AustralieFrV1, Main, Exploration, bibRecord, 005780

Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial

Identifieur interne : 005780 ( Main/Exploration ); précédent : 005779; suivant : 005781

Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial

Auteurs : Samuel A. Jr Wells [États-Unis] ; Bruce G. Robinson [Australie] ; Robert F. Gagel [États-Unis] ; Henning Dralle [Allemagne] ; James A. Fagin [États-Unis] ; Massimo Santoro [Italie] ; Eric Baudin [France] ; Rossella Elisei [Italie] ; Barbara Jarzab [Pologne] ; James R. Vasselli [Royaume-Uni] ; Jessica Read [Royaume-Uni] ; Peter Langmuir [Royaume-Uni] ; Anderson J. Ryan [Royaume-Uni] ; Martin J. Schlumberger [France]

Source :

Journal of clinical oncology [ 0732-183X ] ; 2012.

RBID : Pascal:12-0103079

Descripteurs français

Pascal (Inist)
- Vandétanib, Homme, Stade avancé, Métastase, Essai clinique, Randomisation, Cancer de la thyroïde, Cancérologie, Essai clinique phase III, Chimiothérapie, Anticancéreux, Antiangiogénique, Stade localement avancé.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antiangiogenic agent, Antineoplastic agent, Cancerology, Chemotherapy, Clinical trial, Human, Locally advanced stage, Metastasis, Phase III trial, Randomization, Thyroid cancer, Vandetanib.

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.

Affiliations:

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Le document en format XML

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<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>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Italie</li>
<li>Pologne</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Angleterre</li>
<li>Nouvelle-Galles du Sud</li>
<li>Oxfordshire</li>
<li>Toscane</li>
</region>
<settlement><li>Oxford</li>
<li>Pise</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université d'Oxford</li>
<li>Université de Pise</li>
<li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="États-Unis"><noRegion><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>
</noRegion>
<name sortKey="Fagin, James A" sort="Fagin, James A" uniqKey="Fagin J" first="James A." last="Fagin">James A. Fagin</name>
<name sortKey="Gagel, Robert F" sort="Gagel, Robert F" uniqKey="Gagel R" first="Robert F." last="Gagel">Robert F. Gagel</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Robinson, Bruce G" sort="Robinson, Bruce G" uniqKey="Robinson B" first="Bruce G." last="Robinson">Bruce G. Robinson</name>
</region>
</country>
<country name="Allemagne"><noRegion><name sortKey="Dralle, Henning" sort="Dralle, Henning" uniqKey="Dralle H" first="Henning" last="Dralle">Henning Dralle</name>
</noRegion>
</country>
<country name="Italie"><noRegion><name sortKey="Santoro, Massimo" sort="Santoro, Massimo" uniqKey="Santoro M" first="Massimo" last="Santoro">Massimo Santoro</name>
</noRegion>
<name sortKey="Elisei, Rossella" sort="Elisei, Rossella" uniqKey="Elisei R" first="Rossella" last="Elisei">Rossella Elisei</name>
</country>
<country name="France"><noRegion><name sortKey="Baudin, Eric" sort="Baudin, Eric" uniqKey="Baudin E" first="Eric" last="Baudin">Eric Baudin</name>
</noRegion>
<name sortKey="Schlumberger, Martin J" sort="Schlumberger, Martin J" uniqKey="Schlumberger M" first="Martin J." last="Schlumberger">Martin J. Schlumberger</name>
</country>
<country name="Pologne"><noRegion><name sortKey="Jarzab, Barbara" sort="Jarzab, Barbara" uniqKey="Jarzab B" first="Barbara" last="Jarzab">Barbara Jarzab</name>
</noRegion>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Vasselli, James R" sort="Vasselli, James R" uniqKey="Vasselli J" first="James R." last="Vasselli">James R. Vasselli</name>
</noRegion>
<name sortKey="Langmuir, Peter" sort="Langmuir, Peter" uniqKey="Langmuir P" first="Peter" last="Langmuir">Peter Langmuir</name>
<name sortKey="Read, Jessica" sort="Read, Jessica" uniqKey="Read J" first="Jessica" last="Read">Jessica Read</name>
<name sortKey="Ryan, Anderson J" sort="Ryan, Anderson J" uniqKey="Ryan A" first="Anderson J." last="Ryan">Anderson J. Ryan</name>
</country>
</tree>
</affiliations>
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Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial

Vandetanib in Patients With Locally Advanced or Metastatic Medullary Thyroid Cancer: A Randomized, Double-Blind Phase III Trial

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