AustralieFrV1, Main, Exploration, bibRecord, 003F89

Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study

Identifieur interne : 003F89 ( Main/Exploration ); précédent : 003F88; suivant : 003F90

Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study

Auteurs : Ignace B. Vergote [Belgique] ; Antonio Jimeno [États-Unis] ; Florence Joly [France] ; Dionyssios Katsaros [Italie] ; Corneel Coens [Belgique] ; Evelyn Despierre [Belgique] ; Christian Marth [Autriche] ; Marcia Hall [États-Unis] ; Christopher B. Steer [Australie] ; Nicoletta Colombo [Italie] ; Anne Lesoin [France] ; Antonio Casado [Espagne] ; Alexander Reinthaller [Autriche] ; John Green [Royaume-Uni] ; Martin Buck [Australie] ; Isabelle Ray-Coquard [France] ; Annamaria Ferrero [Italie] ; Laure Favier [France] ; Nick Simon Reed [Royaume-Uni] ; Hervé Cure [France] ; Eric Pujade-Lauraine [France]

Source :

Journal of clinical oncology [ 0732-183X ] ; 2014.

RBID : Pascal:14-0051569

Descripteurs français

Pascal (Inist)
- Essai clinique phase III, Randomisation, Etude comparative, Erlotinib, Homme, Europe, Traitement de première intention, Recherche, Tumeur maligne, Carcinome de l'ovaire, Pathologie de l'appareil génital femelle, Cancérologie, Cancer de l'ovaire, Anticancéreux.
Wicri :
- topic : Homme, Recherche.

English descriptors

KwdEn :
- Antineoplastic agent, Cancerology, Comparative study, Erlotinib, Europe, Female genital diseases, First line treatment, Human, Malignant tumor, Ovary cancer, Ovary carcinoma, Phase III trial, Randomization, Research.

Abstract

Purpose This trial evaluated the efficacy of maintenance erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, after first-line chemotherapy. Patients and Methods Eligible patients had high-risk International Federation of Gynecology and Obstetrics stage I or stage II to IV epithelial ovarian, primary peritoneal, or fallopian tube cancer and were not selected for EGFR expression. All patients underwent first-line platinum-based chemotherapy (CT) and showed no signs of progression at the end of CT. Patients were randomly assigned to maintenance erlotinib 150 mg orally daily for 2 years or to observation. EGFR immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), and mutation analyses were performed in 318 patients. Results Between October 2005 and February 2008, 835 patients were randomly assigned (median follow-up, 51 months). Twenty-six percent of the patients stopped erlotinib as a result of adverse effects (of these, 67% were due to rash). For erlotinib and observation, respectively, the median progression-free survival was 12.7 and 12.4 months (hazard ratio [HR], 1.05; 95% Cl, 0.90 to 1.23), and the median overall survival was 50.8 and 59.1 months (HR, 0.99; 95% Cl, 0.81 to 1.20 months), respectively. No subgroup could be identified with improved effect of erlotinib, based on IHC or FISH for EGFR, or mutations in genes related to the EGFR pathway, or on rash during erlotinib therapy. However, patients with a positive FISH EGFR score had a worse overall survival (46.1 months) than those with a negative score (67.0 months; HR, 1.56; 95% Cl, 1.01 to 2.40; P = .044). Global health/quality-of-life scores showed a significant difference during the first year (P = .0102) in favor of the observation arm. Conclusion Maintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival.

Affiliations:

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Le document en format XML

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<sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study</title>
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<author><name sortKey="Casado, Antonio" sort="Casado, Antonio" uniqKey="Casado A" first="Antonio" last="Casado">Antonio Casado</name>
<affiliation wicri:level="3"><inist:fA14 i1="20"><s1>Universitario San Carlos</s1>
<s2>Madrid</s2>
<s3>ESP</s3>
<sZ>12 aut.</sZ>
</inist:fA14>
<country>Espagne</country>
<placeName><settlement type="city">Madrid</settlement>
<region nuts="2" type="region">Communauté de Madrid</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name>
<affiliation wicri:level="3"><inist:fA14 i1="14"><s1>Medical University of Vienna</s1>
<s2>Vienna</s2>
<s3>AUT</s3>
<sZ>13 aut.</sZ>
</inist:fA14>
<country>Autriche</country>
<placeName><settlement type="city">Vienne (Autriche)</settlement>
<region nuts="2" type="province">Vienne (Autriche)</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Green, John" sort="Green, John" uniqKey="Green J" first="John" last="Green">John Green</name>
<affiliation wicri:level="1"><inist:fA14 i1="16"><s1>University of Liverpool</s1>
<s2>Liverpool</s2>
<s3>GBR</s3>
<sZ>14 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>University of Liverpool</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Buck, Martin" sort="Buck, Martin" uniqKey="Buck M" first="Martin" last="Buck">Martin Buck</name>
<affiliation wicri:level="1"><inist:fA14 i1="19"><s1>Government of Western Australia, Department of Health</s1>
<s2>Perth</s2>
<s3>AUS</s3>
<sZ>15 aut.</sZ>
</inist:fA14>
<country>Australie</country>
<wicri:noRegion>Perth</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name>
<affiliation wicri:level="3"><inist:fA14 i1="06"><s1>Centre Léon Béard</s1>
<s2>Lyon</s2>
<s3>FRA</s3>
<sZ>16 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="Ferrero, Annamaria" sort="Ferrero, Annamaria" uniqKey="Ferrero A" first="Annamaria" last="Ferrero">Annamaria Ferrero</name>
<affiliation wicri:level="3"><inist:fA14 i1="11"><s1>Ospedale Mauriziano Umberto I</s1>
<s2>Turin</s2>
<s3>ITA</s3>
<sZ>17 aut.</sZ>
</inist:fA14>
<country>Italie</country>
<placeName><settlement type="city">Turin</settlement>
<region type="région" nuts="2">Piémont</region>
</placeName>
</affiliation>
</author>
<author><name sortKey="Favier, Laure" sort="Favier, Laure" uniqKey="Favier L" first="Laure" last="Favier">Laure Favier</name>
<affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Centre Georges François Leclerc</s1>
<s2>Dijon</s2>
<s3>FRA</s3>
<sZ>18 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Bourgogne-Franche-Comté</region>
<region type="old region">Bourgogne</region>
<settlement type="city">Dijon</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Reed, Nick Simon" sort="Reed, Nick Simon" uniqKey="Reed N" first="Nick Simon" last="Reed">Nick Simon Reed</name>
<affiliation wicri:level="1"><inist:fA14 i1="17"><s1>Gartnavel General Hospitals</s1>
<s2>Glasgow</s2>
<s3>GBR</s3>
<sZ>19 aut.</sZ>
</inist:fA14>
<country>Royaume-Uni</country>
<wicri:noRegion>Gartnavel General Hospitals</wicri:noRegion>
</affiliation>
</author>
<author><name sortKey="Cure, Herve" sort="Cure, Herve" uniqKey="Cure H" first="Hervé" last="Cure">Hervé Cure</name>
<affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Unicancer Institut Jean Godinot</s1>
<s2>Reims</s2>
<s3>FRA</s3>
<sZ>20 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Grand Est</region>
<region type="old region">Champagne-Ardenne</region>
<settlement type="city">Reims</settlement>
</placeName>
</affiliation>
</author>
<author><name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name>
<affiliation wicri:level="3"><inist:fA14 i1="09"><s1>Hôpital Hôtel-Dieu</s1>
<s2>Paris</s2>
<s3>FRA</s3>
<sZ>21 aut.</sZ>
</inist:fA14>
<country>France</country>
<placeName><region type="region">Île-de-France</region>
<region type="old region">Île-de-France</region>
<settlement type="city">Paris</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="2014">2014</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>Antineoplastic agent</term>
<term>Cancerology</term>
<term>Comparative study</term>
<term>Erlotinib</term>
<term>Europe</term>
<term>Female genital diseases</term>
<term>First line treatment</term>
<term>Human</term>
<term>Malignant tumor</term>
<term>Ovary cancer</term>
<term>Ovary carcinoma</term>
<term>Phase III trial</term>
<term>Randomization</term>
<term>Research</term>
</keywords>
<keywords scheme="Pascal" xml:lang="fr"><term>Essai clinique phase III</term>
<term>Randomisation</term>
<term>Etude comparative</term>
<term>Erlotinib</term>
<term>Homme</term>
<term>Europe</term>
<term>Traitement de première intention</term>
<term>Recherche</term>
<term>Tumeur maligne</term>
<term>Carcinome de l'ovaire</term>
<term>Pathologie de l'appareil génital femelle</term>
<term>Cancérologie</term>
<term>Cancer de l'ovaire</term>
<term>Anticancéreux</term>
</keywords>
<keywords scheme="Wicri" type="topic" xml:lang="fr"><term>Homme</term>
<term>Recherche</term>
</keywords>
</textClass>
</profileDesc>
</teiHeader>
<front><div type="abstract" xml:lang="en">Purpose This trial evaluated the efficacy of maintenance erlotinib, an epidermal growth factor receptor (EGFR) tyrosine kinase inhibitor, after first-line chemotherapy. Patients and Methods Eligible patients had high-risk International Federation of Gynecology and Obstetrics stage I or stage II to IV epithelial ovarian, primary peritoneal, or fallopian tube cancer and were not selected for EGFR expression. All patients underwent first-line platinum-based chemotherapy (CT) and showed no signs of progression at the end of CT. Patients were randomly assigned to maintenance erlotinib 150 mg orally daily for 2 years or to observation. EGFR immunohistochemistry (IHC), fluorescent in situ hybridization (FISH), and mutation analyses were performed in 318 patients. Results Between October 2005 and February 2008, 835 patients were randomly assigned (median follow-up, 51 months). Twenty-six percent of the patients stopped erlotinib as a result of adverse effects (of these, 67% were due to rash). For erlotinib and observation, respectively, the median progression-free survival was 12.7 and 12.4 months (hazard ratio [HR], 1.05; 95% Cl, 0.90 to 1.23), and the median overall survival was 50.8 and 59.1 months (HR, 0.99; 95% Cl, 0.81 to 1.20 months), respectively. No subgroup could be identified with improved effect of erlotinib, based on IHC or FISH for EGFR, or mutations in genes related to the EGFR pathway, or on rash during erlotinib therapy. However, patients with a positive FISH EGFR score had a worse overall survival (46.1 months) than those with a negative score (67.0 months; HR, 1.56; 95% Cl, 1.01 to 2.40; P = .044). Global health/quality-of-life scores showed a significant difference during the first year (P = .0102) in favor of the observation arm. Conclusion Maintenance erlotinib after first-line treatment in ovarian cancer did not improve progression-free or overall survival.</div>
</front>
</TEI>
<affiliations><list><country><li>Australie</li>
<li>Autriche</li>
<li>Belgique</li>
<li>Espagne</li>
<li>France</li>
<li>Italie</li>
<li>Royaume-Uni</li>
<li>États-Unis</li>
</country>
<region><li>Auvergne-Rhône-Alpes</li>
<li>Basse-Normandie</li>
<li>Bourgogne</li>
<li>Bourgogne-Franche-Comté</li>
<li>Champagne-Ardenne</li>
<li>Communauté de Madrid</li>
<li>Grand Est</li>
<li>Hauts-de-France</li>
<li>Lombardie</li>
<li>Nord-Pas-de-Calais</li>
<li>Piémont</li>
<li>Rhône-Alpes</li>
<li>Région Normandie</li>
<li>Région de Bruxelles-Capitale</li>
<li>Tyrol (Land)</li>
<li>Vienne (Autriche)</li>
<li>Île-de-France</li>
</region>
<settlement><li>Bruxelles</li>
<li>Caen</li>
<li>Dijon</li>
<li>Innsbruck</li>
<li>Lille</li>
<li>Lyon</li>
<li>Madrid</li>
<li>Milan</li>
<li>Paris</li>
<li>Reims</li>
<li>Turin</li>
<li>Vienne (Autriche)</li>
</settlement>
<orgName><li>Université de médecine d'Innsbruck</li>
</orgName>
</list>
<tree><country name="Belgique"><noRegion><name sortKey="Vergote, Ignace B" sort="Vergote, Ignace B" uniqKey="Vergote I" first="Ignace B." last="Vergote">Ignace B. Vergote</name>
</noRegion>
<name sortKey="Coens, Corneel" sort="Coens, Corneel" uniqKey="Coens C" first="Corneel" last="Coens">Corneel Coens</name>
<name sortKey="Despierre, Evelyn" sort="Despierre, Evelyn" uniqKey="Despierre E" first="Evelyn" last="Despierre">Evelyn Despierre</name>
</country>
<country name="États-Unis"><noRegion><name sortKey="Jimeno, Antonio" sort="Jimeno, Antonio" uniqKey="Jimeno A" first="Antonio" last="Jimeno">Antonio Jimeno</name>
</noRegion>
<name sortKey="Hall, Marcia" sort="Hall, Marcia" uniqKey="Hall M" first="Marcia" last="Hall">Marcia Hall</name>
</country>
<country name="France"><region name="Région Normandie"><name sortKey="Joly, Florence" sort="Joly, Florence" uniqKey="Joly F" first="Florence" last="Joly">Florence Joly</name>
</region>
<name sortKey="Cure, Herve" sort="Cure, Herve" uniqKey="Cure H" first="Hervé" last="Cure">Hervé Cure</name>
<name sortKey="Favier, Laure" sort="Favier, Laure" uniqKey="Favier L" first="Laure" last="Favier">Laure Favier</name>
<name sortKey="Lesoin, Anne" sort="Lesoin, Anne" uniqKey="Lesoin A" first="Anne" last="Lesoin">Anne Lesoin</name>
<name sortKey="Pujade Lauraine, Eric" sort="Pujade Lauraine, Eric" uniqKey="Pujade Lauraine E" first="Eric" last="Pujade-Lauraine">Eric Pujade-Lauraine</name>
<name sortKey="Ray Coquard, Isabelle" sort="Ray Coquard, Isabelle" uniqKey="Ray Coquard I" first="Isabelle" last="Ray-Coquard">Isabelle Ray-Coquard</name>
</country>
<country name="Italie"><noRegion><name sortKey="Katsaros, Dionyssios" sort="Katsaros, Dionyssios" uniqKey="Katsaros D" first="Dionyssios" last="Katsaros">Dionyssios Katsaros</name>
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<name sortKey="Colombo, Nicoletta" sort="Colombo, Nicoletta" uniqKey="Colombo N" first="Nicoletta" last="Colombo">Nicoletta Colombo</name>
<name sortKey="Ferrero, Annamaria" sort="Ferrero, Annamaria" uniqKey="Ferrero A" first="Annamaria" last="Ferrero">Annamaria Ferrero</name>
</country>
<country name="Autriche"><region name="Tyrol (Land)"><name sortKey="Marth, Christian" sort="Marth, Christian" uniqKey="Marth C" first="Christian" last="Marth">Christian Marth</name>
</region>
<name sortKey="Reinthaller, Alexander" sort="Reinthaller, Alexander" uniqKey="Reinthaller A" first="Alexander" last="Reinthaller">Alexander Reinthaller</name>
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<country name="Australie"><noRegion><name sortKey="Steer, Christopher B" sort="Steer, Christopher B" uniqKey="Steer C" first="Christopher B." last="Steer">Christopher B. Steer</name>
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<name sortKey="Buck, Martin" sort="Buck, Martin" uniqKey="Buck M" first="Martin" last="Buck">Martin Buck</name>
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<country name="Espagne"><region name="Communauté de Madrid"><name sortKey="Casado, Antonio" sort="Casado, Antonio" uniqKey="Casado A" first="Antonio" last="Casado">Antonio Casado</name>
</region>
</country>
<country name="Royaume-Uni"><noRegion><name sortKey="Green, John" sort="Green, John" uniqKey="Green J" first="John" last="Green">John Green</name>
</noRegion>
<name sortKey="Reed, Nick Simon" sort="Reed, Nick Simon" uniqKey="Reed N" first="Nick Simon" last="Reed">Nick Simon Reed</name>
</country>
</tree>
</affiliations>
</record>

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   |texte=   Randomized Phase III Study of Erlotinib Versus Observation in Patients With No Evidence of Disease Progression After First-Line Platin-Based Chemotherapy for Ovarian Carcinoma: A European Organisation for Research and Treatment of Cancer-Gynaecological Cancer Group, and Gynecologic Cancer Intergroup Study
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	Serveur d'exploration sur les relations entre la France et l'Australie
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Serveur d'exploration sur les relations entre la France et l'Australie