AustralieFrV1, Main, Exploration, bibRecord, 005D75

Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure

Identifieur interne : 005D75 ( Main/Exploration ); précédent : 005D74; suivant : 005D76

Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure

Auteurs : George D. Demetri [États-Unis] ; Christopher R. Garrett [États-Unis] ; Patrick Schöffski [Belgique] ; Manisha H. Shah [États-Unis] ; Jaap Verweij [Pays-Bas] ; Serge Leyvraz [Suisse] ; Herbert I. Hurwitz [États-Unis] ; Antonio Lopez Pousa [Espagne] ; Axel Le Cesne [France] ; David Goldstein [Australie] ; Luis Paz-Ares [Espagne] ; Jean-Yves Blay [France] ; Grant A. Mcarthur [Australie] ; QIANG XU [États-Unis] ; XIN HUANG [États-Unis] ; Charles S. Harmon [États-Unis] ; Vanessa Tassell [États-Unis] ; Darrel P. Cohen [États-Unis] ; Paolo G. Casali [Italie]

Source :

Clinical cancer research [ 1078-0432 ] ; 2012.

RBID : Pascal:12-0249280

Descripteurs français

Pascal (Inist)
- Analyse, Randomisation, Placebo, Essai clinique phase III, Homme, Chimiothérapie, Sunitinib, Malade, Tumeur stromale gastro-intestinale, Imatinib, Anticancéreux, Antiangiogénique.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Analysis, Antiangiogenic agent, Antineoplastic agent, Chemotherapy, Gastrointestinal stromal tumor, Human, Imatinib, Patient, Phase III trial, Placebo, Randomization, Sunitinib.

Abstract

Purpose: To analyze final long-term survival and clinical outcomes from the randomized phase III study of sunitinib in gastrointestinal stromal tumor patients after imatinib failure; to assess correlative angiogenesis biomarkers with patient outcomes. Experimental Design: Blinded sunitinib or placebo was given daily on a 4-week-on/2-week-off treatment schedule. Placebo-assigned patients could cross over to sunitinib at disease progression/study unblinding. Overall survival (OS) was analyzed using conventional statistical methods and the rank-preserving structural failure time (RPSFT) method to explore cross-over impact. Circulating levels of angiogenesis biomarkers were analyzed. Results: In total, 243 patients were randomized to receive sunitinib and 118 to placebo, 103 of whom crossed over to open-label sunitinib. Conventional statistical analysis showed that OS converged in the sunitinib and placebo arms (median 72.7 vs. 64.9 weeks; HR, 0.876; P= 0.306) as expected, given the cross-over design. RPSFT analysis estimated median OS for placebo of 39.0 weeks (HR, 0.505, 95% CI, 0.262-1.134 ; P = 0.306). No new safety concerns emerged with extended sunitinib treatment. No consistent associations were found between the pharmacodynamics of angiogenesis-related plasma proteins during sunitinib treatment and clinical outcome. Conclusions: The cross-over design provided evidence of sunitinib clinical benefit based on prolonged time to tumor progression during the double-blind phase of this trial. As expected, following cross-over, there was no statistical difference in OS. RPSFT analysis modeled the absence of cross-over, estimating a substantial sunitinib OS benefit relative to placebo. Long-term sunitinib treatment was tolerated without new adverse events.

Url:

http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4030710

Affiliations:

Australie, Belgique, Espagne, France, Italie, Pays-Bas, Suisse, États-Unis
Auvergne-Rhône-Alpes, Californie, Canton de Vaud, Caroline du Nord, Catalogne, Communauté de Madrid, Floride, Hollande-Méridionale, Lombardie, Massachusetts, Ohio, Rhône-Alpes, Victoria (État), État de New York
Barcelone, Lausanne, Lyon, Madrid, Melbourne, Milan, New York, Rotterdam
Université Columbia

Le document en format XML

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<author><name sortKey="Paz Ares, Luis" sort="Paz Ares, Luis" uniqKey="Paz Ares L" first="Luis" last="Paz-Ares">Luis Paz-Ares</name>
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</inist:fA14>
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</author>
<author><name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name>
<affiliation wicri:level="3"><inist:fA14 i1="12"><s1>University Claude Bernard Lyon I, Centre Leon Berard</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Auvergne-Rhône-Alpes</region>
<region type="old region">Rhône-Alpes</region>
<settlement type="city">Lyon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>Peter MacCallum Cancer Centre</s1>
<s2>Melbourne</s2>
<s3>AUS</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Melbourne</settlement>
<region type="état">Victoria (État)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Qiang Xu" sort="Qiang Xu" uniqKey="Qiang Xu" last="Qiang Xu">QIANG XU</name>
<affiliation wicri:level="4"><inist:fA14 i1="14"><s1>Columbia University</s1>
<s2>New York, New York</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">État de New York</region>
<settlement type="city">New York</settlement>
</placeName>
<orgName type="university">Université Columbia</orgName>
</affiliation>
</author>
<author><name sortKey="Xin Huang" sort="Xin Huang" uniqKey="Xin Huang" last="Xin Huang">XIN HUANG</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>Pfizer Oncology</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Harmon, Charles S" sort="Harmon, Charles S" uniqKey="Harmon C" first="Charles S." last="Harmon">Charles S. Harmon</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>Pfizer Oncology</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Tassell, Vanessa" sort="Tassell, Vanessa" uniqKey="Tassell V" first="Vanessa" last="Tassell">Vanessa Tassell</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>Pfizer Oncology</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Cohen, Darrel P" sort="Cohen, Darrel P" uniqKey="Cohen D" first="Darrel P." last="Cohen">Darrel P. Cohen</name>
<affiliation wicri:level="2"><inist:fA14 i1="15"><s1>Pfizer Oncology</s1>
<s2>La Jolla, California</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
<sZ>16 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><region type="state">Californie</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Casali, Paolo G" sort="Casali, Paolo G" uniqKey="Casali P" first="Paolo G." last="Casali">Paolo G. Casali</name>
<affiliation wicri:level="3"><inist:fA14 i1="16"><s1>Istituto Nazionale Tumori</s1>
<s2>Milan</s2>
<s3>ITA</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName><settlement type="city">Milan</settlement>
<region nuts="2">Lombardie</region>
</placeName>
</affiliation>
</author>
</analytic>
<series><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
<imprint><date when="2012">2012</date>
</imprint>
</series>
</biblStruct>
</sourceDesc>
<seriesStmt><title level="j" type="main">Clinical cancer research</title>
<title level="j" type="abbreviated">Clin. cancer res.</title>
<idno type="ISSN">1078-0432</idno>
</seriesStmt>
</fileDesc>
<profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Analysis</term>
<term>Antiangiogenic agent</term>
<term>Antineoplastic agent</term>
<term>Chemotherapy</term>
<term>Gastrointestinal stromal tumor</term>
<term>Human</term>
<term>Imatinib</term>
<term>Patient</term>
<term>Phase III trial</term>
<term>Placebo</term>
<term>Randomization</term>
<term>Sunitinib</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Analyse</term>
<term>Randomisation</term>
<term>Placebo</term>
<term>Essai clinique phase III</term>
<term>Homme</term>
<term>Chimiothérapie</term>
<term>Sunitinib</term>
<term>Malade</term>
<term>Tumeur stromale gastro-intestinale</term>
<term>Imatinib</term>
<term>Anticancéreux</term>
<term>Antiangiogénique</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose: To analyze final long-term survival and clinical outcomes from the randomized phase III study of sunitinib in gastrointestinal stromal tumor patients after imatinib failure; to assess correlative angiogenesis biomarkers with patient outcomes. Experimental Design: Blinded sunitinib or placebo was given daily on a 4-week-on/2-week-off treatment schedule. Placebo-assigned patients could cross over to sunitinib at disease progression/study unblinding. Overall survival (OS) was analyzed using conventional statistical methods and the rank-preserving structural failure time (RPSFT) method to explore cross-over impact. Circulating levels of angiogenesis biomarkers were analyzed. Results: In total, 243 patients were randomized to receive sunitinib and 118 to placebo, 103 of whom crossed over to open-label sunitinib. Conventional statistical analysis showed that OS converged in the sunitinib and placebo arms (median 72.7 vs. 64.9 weeks; HR, 0.876; P= 0.306) as expected, given the cross-over design. RPSFT analysis estimated median OS for placebo of 39.0 weeks (HR, 0.505, 95% CI, 0.262-1.134 ; P = 0.306). No new safety concerns emerged with extended sunitinib treatment. No consistent associations were found between the pharmacodynamics of angiogenesis-related plasma proteins during sunitinib treatment and clinical outcome. Conclusions: The cross-over design provided evidence of sunitinib clinical benefit based on prolonged time to tumor progression during the double-blind phase of this trial. As expected, following cross-over, there was no statistical difference in OS. RPSFT analysis modeled the absence of cross-over, estimating a substantial sunitinib OS benefit relative to placebo. Long-term sunitinib treatment was tolerated without new adverse events.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Belgique</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Pays-Bas</li>
<li>Suisse</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Californie</li>
<li>Canton de Vaud</li>
<li>Caroline du Nord</li>
<li>Catalogne</li>
<li>Communauté de Madrid</li>
<li>Floride</li>
<li>Hollande-Méridionale</li>
<li>Lombardie</li>
<li>Massachusetts</li>
<li>Ohio</li>
<li>Rhône-Alpes</li>
<li>Victoria (État)</li>
<li>État de New York</li>
</region>
<settlement><li>Barcelone</li>
<li>Lausanne</li>
<li>Lyon</li>
<li>Madrid</li>
<li>Melbourne</li>
<li>Milan</li>
<li>New York</li>
<li>Rotterdam</li>
</settlement>
<orgName><li>Université Columbia</li>
</orgName>
</list>
<tree><country name="États-Unis"><region name="Massachusetts"><name sortKey="Demetri, George D" sort="Demetri, George D" uniqKey="Demetri G" first="George D." last="Demetri">George D. Demetri</name>
</region>
<name sortKey="Cohen, Darrel P" sort="Cohen, Darrel P" uniqKey="Cohen D" first="Darrel P." last="Cohen">Darrel P. Cohen</name>
<name sortKey="Garrett, Christopher R" sort="Garrett, Christopher R" uniqKey="Garrett C" first="Christopher R." last="Garrett">Christopher R. Garrett</name>
<name sortKey="Harmon, Charles S" sort="Harmon, Charles S" uniqKey="Harmon C" first="Charles S." last="Harmon">Charles S. Harmon</name>
<name sortKey="Hurwitz, Herbert I" sort="Hurwitz, Herbert I" uniqKey="Hurwitz H" first="Herbert I." last="Hurwitz">Herbert I. Hurwitz</name>
<name sortKey="Qiang Xu" sort="Qiang Xu" uniqKey="Qiang Xu" last="Qiang Xu">QIANG XU</name>
<name sortKey="Shah, Manisha H" sort="Shah, Manisha H" uniqKey="Shah M" first="Manisha H." last="Shah">Manisha H. Shah</name>
<name sortKey="Tassell, Vanessa" sort="Tassell, Vanessa" uniqKey="Tassell V" first="Vanessa" last="Tassell">Vanessa Tassell</name>
<name sortKey="Xin Huang" sort="Xin Huang" uniqKey="Xin Huang" last="Xin Huang">XIN HUANG</name>
</country>
<country name="Belgique"><noRegion><name sortKey="Schoffski, Patrick" sort="Schoffski, Patrick" uniqKey="Schoffski P" first="Patrick" last="Schöffski">Patrick Schöffski</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Verweij, Jaap" sort="Verweij, Jaap" uniqKey="Verweij J" first="Jaap" last="Verweij">Jaap Verweij</name>
</region>
</country>
<country name="Suisse"><region name="Canton de Vaud"><name sortKey="Leyvraz, Serge" sort="Leyvraz, Serge" uniqKey="Leyvraz S" first="Serge" last="Leyvraz">Serge Leyvraz</name>
</region>
</country>
<country name="Espagne"><region name="Catalogne"><name sortKey="Lopez Pousa, Antonio" sort="Lopez Pousa, Antonio" uniqKey="Lopez Pousa A" first="Antonio" last="Lopez Pousa">Antonio Lopez Pousa</name>
</region>
<name sortKey="Paz Ares, Luis" sort="Paz Ares, Luis" uniqKey="Paz Ares L" first="Luis" last="Paz-Ares">Luis Paz-Ares</name>
</country>
<country name="France"><noRegion><name sortKey="Le Cesne, Axel" sort="Le Cesne, Axel" uniqKey="Le Cesne A" first="Axel" last="Le Cesne">Axel Le Cesne</name>
</noRegion>
<name sortKey="Blay, Jean Yves" sort="Blay, Jean Yves" uniqKey="Blay J" first="Jean-Yves" last="Blay">Jean-Yves Blay</name>
</country>
<country name="Australie"><noRegion><name sortKey="Goldstein, David" sort="Goldstein, David" uniqKey="Goldstein D" first="David" last="Goldstein">David Goldstein</name>
</noRegion>
<name sortKey="Mcarthur, Grant A" sort="Mcarthur, Grant A" uniqKey="Mcarthur G" first="Grant A." last="Mcarthur">Grant A. Mcarthur</name>
</country>
<country name="Italie"><region name="Lombardie"><name sortKey="Casali, Paolo G" sort="Casali, Paolo G" uniqKey="Casali P" first="Paolo G." last="Casali">Paolo G. Casali</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure

Complete Longitudinal Analyses of the Randomized, Placebo-Controlled, Phase III Trial of Sunitinib in Patients with Gastrointestinal Stromal Tumor following Imatinib Failure

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