Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial
Identifieur interne : 001584 ( PascalFrancis/Corpus ); précédent : 001583; suivant : 001585Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial
Auteurs : Samuel A. Jr Wells ; Bruce G. Robinson ; Robert F. Gagel ; Henning Dralle ; James A. Fagin ; Massimo Santoro ; Eric Baudin ; Rossella Elisei ; Barbara Jarzab ; James R. Vasselli ; Jessica Read ; Peter Langmuir ; Anderson J. Ryan ; Martin J. SchlumbergerSource :
- Journal of clinical oncology [ 0732-183X ] ; 2012.
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English descriptors
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Abstract
Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients and Methods Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Results Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Conclusion Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC.
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| NO : | PASCAL 12-0103079 INIST |
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| ET : | Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial |
| AU : | WELLS (Samuel A. JR); ROBINSON (Bruce G.); GAGEL (Robert F.); DRALLE (Henning); FAGIN (James A.); SANTORO (Massimo); BAUDIN (Eric); ELISEI (Rossella); JARZAB (Barbara); VASSELLI (James R.); READ (Jessica); LANGMUIR (Peter); RYAN (Anderson J.); SCHLUMBERGER (Martin J.) |
| AF : | National Cancer Institute, National Institutes of Health/Bethesda, MD/Etats-Unis (1 aut.); Robinson, Kolling Institute of Medical Research, University of Sydney/Sydney/Australie (2 aut.); University of Texas MD Anderson Cancer Center/Houston, TX/Etats-Unis (3 aut.); Martin Luther University Halle-Wittenberg/Halle/Allemagne (4 aut.); Memorial Sloan-Kettering Cancer Center/New York, NY/Etats-Unis (5 aut.); Universita' di Napoli Federico II/Naples/Italie (6 aut.); Institut Gustave Roussy/Villejuif/France (7 aut., 14 aut.); University of Pisa/Pisa/Italie (8 aut.); Maria Sklodowska-Curie Memorial Cancer Center/Gliwice/Pologne (9 aut.); AstraZeneca/Wilmington, DE/Royaume-Uni (10 aut., 12 aut.); AstraZeneca/Macclesfield/Royaume-Uni (11 aut.); University of Oxford/Oxford/Royaume-Uni (13 aut.) |
| DT : | Publication en série; Niveau analytique |
| SO : | Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 2; Pp. 134-141; Bibl. 29 ref. |
| LA : | Anglais |
| EA : | Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients and Methods Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Results Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Conclusion Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC. |
| CC : | 002B04; 002B21C02 |
| FD : | Vandétanib; Homme; Stade avancé; Métastase; Essai clinique; Randomisation; Cancer de la thyroïde; Cancérologie; Essai clinique phase III; Chimiothérapie; Anticancéreux; Antiangiogénique; Stade localement avancé |
| FG : | Traitement; Inhibiteur enzyme; Protein-tyrosine kinase; Transferases; Enzyme; Inhibiteur de la tyrosine kinase; Inhibiteur multikinase; Tumeur maligne; Cancer; Endocrinopathie; Pathologie de la thyroïde |
| ED : | Vandetanib; Human; Advanced stage; Metastasis; Clinical trial; Randomization; Thyroid cancer; Cancerology; Phase III trial; Chemotherapy; Antineoplastic agent; Antiangiogenic agent; Locally advanced stage |
| EG : | Treatment; Enzyme inhibitor; Protein-tyrosine kinase; Transferases; Enzyme; Tyrosine kinase inhibitor; Multikinase inhibitor; Malignant tumor; Cancer; Endocrinopathy; Thyroid diseases |
| SD : | Vandetanib; Hombre; Estadio avanzado; Metástasis; Ensayo clínico; Aleatorización; Cáncer de la tiroides; Cancerología; Ensayo clínico fase III; Quimioterapia; Anticanceroso; Antiangiogenico; Estadio localmente avanzado |
| LO : | INIST-20094.354000508873560070 |
| ID : | 12-0103079 |
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Pascal:12-0103079Le document en format XML
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Ryan</name><affiliation><inist:fA14 i1="12"><s1>University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Schlumberger, Martin J" sort="Schlumberger, Martin J" uniqKey="Schlumberger M" first="Martin J." last="Schlumberger">Martin J. Schlumberger</name><affiliation><inist:fA14 i1="07"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>14 aut.</sZ></inist:fA14></affiliation></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">12-0103079</idno><date when="2012">2012</date><idno type="stanalyst">PASCAL 12-0103079 INIST</idno><idno type="RBID">Pascal:12-0103079</idno><idno type="wicri:Area/PascalFrancis/Corpus">001584</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial</title><author><name sortKey="Wells, Samuel A Jr" sort="Wells, Samuel A Jr" uniqKey="Wells S" first="Samuel A. Jr" last="Wells">Samuel A. Jr Wells</name><affiliation><inist:fA14 i1="01"><s1>National Cancer Institute, National Institutes of Health</s1><s2>Bethesda, MD</s2><s3>USA</s3><sZ>1 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Robinson, Bruce G" sort="Robinson, Bruce G" uniqKey="Robinson B" first="Bruce G." last="Robinson">Bruce G. Robinson</name><affiliation><inist:fA14 i1="02"><s1>Robinson, Kolling Institute of Medical Research, University of Sydney</s1><s2>Sydney</s2><s3>AUS</s3><sZ>2 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Gagel, Robert F" sort="Gagel, Robert F" uniqKey="Gagel R" first="Robert F." last="Gagel">Robert F. Gagel</name><affiliation><inist:fA14 i1="03"><s1>University of Texas MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>3 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Dralle, Henning" sort="Dralle, Henning" uniqKey="Dralle H" first="Henning" last="Dralle">Henning Dralle</name><affiliation><inist:fA14 i1="04"><s1>Martin Luther University Halle-Wittenberg</s1><s2>Halle</s2><s3>DEU</s3><sZ>4 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Fagin, James A" sort="Fagin, James A" uniqKey="Fagin J" first="James A." last="Fagin">James A. Fagin</name><affiliation><inist:fA14 i1="05"><s1>Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>5 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Santoro, Massimo" sort="Santoro, Massimo" uniqKey="Santoro M" first="Massimo" last="Santoro">Massimo Santoro</name><affiliation><inist:fA14 i1="06"><s1>Universita' di Napoli Federico II</s1><s2>Naples</s2><s3>ITA</s3><sZ>6 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Baudin, Eric" sort="Baudin, Eric" uniqKey="Baudin E" first="Eric" last="Baudin">Eric Baudin</name><affiliation><inist:fA14 i1="07"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>14 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Elisei, Rossella" sort="Elisei, Rossella" uniqKey="Elisei R" first="Rossella" last="Elisei">Rossella Elisei</name><affiliation><inist:fA14 i1="08"><s1>University of Pisa</s1><s2>Pisa</s2><s3>ITA</s3><sZ>8 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Jarzab, Barbara" sort="Jarzab, Barbara" uniqKey="Jarzab B" first="Barbara" last="Jarzab">Barbara Jarzab</name><affiliation><inist:fA14 i1="09"><s1>Maria Sklodowska-Curie Memorial Cancer Center</s1><s2>Gliwice</s2><s3>POL</s3><sZ>9 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Vasselli, James R" sort="Vasselli, James R" uniqKey="Vasselli J" first="James R." last="Vasselli">James R. Vasselli</name><affiliation><inist:fA14 i1="10"><s1>AstraZeneca</s1><s2>Wilmington, DE</s2><s3>GBR</s3><sZ>10 aut.</sZ><sZ>12 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Read, Jessica" sort="Read, Jessica" uniqKey="Read J" first="Jessica" last="Read">Jessica Read</name><affiliation><inist:fA14 i1="11"><s1>AstraZeneca</s1><s2>Macclesfield</s2><s3>GBR</s3><sZ>11 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Langmuir, Peter" sort="Langmuir, Peter" uniqKey="Langmuir P" first="Peter" last="Langmuir">Peter Langmuir</name><affiliation><inist:fA14 i1="10"><s1>AstraZeneca</s1><s2>Wilmington, DE</s2><s3>GBR</s3><sZ>10 aut.</sZ><sZ>12 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Ryan, Anderson J" sort="Ryan, Anderson J" uniqKey="Ryan A" first="Anderson J." last="Ryan">Anderson J. Ryan</name><affiliation><inist:fA14 i1="12"><s1>University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>13 aut.</sZ></inist:fA14></affiliation></author><author><name sortKey="Schlumberger, Martin J" sort="Schlumberger, Martin J" uniqKey="Schlumberger M" first="Martin J." last="Schlumberger">Martin J. Schlumberger</name><affiliation><inist:fA14 i1="07"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>14 aut.</sZ></inist:fA14></affiliation></author></analytic><series><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno><imprint><date when="2012">2012</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Journal of clinical oncology</title><title level="j" type="abbreviated">J. clin. oncol.</title><idno type="ISSN">0732-183X</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Advanced stage</term><term>Antiangiogenic agent</term><term>Antineoplastic agent</term><term>Cancerology</term><term>Chemotherapy</term><term>Clinical trial</term><term>Human</term><term>Locally advanced stage</term><term>Metastasis</term><term>Phase III trial</term><term>Randomization</term><term>Thyroid cancer</term><term>Vandetanib</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Vandétanib</term><term>Homme</term><term>Stade avancé</term><term>Métastase</term><term>Essai clinique</term><term>Randomisation</term><term>Cancer de la thyroïde</term><term>Cancérologie</term><term>Essai clinique phase III</term><term>Chimiothérapie</term><term>Anticancéreux</term><term>Antiangiogénique</term><term>Stade localement avancé</term></keywords></textClass></profileDesc></teiHeader><front><div type="abstract" xml:lang="en">Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients and Methods Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Results Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Conclusion Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC.</div></front></TEI><inist><standard h6="B"><pA><fA01 i1="01" i2="1"><s0>0732-183X</s0></fA01><fA03 i2="1"><s0>J. clin. oncol.</s0></fA03><fA05><s2>30</s2></fA05><fA06><s2>2</s2></fA06><fA08 i1="01" i2="1" l="ENG"><s1>Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial</s1></fA08><fA11 i1="01" i2="1"><s1>WELLS (Samuel A. JR)</s1></fA11><fA11 i1="02" i2="1"><s1>ROBINSON (Bruce G.)</s1></fA11><fA11 i1="03" i2="1"><s1>GAGEL (Robert F.)</s1></fA11><fA11 i1="04" i2="1"><s1>DRALLE (Henning)</s1></fA11><fA11 i1="05" i2="1"><s1>FAGIN (James A.)</s1></fA11><fA11 i1="06" i2="1"><s1>SANTORO (Massimo)</s1></fA11><fA11 i1="07" i2="1"><s1>BAUDIN (Eric)</s1></fA11><fA11 i1="08" i2="1"><s1>ELISEI (Rossella)</s1></fA11><fA11 i1="09" i2="1"><s1>JARZAB (Barbara)</s1></fA11><fA11 i1="10" i2="1"><s1>VASSELLI (James R.)</s1></fA11><fA11 i1="11" i2="1"><s1>READ (Jessica)</s1></fA11><fA11 i1="12" i2="1"><s1>LANGMUIR (Peter)</s1></fA11><fA11 i1="13" i2="1"><s1>RYAN (Anderson J.)</s1></fA11><fA11 i1="14" i2="1"><s1>SCHLUMBERGER (Martin J.)</s1></fA11><fA14 i1="01"><s1>National Cancer Institute, National Institutes of Health</s1><s2>Bethesda, MD</s2><s3>USA</s3><sZ>1 aut.</sZ></fA14><fA14 i1="02"><s1>Robinson, Kolling Institute of Medical Research, University of Sydney</s1><s2>Sydney</s2><s3>AUS</s3><sZ>2 aut.</sZ></fA14><fA14 i1="03"><s1>University of Texas MD Anderson Cancer Center</s1><s2>Houston, TX</s2><s3>USA</s3><sZ>3 aut.</sZ></fA14><fA14 i1="04"><s1>Martin Luther University Halle-Wittenberg</s1><s2>Halle</s2><s3>DEU</s3><sZ>4 aut.</sZ></fA14><fA14 i1="05"><s1>Memorial Sloan-Kettering Cancer Center</s1><s2>New York, NY</s2><s3>USA</s3><sZ>5 aut.</sZ></fA14><fA14 i1="06"><s1>Universita' di Napoli Federico II</s1><s2>Naples</s2><s3>ITA</s3><sZ>6 aut.</sZ></fA14><fA14 i1="07"><s1>Institut Gustave Roussy</s1><s2>Villejuif</s2><s3>FRA</s3><sZ>7 aut.</sZ><sZ>14 aut.</sZ></fA14><fA14 i1="08"><s1>University of Pisa</s1><s2>Pisa</s2><s3>ITA</s3><sZ>8 aut.</sZ></fA14><fA14 i1="09"><s1>Maria Sklodowska-Curie Memorial Cancer Center</s1><s2>Gliwice</s2><s3>POL</s3><sZ>9 aut.</sZ></fA14><fA14 i1="10"><s1>AstraZeneca</s1><s2>Wilmington, DE</s2><s3>GBR</s3><sZ>10 aut.</sZ><sZ>12 aut.</sZ></fA14><fA14 i1="11"><s1>AstraZeneca</s1><s2>Macclesfield</s2><s3>GBR</s3><sZ>11 aut.</sZ></fA14><fA14 i1="12"><s1>University of Oxford</s1><s2>Oxford</s2><s3>GBR</s3><sZ>13 aut.</sZ></fA14><fA20><s1>134-141</s1></fA20><fA21><s1>2012</s1></fA21><fA23 i1="01"><s0>ENG</s0></fA23><fA43 i1="01"><s1>INIST</s1><s2>20094</s2><s5>354000508873560070</s5></fA43><fA44><s0>0000</s0><s1>© 2012 INIST-CNRS. All rights reserved.</s1></fA44><fA45><s0>29 ref.</s0></fA45><fA47 i1="01" i2="1"><s0>12-0103079</s0></fA47><fA60><s1>P</s1></fA60><fA61><s0>A</s0></fA61><fA64 i1="01" i2="1"><s0>Journal of clinical oncology</s0></fA64><fA66 i1="01"><s0>USA</s0></fA66><fC01 i1="01" l="ENG"><s0>Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients and Methods Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Results Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Conclusion Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC.</s0></fC01><fC02 i1="01" i2="X"><s0>002B04</s0></fC02><fC02 i1="02" i2="X"><s0>002B21C02</s0></fC02><fC03 i1="01" i2="X" l="FRE"><s0>Vandétanib</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="ENG"><s0>Vandetanib</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="01" i2="X" l="SPA"><s0>Vandetanib</s0><s2>FR</s2><s5>01</s5></fC03><fC03 i1="02" i2="X" l="FRE"><s0>Homme</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="ENG"><s0>Human</s0><s5>02</s5></fC03><fC03 i1="02" i2="X" l="SPA"><s0>Hombre</s0><s5>02</s5></fC03><fC03 i1="03" i2="X" l="FRE"><s0>Stade avancé</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="ENG"><s0>Advanced stage</s0><s5>03</s5></fC03><fC03 i1="03" i2="X" l="SPA"><s0>Estadio avanzado</s0><s5>03</s5></fC03><fC03 i1="04" i2="X" l="FRE"><s0>Métastase</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="ENG"><s0>Metastasis</s0><s5>04</s5></fC03><fC03 i1="04" i2="X" l="SPA"><s0>Metástasis</s0><s5>04</s5></fC03><fC03 i1="05" i2="X" l="FRE"><s0>Essai clinique</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="ENG"><s0>Clinical trial</s0><s5>05</s5></fC03><fC03 i1="05" i2="X" l="SPA"><s0>Ensayo clínico</s0><s5>05</s5></fC03><fC03 i1="06" i2="X" l="FRE"><s0>Randomisation</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="ENG"><s0>Randomization</s0><s5>06</s5></fC03><fC03 i1="06" i2="X" l="SPA"><s0>Aleatorización</s0><s5>06</s5></fC03><fC03 i1="07" i2="X" l="FRE"><s0>Cancer de la thyroïde</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="ENG"><s0>Thyroid cancer</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="07" i2="X" l="SPA"><s0>Cáncer de la tiroides</s0><s2>NM</s2><s5>07</s5></fC03><fC03 i1="08" i2="X" l="FRE"><s0>Cancérologie</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="ENG"><s0>Cancerology</s0><s5>08</s5></fC03><fC03 i1="08" i2="X" l="SPA"><s0>Cancerología</s0><s5>08</s5></fC03><fC03 i1="09" i2="X" l="FRE"><s0>Essai clinique phase III</s0><s5>10</s5></fC03><fC03 i1="09" i2="X" l="ENG"><s0>Phase III trial</s0><s5>10</s5></fC03><fC03 i1="09" i2="X" l="SPA"><s0>Ensayo clínico fase III</s0><s5>10</s5></fC03><fC03 i1="10" i2="X" l="FRE"><s0>Chimiothérapie</s0><s5>13</s5></fC03><fC03 i1="10" i2="X" l="ENG"><s0>Chemotherapy</s0><s5>13</s5></fC03><fC03 i1="10" i2="X" l="SPA"><s0>Quimioterapia</s0><s5>13</s5></fC03><fC03 i1="11" i2="X" l="FRE"><s0>Anticancéreux</s0><s5>25</s5></fC03><fC03 i1="11" i2="X" l="ENG"><s0>Antineoplastic agent</s0><s5>25</s5></fC03><fC03 i1="11" i2="X" l="SPA"><s0>Anticanceroso</s0><s5>25</s5></fC03><fC03 i1="12" i2="X" l="FRE"><s0>Antiangiogénique</s0><s2>FR</s2><s5>26</s5></fC03><fC03 i1="12" i2="X" l="ENG"><s0>Antiangiogenic agent</s0><s2>FR</s2><s5>26</s5></fC03><fC03 i1="12" i2="X" l="SPA"><s0>Antiangiogenico</s0><s2>FR</s2><s5>26</s5></fC03><fC03 i1="13" i2="X" l="FRE"><s0>Stade localement avancé</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="13" i2="X" l="ENG"><s0>Locally advanced stage</s0><s4>CD</s4><s5>96</s5></fC03><fC03 i1="13" i2="X" l="SPA"><s0>Estadio localmente avanzado</s0><s4>CD</s4><s5>96</s5></fC03><fC07 i1="01" i2="X" l="FRE"><s0>Traitement</s0></fC07><fC07 i1="01" i2="X" l="ENG"><s0>Treatment</s0></fC07><fC07 i1="01" i2="X" l="SPA"><s0>Tratamiento</s0></fC07><fC07 i1="02" i2="X" l="FRE"><s0>Inhibiteur enzyme</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="ENG"><s0>Enzyme inhibitor</s0><s5>37</s5></fC07><fC07 i1="02" i2="X" l="SPA"><s0>Inhibidor enzima</s0><s5>37</s5></fC07><fC07 i1="03" i2="X" l="FRE"><s0>Protein-tyrosine kinase</s0><s2>FE</s2><s5>38</s5></fC07><fC07 i1="03" i2="X" l="ENG"><s0>Protein-tyrosine kinase</s0><s2>FE</s2><s5>38</s5></fC07><fC07 i1="03" i2="X" l="SPA"><s0>Protein-tyrosine kinase</s0><s2>FE</s2><s5>38</s5></fC07><fC07 i1="04" i2="X" l="FRE"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="04" i2="X" l="ENG"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="04" i2="X" l="SPA"><s0>Transferases</s0><s2>FE</s2></fC07><fC07 i1="05" i2="X" l="FRE"><s0>Enzyme</s0><s2>FE</s2></fC07><fC07 i1="05" i2="X" l="ENG"><s0>Enzyme</s0><s2>FE</s2></fC07><fC07 i1="05" i2="X" l="SPA"><s0>Enzima</s0><s2>FE</s2></fC07><fC07 i1="06" i2="X" l="FRE"><s0>Inhibiteur de la tyrosine kinase</s0><s5>39</s5></fC07><fC07 i1="06" i2="X" l="ENG"><s0>Tyrosine kinase inhibitor</s0><s5>39</s5></fC07><fC07 i1="06" i2="X" l="SPA"><s0>Inhibidor tyrosine kinase</s0><s5>39</s5></fC07><fC07 i1="07" i2="X" l="FRE"><s0>Inhibiteur multikinase</s0><s5>40</s5></fC07><fC07 i1="07" i2="X" l="ENG"><s0>Multikinase inhibitor</s0><s5>40</s5></fC07><fC07 i1="07" i2="X" l="SPA"><s0>inhibidor multicinasa</s0><s5>40</s5></fC07><fC07 i1="08" i2="X" l="FRE"><s0>Tumeur maligne</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="08" i2="X" l="ENG"><s0>Malignant tumor</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="08" i2="X" l="SPA"><s0>Tumor maligno</s0><s2>NM</s2><s5>41</s5></fC07><fC07 i1="09" i2="X" l="FRE"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="09" i2="X" l="ENG"><s0>Cancer</s0><s2>NM</s2></fC07><fC07 i1="09" i2="X" l="SPA"><s0>Cáncer</s0><s2>NM</s2></fC07><fC07 i1="10" i2="X" l="FRE"><s0>Endocrinopathie</s0><s5>42</s5></fC07><fC07 i1="10" i2="X" l="ENG"><s0>Endocrinopathy</s0><s5>42</s5></fC07><fC07 i1="10" i2="X" l="SPA"><s0>Endocrinopatía</s0><s5>42</s5></fC07><fC07 i1="11" i2="X" l="FRE"><s0>Pathologie de la thyroïde</s0><s5>43</s5></fC07><fC07 i1="11" i2="X" l="ENG"><s0>Thyroid diseases</s0><s5>43</s5></fC07><fC07 i1="11" i2="X" l="SPA"><s0>Tiroides patología</s0><s5>43</s5></fC07><fN21><s1>079</s1></fN21><fN44 i1="01"><s1>OTO</s1></fN44><fN82><s1>OTO</s1></fN82></pA></standard><server><NO>PASCAL 12-0103079 INIST</NO><ET>Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial</ET><AU>WELLS (Samuel A. JR); ROBINSON (Bruce G.); GAGEL (Robert F.); DRALLE (Henning); FAGIN (James A.); SANTORO (Massimo); BAUDIN (Eric); ELISEI (Rossella); JARZAB (Barbara); VASSELLI (James R.); READ (Jessica); LANGMUIR (Peter); RYAN (Anderson J.); SCHLUMBERGER (Martin J.)</AU><AF>National Cancer Institute, National Institutes of Health/Bethesda, MD/Etats-Unis (1 aut.); Robinson, Kolling Institute of Medical Research, University of Sydney/Sydney/Australie (2 aut.); University of Texas MD Anderson Cancer Center/Houston, TX/Etats-Unis (3 aut.); Martin Luther University Halle-Wittenberg/Halle/Allemagne (4 aut.); Memorial Sloan-Kettering Cancer Center/New York, NY/Etats-Unis (5 aut.); Universita' di Napoli Federico II/Naples/Italie (6 aut.); Institut Gustave Roussy/Villejuif/France (7 aut., 14 aut.); University of Pisa/Pisa/Italie (8 aut.); Maria Sklodowska-Curie Memorial Cancer Center/Gliwice/Pologne (9 aut.); AstraZeneca/Wilmington, DE/Royaume-Uni (10 aut., 12 aut.); AstraZeneca/Macclesfield/Royaume-Uni (11 aut.); University of Oxford/Oxford/Royaume-Uni (13 aut.)</AF><DT>Publication en série; Niveau analytique</DT><SO>Journal of clinical oncology; ISSN 0732-183X; Etats-Unis; Da. 2012; Vol. 30; No. 2; Pp. 134-141; Bibl. 29 ref.</SO><LA>Anglais</LA><EA>Purpose There is no effective therapy for patients with advanced medullary thyroid carcinoma (MTC). Vandetanib, a once-daily oral inhibitor of RET kinase, vascular endothelial growth factor receptor, and epidermal growth factor receptor signaling, has previously shown antitumor activity in a phase II study of patients with advanced hereditary MTC. Patients and Methods Patients with advanced MTC were randomly assigned in a 2:1 ratio to receive vandetanib 300 mg/d or placebo. On objective disease progression, patients could elect to receive open-label vandetanib. The primary end point was progression-free survival (PFS), determined by independent central Response Evaluation Criteria in Solid Tumors (RECIST) assessments. Results Between December 2006 and November 2007, 331 patients (mean age, 52 years; 90% sporadic; 95% metastatic) were randomly assigned to receive vandetanib (231) or placebo (100). At data cutoff (July 2009; median follow-up, 24 months), 37% of patients had progressed and 15% had died. The study met its primary objective of PFS prolongation with vandetanib versus placebo (hazard ratio [HR], 0.46; 95% CI, 0.31 to 0.69; P < .001). Statistically significant advantages for vandetanib were also seen for objective response rate (P < .001), disease control rate (P = .001), and biochemical response (P < .001). Overall survival data were immature at data cutoff (HR, 0.89; 95% CI, 0.48 to 1.65). A final survival analysis will take place when 50% of the patients have died. Common adverse events (any grade) occurred more frequently with vandetanib compared with placebo, including diarrhea (56% v 26%), rash (45% v 11%), nausea (33% v 16%), hypertension (32% v 5%), and headache (26% v 9%). Conclusion Vandetanib demonstrated therapeutic efficacy in a phase III trial of patients with advanced MTC.</EA><CC>002B04; 002B21C02</CC><FD>Vandétanib; Homme; Stade avancé; Métastase; Essai clinique; Randomisation; Cancer de la thyroïde; Cancérologie; Essai clinique phase III; Chimiothérapie; Anticancéreux; Antiangiogénique; Stade localement avancé</FD><FG>Traitement; Inhibiteur enzyme; Protein-tyrosine kinase; Transferases; Enzyme; Inhibiteur de la tyrosine kinase; Inhibiteur multikinase; Tumeur maligne; Cancer; Endocrinopathie; Pathologie de la thyroïde</FG><ED>Vandetanib; Human; Advanced stage; Metastasis; Clinical trial; Randomization; Thyroid cancer; Cancerology; Phase III trial; Chemotherapy; Antineoplastic agent; Antiangiogenic agent; Locally advanced stage</ED><EG>Treatment; Enzyme inhibitor; Protein-tyrosine kinase; Transferases; Enzyme; Tyrosine kinase inhibitor; Multikinase inhibitor; Malignant tumor; Cancer; Endocrinopathy; Thyroid diseases</EG><SD>Vandetanib; Hombre; Estadio avanzado; Metástasis; Ensayo clínico; Aleatorización; Cáncer de la tiroides; Cancerología; Ensayo clínico fase III; Quimioterapia; Anticanceroso; Antiangiogenico; Estadio localmente avanzado</SD><LO>INIST-20094.354000508873560070</LO><ID>12-0103079</ID></server></inist></record>Pour manipuler ce document sous Unix (Dilib)
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