A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results
Background: This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC). Methods: Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg −1 once daily (4...
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| Veröffentlicht in: | British journal of cancer 2015-10, Vol.113 (8), p.1140-1147 |
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| creator | Eisen, T Loembé, A-B Shparyk, Y MacLeod, N Jones, R J Mazurkiewicz, M Temple, G Dressler, H Bondarenko, I |
| description | Background:
This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC).
Methods:
Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg
−1
once daily (4 weeks on treatment; 2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months.
P
-values reported are descriptive only; the study was not powered for such comparisons.
Results:
Progression-free survival at 9 months was comparable between nintedanib and sunitinib (43.1%
vs
45.2%, respectively;
P
=0.85). Median PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence interval (CI): 0.70–1.80;
P
=0.64). Median overall survival was 20.4 and 21.2 months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54–1.56;
P
=0.76). Overall incidence of any grade adverse events (AEs) was comparable (90.6%
vs
93.8%); AEs grade ⩾3 were lower with nintedanib than sunitinib (48.4%
vs
59.4%). Nintedanib was associated with lower incidences of some AEs typical of antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, hand–foot syndrome, cardiac disorders and haematological abnormalities.
Conclusions:
In patients with advanced RCC, nintedanib has promising efficacy and similar tolerability to sunitinib, and a manageable safety profile with fewer TKI-associated AEs. |
| doi_str_mv | 10.1038/bjc.2015.313 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_pubme</sourceid><recordid>TN_cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4647871</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>1725513058</sourcerecordid><originalsourceid>FETCH-LOGICAL-c450t-424d74e6d97a6ca92374f45670fe49bf07fc8bdbde633b0d90e75fb8d41e82d43</originalsourceid><addsrcrecordid>eNptkU1v1DAQhi0EokvhxhlZ4sKhWfyV2OGAVFUFVqrEBc6WE0-6XmXtYDuL9h_ws-uwpSqIi62ZefTOx4vQa0rWlHD1vtv1a0ZoveaUP0ErWnNWUcXkU7QihMiKtIycoRcp7UrYEiWfozPWCKGoVCv06xJH423YuwT2Ak9bkwBvNjjl2R5xGLB3PoM13nU4RJxm77JbAufxFOHgwpzGI559jmAKiCeTHfic8E-Xt9jYg_F9SUfwZsQ9jOVZMvED5tURTCyVNI85vUTPBjMmeHX_n6Pvn66_XX2pbr5-3lxd3lS9qEmuBBNWCmhsK03Tm5ZxKQZRN5IMINpuIHLoVWc7Cw3nHbEtAVkPnbKCgmJW8HP08aQ7zd0ebF9mjWbUU3R7E486GKf_rni31bfhoEUjpJK0CLy7F4jhxwwp63K7ZTHjoRxDU8nqmnJSq4K-_QfdhTmWQ_ymBKu5bFihLk5UH0NKEYaHYSjRi8W6WKwXi3WxuOBvHi_wAP_xtADVCUil5G8hPur6P8E7pu6zdg</addsrcrecordid><sourcetype>Open Access Repository</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>1724253762</pqid></control><display><type>article</type><title>A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results</title><source>MEDLINE</source><source>SpringerLink Journals</source><source>Nature</source><source>Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals</source><source>PubMed Central</source><creator>Eisen, T ; Loembé, A-B ; Shparyk, Y ; MacLeod, N ; Jones, R J ; Mazurkiewicz, M ; Temple, G ; Dressler, H ; Bondarenko, I</creator><creatorcontrib>Eisen, T ; Loembé, A-B ; Shparyk, Y ; MacLeod, N ; Jones, R J ; Mazurkiewicz, M ; Temple, G ; Dressler, H ; Bondarenko, I</creatorcontrib><description>Background:
This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC).
Methods:
Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg
−1
once daily (4 weeks on treatment; 2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months.
P
-values reported are descriptive only; the study was not powered for such comparisons.
Results:
Progression-free survival at 9 months was comparable between nintedanib and sunitinib (43.1%
vs
45.2%, respectively;
P
=0.85). Median PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence interval (CI): 0.70–1.80;
P
=0.64). Median overall survival was 20.4 and 21.2 months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54–1.56;
P
=0.76). Overall incidence of any grade adverse events (AEs) was comparable (90.6%
vs
93.8%); AEs grade ⩾3 were lower with nintedanib than sunitinib (48.4%
vs
59.4%). Nintedanib was associated with lower incidences of some AEs typical of antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, hand–foot syndrome, cardiac disorders and haematological abnormalities.
Conclusions:
In patients with advanced RCC, nintedanib has promising efficacy and similar tolerability to sunitinib, and a manageable safety profile with fewer TKI-associated AEs.</description><identifier>ISSN: 0007-0920</identifier><identifier>EISSN: 1532-1827</identifier><identifier>DOI: 10.1038/bjc.2015.313</identifier><identifier>PMID: 26448178</identifier><identifier>CODEN: BJCAAI</identifier><language>eng</language><publisher>London: Nature Publishing Group UK</publisher><subject>631/92/436/108 ; 692/699/67/589/1588/1351 ; Adult ; Aged ; Aged, 80 and over ; Angiogenesis Inhibitors - therapeutic use ; Antineoplastic Agents - therapeutic use ; Biomedical and Life Sciences ; Biomedicine ; Cancer Research ; Carcinoma, Renal Cell - drug therapy ; Clinical Study ; Disease-Free Survival ; Drug Resistance ; Epidemiology ; Female ; Humans ; Indoles - therapeutic use ; Kidney Neoplasms - drug therapy ; Male ; Middle Aged ; Molecular Medicine ; Oncology ; Protein Kinase Inhibitors - therapeutic use ; Protein-Tyrosine Kinases - antagonists & inhibitors ; Pyrroles - therapeutic use ; Sunitinib</subject><ispartof>British journal of cancer, 2015-10, Vol.113 (8), p.1140-1147</ispartof><rights>The Author(s) 2015</rights><rights>Copyright Nature Publishing Group Oct 20, 2015</rights><rights>Copyright © 2015 Cancer Research UK 2015 Cancer Research UK</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c450t-424d74e6d97a6ca92374f45670fe49bf07fc8bdbde633b0d90e75fb8d41e82d43</citedby><cites>FETCH-LOGICAL-c450t-424d74e6d97a6ca92374f45670fe49bf07fc8bdbde633b0d90e75fb8d41e82d43</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4647871/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC4647871/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,881,27901,27902,41464,42533,51294,53766,53768</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/26448178$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Eisen, T</creatorcontrib><creatorcontrib>Loembé, A-B</creatorcontrib><creatorcontrib>Shparyk, Y</creatorcontrib><creatorcontrib>MacLeod, N</creatorcontrib><creatorcontrib>Jones, R J</creatorcontrib><creatorcontrib>Mazurkiewicz, M</creatorcontrib><creatorcontrib>Temple, G</creatorcontrib><creatorcontrib>Dressler, H</creatorcontrib><creatorcontrib>Bondarenko, I</creatorcontrib><title>A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results</title><title>British journal of cancer</title><addtitle>Br J Cancer</addtitle><addtitle>Br J Cancer</addtitle><description>Background:
This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC).
Methods:
Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg
−1
once daily (4 weeks on treatment; 2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months.
P
-values reported are descriptive only; the study was not powered for such comparisons.
Results:
Progression-free survival at 9 months was comparable between nintedanib and sunitinib (43.1%
vs
45.2%, respectively;
P
=0.85). Median PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence interval (CI): 0.70–1.80;
P
=0.64). Median overall survival was 20.4 and 21.2 months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54–1.56;
P
=0.76). Overall incidence of any grade adverse events (AEs) was comparable (90.6%
vs
93.8%); AEs grade ⩾3 were lower with nintedanib than sunitinib (48.4%
vs
59.4%). Nintedanib was associated with lower incidences of some AEs typical of antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, hand–foot syndrome, cardiac disorders and haematological abnormalities.
Conclusions:
In patients with advanced RCC, nintedanib has promising efficacy and similar tolerability to sunitinib, and a manageable safety profile with fewer TKI-associated AEs.</description><subject>631/92/436/108</subject><subject>692/699/67/589/1588/1351</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Angiogenesis Inhibitors - therapeutic use</subject><subject>Antineoplastic Agents - therapeutic use</subject><subject>Biomedical and Life Sciences</subject><subject>Biomedicine</subject><subject>Cancer Research</subject><subject>Carcinoma, Renal Cell - drug therapy</subject><subject>Clinical Study</subject><subject>Disease-Free Survival</subject><subject>Drug Resistance</subject><subject>Epidemiology</subject><subject>Female</subject><subject>Humans</subject><subject>Indoles - therapeutic use</subject><subject>Kidney Neoplasms - drug therapy</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Molecular Medicine</subject><subject>Oncology</subject><subject>Protein Kinase Inhibitors - therapeutic use</subject><subject>Protein-Tyrosine Kinases - antagonists & inhibitors</subject><subject>Pyrroles - therapeutic use</subject><subject>Sunitinib</subject><issn>0007-0920</issn><issn>1532-1827</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2015</creationdate><recordtype>article</recordtype><sourceid>C6C</sourceid><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNptkU1v1DAQhi0EokvhxhlZ4sKhWfyV2OGAVFUFVqrEBc6WE0-6XmXtYDuL9h_ws-uwpSqIi62ZefTOx4vQa0rWlHD1vtv1a0ZoveaUP0ErWnNWUcXkU7QihMiKtIycoRcp7UrYEiWfozPWCKGoVCv06xJH423YuwT2Ak9bkwBvNjjl2R5xGLB3PoM13nU4RJxm77JbAufxFOHgwpzGI559jmAKiCeTHfic8E-Xt9jYg_F9SUfwZsQ9jOVZMvED5tURTCyVNI85vUTPBjMmeHX_n6Pvn66_XX2pbr5-3lxd3lS9qEmuBBNWCmhsK03Tm5ZxKQZRN5IMINpuIHLoVWc7Cw3nHbEtAVkPnbKCgmJW8HP08aQ7zd0ebF9mjWbUU3R7E486GKf_rni31bfhoEUjpJK0CLy7F4jhxwwp63K7ZTHjoRxDU8nqmnJSq4K-_QfdhTmWQ_ymBKu5bFihLk5UH0NKEYaHYSjRi8W6WKwXi3WxuOBvHi_wAP_xtADVCUil5G8hPur6P8E7pu6zdg</recordid><startdate>20151020</startdate><enddate>20151020</enddate><creator>Eisen, T</creator><creator>Loembé, A-B</creator><creator>Shparyk, Y</creator><creator>MacLeod, N</creator><creator>Jones, R J</creator><creator>Mazurkiewicz, M</creator><creator>Temple, G</creator><creator>Dressler, H</creator><creator>Bondarenko, I</creator><general>Nature Publishing Group UK</general><general>Nature Publishing Group</general><scope>C6C</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>3V.</scope><scope>7RV</scope><scope>7TO</scope><scope>7U9</scope><scope>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8C1</scope><scope>8FE</scope><scope>8FH</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AN0</scope><scope>AZQEC</scope><scope>BBNVY</scope><scope>BENPR</scope><scope>BHPHI</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>GNUQQ</scope><scope>H94</scope><scope>HCIFZ</scope><scope>K9.</scope><scope>KB0</scope><scope>LK8</scope><scope>M0S</scope><scope>M1P</scope><scope>M7P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>7X8</scope><scope>5PM</scope></search><sort><creationdate>20151020</creationdate><title>A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results</title><author>Eisen, T ; Loembé, A-B ; Shparyk, Y ; MacLeod, N ; Jones, R J ; Mazurkiewicz, M ; Temple, G ; Dressler, H ; Bondarenko, I</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c450t-424d74e6d97a6ca92374f45670fe49bf07fc8bdbde633b0d90e75fb8d41e82d43</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2015</creationdate><topic>631/92/436/108</topic><topic>692/699/67/589/1588/1351</topic><topic>Adult</topic><topic>Aged</topic><topic>Aged, 80 and over</topic><topic>Angiogenesis Inhibitors - therapeutic use</topic><topic>Antineoplastic Agents - therapeutic use</topic><topic>Biomedical and Life Sciences</topic><topic>Biomedicine</topic><topic>Cancer Research</topic><topic>Carcinoma, Renal Cell - drug therapy</topic><topic>Clinical Study</topic><topic>Disease-Free Survival</topic><topic>Drug Resistance</topic><topic>Epidemiology</topic><topic>Female</topic><topic>Humans</topic><topic>Indoles - therapeutic use</topic><topic>Kidney Neoplasms - drug therapy</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Molecular Medicine</topic><topic>Oncology</topic><topic>Protein Kinase Inhibitors - therapeutic use</topic><topic>Protein-Tyrosine Kinases - antagonists & inhibitors</topic><topic>Pyrroles - therapeutic use</topic><topic>Sunitinib</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Eisen, T</creatorcontrib><creatorcontrib>Loembé, A-B</creatorcontrib><creatorcontrib>Shparyk, Y</creatorcontrib><creatorcontrib>MacLeod, N</creatorcontrib><creatorcontrib>Jones, R J</creatorcontrib><creatorcontrib>Mazurkiewicz, M</creatorcontrib><creatorcontrib>Temple, G</creatorcontrib><creatorcontrib>Dressler, H</creatorcontrib><creatorcontrib>Bondarenko, I</creatorcontrib><collection>Springer Nature OA Free Journals</collection><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Nursing & Allied Health Database</collection><collection>Oncogenes and Growth Factors Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Medical Database (Alumni Edition)</collection><collection>ProQuest Pharma Collection</collection><collection>Public Health Database</collection><collection>ProQuest SciTech Collection</collection><collection>ProQuest Natural Science Collection</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>British Nursing Database</collection><collection>ProQuest Central Essentials</collection><collection>Biological Science Collection</collection><collection>ProQuest Central</collection><collection>Natural Science Collection</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Central Student</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>SciTech Premium Collection</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Nursing & Allied Health Database (Alumni Edition)</collection><collection>ProQuest Biological Science Collection</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Biological Science Database</collection><collection>Nursing & Allied Health Premium</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><jtitle>British journal of cancer</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Eisen, T</au><au>Loembé, A-B</au><au>Shparyk, Y</au><au>MacLeod, N</au><au>Jones, R J</au><au>Mazurkiewicz, M</au><au>Temple, G</au><au>Dressler, H</au><au>Bondarenko, I</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results</atitle><jtitle>British journal of cancer</jtitle><stitle>Br J Cancer</stitle><addtitle>Br J Cancer</addtitle><date>2015-10-20</date><risdate>2015</risdate><volume>113</volume><issue>8</issue><spage>1140</spage><epage>1147</epage><pages>1140-1147</pages><issn>0007-0920</issn><eissn>1532-1827</eissn><coden>BJCAAI</coden><abstract>Background:
This exploratory study evaluated the safety/efficacy of nintedanib or sunitinib as first-line therapy in patients with advanced renal cell carcinoma (RCC).
Methods:
Ninety-six patients were randomised (2:1) to either nintedanib (200 mg twice daily) or sunitinib (50 mg kg
−1
once daily (4 weeks on treatment; 2 weeks off)). Primary endpoint was progression-free survival (PFS) at 9 months.
P
-values reported are descriptive only; the study was not powered for such comparisons.
Results:
Progression-free survival at 9 months was comparable between nintedanib and sunitinib (43.1%
vs
45.2%, respectively;
P
=0.85). Median PFS was 8.4 months in each group (hazard ratio (HR), 1.12; 95% confidence interval (CI): 0.70–1.80;
P
=0.64). Median overall survival was 20.4 and 21.2 months for nintedanib and sunitinib, respectively (HR, 0.92; 95% CI: 0.54–1.56;
P
=0.76). Overall incidence of any grade adverse events (AEs) was comparable (90.6%
vs
93.8%); AEs grade ⩾3 were lower with nintedanib than sunitinib (48.4%
vs
59.4%). Nintedanib was associated with lower incidences of some AEs typical of antiangiogenic tyrosine kinase inhibitors (TKIs): hypertension, hypothyroidism, hand–foot syndrome, cardiac disorders and haematological abnormalities.
Conclusions:
In patients with advanced RCC, nintedanib has promising efficacy and similar tolerability to sunitinib, and a manageable safety profile with fewer TKI-associated AEs.</abstract><cop>London</cop><pub>Nature Publishing Group UK</pub><pmid>26448178</pmid><doi>10.1038/bjc.2015.313</doi><tpages>8</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | British journal of cancer, 2015-10, Vol.113 (8), p.1140-1147 |
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| language | eng |
| recordid | cdi_pubmedcentral_primary_oai_pubmedcentral_nih_gov_4647871 |
| source | MEDLINE; SpringerLink Journals; Nature; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; PubMed Central |
| subjects | 631/92/436/108 692/699/67/589/1588/1351 Adult Aged Aged, 80 and over Angiogenesis Inhibitors - therapeutic use Antineoplastic Agents - therapeutic use Biomedical and Life Sciences Biomedicine Cancer Research Carcinoma, Renal Cell - drug therapy Clinical Study Disease-Free Survival Drug Resistance Epidemiology Female Humans Indoles - therapeutic use Kidney Neoplasms - drug therapy Male Middle Aged Molecular Medicine Oncology Protein Kinase Inhibitors - therapeutic use Protein-Tyrosine Kinases - antagonists & inhibitors Pyrroles - therapeutic use Sunitinib |
| title | A randomised, phase II study of nintedanib or sunitinib in previously untreated patients with advanced renal cell cancer: 3-year results |
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