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Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study
Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and...
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| Published in: | Clinical cancer research 2017-10, Vol.23 (19), p.5720-5728 |
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| container_end_page | 5728 |
| container_issue | 19 |
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| container_title | Clinical cancer research |
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| creator | Ganten, Tom M Stauber, Rudolf E Schott, Eckardt Malfertheiner, Peter Buder, Robert Galle, Peter R Göhler, Thomas Walther, Matthias Koschny, Ronald Gerken, Guido |
| description | Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months.
The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014.
Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor stage (A: 29.2, B: 19.6, C: 13.6, D: 3.1 and A: 6.0, B: 5.5, C: 3.9, and D: 1.7 months, respectively), Child-Pugh liver function (A: 17.6, B: 8.1, C: 5.6 and A: 5.3, B: 3.3, C: 2.5 months, respectively), and performance status of the patient; however, age did not affect prognosis. Sorafenib-related adverse events at any grade occurred in 64.9% of patients, with diarrhea (35.4%), hand-foot-skin reaction (16.6%), nausea (10.3%), and fatigue (11.2%) occurring most frequently.
Sorafenib treatment was shown to be effective in a real-life setting, in agreement with previously reported clinical trial data. The therapy was found to have an acceptable safety profile, with predominantly mild to moderate side effects.
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| doi_str_mv | 10.1158/1078-0432.CCR-16-0919 |
| format | article |
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The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014.
Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor stage (A: 29.2, B: 19.6, C: 13.6, D: 3.1 and A: 6.0, B: 5.5, C: 3.9, and D: 1.7 months, respectively), Child-Pugh liver function (A: 17.6, B: 8.1, C: 5.6 and A: 5.3, B: 3.3, C: 2.5 months, respectively), and performance status of the patient; however, age did not affect prognosis. Sorafenib-related adverse events at any grade occurred in 64.9% of patients, with diarrhea (35.4%), hand-foot-skin reaction (16.6%), nausea (10.3%), and fatigue (11.2%) occurring most frequently.
Sorafenib treatment was shown to be effective in a real-life setting, in agreement with previously reported clinical trial data. The therapy was found to have an acceptable safety profile, with predominantly mild to moderate side effects.
.</description><identifier>ISSN: 1078-0432</identifier><identifier>EISSN: 1557-3265</identifier><identifier>DOI: 10.1158/1078-0432.CCR-16-0919</identifier><identifier>PMID: 28698202</identifier><language>eng</language><publisher>United States: American Association for Cancer Research Inc</publisher><subject>Adult ; Aged ; Cancer ; Carcinoma, Hepatocellular - drug therapy ; Carcinoma, Hepatocellular - pathology ; Diarrhea ; Disease Progression ; Disease-Free Survival ; Drug-Related Side Effects and Adverse Reactions - pathology ; Experimental design ; Fatigue ; Female ; Hepatocellular carcinoma ; Humans ; Liver ; Liver cancer ; Liver Neoplasms - drug therapy ; Liver Neoplasms - pathology ; Male ; Medical prognosis ; Middle Aged ; Nausea ; Neoplasm Staging ; Niacinamide - administration & dosage ; Niacinamide - adverse effects ; Niacinamide - analogs & derivatives ; Patients ; Phenylurea Compounds - administration & dosage ; Phenylurea Compounds - adverse effects ; Prognosis ; Protein Kinase Inhibitors - administration & dosage ; Protein Kinase Inhibitors - adverse effects ; Quality ; Safety ; Side effects ; Skin ; Therapy</subject><ispartof>Clinical cancer research, 2017-10, Vol.23 (19), p.5720-5728</ispartof><rights>2017 American Association for Cancer Research.</rights><rights>Copyright American Association for Cancer Research Inc Oct 1, 2017</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c337t-47e58b528e0f82dc1eee2303734bfac7cdde0468cc48e2142341fca007c2cfd83</citedby><cites>FETCH-LOGICAL-c337t-47e58b528e0f82dc1eee2303734bfac7cdde0468cc48e2142341fca007c2cfd83</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><link.rule.ids>314,780,784,27924,27925</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28698202$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Ganten, Tom M</creatorcontrib><creatorcontrib>Stauber, Rudolf E</creatorcontrib><creatorcontrib>Schott, Eckardt</creatorcontrib><creatorcontrib>Malfertheiner, Peter</creatorcontrib><creatorcontrib>Buder, Robert</creatorcontrib><creatorcontrib>Galle, Peter R</creatorcontrib><creatorcontrib>Göhler, Thomas</creatorcontrib><creatorcontrib>Walther, Matthias</creatorcontrib><creatorcontrib>Koschny, Ronald</creatorcontrib><creatorcontrib>Gerken, Guido</creatorcontrib><title>Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study</title><title>Clinical cancer research</title><addtitle>Clin Cancer Res</addtitle><description>Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months.
The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014.
Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor stage (A: 29.2, B: 19.6, C: 13.6, D: 3.1 and A: 6.0, B: 5.5, C: 3.9, and D: 1.7 months, respectively), Child-Pugh liver function (A: 17.6, B: 8.1, C: 5.6 and A: 5.3, B: 3.3, C: 2.5 months, respectively), and performance status of the patient; however, age did not affect prognosis. Sorafenib-related adverse events at any grade occurred in 64.9% of patients, with diarrhea (35.4%), hand-foot-skin reaction (16.6%), nausea (10.3%), and fatigue (11.2%) occurring most frequently.
Sorafenib treatment was shown to be effective in a real-life setting, in agreement with previously reported clinical trial data. The therapy was found to have an acceptable safety profile, with predominantly mild to moderate side effects.
.</description><subject>Adult</subject><subject>Aged</subject><subject>Cancer</subject><subject>Carcinoma, Hepatocellular - drug therapy</subject><subject>Carcinoma, Hepatocellular - pathology</subject><subject>Diarrhea</subject><subject>Disease Progression</subject><subject>Disease-Free Survival</subject><subject>Drug-Related Side Effects and Adverse Reactions - pathology</subject><subject>Experimental design</subject><subject>Fatigue</subject><subject>Female</subject><subject>Hepatocellular carcinoma</subject><subject>Humans</subject><subject>Liver</subject><subject>Liver cancer</subject><subject>Liver Neoplasms - drug therapy</subject><subject>Liver Neoplasms - pathology</subject><subject>Male</subject><subject>Medical prognosis</subject><subject>Middle Aged</subject><subject>Nausea</subject><subject>Neoplasm Staging</subject><subject>Niacinamide - administration & dosage</subject><subject>Niacinamide - adverse effects</subject><subject>Niacinamide - analogs & derivatives</subject><subject>Patients</subject><subject>Phenylurea Compounds - administration & dosage</subject><subject>Phenylurea Compounds - adverse effects</subject><subject>Prognosis</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Protein Kinase Inhibitors - adverse effects</subject><subject>Quality</subject><subject>Safety</subject><subject>Side effects</subject><subject>Skin</subject><subject>Therapy</subject><issn>1078-0432</issn><issn>1557-3265</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2017</creationdate><recordtype>article</recordtype><recordid>eNpdkU9Lw0AUxBdRbK1-BGXBi5fU_ZtsjxK0LRQVq1eXzeaFpiTZupso_fYmWD14eu_wm2GYQeiSkimlUt1SkqiICM6mafoS0TgiMzo7QmMqZRJxFsvj_v9lRugshC0hVFAiTtGIqXimGGFj9L523hTQlBkuG_xs2hKaNuCvst3gBexM6yxUVVcZj1Pjbdm42kQvELqqp1yB2w3gpyyA_-ylrjEVXj6ul_PFK163Xb4_RyeFqQJcHO4EvT3cv6aLaPU0X6Z3q8hynrSRSECqTDIFpFAstxQAGCc84SIrjE1sngMRsbJWKGBUMC5oYQ0hiWW2yBWfoJsf3513Hx2EVtdlGJKbBlwXNJ1RxRXhUvbo9T906zrfJx8o1RvHMR8o-UNZ70LwUOidL2vj95oSPQygh3L1UK7uB9A01sMAve7q4N5lNeR_qt_G-Tf3EYEH</recordid><startdate>20171001</startdate><enddate>20171001</enddate><creator>Ganten, Tom M</creator><creator>Stauber, Rudolf E</creator><creator>Schott, Eckardt</creator><creator>Malfertheiner, Peter</creator><creator>Buder, Robert</creator><creator>Galle, Peter R</creator><creator>Göhler, Thomas</creator><creator>Walther, Matthias</creator><creator>Koschny, Ronald</creator><creator>Gerken, Guido</creator><general>American Association for Cancer Research Inc</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>7QO</scope><scope>7T5</scope><scope>7TO</scope><scope>7U9</scope><scope>8FD</scope><scope>FR3</scope><scope>H94</scope><scope>P64</scope><scope>7X8</scope></search><sort><creationdate>20171001</creationdate><title>Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study</title><author>Ganten, Tom M ; Stauber, Rudolf E ; Schott, Eckardt ; Malfertheiner, Peter ; Buder, Robert ; Galle, Peter R ; Göhler, Thomas ; Walther, Matthias ; Koschny, Ronald ; Gerken, Guido</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c337t-47e58b528e0f82dc1eee2303734bfac7cdde0468cc48e2142341fca007c2cfd83</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2017</creationdate><topic>Adult</topic><topic>Aged</topic><topic>Cancer</topic><topic>Carcinoma, Hepatocellular - drug therapy</topic><topic>Carcinoma, Hepatocellular - pathology</topic><topic>Diarrhea</topic><topic>Disease Progression</topic><topic>Disease-Free Survival</topic><topic>Drug-Related Side Effects and Adverse Reactions - pathology</topic><topic>Experimental design</topic><topic>Fatigue</topic><topic>Female</topic><topic>Hepatocellular carcinoma</topic><topic>Humans</topic><topic>Liver</topic><topic>Liver cancer</topic><topic>Liver Neoplasms - drug therapy</topic><topic>Liver Neoplasms - pathology</topic><topic>Male</topic><topic>Medical prognosis</topic><topic>Middle Aged</topic><topic>Nausea</topic><topic>Neoplasm Staging</topic><topic>Niacinamide - administration & dosage</topic><topic>Niacinamide - adverse effects</topic><topic>Niacinamide - analogs & derivatives</topic><topic>Patients</topic><topic>Phenylurea Compounds - administration & dosage</topic><topic>Phenylurea Compounds - adverse effects</topic><topic>Prognosis</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Protein Kinase Inhibitors - adverse effects</topic><topic>Quality</topic><topic>Safety</topic><topic>Side effects</topic><topic>Skin</topic><topic>Therapy</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Ganten, Tom M</creatorcontrib><creatorcontrib>Stauber, Rudolf E</creatorcontrib><creatorcontrib>Schott, Eckardt</creatorcontrib><creatorcontrib>Malfertheiner, Peter</creatorcontrib><creatorcontrib>Buder, Robert</creatorcontrib><creatorcontrib>Galle, Peter R</creatorcontrib><creatorcontrib>Göhler, Thomas</creatorcontrib><creatorcontrib>Walther, Matthias</creatorcontrib><creatorcontrib>Koschny, Ronald</creatorcontrib><creatorcontrib>Gerken, Guido</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Biotechnology Research Abstracts</collection><collection>Immunology Abstracts</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Technology Research Database</collection><collection>Engineering Research Database</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Clinical cancer research</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Ganten, Tom M</au><au>Stauber, Rudolf E</au><au>Schott, Eckardt</au><au>Malfertheiner, Peter</au><au>Buder, Robert</au><au>Galle, Peter R</au><au>Göhler, Thomas</au><au>Walther, Matthias</au><au>Koschny, Ronald</au><au>Gerken, Guido</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study</atitle><jtitle>Clinical cancer research</jtitle><addtitle>Clin Cancer Res</addtitle><date>2017-10-01</date><risdate>2017</risdate><volume>23</volume><issue>19</issue><spage>5720</spage><epage>5728</epage><pages>5720-5728</pages><issn>1078-0432</issn><eissn>1557-3265</eissn><abstract>Sorafenib is the only currently approved systemic therapy for advanced hepatocellular carcinoma (HCC). We aimed to evaluate the safety and efficacy of sorafenib therapy in patients with HCC under real-life conditions regarding patient, tumor characteristics, and any adverse events at study entry and at follow-up visits every 2 to 4 months.
The current INSIGHT study is a noninterventional, prospective, multicenter, observational study performed in 124 sites across Austria and Germany between 2008 and 2014.
Median overall survival and time to progression (RECIST) were found to be dependent on baseline Barcelona Clinic Liver Cancer (BCLC) tumor stage (A: 29.2, B: 19.6, C: 13.6, D: 3.1 and A: 6.0, B: 5.5, C: 3.9, and D: 1.7 months, respectively), Child-Pugh liver function (A: 17.6, B: 8.1, C: 5.6 and A: 5.3, B: 3.3, C: 2.5 months, respectively), and performance status of the patient; however, age did not affect prognosis. Sorafenib-related adverse events at any grade occurred in 64.9% of patients, with diarrhea (35.4%), hand-foot-skin reaction (16.6%), nausea (10.3%), and fatigue (11.2%) occurring most frequently.
Sorafenib treatment was shown to be effective in a real-life setting, in agreement with previously reported clinical trial data. The therapy was found to have an acceptable safety profile, with predominantly mild to moderate side effects.
.</abstract><cop>United States</cop><pub>American Association for Cancer Research Inc</pub><pmid>28698202</pmid><doi>10.1158/1078-0432.CCR-16-0919</doi><tpages>9</tpages></addata></record> |
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| source | Freely Accessible Science Journals - check A-Z of ejournals |
| subjects | Adult Aged Cancer Carcinoma, Hepatocellular - drug therapy Carcinoma, Hepatocellular - pathology Diarrhea Disease Progression Disease-Free Survival Drug-Related Side Effects and Adverse Reactions - pathology Experimental design Fatigue Female Hepatocellular carcinoma Humans Liver Liver cancer Liver Neoplasms - drug therapy Liver Neoplasms - pathology Male Medical prognosis Middle Aged Nausea Neoplasm Staging Niacinamide - administration & dosage Niacinamide - adverse effects Niacinamide - analogs & derivatives Patients Phenylurea Compounds - administration & dosage Phenylurea Compounds - adverse effects Prognosis Protein Kinase Inhibitors - administration & dosage Protein Kinase Inhibitors - adverse effects Quality Safety Side effects Skin Therapy |
| title | Sorafenib in Patients with Hepatocellular Carcinoma-Results of the Observational INSIGHT Study |
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