A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion
Malignant ascites and pleural effusion are challenging clinical problems, with a major impact on quality of life. We conducted a randomized phase II trial to assess the palliative value of cediranib, an oral vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI). After a baseline pa...
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| Veröffentlicht in: | Targeted oncology 2014-12, Vol.9 (4), p.331-338 |
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| creator | Mulder, S. F. Boers-Sonderen, M. J. van der Heijden, H. F. M. Vissers, K. C. P. Punt, C. J. A. van Herpen, C. M. L. |
| description | Malignant ascites and pleural effusion are challenging clinical problems, with a major impact on quality of life. We conducted a randomized phase II trial to assess the palliative value of cediranib, an oral vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI). After a baseline paracentesis or thoracentesis (on day 0), patients with symptomatic malignant ascites and/or pleural effusion were randomized between immediate treatment with cediranib (Immediate Cediranib) or delayed treatment with cediranib (Delayed Cediranib) on day 29, or after a new puncture was needed. The primary objective of the study was the puncture-free survival, defined as the time from study start (day 1) to the first need for paracentesis or thoracentesis, or time to death, whichever event occurred first. Twelve patients were enrolled. The median puncture-free survival was 45 days (range 10–368) in the Immediate Cediranib patients and 7 days (range 4–13) in the Delayed Cediranib patients (
P
= 0.011). The change in puncture-free interval (the puncture-free survival after study start minus the puncture-free interval before study start) increased with a median of 31 days in the Immediate Cediranib patients and shortened with a median of 3 days in the Delayed Cediranib patients (
P
= 0.015). The most common adverse events were fatigue and anorexia. In conclusion, cediranib increased the puncture-free survival and puncture-free interval with an acceptable toxicity profile. This is the first study in which an oral VEGFR TKI showed beneficial palliative effects in patients with malignant effusions. |
| doi_str_mv | 10.1007/s11523-014-0306-0 |
| format | Article |
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P
= 0.011). The change in puncture-free interval (the puncture-free survival after study start minus the puncture-free interval before study start) increased with a median of 31 days in the Immediate Cediranib patients and shortened with a median of 3 days in the Delayed Cediranib patients (
P
= 0.015). The most common adverse events were fatigue and anorexia. In conclusion, cediranib increased the puncture-free survival and puncture-free interval with an acceptable toxicity profile. This is the first study in which an oral VEGFR TKI showed beneficial palliative effects in patients with malignant effusions.</description><identifier>ISSN: 1776-2596</identifier><identifier>EISSN: 1776-260X</identifier><identifier>DOI: 10.1007/s11523-014-0306-0</identifier><identifier>PMID: 24446026</identifier><language>eng</language><publisher>Cham: Springer International Publishing</publisher><subject><![CDATA[Abdomen ; Administration, Oral ; Aged ; Antineoplastic Agents - administration & dosage ; Ascites - drug therapy ; Biological and medical sciences ; Biomedicine ; Disease Progression ; Drug Administration Schedule ; Female ; Gastroenterology. Liver. Pancreas. Abdomen ; Humans ; Male ; Medical sciences ; Medicine ; Medicine & Public Health ; Middle Aged ; Oncology ; Original Research ; Other diseases. Semiology ; Palliative Care - methods ; Paracentesis ; Pleural Effusion - drug therapy ; Pneumology ; Protein Kinase Inhibitors - administration & dosage ; Quality of Life ; Quinazolines - administration & dosage ; Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors ; Time Factors ; Treatment Outcome ; Tumors of the respiratory system and mediastinum ; Vascular Endothelial Growth Factor Receptor-1 - antagonists & inhibitors]]></subject><ispartof>Targeted oncology, 2014-12, Vol.9 (4), p.331-338</ispartof><rights>Springer-Verlag France 2014</rights><rights>2015 INIST-CNRS</rights><rights>Springer International Publishing Switzerland 2014</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c472t-91d378a5630be7f12e4d397e4842ec4ccc3c1890fee3c7ac43e242eedcf7ac643</citedby><cites>FETCH-LOGICAL-c472t-91d378a5630be7f12e4d397e4842ec4ccc3c1890fee3c7ac43e242eedcf7ac643</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://link.springer.com/content/pdf/10.1007/s11523-014-0306-0$$EPDF$$P50$$Gspringer$$H</linktopdf><linktohtml>$$Uhttps://link.springer.com/10.1007/s11523-014-0306-0$$EHTML$$P50$$Gspringer$$H</linktohtml><link.rule.ids>314,776,780,27901,27902,41464,42533,51294</link.rule.ids><backlink>$$Uhttp://pascal-francis.inist.fr/vibad/index.php?action=getRecordDetail&idt=29053884$$DView record in Pascal Francis$$Hfree_for_read</backlink><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/24446026$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Mulder, S. F.</creatorcontrib><creatorcontrib>Boers-Sonderen, M. J.</creatorcontrib><creatorcontrib>van der Heijden, H. F. M.</creatorcontrib><creatorcontrib>Vissers, K. C. P.</creatorcontrib><creatorcontrib>Punt, C. J. A.</creatorcontrib><creatorcontrib>van Herpen, C. M. L.</creatorcontrib><title>A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion</title><title>Targeted oncology</title><addtitle>Targ Oncol</addtitle><addtitle>Target Oncol</addtitle><description>Malignant ascites and pleural effusion are challenging clinical problems, with a major impact on quality of life. We conducted a randomized phase II trial to assess the palliative value of cediranib, an oral vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI). After a baseline paracentesis or thoracentesis (on day 0), patients with symptomatic malignant ascites and/or pleural effusion were randomized between immediate treatment with cediranib (Immediate Cediranib) or delayed treatment with cediranib (Delayed Cediranib) on day 29, or after a new puncture was needed. The primary objective of the study was the puncture-free survival, defined as the time from study start (day 1) to the first need for paracentesis or thoracentesis, or time to death, whichever event occurred first. Twelve patients were enrolled. The median puncture-free survival was 45 days (range 10–368) in the Immediate Cediranib patients and 7 days (range 4–13) in the Delayed Cediranib patients (
P
= 0.011). The change in puncture-free interval (the puncture-free survival after study start minus the puncture-free interval before study start) increased with a median of 31 days in the Immediate Cediranib patients and shortened with a median of 3 days in the Delayed Cediranib patients (
P
= 0.015). The most common adverse events were fatigue and anorexia. In conclusion, cediranib increased the puncture-free survival and puncture-free interval with an acceptable toxicity profile. This is the first study in which an oral VEGFR TKI showed beneficial palliative effects in patients with malignant effusions.</description><subject>Abdomen</subject><subject>Administration, Oral</subject><subject>Aged</subject><subject>Antineoplastic Agents - administration & dosage</subject><subject>Ascites - drug therapy</subject><subject>Biological and medical sciences</subject><subject>Biomedicine</subject><subject>Disease Progression</subject><subject>Drug Administration Schedule</subject><subject>Female</subject><subject>Gastroenterology. Liver. Pancreas. Abdomen</subject><subject>Humans</subject><subject>Male</subject><subject>Medical sciences</subject><subject>Medicine</subject><subject>Medicine & Public Health</subject><subject>Middle Aged</subject><subject>Oncology</subject><subject>Original Research</subject><subject>Other diseases. Semiology</subject><subject>Palliative Care - methods</subject><subject>Paracentesis</subject><subject>Pleural Effusion - drug therapy</subject><subject>Pneumology</subject><subject>Protein Kinase Inhibitors - administration & dosage</subject><subject>Quality of Life</subject><subject>Quinazolines - administration & dosage</subject><subject>Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors</subject><subject>Time Factors</subject><subject>Treatment Outcome</subject><subject>Tumors of the respiratory system and mediastinum</subject><subject>Vascular Endothelial Growth Factor Receptor-1 - antagonists & inhibitors</subject><issn>1776-2596</issn><issn>1776-260X</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2014</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><sourceid>BENPR</sourceid><recordid>eNp1kVtrFTEQx4NYbD36AXyRgBR82ZrbJruPpbR6oOCLgm9LTnbSpmQvZrLa8-3Nck5VBF-SycxvLpk_IW84u-CMmQ_IeS1kxbiqmGS6Ys_IGTdGV0Kzb8-f7LrVp-Ql4gNjyoiavSCnQimlmdBn5PGSzvcWgW63FPPS7-nkqYM-JDuGHbVIZxtjsDn8AJoT2DzAmGkYiz-HYiL9GfI9xf0w52koPkcHG8PdaAtm0YUMSKdE5whLspGC9wuGaXxFTryNCK-P94Z8vbn-cvWpuv38cXt1eVu5MmyuWt5L09haS7YD47kA1cvWgGqUAKecc9LxpmUeQDpjnZIgSgR658tLK7kh7w915zR9XwBzNwR0EKMdYVqw41q2qtWNagv67h_0YVrSWKZbqUYZ3rK6UPxAuTQhJvDdnMJg077jrFtl6Q6ydEWWbpWlHBvy9lh52Q3Q_8540qEA50egrMxGX7bvAv7h1sZNs_5GHDgsofEO0l8j_rf7L9Nspl0</recordid><startdate>20141201</startdate><enddate>20141201</enddate><creator>Mulder, S. F.</creator><creator>Boers-Sonderen, M. J.</creator><creator>van der Heijden, H. F. M.</creator><creator>Vissers, K. C. P.</creator><creator>Punt, C. J. A.</creator><creator>van Herpen, C. M. L.</creator><general>Springer International Publishing</general><general>Springer</general><general>Springer Nature B.V</general><scope>IQODW</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>7X7</scope><scope>7XB</scope><scope>88E</scope><scope>8AO</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>CCPQU</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9-</scope><scope>K9.</scope><scope>KB0</scope><scope>M0R</scope><scope>M0S</scope><scope>M1P</scope><scope>NAPCQ</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>PRINS</scope><scope>7X8</scope></search><sort><creationdate>20141201</creationdate><title>A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion</title><author>Mulder, S. F. ; Boers-Sonderen, M. J. ; van der Heijden, H. F. M. ; Vissers, K. C. P. ; Punt, C. J. A. ; van Herpen, C. M. L.</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c472t-91d378a5630be7f12e4d397e4842ec4ccc3c1890fee3c7ac43e242eedcf7ac643</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2014</creationdate><topic>Abdomen</topic><topic>Administration, Oral</topic><topic>Aged</topic><topic>Antineoplastic Agents - administration & dosage</topic><topic>Ascites - drug therapy</topic><topic>Biological and medical sciences</topic><topic>Biomedicine</topic><topic>Disease Progression</topic><topic>Drug Administration Schedule</topic><topic>Female</topic><topic>Gastroenterology. Liver. Pancreas. Abdomen</topic><topic>Humans</topic><topic>Male</topic><topic>Medical sciences</topic><topic>Medicine</topic><topic>Medicine & Public Health</topic><topic>Middle Aged</topic><topic>Oncology</topic><topic>Original Research</topic><topic>Other diseases. Semiology</topic><topic>Palliative Care - methods</topic><topic>Paracentesis</topic><topic>Pleural Effusion - drug therapy</topic><topic>Pneumology</topic><topic>Protein Kinase Inhibitors - administration & dosage</topic><topic>Quality of Life</topic><topic>Quinazolines - administration & dosage</topic><topic>Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors</topic><topic>Time Factors</topic><topic>Treatment Outcome</topic><topic>Tumors of the respiratory system and mediastinum</topic><topic>Vascular Endothelial Growth Factor Receptor-1 - antagonists & inhibitors</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Mulder, S. 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F.</au><au>Boers-Sonderen, M. J.</au><au>van der Heijden, H. F. M.</au><au>Vissers, K. C. P.</au><au>Punt, C. J. A.</au><au>van Herpen, C. M. L.</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion</atitle><jtitle>Targeted oncology</jtitle><stitle>Targ Oncol</stitle><addtitle>Target Oncol</addtitle><date>2014-12-01</date><risdate>2014</risdate><volume>9</volume><issue>4</issue><spage>331</spage><epage>338</epage><pages>331-338</pages><issn>1776-2596</issn><eissn>1776-260X</eissn><abstract>Malignant ascites and pleural effusion are challenging clinical problems, with a major impact on quality of life. We conducted a randomized phase II trial to assess the palliative value of cediranib, an oral vascular endothelial growth factor tyrosine kinase inhibitor (VEGF TKI). After a baseline paracentesis or thoracentesis (on day 0), patients with symptomatic malignant ascites and/or pleural effusion were randomized between immediate treatment with cediranib (Immediate Cediranib) or delayed treatment with cediranib (Delayed Cediranib) on day 29, or after a new puncture was needed. The primary objective of the study was the puncture-free survival, defined as the time from study start (day 1) to the first need for paracentesis or thoracentesis, or time to death, whichever event occurred first. Twelve patients were enrolled. The median puncture-free survival was 45 days (range 10–368) in the Immediate Cediranib patients and 7 days (range 4–13) in the Delayed Cediranib patients (
P
= 0.011). The change in puncture-free interval (the puncture-free survival after study start minus the puncture-free interval before study start) increased with a median of 31 days in the Immediate Cediranib patients and shortened with a median of 3 days in the Delayed Cediranib patients (
P
= 0.015). The most common adverse events were fatigue and anorexia. In conclusion, cediranib increased the puncture-free survival and puncture-free interval with an acceptable toxicity profile. This is the first study in which an oral VEGFR TKI showed beneficial palliative effects in patients with malignant effusions.</abstract><cop>Cham</cop><pub>Springer International Publishing</pub><pmid>24446026</pmid><doi>10.1007/s11523-014-0306-0</doi><tpages>8</tpages></addata></record> |
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| subjects | Abdomen Administration, Oral Aged Antineoplastic Agents - administration & dosage Ascites - drug therapy Biological and medical sciences Biomedicine Disease Progression Drug Administration Schedule Female Gastroenterology. Liver. Pancreas. Abdomen Humans Male Medical sciences Medicine Medicine & Public Health Middle Aged Oncology Original Research Other diseases. Semiology Palliative Care - methods Paracentesis Pleural Effusion - drug therapy Pneumology Protein Kinase Inhibitors - administration & dosage Quality of Life Quinazolines - administration & dosage Receptors, Vascular Endothelial Growth Factor - antagonists & inhibitors Time Factors Treatment Outcome Tumors of the respiratory system and mediastinum Vascular Endothelial Growth Factor Receptor-1 - antagonists & inhibitors |
| title | A phase II study of cediranib as palliative treatment in patients with symptomatic malignant ascites or pleural effusion |
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