AustralieFrV1, Main, Exploration, bibRecord, 004F46

Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma

Identifieur interne : 004F46 ( Main/Exploration ); précédent : 004F45; suivant : 004F47

Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma

Auteurs : Steven J. O'Day [États-Unis] ; Alexander M. M. Eggermont [France] ; Vanna Chiarion-Sileni [Italie] ; Richard Kefford [Australie] ; Jean Jacques Grob [France] ; Laurent Mortier [France] ; Caroline Robert [France] ; Jacob Schachter [Israël] ; Alessandro Testori [Italie] ; Jacek Mackiewicz [Pologne] ; Philip Friedlander [États-Unis] ; Claus Garbe [Allemagne] ; Selma Ugurel [Autriche] ; Frances Collichio [États-Unis] ; WEI GUO [États-Unis] ; Joelle Lufkin [États-Unis] ; Safi Bahcall [États-Unis] ; Vojo Vukovic [États-Unis] ; Axel Hauschild [Allemagne]

Source :

Journal of clinical oncology [ 0732-183X ] ; 2013.

RBID : Pascal:13-0142875

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Résultat, Traitement, Paclitaxel, Etude double insu, Essai clinique, Chimiothérapie, Randomisation, Etude comparative, Mélanome malin, Homme, Malade, Stade avancé, Cancérologie, Anticancéreux, Elesclomol.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, Antineoplastic agent, Cancerology, Chemotherapy, Clinical trial, Comparative study, Double blind study, Elesclomol, Human, Malignant melanoma, Paclitaxel, Patient, Phase III trial, Randomization, Result, Treatment.

Abstract

Purpose Elesclomol, an investigational first-in-class compound, induces oxidative stress, triggers mitochondrial-induced apoptosis in cancer cells, and shows synergy with taxanes in tumor models. Following completion of a phase II trial of elesclomol in combination with paclitaxel that met its primary end point of progression-free survival (PFS), this randomized, double-blind, controlled phase III study was conducted to confirm the efficacy and tolerability of elesclomol in combination with paclitaxel versus paclitaxel alone in patients with advanced melanoma. Patients and Methods Patients with stage IV chemotherapy-naive melanoma (n = 651) were randomly assigned 1:1 to paclitaxel 80 mg/m² either alone or in combination with elesclomol 213 mg/m² administered weekly for 3 weeks of a 4-week cycle. Patients were stratified by prior systemic treatment, M1 subclass, and baseline lactate dehydrogenase (LDH) levels. The primary end point was PFS. Results The study did not achieve its PFS end point (hazard ratio, 0.89; P = .23). The study was stopped when an early overall survival data analysis indicated an imbalance in total deaths favoring paclitaxel, predominantly in patients with high LDH levels. A prospectively defined subgroup analysis revealed a statistically significant improvement in median PFS for the combination in patients with normal baseline LDH. Conclusion The addition of elesclomol to paclitaxel did not significantly improve PFS in unselected patients with advanced melanoma. The association between baseline LDH and clinical outcomes suggests that LDH may be a predictive factor for treatment with this combination, consistent with recent findings on the association between elesclomol anticancer activity and cellular metabolic state.

Affiliations:

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma</title>
<author><name sortKey="O Day, Steven J" sort="O Day, Steven J" uniqKey="O Day S" first="Steven J." last="O'Day">Steven J. O'Day</name>
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<s2>Beverly Hills, CA</s2>
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<author><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M. M." last="Eggermont">Alexander M. M. Eggermont</name>
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<author><name sortKey="Collichio, Frances" sort="Collichio, Frances" uniqKey="Collichio F" first="Frances" last="Collichio">Frances Collichio</name>
<affiliation wicri:level="4"><inist:fA14 i1="15"><s1>University of North Carolina at Chapel Hill</s1>
<s2>Chapel Hill, NC</s2>
<s3>USA</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<placeName><settlement type="city">Chapel Hill (Caroline du Nord)</settlement>
<region type="state">Caroline du Nord</region>
</placeName>
<orgName type="university">Université de Caroline du Nord à Chapel Hill</orgName>
</affiliation>
</author>
<author><name sortKey="Wei Guo" sort="Wei Guo" uniqKey="Wei Guo" last="Wei Guo">WEI GUO</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Synta Pharmaceuticals</s1>
<s2>Lexington, MA</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>
<wicri:noRegion>Synta Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Lufkin, Joelle" sort="Lufkin, Joelle" uniqKey="Lufkin J" first="Joelle" last="Lufkin">Joelle Lufkin</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Synta Pharmaceuticals</s1>
<s2>Lexington, MA</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>
<wicri:noRegion>Synta Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Bahcall, Safi" sort="Bahcall, Safi" uniqKey="Bahcall S" first="Safi" last="Bahcall">Safi Bahcall</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Synta Pharmaceuticals</s1>
<s2>Lexington, MA</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>
<wicri:noRegion>Synta Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Vukovic, Vojo" sort="Vukovic, Vojo" uniqKey="Vukovic V" first="Vojo" last="Vukovic">Vojo Vukovic</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>Synta Pharmaceuticals</s1>
<s2>Lexington, MA</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>
<wicri:noRegion>Synta Pharmaceuticals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
<affiliation wicri:level="3"><inist:fA14 i1="13"><s1>University Hospital Schleswig-Holstein/Campus Kiel</s1>
<s2>Kiel</s2>
<s3>DEU</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="2">Schleswig-Holstein</region>
<settlement type="city">Kiel</settlement>
</placeName>
</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="2013">2013</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>Antineoplastic agent</term>
<term>Cancerology</term>
<term>Chemotherapy</term>
<term>Clinical trial</term>
<term>Comparative study</term>
<term>Double blind study</term>
<term>Elesclomol</term>
<term>Human</term>
<term>Malignant melanoma</term>
<term>Paclitaxel</term>
<term>Patient</term>
<term>Phase III trial</term>
<term>Randomization</term>
<term>Result</term>
<term>Treatment</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Résultat</term>
<term>Traitement</term>
<term>Paclitaxel</term>
<term>Etude double insu</term>
<term>Essai clinique</term>
<term>Chimiothérapie</term>
<term>Randomisation</term>
<term>Etude comparative</term>
<term>Mélanome malin</term>
<term>Homme</term>
<term>Malade</term>
<term>Stade avancé</term>
<term>Cancérologie</term>
<term>Anticancéreux</term>
<term>Elesclomol</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 Elesclomol, an investigational first-in-class compound, induces oxidative stress, triggers mitochondrial-induced apoptosis in cancer cells, and shows synergy with taxanes in tumor models. Following completion of a phase II trial of elesclomol in combination with paclitaxel that met its primary end point of progression-free survival (PFS), this randomized, double-blind, controlled phase III study was conducted to confirm the efficacy and tolerability of elesclomol in combination with paclitaxel versus paclitaxel alone in patients with advanced melanoma. Patients and Methods Patients with stage IV chemotherapy-naive melanoma (n = 651) were randomly assigned 1:1 to paclitaxel 80 mg/m<sup>2</sup>
 either alone or in combination with elesclomol 213 mg/m<sup>2</sup>
 administered weekly for 3 weeks of a 4-week cycle. Patients were stratified by prior systemic treatment, M1 subclass, and baseline lactate dehydrogenase (LDH) levels. The primary end point was PFS. Results The study did not achieve its PFS end point (hazard ratio, 0.89; P = .23). The study was stopped when an early overall survival data analysis indicated an imbalance in total deaths favoring paclitaxel, predominantly in patients with high LDH levels. A prospectively defined subgroup analysis revealed a statistically significant improvement in median PFS for the combination in patients with normal baseline LDH. Conclusion The addition of elesclomol to paclitaxel did not significantly improve PFS in unselected patients with advanced melanoma. The association between baseline LDH and clinical outcomes suggests that LDH may be a predictive factor for treatment with this combination, consistent with recent findings on the association between elesclomol anticancer activity and cellular metabolic state.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>Autriche</li>
<li>France</li>
<li>Israël</li>
<li>Italie</li>
<li>Pologne</li>
<li>États-Unis</li>
</country>
<region><li>Bade-Wurtemberg</li>
<li>Caroline du Nord</li>
<li>District de Tübingen</li>
<li>Hauts-de-France</li>
<li>Lombardie</li>
<li>Nord-Pas-de-Calais</li>
<li>Nouvelle-Galles du Sud</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Schleswig-Holstein</li>
<li>Île-de-France</li>
</region>
<settlement><li>Chapel Hill (Caroline du Nord)</li>
<li>Kiel</li>
<li>Lille</li>
<li>Marseille</li>
<li>Milan</li>
<li>Paris</li>
<li>Sydney</li>
<li>Tübingen</li>
</settlement>
<orgName><li>Université de Caroline du Nord à Chapel Hill</li>
</orgName>
</list>
<tree><country name="États-Unis"><noRegion><name sortKey="O Day, Steven J" sort="O Day, Steven J" uniqKey="O Day S" first="Steven J." last="O'Day">Steven J. O'Day</name>
</noRegion>
<name sortKey="Bahcall, Safi" sort="Bahcall, Safi" uniqKey="Bahcall S" first="Safi" last="Bahcall">Safi Bahcall</name>
<name sortKey="Collichio, Frances" sort="Collichio, Frances" uniqKey="Collichio F" first="Frances" last="Collichio">Frances Collichio</name>
<name sortKey="Friedlander, Philip" sort="Friedlander, Philip" uniqKey="Friedlander P" first="Philip" last="Friedlander">Philip Friedlander</name>
<name sortKey="Lufkin, Joelle" sort="Lufkin, Joelle" uniqKey="Lufkin J" first="Joelle" last="Lufkin">Joelle Lufkin</name>
<name sortKey="Vukovic, Vojo" sort="Vukovic, Vojo" uniqKey="Vukovic V" first="Vojo" last="Vukovic">Vojo Vukovic</name>
<name sortKey="Wei Guo" sort="Wei Guo" uniqKey="Wei Guo" last="Wei Guo">WEI GUO</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Eggermont, Alexander M M" sort="Eggermont, Alexander M M" uniqKey="Eggermont A" first="Alexander M. M." last="Eggermont">Alexander M. M. Eggermont</name>
</region>
<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean Jacques" last="Grob">Jean Jacques Grob</name>
<name sortKey="Mortier, Laurent" sort="Mortier, Laurent" uniqKey="Mortier L" first="Laurent" last="Mortier">Laurent Mortier</name>
<name sortKey="Robert, Caroline" sort="Robert, Caroline" uniqKey="Robert C" first="Caroline" last="Robert">Caroline Robert</name>
</country>
<country name="Italie"><noRegion><name sortKey="Chiarion Sileni, Vanna" sort="Chiarion Sileni, Vanna" uniqKey="Chiarion Sileni V" first="Vanna" last="Chiarion-Sileni">Vanna Chiarion-Sileni</name>
</noRegion>
<name sortKey="Testori, Alessandro" sort="Testori, Alessandro" uniqKey="Testori A" first="Alessandro" last="Testori">Alessandro Testori</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Kefford, Richard" sort="Kefford, Richard" uniqKey="Kefford R" first="Richard" last="Kefford">Richard Kefford</name>
</region>
</country>
<country name="Israël"><noRegion><name sortKey="Schachter, Jacob" sort="Schachter, Jacob" uniqKey="Schachter J" first="Jacob" last="Schachter">Jacob Schachter</name>
</noRegion>
</country>
<country name="Pologne"><noRegion><name sortKey="Mackiewicz, Jacek" sort="Mackiewicz, Jacek" uniqKey="Mackiewicz J" first="Jacek" last="Mackiewicz">Jacek Mackiewicz</name>
</noRegion>
</country>
<country name="Allemagne"><region name="Bade-Wurtemberg"><name sortKey="Garbe, Claus" sort="Garbe, Claus" uniqKey="Garbe C" first="Claus" last="Garbe">Claus Garbe</name>
</region>
<name sortKey="Hauschild, Axel" sort="Hauschild, Axel" uniqKey="Hauschild A" first="Axel" last="Hauschild">Axel Hauschild</name>
</country>
<country name="Autriche"><noRegion><name sortKey="Ugurel, Selma" sort="Ugurel, Selma" uniqKey="Ugurel S" first="Selma" last="Ugurel">Selma Ugurel</name>
</noRegion>
</country>
</tree>
</affiliations>
</record>

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Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma

Final Results of Phase III SYMMETRY Study: Randomized, Double-Blind Trial of Elesclomol Plus Paclitaxel Versus Paclitaxel Alone As Treatment for Chemotherapy-Naive Patients With Advanced Melanoma

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