AustralieFrV1, Main, Exploration, bibRecord, 008116

Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma

Identifieur interne : 008116 ( Main/Exploration ); précédent : 008115; suivant : 008117

Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma

Auteurs : Axel Hauschild [Allemagne, États-Unis, Canada, France, Australie, Pays-Bas] ; Sanjiv S. Agarwala ; Uwe Trefzer ; David Hogg ; Caroline Robert ; Peter Hersey ; Alexander Eggermont ; Stephan Grabbe ; Rene Gonzalez ; Jens Gille ; Christian Peschel ; Dirk Schadendorf ; Claus Garbe ; Steven O'Day ; Adil Daud ; J. Michael White ; CHENGHUA XIA ; Kiran Patel ; John M. Kirkwood ; Ulrich Keilholz

Source :

Journal of clinical oncology [ 0732-183X ] ; 2009.

RBID : Pascal:09-0275922

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Randomisation, Placebo, Sorafénib, Association médicamenteuse, Homme, Traitement de deuxième intention, Inopérable, Stade avancé, Carboplatine, Mélanome malin, Cancérologie, Paclitaxel, Anticancéreux, Antiangiogénique, Stade localement avancé.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antiangiogenic agent, Antineoplastic agent, Cancerology, Carboplatin, Drug combination, Human, Locally advanced stage, Malignant melanoma, Paclitaxel, Phase III trial, Placebo, Randomization, Second line treatment, Sorafenib, Unresectable.

Abstract

Purpose This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen. Patients and Methods A total of 270 patients were randomly assigned to receive intravenous paclitaxel 225 mg/m² plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n = 135) or oral sorafenib 400 mg (n = 135) twice daily on days 2 to 19. The primary efficacy end point was progression-free survival (PFS); secondary and tertiary end points included overall survival and incidence of best response, respectively. Results The median PFS was 17.9 weeks for the placebo plus CP arm and 17.4 weeks for the sorafenib plus CP arm (hazard ratio, 0.91; 99% CI, 0.63 to 1.31; two-sided log-rank test P = .49). Response rate was 11 % with placebo versus 12% with sorafenib. Dermatologic events, grade 3 thrombocytopenia, diarrhea, and fatigue were more common in patients treated with sorafenib plus CP versus placebo plus CP. Conclusion In this study, the addition of sorafenib to CP did not improve any of the end points over placebo plus CP and cannot be recommended in the second-line setting for patients with advanced melanoma. Both regimens had clinically acceptable toxicity profiles with no unexpected adverse events. A trial of similar design for the first-line treatment of patients with advanced melanoma (intergroup trial E2603) is currently ongoing.

Affiliations:

Links toward previous steps (curation, corpus...)

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Le document en format XML

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<author><name sortKey="Agarwala, Sanjiv S" sort="Agarwala, Sanjiv S" uniqKey="Agarwala S" first="Sanjiv S." last="Agarwala">Sanjiv S. Agarwala</name>
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<author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name>
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<author><name sortKey="Hogg, David" sort="Hogg, David" uniqKey="Hogg D" first="David" last="Hogg">David Hogg</name>
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<author><name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
</author>
<author><name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
</author>
<author><name sortKey="Eggermont, Alexander" sort="Eggermont, Alexander" uniqKey="Eggermont A" first="Alexander" last="Eggermont">Alexander Eggermont</name>
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<author><name sortKey="Grabbe, Stephan" sort="Grabbe, Stephan" uniqKey="Grabbe S" first="Stephan" last="Grabbe">Stephan Grabbe</name>
</author>
<author><name sortKey="Gonzalez, Rene" sort="Gonzalez, Rene" uniqKey="Gonzalez R" first="Rene" last="Gonzalez">Rene Gonzalez</name>
</author>
<author><name sortKey="Gille, Jens" sort="Gille, Jens" uniqKey="Gille J" first="Jens" last="Gille">Jens Gille</name>
</author>
<author><name sortKey="Peschel, Christian" sort="Peschel, Christian" uniqKey="Peschel C" first="Christian" last="Peschel">Christian Peschel</name>
</author>
<author><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
</author>
<author><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
</author>
<author><name sortKey="O Day, Steven" sort="O Day, Steven" uniqKey="O Day S" first="Steven" last="O'Day">Steven O'Day</name>
</author>
<author><name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
</author>
<author><name sortKey="White, J Michael" sort="White, J Michael" uniqKey="White J" first="J. Michael" last="White">J. Michael White</name>
</author>
<author><name sortKey="Chenghua Xia" sort="Chenghua Xia" uniqKey="Chenghua Xia" last="Chenghua Xia">CHENGHUA XIA</name>
</author>
<author><name sortKey="Patel, Kiran" sort="Patel, Kiran" uniqKey="Patel K" first="Kiran" last="Patel">Kiran Patel</name>
</author>
<author><name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
</author>
<author><name sortKey="Keilholz, Ulrich" sort="Keilholz, Ulrich" uniqKey="Keilholz U" first="Ulrich" last="Keilholz">Ulrich Keilholz</name>
</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="2009">2009</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>Carboplatin</term>
<term>Drug combination</term>
<term>Human</term>
<term>Locally advanced stage</term>
<term>Malignant melanoma</term>
<term>Paclitaxel</term>
<term>Phase III trial</term>
<term>Placebo</term>
<term>Randomization</term>
<term>Second line treatment</term>
<term>Sorafenib</term>
<term>Unresectable</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Randomisation</term>
<term>Placebo</term>
<term>Sorafénib</term>
<term>Association médicamenteuse</term>
<term>Homme</term>
<term>Traitement de deuxième intention</term>
<term>Inopérable</term>
<term>Stade avancé</term>
<term>Carboplatine</term>
<term>Mélanome malin</term>
<term>Cancérologie</term>
<term>Paclitaxel</term>
<term>Anticancéreux</term>
<term>Antiangiogénique</term>
<term>Stade localement avancé</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 This phase III, randomized, double-blind, placebo-controlled study was conducted to evaluate the efficacy and safety of sorafenib with carboplatin and paclitaxel (CP) in patients with advanced melanoma who had progressed on a dacarbazine- or temozolomide-containing regimen. Patients and Methods A total of 270 patients were randomly assigned to receive intravenous paclitaxel 225 mg/m<sup>2</sup>
 plus intravenous carboplatin at area under curve 6 (AUC 6) on day 1 of a 21-day cycle followed by either placebo (n = 135) or oral sorafenib 400 mg (n = 135) twice daily on days 2 to 19. The primary efficacy end point was progression-free survival (PFS); secondary and tertiary end points included overall survival and incidence of best response, respectively. Results The median PFS was 17.9 weeks for the placebo plus CP arm and 17.4 weeks for the sorafenib plus CP arm (hazard ratio, 0.91; 99% CI, 0.63 to 1.31; two-sided log-rank test P = .49). Response rate was 11 % with placebo versus 12% with sorafenib. Dermatologic events, grade 3 thrombocytopenia, diarrhea, and fatigue were more common in patients treated with sorafenib plus CP versus placebo plus CP. Conclusion In this study, the addition of sorafenib to CP did not improve any of the end points over placebo plus CP and cannot be recommended in the second-line setting for patients with advanced melanoma. Both regimens had clinically acceptable toxicity profiles with no unexpected adverse events. A trial of similar design for the first-line treatment of patients with advanced melanoma (intergroup trial E2603) is currently ongoing.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Canada</li>
<li>France</li>
<li>Pays-Bas</li>
<li>États-Unis</li>
</country>
<region><li>Bade-Wurtemberg</li>
<li>Bavière</li>
<li>Berlin</li>
<li>District de Darmstadt</li>
<li>District de Haute-Bavière</li>
<li>District de Karlsruhe</li>
<li>District de Tübingen</li>
<li>Hesse (Land)</li>
<li>Hollande-Méridionale</li>
<li>Rhénanie-Palatinat</li>
<li>Schleswig-Holstein</li>
</region>
<settlement><li>Berlin</li>
<li>Francfort-sur-le-Main</li>
<li>Kiel</li>
<li>Mannheim</li>
<li>Mayence</li>
<li>Munich</li>
<li>Rotterdam</li>
<li>Tübingen</li>
</settlement>
</list>
<tree><noCountry><name sortKey="Agarwala, Sanjiv S" sort="Agarwala, Sanjiv S" uniqKey="Agarwala S" first="Sanjiv S." last="Agarwala">Sanjiv S. Agarwala</name>
<name sortKey="Chenghua Xia" sort="Chenghua Xia" uniqKey="Chenghua Xia" last="Chenghua Xia">CHENGHUA XIA</name>
<name sortKey="Daud, Adil" sort="Daud, Adil" uniqKey="Daud A" first="Adil" last="Daud">Adil Daud</name>
<name sortKey="Eggermont, Alexander" sort="Eggermont, Alexander" uniqKey="Eggermont A" first="Alexander" last="Eggermont">Alexander Eggermont</name>
<name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
<name sortKey="Gille, Jens" sort="Gille, Jens" uniqKey="Gille J" first="Jens" last="Gille">Jens Gille</name>
<name sortKey="Gonzalez, Rene" sort="Gonzalez, Rene" uniqKey="Gonzalez R" first="Rene" last="Gonzalez">Rene Gonzalez</name>
<name sortKey="Grabbe, Stephan" sort="Grabbe, Stephan" uniqKey="Grabbe S" first="Stephan" last="Grabbe">Stephan Grabbe</name>
<name sortKey="Hersey, Peter" sort="Hersey, Peter" uniqKey="Hersey P" first="Peter" last="Hersey">Peter Hersey</name>
<name sortKey="Hogg, David" sort="Hogg, David" uniqKey="Hogg D" first="David" last="Hogg">David Hogg</name>
<name sortKey="Keilholz, Ulrich" sort="Keilholz, Ulrich" uniqKey="Keilholz U" first="Ulrich" last="Keilholz">Ulrich Keilholz</name>
<name sortKey="Kirkwood, John M" sort="Kirkwood, John M" uniqKey="Kirkwood J" first="John M." last="Kirkwood">John M. Kirkwood</name>
<name sortKey="O Day, Steven" sort="O Day, Steven" uniqKey="O Day S" first="Steven" last="O'Day">Steven O'Day</name>
<name sortKey="Patel, Kiran" sort="Patel, Kiran" uniqKey="Patel K" first="Kiran" last="Patel">Kiran Patel</name>
<name sortKey="Peschel, Christian" sort="Peschel, Christian" uniqKey="Peschel C" first="Christian" last="Peschel">Christian Peschel</name>
<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
<name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
<name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name>
<name sortKey="White, J Michael" sort="White, J Michael" uniqKey="White J" first="J. Michael" last="White">J. Michael White</name>
</noCountry>
<country name="Allemagne"><region name="Schleswig-Holstein"><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</region>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</noRegion>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</country>
<country name="Canada"><noRegion><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</noRegion>
</country>
<country name="France"><noRegion><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</noRegion>
</country>
<country name="Australie"><noRegion><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</noRegion>
</country>
<country name="Pays-Bas"><region name="Hollande-Méridionale"><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</region>
</country>
</tree>
</affiliations>
</record>

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Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma

Results of a Phase III, Randomized, Placebo-Controlled Study of Sorafenib in Combination With Carboplatin and Paclitaxel As Second-Line Treatment in Patients With Unresectable Stage III or Stage IV Melanoma

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