><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>7QP</scope><scope>7TK</scope><scope>K9.</scope></search><sort><creationdate>201502</creationdate><title>Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck</title><author>Thomson, David J. ; Silva, Priyamal ; Denton, Kim ; Bonington, Suzanne ; Mak, Soo K. ; Swindell, Ric ; Homer, Jarrod ; Sykes, Andrew J. ; Lee, Lip W. ; Yap, Beng K. ; Slevin, Nicholas J.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c5627-5d8fbd5c34b21873ada857de9d6698a43cb77a1dacffde13129fa372d5e20b883</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>adenoid cystic carcinoma</topic><topic>Adult</topic><topic>Aged</topic><topic>Carcinoma, Adenoid Cystic - drug therapy</topic><topic>Carcinoma, Adenoid Cystic - mortality</topic><topic>Disease Progression</topic><topic>Female</topic><topic>Humans</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Niacinamide - analogs &amp; derivatives</topic><topic>Niacinamide - therapeutic use</topic><topic>Phenylurea Compounds - therapeutic use</topic><topic>Protein Kinase Inhibitors - therapeutic use</topic><topic>Salivary Gland Neoplasms - drug therapy</topic><topic>Salivary Gland Neoplasms - mortality</topic><topic>sorafenib</topic><topic>trial</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Thomson, David J.</creatorcontrib><creatorcontrib>Silva, Priyamal</creatorcontrib><creatorcontrib>Denton, Kim</creatorcontrib><creatorcontrib>Bonington, Suzanne</creatorcontrib><creatorcontrib>Mak, Soo K.</creatorcontrib><creatorcontrib>Swindell, Ric</creatorcontrib><creatorcontrib>Homer, Jarrod</creatorcontrib><creatorcontrib>Sykes, Andrew J.</creatorcontrib><creatorcontrib>Lee, Lip W.</creatorcontrib><creatorcontrib>Yap, Beng K.</creatorcontrib><creatorcontrib>Slevin, Nicholas J.</creatorcontrib><collection>Istex</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Calcium &amp; Calcified Tissue Abstracts</collection><collection>Neurosciences Abstracts</collection><collection>ProQuest Health &amp; Medical Complete (Alumni)</collection><jtitle>Head &amp; neck</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Thomson, David J.</au><au>Silva, Priyamal</au><au>Denton, Kim</au><au>Bonington, Suzanne</au><au>Mak, Soo K.</au><au>Swindell, Ric</au><au>Homer, Jarrod</au><au>Sykes, Andrew J.</au><au>Lee, Lip W.</au><au>Yap, Beng K.</au><au>Slevin, Nicholas J.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck</atitle><jtitle>Head &amp; neck</jtitle><addtitle>Head Neck</addtitle><date>2015-02</date><risdate>2015</risdate><volume>37</volume><issue>2</issue><spage>182</spage><epage>187</epage><pages>182-187</pages><issn>1043-3074</issn><eissn>1097-0347</eissn><coden>HEANEE</coden><abstract>Background There is a need to improve the systemic treatment of advanced adenoid cystic carcinoma (ACC). Response rates to chemotherapy are poor and preliminary investigations of molecularly targeted agents have been disappointing. In this study, we evaluate sorafenib, an oral multikinase inhibitor, which has an attractive targeting profile for this disease. Methods In a single‐arm phase II trial, patients with unresectable locally recurrent and/or metastatic ACC were treated with sorafenib 400 mg bid. Results Twenty‐three patients, median age 51 years, were recruited from 2009 to 2011. Median progression‐free survival (PFS) and overall survival (OS) were 11.3 and 19.6 months, respectively. PFS at 6 and 12 months were 69.3% and 46.2%, respectively. Sorafenib was only reasonably well tolerated, and 13 patients (57%) experienced grade 3 toxicity. Conclusion Sorafenib showed modest activity in ACC with a 12‐month PFS of 46.2%. Sorafenib 400 mg bid was associated with significant toxicity and, taken together with limited effectiveness, cannot be enthusiastically recommended for further evaluation. © 2014 Wiley Periodicals, Inc. Head Neck 37: 182‐187, 2015</abstract><cop>United States</cop><pub>Blackwell Publishing Ltd</pub><pmid>24346857</pmid><doi>10.1002/hed.23577</doi><tpages>6</tpages><oa>free_for_read</oa></addata></record>
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subjects adenoid cystic carcinoma
Adult
Aged
Carcinoma, Adenoid Cystic - drug therapy
Carcinoma, Adenoid Cystic - mortality
Disease Progression
Female
Humans
Male
Middle Aged
Niacinamide - analogs & derivatives
Niacinamide - therapeutic use
Phenylurea Compounds - therapeutic use
Protein Kinase Inhibitors - therapeutic use
Salivary Gland Neoplasms - drug therapy
Salivary Gland Neoplasms - mortality
sorafenib
trial
title Phase II trial of sorafenib in advanced salivary adenoid cystic carcinoma of the head and neck
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