An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer
Identifieur interne : 000098 ( OpenAccess/Analysis ); précédent : 000097; suivant : 000099An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer
Auteurs : G. Capri [Italie] ; J. Chang [Canada] ; S.-C. Chen [Taïwan] ; P. Conte [Italie] ; K. Cwiertka [République tchèque] ; G. Jerusalem [Belgique] ; Z. Jiang [République populaire de Chine] ; S. Johnston [Royaume-Uni] ; B. Kaufman [Israël] ; J. Link [États-Unis] ; J. Ro ; J. Schütte ; C. Oliva ; R. Parikh ; A. Preston ; J. Rosenlund ; M. Selzer ; D. Zembryki ; S. De PlacidoSource :
- Annals of oncology [ 0923-7534 ] ; 2010.
Descripteurs français
- Pascal (Inist)
- Wicri :
- topic : Homme.
English descriptors
- KwdEn :
- Accessibility, Advanced stage, Antineoplastic agent, Breast cancer, C-Onc gene, Capecitabine, Epidermal growth factor receptor, Gene overexpression, Human, Human Epidermal growth factor Receptor 2, Lapatinib, Locally advanced stage, Metastasis, Open access, Patient, Prodrug, Protooncogene, erbB2 Gene.
Abstract
Background: The Lapatinib Expanded Access Program (LEAP) was designed to provide access to lapatinib plus capecitabine for HER2-positive metastatic breast cancer patients who previously received an anthracycline, a taxane, and a trastuzumab and had no other treatment options. Patients and methods: LEAP opened globally and enrollment continued until lapatinib received regulatory approval in each participating country. Patients were assessed for progression-free survival (PFS) and overall survival (OS) and monitored for serious adverse events (SAEs). Results: As of 30 September 2008, 4283 patients from 45 countries enrolled in LEAP. The median treatment duration was 24.7 weeks. The most common drug-related SAEs were diarrhea (9.7%), vomiting (4.3%), and nausea (2.4%) and were mainly grade 3 or higher. The incidences of special interest SAEs were decreased left ventricle ejection fraction (0.5%), interstitial lung disease/pneumonitis (0.2%), and serious hepatobiliary events (0.4%). This safety profile is consistent with the overall lapatinib program. The median PFS and OS were 21.1 [95% confidence interval (CI) =20.1-22.3] and 39.6 (95% CI = 37.7-40.7) weeks, respectively (n = 4006). Subgroup analysis showed longer PFS and OS in patients who had not received prior capecitabine. Conclusions: These results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial.
Affiliations:
- Belgique, Canada, Israël, Italie, Royaume-Uni, République populaire de Chine, République tchèque, Taïwan, États-Unis
- Angleterre, Californie, Grand Londres
- Londres, Pékin
Links toward previous steps (curation, corpus...)
- to stream PascalFrancis, to step Corpus: 000053
- to stream PascalFrancis, to step Curation: 000093
- to stream PascalFrancis, to step Checkpoint: 000045
- to stream Main, to step Merge: 001054
- to stream Main, to step Curation: 001052
- to stream Main, to step Exploration: 001052
- to stream OpenAccess, to step Extraction: 000098
Links to Exploration step
Pascal:10-0256201Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en" level="a">An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer</title><author><name sortKey="Capri, G" sort="Capri, G" uniqKey="Capri G" first="G." last="Capri">G. Capri</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medical Oncology, Fondazione IRCCS Istituto Tumori</s1><s2>Milano</s2><s3>ITA</s3><sZ>1 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Milano</wicri:noRegion></affiliation></author><author><name sortKey="Chang, J" sort="Chang, J" uniqKey="Chang J" first="J." last="Chang">J. Chang</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Medical Oncology Program, RS McLaughlin Durham Regional Cancer Centre</s1><s2>Oshawa, Ontario</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Oshawa, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Chen, S C" sort="Chen, S C" uniqKey="Chen S" first="S.-C." last="Chen">S.-C. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of General Surgery, Chang Gung Memorial Hospital</s1><s2>Taipei</s2><s3>TWN</s3><sZ>3 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taipei</wicri:noRegion></affiliation></author><author><name sortKey="Conte, P" sort="Conte, P" uniqKey="Conte P" first="P." last="Conte">P. Conte</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Oncology and Hematology, Universita degli Studi di Modena e Reggio Emilia</s1><s2>Modena</s2><s3>ITA</s3><sZ>4 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Modena</wicri:noRegion></affiliation></author><author><name sortKey="Cwiertka, K" sort="Cwiertka, K" uniqKey="Cwiertka K" first="K." last="Cwiertka">K. Cwiertka</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Oncology, Hospital Olomouc</s1><s2>Olomouc</s2><s3>CZE</s3><sZ>5 aut.</sZ></inist:fA14><country>République tchèque</country><wicri:noRegion>Olomouc</wicri:noRegion></affiliation></author><author><name sortKey="Jerusalem, G" sort="Jerusalem, G" uniqKey="Jerusalem G" first="G." last="Jerusalem">G. Jerusalem</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Medical Oncology, CHU Liège Hospital du Sart-Tilman</s1><s2>Liège</s2><s3>BEL</s3><sZ>6 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Liège</wicri:noRegion></affiliation></author><author><name sortKey="Jiang, Z" sort="Jiang, Z" uniqKey="Jiang Z" first="Z." last="Jiang">Z. Jiang</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Breast Cancer Department, The Hospital Associated With Military Medical Science</s1><s2>Beijing</s2><s3>CHN</s3><sZ>7 aut.</sZ></inist:fA14><country>République populaire de Chine</country><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Johnston, S" sort="Johnston, S" uniqKey="Johnston S" first="S." last="Johnston">S. Johnston</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Medical Oncology, Royal Marsden NHS Foundation Trust & Institute of Cancer Research</s1><s2>London</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kaufman, B" sort="Kaufman, B" uniqKey="Kaufman B" first="B." last="Kaufman">B. Kaufman</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Breast Cancer Unit, Sheba Medical Center</s1><s2>Ramat Gan</s2><s3>ISR</s3><sZ>9 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Ramat Gan</wicri:noRegion></affiliation></author><author><name sortKey="Link, J" sort="Link, J" uniqKey="Link J" first="J." last="Link">J. Link</name><affiliation wicri:level="2"><inist:fA14 i1="10"><s1>Breast Link Medical Group, Inc.</s1><s2>Long Beach, CA</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Ro, J" sort="Ro, J" uniqKey="Ro J" first="J." last="Ro">J. Ro</name></author><author><name sortKey="Schutte, J" sort="Schutte, J" uniqKey="Schutte J" first="J." last="Schütte">J. Schütte</name></author><author><name sortKey="Oliva, C" sort="Oliva, C" uniqKey="Oliva C" first="C." last="Oliva">C. Oliva</name></author><author><name sortKey="Parikh, R" sort="Parikh, R" uniqKey="Parikh R" first="R." last="Parikh">R. Parikh</name></author><author><name sortKey="Preston, A" sort="Preston, A" uniqKey="Preston A" first="A." last="Preston">A. Preston</name></author><author><name sortKey="Rosenlund, J" sort="Rosenlund, J" uniqKey="Rosenlund J" first="J." last="Rosenlund">J. Rosenlund</name></author><author><name sortKey="Selzer, M" sort="Selzer, M" uniqKey="Selzer M" first="M." last="Selzer">M. Selzer</name></author><author><name sortKey="Zembryki, D" sort="Zembryki, D" uniqKey="Zembryki D" first="D." last="Zembryki">D. Zembryki</name></author><author><name sortKey="De Placido, S" sort="De Placido, S" uniqKey="De Placido S" first="S." last="De Placido">S. De Placido</name></author></titleStmt><publicationStmt><idno type="wicri:source">INIST</idno><idno type="inist">10-0256201</idno><date when="2010">2010</date><idno type="stanalyst">PASCAL 10-0256201 INIST</idno><idno type="RBID">Pascal:10-0256201</idno><idno type="wicri:Area/PascalFrancis/Corpus">000053</idno><idno type="wicri:Area/PascalFrancis/Curation">000093</idno><idno type="wicri:Area/PascalFrancis/Checkpoint">000045</idno><idno type="wicri:doubleKey">0923-7534:2010:Capri G:an:open:label</idno><idno type="wicri:Area/Main/Merge">001054</idno><idno type="wicri:Area/Main/Curation">001052</idno><idno type="wicri:Area/Main/Exploration">001052</idno><idno type="wicri:Area/OpenAccess/Extraction">000098</idno></publicationStmt><sourceDesc><biblStruct><analytic><title xml:lang="en" level="a">An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer</title><author><name sortKey="Capri, G" sort="Capri, G" uniqKey="Capri G" first="G." last="Capri">G. Capri</name><affiliation wicri:level="1"><inist:fA14 i1="01"><s1>Department of Medical Oncology, Fondazione IRCCS Istituto Tumori</s1><s2>Milano</s2><s3>ITA</s3><sZ>1 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Milano</wicri:noRegion></affiliation></author><author><name sortKey="Chang, J" sort="Chang, J" uniqKey="Chang J" first="J." last="Chang">J. Chang</name><affiliation wicri:level="1"><inist:fA14 i1="02"><s1>Medical Oncology Program, RS McLaughlin Durham Regional Cancer Centre</s1><s2>Oshawa, Ontario</s2><s3>CAN</s3><sZ>2 aut.</sZ></inist:fA14><country>Canada</country><wicri:noRegion>Oshawa, Ontario</wicri:noRegion></affiliation></author><author><name sortKey="Chen, S C" sort="Chen, S C" uniqKey="Chen S" first="S.-C." last="Chen">S.-C. Chen</name><affiliation wicri:level="1"><inist:fA14 i1="03"><s1>Department of General Surgery, Chang Gung Memorial Hospital</s1><s2>Taipei</s2><s3>TWN</s3><sZ>3 aut.</sZ></inist:fA14><country>Taïwan</country><wicri:noRegion>Taipei</wicri:noRegion></affiliation></author><author><name sortKey="Conte, P" sort="Conte, P" uniqKey="Conte P" first="P." last="Conte">P. Conte</name><affiliation wicri:level="1"><inist:fA14 i1="04"><s1>Department of Oncology and Hematology, Universita degli Studi di Modena e Reggio Emilia</s1><s2>Modena</s2><s3>ITA</s3><sZ>4 aut.</sZ></inist:fA14><country>Italie</country><wicri:noRegion>Modena</wicri:noRegion></affiliation></author><author><name sortKey="Cwiertka, K" sort="Cwiertka, K" uniqKey="Cwiertka K" first="K." last="Cwiertka">K. Cwiertka</name><affiliation wicri:level="1"><inist:fA14 i1="05"><s1>Department of Oncology, Hospital Olomouc</s1><s2>Olomouc</s2><s3>CZE</s3><sZ>5 aut.</sZ></inist:fA14><country>République tchèque</country><wicri:noRegion>Olomouc</wicri:noRegion></affiliation></author><author><name sortKey="Jerusalem, G" sort="Jerusalem, G" uniqKey="Jerusalem G" first="G." last="Jerusalem">G. Jerusalem</name><affiliation wicri:level="1"><inist:fA14 i1="06"><s1>Department of Medical Oncology, CHU Liège Hospital du Sart-Tilman</s1><s2>Liège</s2><s3>BEL</s3><sZ>6 aut.</sZ></inist:fA14><country>Belgique</country><wicri:noRegion>Liège</wicri:noRegion></affiliation></author><author><name sortKey="Jiang, Z" sort="Jiang, Z" uniqKey="Jiang Z" first="Z." last="Jiang">Z. Jiang</name><affiliation wicri:level="3"><inist:fA14 i1="07"><s1>Breast Cancer Department, The Hospital Associated With Military Medical Science</s1><s2>Beijing</s2><s3>CHN</s3><sZ>7 aut.</sZ></inist:fA14><country>République populaire de Chine</country><placeName><settlement type="city">Pékin</settlement></placeName></affiliation></author><author><name sortKey="Johnston, S" sort="Johnston, S" uniqKey="Johnston S" first="S." last="Johnston">S. Johnston</name><affiliation wicri:level="3"><inist:fA14 i1="08"><s1>Department of Medical Oncology, Royal Marsden NHS Foundation Trust & Institute of Cancer Research</s1><s2>London</s2><s3>GBR</s3><sZ>8 aut.</sZ></inist:fA14><country>Royaume-Uni</country><placeName><settlement type="city">Londres</settlement><region type="country">Angleterre</region><region type="région" nuts="1">Grand Londres</region></placeName></affiliation></author><author><name sortKey="Kaufman, B" sort="Kaufman, B" uniqKey="Kaufman B" first="B." last="Kaufman">B. Kaufman</name><affiliation wicri:level="1"><inist:fA14 i1="09"><s1>Breast Cancer Unit, Sheba Medical Center</s1><s2>Ramat Gan</s2><s3>ISR</s3><sZ>9 aut.</sZ></inist:fA14><country>Israël</country><wicri:noRegion>Ramat Gan</wicri:noRegion></affiliation></author><author><name sortKey="Link, J" sort="Link, J" uniqKey="Link J" first="J." last="Link">J. Link</name><affiliation wicri:level="2"><inist:fA14 i1="10"><s1>Breast Link Medical Group, Inc.</s1><s2>Long Beach, CA</s2><s3>USA</s3><sZ>10 aut.</sZ></inist:fA14><country>États-Unis</country><placeName><region type="state">Californie</region></placeName></affiliation></author><author><name sortKey="Ro, J" sort="Ro, J" uniqKey="Ro J" first="J." last="Ro">J. Ro</name></author><author><name sortKey="Schutte, J" sort="Schutte, J" uniqKey="Schutte J" first="J." last="Schütte">J. Schütte</name></author><author><name sortKey="Oliva, C" sort="Oliva, C" uniqKey="Oliva C" first="C." last="Oliva">C. Oliva</name></author><author><name sortKey="Parikh, R" sort="Parikh, R" uniqKey="Parikh R" first="R." last="Parikh">R. Parikh</name></author><author><name sortKey="Preston, A" sort="Preston, A" uniqKey="Preston A" first="A." last="Preston">A. Preston</name></author><author><name sortKey="Rosenlund, J" sort="Rosenlund, J" uniqKey="Rosenlund J" first="J." last="Rosenlund">J. Rosenlund</name></author><author><name sortKey="Selzer, M" sort="Selzer, M" uniqKey="Selzer M" first="M." last="Selzer">M. Selzer</name></author><author><name sortKey="Zembryki, D" sort="Zembryki, D" uniqKey="Zembryki D" first="D." last="Zembryki">D. Zembryki</name></author><author><name sortKey="De Placido, S" sort="De Placido, S" uniqKey="De Placido S" first="S." last="De Placido">S. De Placido</name></author></analytic><series><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno><imprint><date when="2010">2010</date></imprint></series></biblStruct></sourceDesc><seriesStmt><title level="j" type="main">Annals of oncology</title><title level="j" type="abbreviated">Ann. oncol.</title><idno type="ISSN">0923-7534</idno></seriesStmt></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Accessibility</term><term>Advanced stage</term><term>Antineoplastic agent</term><term>Breast cancer</term><term>C-Onc gene</term><term>Capecitabine</term><term>Epidermal growth factor receptor</term><term>Gene overexpression</term><term>Human</term><term>Human Epidermal growth factor Receptor 2</term><term>Lapatinib</term><term>Locally advanced stage</term><term>Metastasis</term><term>Open access</term><term>Patient</term><term>Prodrug</term><term>Protooncogene</term><term>erbB2 Gene</term></keywords><keywords scheme="Pascal" xml:lang="fr"><term>Libre accès</term><term>Lapatinib</term><term>Capécitabine</term><term>Homme</term><term>Malade</term><term>Gène onc cellulaire</term><term>Protooncogène</term><term>Gène erbB2</term><term>Surexpression génique</term><term>Stade avancé</term><term>Métastase</term><term>Cancer du sein</term><term>Récepteur facteur croissance épiderme</term><term>Accessibilité</term><term>Anticancéreux</term><term>Promédicament</term><term>Récepteur HER2</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">Background: The Lapatinib Expanded Access Program (LEAP) was designed to provide access to lapatinib plus capecitabine for HER2-positive metastatic breast cancer patients who previously received an anthracycline, a taxane, and a trastuzumab and had no other treatment options. Patients and methods: LEAP opened globally and enrollment continued until lapatinib received regulatory approval in each participating country. Patients were assessed for progression-free survival (PFS) and overall survival (OS) and monitored for serious adverse events (SAEs). Results: As of 30 September 2008, 4283 patients from 45 countries enrolled in LEAP. The median treatment duration was 24.7 weeks. The most common drug-related SAEs were diarrhea (9.7%), vomiting (4.3%), and nausea (2.4%) and were mainly grade 3 or higher. The incidences of special interest SAEs were decreased left ventricle ejection fraction (0.5%), interstitial lung disease/pneumonitis (0.2%), and serious hepatobiliary events (0.4%). This safety profile is consistent with the overall lapatinib program. The median PFS and OS were 21.1 [95% confidence interval (CI) =20.1-22.3] and 39.6 (95% CI = 37.7-40.7) weeks, respectively (n = 4006). Subgroup analysis showed longer PFS and OS in patients who had not received prior capecitabine. Conclusions: These results demonstrate the safety and efficacy of lapatinib in a broader patient population compared with a clinical trial.</div></front></TEI><affiliations><list><country><li>Belgique</li><li>Canada</li><li>Israël</li><li>Italie</li><li>Royaume-Uni</li><li>République populaire de Chine</li><li>République tchèque</li><li>Taïwan</li><li>États-Unis</li></country><region><li>Angleterre</li><li>Californie</li><li>Grand Londres</li></region><settlement><li>Londres</li><li>Pékin</li></settlement></list><tree><noCountry><name sortKey="De Placido, S" sort="De Placido, S" uniqKey="De Placido S" first="S." last="De Placido">S. De Placido</name><name sortKey="Oliva, C" sort="Oliva, C" uniqKey="Oliva C" first="C." last="Oliva">C. Oliva</name><name sortKey="Parikh, R" sort="Parikh, R" uniqKey="Parikh R" first="R." last="Parikh">R. Parikh</name><name sortKey="Preston, A" sort="Preston, A" uniqKey="Preston A" first="A." last="Preston">A. Preston</name><name sortKey="Ro, J" sort="Ro, J" uniqKey="Ro J" first="J." last="Ro">J. Ro</name><name sortKey="Rosenlund, J" sort="Rosenlund, J" uniqKey="Rosenlund J" first="J." last="Rosenlund">J. Rosenlund</name><name sortKey="Schutte, J" sort="Schutte, J" uniqKey="Schutte J" first="J." last="Schütte">J. Schütte</name><name sortKey="Selzer, M" sort="Selzer, M" uniqKey="Selzer M" first="M." last="Selzer">M. Selzer</name><name sortKey="Zembryki, D" sort="Zembryki, D" uniqKey="Zembryki D" first="D." last="Zembryki">D. Zembryki</name></noCountry><country name="Italie"><noRegion><name sortKey="Capri, G" sort="Capri, G" uniqKey="Capri G" first="G." last="Capri">G. Capri</name></noRegion><name sortKey="Conte, P" sort="Conte, P" uniqKey="Conte P" first="P." last="Conte">P. Conte</name></country><country name="Canada"><noRegion><name sortKey="Chang, J" sort="Chang, J" uniqKey="Chang J" first="J." last="Chang">J. Chang</name></noRegion></country><country name="Taïwan"><noRegion><name sortKey="Chen, S C" sort="Chen, S C" uniqKey="Chen S" first="S.-C." last="Chen">S.-C. Chen</name></noRegion></country><country name="République tchèque"><noRegion><name sortKey="Cwiertka, K" sort="Cwiertka, K" uniqKey="Cwiertka K" first="K." last="Cwiertka">K. Cwiertka</name></noRegion></country><country name="Belgique"><noRegion><name sortKey="Jerusalem, G" sort="Jerusalem, G" uniqKey="Jerusalem G" first="G." last="Jerusalem">G. Jerusalem</name></noRegion></country><country name="République populaire de Chine"><noRegion><name sortKey="Jiang, Z" sort="Jiang, Z" uniqKey="Jiang Z" first="Z." last="Jiang">Z. Jiang</name></noRegion></country><country name="Royaume-Uni"><region name="Angleterre"><name sortKey="Johnston, S" sort="Johnston, S" uniqKey="Johnston S" first="S." last="Johnston">S. Johnston</name></region></country><country name="Israël"><noRegion><name sortKey="Kaufman, B" sort="Kaufman, B" uniqKey="Kaufman B" first="B." last="Kaufman">B. Kaufman</name></noRegion></country><country name="États-Unis"><region name="Californie"><name sortKey="Link, J" sort="Link, J" uniqKey="Link J" first="J." last="Link">J. Link</name></region></country></tree></affiliations></record>Pour manipuler ce document sous Unix (Dilib)
EXPLOR_STEP=$WICRI_ROOT/Wicri/Belgique/explor/OpenAccessBelV2/Data/OpenAccess/Analysis
HfdSelect -h $EXPLOR_STEP/biblio.hfd -nk 000098 | SxmlIndent | more
Ou
HfdSelect -h $EXPLOR_AREA/Data/OpenAccess/Analysis/biblio.hfd -nk 000098 | SxmlIndent | more
Pour mettre un lien sur cette page dans le réseau Wicri
{{Explor lien
|wiki= Wicri/Belgique
|area= OpenAccessBelV2
|flux= OpenAccess
|étape= Analysis
|type= RBID
|clé= Pascal:10-0256201
|texte= An open-label expanded access study of lapatinib and capecitabine in patients with HER2-overexpressing locally advanced or metastatic breast cancer
}}
| This area was generated with Dilib version V0.6.25. |  |