AustralieFrV1, Main, Exploration, bibRecord, 004D48

Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma

Identifieur interne : 004D48 ( Main/Exploration ); précédent : 004D47; suivant : 004D49

Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma

Auteurs : Paolo A. Ascierto [Italie] ; David Minor [États-Unis] ; Antoni Ribas [États-Unis] ; Celeste Lebbe [France] ; Anne O'Hagan [États-Unis] ; Niki Arya [États-Unis] ; Mary Guckert [États-Unis] ; Dirk Schadendorf [Allemagne] ; Richard F. Kefford [Australie] ; Jean-Jacques Grob [France] ; Omid Hamid [États-Unis] ; Ravi Amaravadi [États-Unis] ; Ester Simeone [Italie] ; Tabea Wilhelm [Allemagne] ; Kevin B. Kim [États-Unis] ; Georgina V. Long [Australie] ; Anne-Marie Martin [États-Unis] ; Jolly Mazumdar [États-Unis] ; Vicki L. Goodman [États-Unis] ; Uwe Trefzer [Allemagne]

Source :

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

RBID : Pascal:13-0301223

Descripteurs français

Pascal (Inist)
- Essai clinique phase II, Déchirure, Protooncogène, Mélanome malin, Gène onc cellulaire, Inhibiteur, Homme, Stade avancé, Métastase, Cancérologie, Gène BRAF, Dabrafénib.
Wicri :
- topic : Homme.

English descriptors

KwdEn :
- Advanced stage, BRAF Gene, Break, C-Onc gene, Cancerology, Dabrafenib, Human, Inhibitor, Malignant melanoma, Metastasis, Phase II trial, Protooncogene.

Abstract

Purpose Dabrafenib (GSK2118436) is a potent inhibitor of mutated BRAF kinase. Our multicenter, single-arm, phase II study assessed the safety and clinical activity of dabrafenib in BRAF^V600E/K mutation-positive metastatic melanoma (mut⁺ MM). Patients and Methods Histologically confirmed patients with stage IV BRAF^V600E/K mut⁺ MM received oral dabrafenib 150 mg twice daily until disease progression, death, or unacceptable adverse events (AEs). The primary end point was investigator-assessed overall response rate in BRAF^V600E mut⁺ MM patients. Secondary end points included progression-free survival (PFS) and overall survival (OS). Exploratory objectives included the comparison of BRAF mutation status between tumor-specific circulating cell-free DNA (cfDNA) and tumor tissue, and the evaluation of cfDNA as a predictor of clinical outcome. Results Seventy-six patients with BRAF^V600E and 16 patients with BRAF^V600K mut⁺ MM were enrolled onto the study. In the BRAF^V600E group, 45 patients (59%) had a confirmed response (95% CI, 48.2 to 70.3), including five patients (7%) with complete responses. Two patients (13%) with BRAF^V600K mut⁺ MM had a confirmed partial response (95% CI, 0 to 28.7). In the BRAF^V600E and BRAF^V600K groups, median PFS was 6.3 months and 4.5 months, and median OS was 13.1 months and 12.9 months, respectively. The most common AEs were arthralgia (33%), hyperkeratosis (27%), and pyrexia (24%). Overall, 25 patients (27%) experienced a serious AE and nine patients (10%) had squamous cell carcinoma. Baseline cfDNA levels predicted response rate and PFS in BRAF^V600E mut⁺ MM patients. Conclusion Dabrafenib was well tolerated and clinically active in patients with BRAF^V600E/K mut⁺ MM. cfDNA may be a useful prognostic and response marker in future studies.

Affiliations:

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

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma</title>
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<author><name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Aix-Marseille University, Assistance Publique-Hôpitaux de Marseille, Hôpital Timone</s1>
<s2>Marseille</s2>
<s3>FRA</s3>
<sZ>10 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Provence-Alpes-Côte d'Azur</region>
<region type="old region">Provence-Alpes-Côte d'Azur</region>
<settlement type="city">Marseille</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
<affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Experimental Therapeutics/Immunotherapy, The Angeles Clinic and Research Institute</s1>
<s2>Los Angeles, CA</s2>
<s3>USA</s3>
<sZ>11 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Los Angeles, CA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Amaravadi, Ravi" sort="Amaravadi, Ravi" uniqKey="Amaravadi R" first="Ravi" last="Amaravadi">Ravi Amaravadi</name>
<affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Abramson Cancer Center, University of Pennsylvania</s1>
<s2>Philadelphia, PA</s2>
<s3>USA</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>Philadelphia, PA</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Simeone, Ester" sort="Simeone, Ester" uniqKey="Simeone E" first="Ester" last="Simeone">Ester Simeone</name>
<affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Instituto Nazionale Tumori Fondazione "G. Pascale</s1>
<s2>Napoli</s2>
<s3>ITA</s3>
<sZ>1 aut.</sZ>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<wicri:noRegion>Instituto Nazionale Tumori Fondazione "G. Pascale</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Wilhelm, Tabea" sort="Wilhelm, Tabea" uniqKey="Wilhelm T" first="Tabea" last="Wilhelm">Tabea Wilhelm</name>
<affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Charité-Universitätsmedizin</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>14 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Kim, Kevin B" sort="Kim, Kevin B" uniqKey="Kim K" first="Kevin B." last="Kim">Kevin B. Kim</name>
<affiliation wicri:level="1"><inist:fA14 i1="07"><s1>The University of Texas MD Anderson Cancer Center</s1>
<s2>Houston, TX</s2>
<s3>USA</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>The University of Texas MD Anderson Cancer Center</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V." last="Long">Georgina V. Long</name>
<affiliation wicri:level="4"><inist:fA14 i1="12"><s1>Westmead Hospital and Melanoma Institute Australia, University of Sydney</s1>
<s2>Sydney</s2>
<s3>AUS</s3>
<sZ>9 aut.</sZ>
<sZ>16 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<placeName><settlement type="city">Sydney</settlement>
<region type="état">Nouvelle-Galles du Sud</region>
<settlement type="city">Sydney</settlement>
</placeName>
<orgName type="university">Université de Sydney</orgName>
</affiliation>
</author>
<author><name sortKey="Martin, Anne Marie" sort="Martin, Anne Marie" uniqKey="Martin A" first="Anne-Marie" last="Martin">Anne-Marie Martin</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>GlaxoSmithKline Oncology</s1>
<s2>Collegeville</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline Oncology</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Mazumdar, Jolly" sort="Mazumdar, Jolly" uniqKey="Mazumdar J" first="Jolly" last="Mazumdar">Jolly Mazumdar</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>GlaxoSmithKline Oncology</s1>
<s2>Collegeville</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline Oncology</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Goodman, Vicki L" sort="Goodman, Vicki L" uniqKey="Goodman V" first="Vicki L." last="Goodman">Vicki L. Goodman</name>
<affiliation wicri:level="1"><inist:fA14 i1="05"><s1>GlaxoSmithKline Oncology</s1>
<s2>Collegeville</s2>
<s3>USA</s3>
<sZ>5 aut.</sZ>
<sZ>6 aut.</sZ>
<sZ>7 aut.</sZ>
<sZ>17 aut.</sZ>
<sZ>18 aut.</sZ>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>États-Unis</country>
<wicri:noRegion>GlaxoSmithKline Oncology</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name>
<affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Charité-Universitätsmedizin</s1>
<s2>Berlin</s2>
<s3>DEU</s3>
<sZ>14 aut.</sZ>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>Allemagne</country>
<placeName><region type="land" nuts="3">Berlin</region>
<settlement type="city">Berlin</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>BRAF Gene</term>
<term>Break</term>
<term>C-Onc gene</term>
<term>Cancerology</term>
<term>Dabrafenib</term>
<term>Human</term>
<term>Inhibitor</term>
<term>Malignant melanoma</term>
<term>Metastasis</term>
<term>Phase II trial</term>
<term>Protooncogene</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase II</term>
<term>Déchirure</term>
<term>Protooncogène</term>
<term>Mélanome malin</term>
<term>Gène onc cellulaire</term>
<term>Inhibiteur</term>
<term>Homme</term>
<term>Stade avancé</term>
<term>Métastase</term>
<term>Cancérologie</term>
<term>Gène BRAF</term>
<term>Dabrafénib</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 Dabrafenib (GSK2118436) is a potent inhibitor of mutated BRAF kinase. Our multicenter, single-arm, phase II study assessed the safety and clinical activity of dabrafenib in BRAF<sup>V600E/K</sup>
 mutation-positive metastatic melanoma (mut<sup>+</sup>
 MM). Patients and Methods Histologically confirmed patients with stage IV BRAF<sup>V600E/K</sup>
 mut<sup>+</sup>
 MM received oral dabrafenib 150 mg twice daily until disease progression, death, or unacceptable adverse events (AEs). The primary end point was investigator-assessed overall response rate in BRAF<sup>V600E</sup>
 mut<sup>+</sup>
 MM patients. Secondary end points included progression-free survival (PFS) and overall survival (OS). Exploratory objectives included the comparison of BRAF mutation status between tumor-specific circulating cell-free DNA (cfDNA) and tumor tissue, and the evaluation of cfDNA as a predictor of clinical outcome. Results Seventy-six patients with BRAF<sup>V600E</sup>
 and 16 patients with BRAF<sup>V600K</sup>
 mut<sup>+</sup>
 MM were enrolled onto the study. In the BRAF<sup>V600E</sup>
 group, 45 patients (59%) had a confirmed response (95% CI, 48.2 to 70.3), including five patients (7%) with complete responses. Two patients (13%) with BRAF<sup>V600K</sup>
 mut<sup>+</sup>
 MM had a confirmed partial response (95% CI, 0 to 28.7). In the BRAF<sup>V600E</sup>
 and BRAF<sup>V600K</sup>
 groups, median PFS was 6.3 months and 4.5 months, and median OS was 13.1 months and 12.9 months, respectively. The most common AEs were arthralgia (33%), hyperkeratosis (27%), and pyrexia (24%). Overall, 25 patients (27%) experienced a serious AE and nine patients (10%) had squamous cell carcinoma. Baseline cfDNA levels predicted response rate and PFS in BRAF<sup>V600E</sup>
 mut<sup>+</sup>
 MM patients. Conclusion Dabrafenib was well tolerated and clinically active in patients with BRAF<sup>V600E/K</sup>
 mut<sup>+</sup>
 MM. cfDNA may be a useful prognostic and response marker in future studies.</div>
</front>
</TEI>
<affiliations><list><country><li>Allemagne</li>
<li>Australie</li>
<li>France</li>
<li>Italie</li>
<li>États-Unis</li>
</country>
<region><li>Berlin</li>
<li>Californie</li>
<li>Nouvelle-Galles du Sud</li>
<li>Provence-Alpes-Côte d'Azur</li>
<li>Île-de-France</li>
</region>
<settlement><li>Berlin</li>
<li>Los Angeles</li>
<li>Marseille</li>
<li>Paris</li>
<li>San Francisco</li>
<li>Sydney</li>
</settlement>
<orgName><li>Université de Sydney</li>
</orgName>
</list>
<tree><country name="Italie"><noRegion><name sortKey="Ascierto, Paolo A" sort="Ascierto, Paolo A" uniqKey="Ascierto P" first="Paolo A." last="Ascierto">Paolo A. Ascierto</name>
</noRegion>
<name sortKey="Simeone, Ester" sort="Simeone, Ester" uniqKey="Simeone E" first="Ester" last="Simeone">Ester Simeone</name>
</country>
<country name="États-Unis"><region name="Californie"><name sortKey="Minor, David" sort="Minor, David" uniqKey="Minor D" first="David" last="Minor">David Minor</name>
</region>
<name sortKey="Amaravadi, Ravi" sort="Amaravadi, Ravi" uniqKey="Amaravadi R" first="Ravi" last="Amaravadi">Ravi Amaravadi</name>
<name sortKey="Arya, Niki" sort="Arya, Niki" uniqKey="Arya N" first="Niki" last="Arya">Niki Arya</name>
<name sortKey="Goodman, Vicki L" sort="Goodman, Vicki L" uniqKey="Goodman V" first="Vicki L." last="Goodman">Vicki L. Goodman</name>
<name sortKey="Guckert, Mary" sort="Guckert, Mary" uniqKey="Guckert M" first="Mary" last="Guckert">Mary Guckert</name>
<name sortKey="Hamid, Omid" sort="Hamid, Omid" uniqKey="Hamid O" first="Omid" last="Hamid">Omid Hamid</name>
<name sortKey="Kim, Kevin B" sort="Kim, Kevin B" uniqKey="Kim K" first="Kevin B." last="Kim">Kevin B. Kim</name>
<name sortKey="Martin, Anne Marie" sort="Martin, Anne Marie" uniqKey="Martin A" first="Anne-Marie" last="Martin">Anne-Marie Martin</name>
<name sortKey="Mazumdar, Jolly" sort="Mazumdar, Jolly" uniqKey="Mazumdar J" first="Jolly" last="Mazumdar">Jolly Mazumdar</name>
<name sortKey="O Hagan, Anne" sort="O Hagan, Anne" uniqKey="O Hagan A" first="Anne" last="O'Hagan">Anne O'Hagan</name>
<name sortKey="Ribas, Antoni" sort="Ribas, Antoni" uniqKey="Ribas A" first="Antoni" last="Ribas">Antoni Ribas</name>
</country>
<country name="France"><region name="Île-de-France"><name sortKey="Lebbe, Celeste" sort="Lebbe, Celeste" uniqKey="Lebbe C" first="Celeste" last="Lebbe">Celeste Lebbe</name>
</region>
<name sortKey="Grob, Jean Jacques" sort="Grob, Jean Jacques" uniqKey="Grob J" first="Jean-Jacques" last="Grob">Jean-Jacques Grob</name>
</country>
<country name="Allemagne"><noRegion><name sortKey="Schadendorf, Dirk" sort="Schadendorf, Dirk" uniqKey="Schadendorf D" first="Dirk" last="Schadendorf">Dirk Schadendorf</name>
</noRegion>
<name sortKey="Trefzer, Uwe" sort="Trefzer, Uwe" uniqKey="Trefzer U" first="Uwe" last="Trefzer">Uwe Trefzer</name>
<name sortKey="Wilhelm, Tabea" sort="Wilhelm, Tabea" uniqKey="Wilhelm T" first="Tabea" last="Wilhelm">Tabea Wilhelm</name>
</country>
<country name="Australie"><region name="Nouvelle-Galles du Sud"><name sortKey="Kefford, Richard F" sort="Kefford, Richard F" uniqKey="Kefford R" first="Richard F." last="Kefford">Richard F. Kefford</name>
</region>
<name sortKey="Long, Georgina V" sort="Long, Georgina V" uniqKey="Long G" first="Georgina V." last="Long">Georgina V. Long</name>
</country>
</tree>
</affiliations>
</record>

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	Serveur d'exploration sur les relations entre la France et l'Australie
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Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma

Phase II Trial (BREAK-2) of the BRAF Inhibitor Dabrafenib (GSK2118436) in Patients With Metastatic Melanoma

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