Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.
Identifieur interne : 003810 ( PubMed/Corpus ); précédent : 003809; suivant : 003811Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.
Auteurs : Fabrice André ; Ruth O'Regan ; Mustafa Ozguroglu ; Masakazu Toi ; Binghe Xu ; Guy Jerusalem ; Norikazu Masuda ; Sharon Wilks ; Francis Arena ; Claudine Isaacs ; Yoon-Sim Yap ; Zsuzsanna Papai ; Istvan Lang ; Anne Armstrong ; Guillermo Lerzo ; Michelle White ; Kunwei Shen ; Jennifer Litton ; David Chen ; Yufen Zhang ; Shyanne Ali ; Tetiana Taran ; Luca GianniSource :
- The Lancet. Oncology [ 1474-5488 ] ; 2014.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antibodies, Monoclonal, Humanized (administration & dosage), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Breast Neoplasms (drug therapy), Breast Neoplasms (genetics), Breast Neoplasms (mortality), Disease-Free Survival, Double-Blind Method, Drug Resistance, Neoplasm (drug effects), Everolimus, Female, Genes, erbB-2, Humans, Kaplan-Meier Estimate, Middle Aged, Proportional Hazards Models, Sirolimus (analogs & derivatives), Sirolimus (therapeutic use), Trastuzumab, Treatment Outcome.
- MESH :
- chemical , administration & dosage : Antibodies, Monoclonal, Humanized.
- chemical , analogs & derivatives : Sirolimus.
- drug effects : Drug Resistance, Neoplasm.
- drug therapy : Breast Neoplasms.
- genetics : Breast Neoplasms.
- mortality : Breast Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Sirolimus.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Double-Blind Method, Everolimus, Female, Genes, erbB-2, Humans, Kaplan-Meier Estimate, Middle Aged, Proportional Hazards Models, Trastuzumab, Treatment Outcome.
Abstract
Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway. We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab.
DOI: 10.1016/S1470-2045(14)70138-X
PubMed: 24742739
Links to Exploration step
pubmed:24742739Le document en format XML
<record><TEI><teiHeader><fileDesc><titleStmt><title xml:lang="en">Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.</title>
<author><name sortKey="Andre, Fabrice" sort="Andre, Fabrice" uniqKey="Andre F" first="Fabrice" last="André">Fabrice André</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, INSERM Unit U981, Université Paris Sud, Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="O Regan, Ruth" sort="O Regan, Ruth" uniqKey="O Regan R" first="Ruth" last="O'Regan">Ruth O'Regan</name>
<affiliation><nlm:affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ozguroglu, Mustafa" sort="Ozguroglu, Mustafa" uniqKey="Ozguroglu M" first="Mustafa" last="Ozguroglu">Mustafa Ozguroglu</name>
<affiliation><nlm:affiliation>Cerrahpasa Medical Faculty, Department of Medicine, Division of Medical Oncology, Istanbul University, Istanbul, Turkey.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Toi, Masakazu" sort="Toi, Masakazu" uniqKey="Toi M" first="Masakazu" last="Toi">Masakazu Toi</name>
<affiliation><nlm:affiliation>Kyoto University, Sakyo-ku, Kyoto, Japan.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Xu, Binghe" sort="Xu, Binghe" uniqKey="Xu B" first="Binghe" last="Xu">Binghe Xu</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang District, Beijing, China.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Jerusalem, Guy" sort="Jerusalem, Guy" uniqKey="Jerusalem G" first="Guy" last="Jerusalem">Guy Jerusalem</name>
<affiliation><nlm:affiliation>Centre Hospitalier Universitaire du Sart-Tilman, Domaine Universitaire B35, Liège, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Masuda, Norikazu" sort="Masuda, Norikazu" uniqKey="Masuda N" first="Norikazu" last="Masuda">Norikazu Masuda</name>
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</affiliation>
</author>
<author><name sortKey="Wilks, Sharon" sort="Wilks, Sharon" uniqKey="Wilks S" first="Sharon" last="Wilks">Sharon Wilks</name>
<affiliation><nlm:affiliation>Cancer Care Centers of South Texas, San Antonio, TX, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Arena, Francis" sort="Arena, Francis" uniqKey="Arena F" first="Francis" last="Arena">Francis Arena</name>
<affiliation><nlm:affiliation>NYU Langone Arena Oncology, Lake Success, NY, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Isaacs, Claudine" sort="Isaacs, Claudine" uniqKey="Isaacs C" first="Claudine" last="Isaacs">Claudine Isaacs</name>
<affiliation><nlm:affiliation>Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Yap, Yoon Sim" sort="Yap, Yoon Sim" uniqKey="Yap Y" first="Yoon-Sim" last="Yap">Yoon-Sim Yap</name>
<affiliation><nlm:affiliation>National Cancer Centre Singapore, Singapore.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Papai, Zsuzsanna" sort="Papai, Zsuzsanna" uniqKey="Papai Z" first="Zsuzsanna" last="Papai">Zsuzsanna Papai</name>
<affiliation><nlm:affiliation>Oncology Department, Military Hospital, Budapest, Hungary.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="Istvan" last="Lang">Istvan Lang</name>
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</affiliation>
</author>
<author><name sortKey="Armstrong, Anne" sort="Armstrong, Anne" uniqKey="Armstrong A" first="Anne" last="Armstrong">Anne Armstrong</name>
<affiliation><nlm:affiliation>Christie Hospital NHS Foundation Trust, Manchester, UK.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lerzo, Guillermo" sort="Lerzo, Guillermo" uniqKey="Lerzo G" first="Guillermo" last="Lerzo">Guillermo Lerzo</name>
<affiliation><nlm:affiliation>Sanatorio de la Providencia, Buenos Aires, Argentina.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="White, Michelle" sort="White, Michelle" uniqKey="White M" first="Michelle" last="White">Michelle White</name>
<affiliation><nlm:affiliation>Monash Medical Center, Moorabbin Hospital, Bentleigh East, VIC, Australia; Cabrini Brighton Hospital, Brighton, VIC, Australia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Shen, Kunwei" sort="Shen, Kunwei" uniqKey="Shen K" first="Kunwei" last="Shen">Kunwei Shen</name>
<affiliation><nlm:affiliation>Comprehensive Breast Health Center, RuiJin Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Litton, Jennifer" sort="Litton, Jennifer" uniqKey="Litton J" first="Jennifer" last="Litton">Jennifer Litton</name>
<affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Chen, David" sort="Chen, David" uniqKey="Chen D" first="David" last="Chen">David Chen</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Zhang, Yufen" sort="Zhang, Yufen" uniqKey="Zhang Y" first="Yufen" last="Zhang">Yufen Zhang</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ali, Shyanne" sort="Ali, Shyanne" uniqKey="Ali S" first="Shyanne" last="Ali">Shyanne Ali</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Taran, Tetiana" sort="Taran, Tetiana" uniqKey="Taran T" first="Tetiana" last="Taran">Tetiana Taran</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name>
<affiliation><nlm:affiliation>Ospedale San Raffaele Scientific Institute, Milan, Italy. Electronic address: gianni.luca@hsr.it.</nlm:affiliation>
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<sourceDesc><biblStruct><analytic><title xml:lang="en">Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.</title>
<author><name sortKey="Andre, Fabrice" sort="Andre, Fabrice" uniqKey="Andre F" first="Fabrice" last="André">Fabrice André</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, INSERM Unit U981, Université Paris Sud, Institut Gustave Roussy, Villejuif, France.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="O Regan, Ruth" sort="O Regan, Ruth" uniqKey="O Regan R" first="Ruth" last="O'Regan">Ruth O'Regan</name>
<affiliation><nlm:affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ozguroglu, Mustafa" sort="Ozguroglu, Mustafa" uniqKey="Ozguroglu M" first="Mustafa" last="Ozguroglu">Mustafa Ozguroglu</name>
<affiliation><nlm:affiliation>Cerrahpasa Medical Faculty, Department of Medicine, Division of Medical Oncology, Istanbul University, Istanbul, Turkey.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Toi, Masakazu" sort="Toi, Masakazu" uniqKey="Toi M" first="Masakazu" last="Toi">Masakazu Toi</name>
<affiliation><nlm:affiliation>Kyoto University, Sakyo-ku, Kyoto, Japan.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Xu, Binghe" sort="Xu, Binghe" uniqKey="Xu B" first="Binghe" last="Xu">Binghe Xu</name>
<affiliation><nlm:affiliation>Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang District, Beijing, China.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Jerusalem, Guy" sort="Jerusalem, Guy" uniqKey="Jerusalem G" first="Guy" last="Jerusalem">Guy Jerusalem</name>
<affiliation><nlm:affiliation>Centre Hospitalier Universitaire du Sart-Tilman, Domaine Universitaire B35, Liège, Belgium.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Masuda, Norikazu" sort="Masuda, Norikazu" uniqKey="Masuda N" first="Norikazu" last="Masuda">Norikazu Masuda</name>
<affiliation><nlm:affiliation>NHO Osaka National Hospital, Chuou-ku, Osaka, Japan.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Wilks, Sharon" sort="Wilks, Sharon" uniqKey="Wilks S" first="Sharon" last="Wilks">Sharon Wilks</name>
<affiliation><nlm:affiliation>Cancer Care Centers of South Texas, San Antonio, TX, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Arena, Francis" sort="Arena, Francis" uniqKey="Arena F" first="Francis" last="Arena">Francis Arena</name>
<affiliation><nlm:affiliation>NYU Langone Arena Oncology, Lake Success, NY, USA.</nlm:affiliation>
</affiliation>
</author>
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<affiliation><nlm:affiliation>Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Yap, Yoon Sim" sort="Yap, Yoon Sim" uniqKey="Yap Y" first="Yoon-Sim" last="Yap">Yoon-Sim Yap</name>
<affiliation><nlm:affiliation>National Cancer Centre Singapore, Singapore.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Papai, Zsuzsanna" sort="Papai, Zsuzsanna" uniqKey="Papai Z" first="Zsuzsanna" last="Papai">Zsuzsanna Papai</name>
<affiliation><nlm:affiliation>Oncology Department, Military Hospital, Budapest, Hungary.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lang, Istvan" sort="Lang, Istvan" uniqKey="Lang I" first="Istvan" last="Lang">Istvan Lang</name>
<affiliation><nlm:affiliation>Orszagos Onkologiai Intezet, Budapest, Hungary.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Armstrong, Anne" sort="Armstrong, Anne" uniqKey="Armstrong A" first="Anne" last="Armstrong">Anne Armstrong</name>
<affiliation><nlm:affiliation>Christie Hospital NHS Foundation Trust, Manchester, UK.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Lerzo, Guillermo" sort="Lerzo, Guillermo" uniqKey="Lerzo G" first="Guillermo" last="Lerzo">Guillermo Lerzo</name>
<affiliation><nlm:affiliation>Sanatorio de la Providencia, Buenos Aires, Argentina.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="White, Michelle" sort="White, Michelle" uniqKey="White M" first="Michelle" last="White">Michelle White</name>
<affiliation><nlm:affiliation>Monash Medical Center, Moorabbin Hospital, Bentleigh East, VIC, Australia; Cabrini Brighton Hospital, Brighton, VIC, Australia.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Shen, Kunwei" sort="Shen, Kunwei" uniqKey="Shen K" first="Kunwei" last="Shen">Kunwei Shen</name>
<affiliation><nlm:affiliation>Comprehensive Breast Health Center, RuiJin Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Litton, Jennifer" sort="Litton, Jennifer" uniqKey="Litton J" first="Jennifer" last="Litton">Jennifer Litton</name>
<affiliation><nlm:affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Chen, David" sort="Chen, David" uniqKey="Chen D" first="David" last="Chen">David Chen</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Zhang, Yufen" sort="Zhang, Yufen" uniqKey="Zhang Y" first="Yufen" last="Zhang">Yufen Zhang</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Ali, Shyanne" sort="Ali, Shyanne" uniqKey="Ali S" first="Shyanne" last="Ali">Shyanne Ali</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Taran, Tetiana" sort="Taran, Tetiana" uniqKey="Taran T" first="Tetiana" last="Taran">Tetiana Taran</name>
<affiliation><nlm:affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</nlm:affiliation>
</affiliation>
</author>
<author><name sortKey="Gianni, Luca" sort="Gianni, Luca" uniqKey="Gianni L" first="Luca" last="Gianni">Luca Gianni</name>
<affiliation><nlm:affiliation>Ospedale San Raffaele Scientific Institute, Milan, Italy. Electronic address: gianni.luca@hsr.it.</nlm:affiliation>
</affiliation>
</author>
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<term>Aged</term>
<term>Aged, 80 and over</term>
<term>Antibodies, Monoclonal, Humanized (administration & dosage)</term>
<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Breast Neoplasms (drug therapy)</term>
<term>Breast Neoplasms (genetics)</term>
<term>Breast Neoplasms (mortality)</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
<term>Drug Resistance, Neoplasm (drug effects)</term>
<term>Everolimus</term>
<term>Female</term>
<term>Genes, erbB-2</term>
<term>Humans</term>
<term>Kaplan-Meier Estimate</term>
<term>Middle Aged</term>
<term>Proportional Hazards Models</term>
<term>Sirolimus (analogs & derivatives)</term>
<term>Sirolimus (therapeutic use)</term>
<term>Trastuzumab</term>
<term>Treatment Outcome</term>
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<front><div type="abstract" xml:lang="en">Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway. We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">24742739</PMID>
<DateCreated><Year>2014</Year>
<Month>05</Month>
<Day>08</Day>
</DateCreated>
<DateCompleted><Year>2014</Year>
<Month>06</Month>
<Day>23</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>10</Month>
<Day>25</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1474-5488</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>15</Volume>
<Issue>6</Issue>
<PubDate><Year>2014</Year>
<Month>May</Month>
</PubDate>
</JournalIssue>
<Title>The Lancet. Oncology</Title>
<ISOAbbreviation>Lancet Oncol.</ISOAbbreviation>
</Journal>
<ArticleTitle>Everolimus for women with trastuzumab-resistant, HER2-positive, advanced breast cancer (BOLERO-3): a randomised, double-blind, placebo-controlled phase 3 trial.</ArticleTitle>
<Pagination><MedlinePgn>580-91</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1016/S1470-2045(14)70138-X</ELocationID>
<ELocationID EIdType="pii" ValidYN="Y">S1470-2045(14)70138-X</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Disease progression in patients with HER2-positive breast cancer receiving trastuzumab might be associated with activation of the PI3K/Akt/mTOR intracellular signalling pathway. We aimed to assess whether the addition of the mTOR inhibitor everolimus to trastuzumab might restore sensitivity to trastuzumab.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">In this randomised, double-blind, placebo-controlled, phase 3 trial, we recruited women with HER2-positive, trastuzumab-resistant, advanced breast carcinoma who had previously received taxane therapy. Eligible patients were randomly assigned (1:1) using a central patient screening and randomisation system to daily everolimus (5 mg/day) plus weekly trastuzumab (2 mg/kg) and vinorelbine (25 mg/m(2)) or to placebo plus trastuzumab plus vinorelbine, in 3-week cycles, stratified by previous lapatinib use. The primary endpoint was progression-free survival (PFS) by local assessment in the intention-to-treat population. We report the final analysis for PFS; overall survival follow-up is still in progress. This trial is registered with ClinicalTrials.gov, number NCT01007942.</AbstractText>
<AbstractText Label="FINDINGS" NlmCategory="RESULTS">Between Oct 26, 2009, and May 23, 2012, 569 patients were randomly assigned to everolimus (n=284) or placebo (n=285). Median follow-up at the time of analysis was 20.2 months (IQR 15.0-27.1). Median PFS was 7.00 months (95% CI 6.74-8.18) with everolimus and 5.78 months (5.49-6.90) with placebo (hazard ratio 0.78 [95% CI 0.65-0.95]; p=0.0067). The most common grade 3-4 adverse events were neutropenia (204 [73%] of 280 patients in the everolimus group vs 175 [62%] of 282 patients in the placebo group), leucopenia (106 [38%] vs 82 [29%]), anaemia (53 [19%] vs 17 [6%]), febrile neutropenia (44 [16%] vs ten [4%]), stomatitis (37 [13%] vs four [1%]), and fatigue (34 [12%] vs 11 [4%]). Serious adverse events were reported in 117 (42%) patients in the everolimus group and 55 (20%) in the placebo group; two on-treatment deaths due to adverse events occurred in each group.</AbstractText>
<AbstractText Label="INTERPRETATION" NlmCategory="CONCLUSIONS">The addition of everolimus to trastuzumab plus vinorelbine significantly prolongs PFS in patients with trastuzumab-resistant and taxane-pretreated, HER2-positive, advanced breast cancer. The clinical benefit should be considered in the context of the adverse event profile in this population.</AbstractText>
<CopyrightInformation>Copyright © 2014 Elsevier Ltd. All rights reserved.</CopyrightInformation>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>André</LastName>
<ForeName>Fabrice</ForeName>
<Initials>F</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, INSERM Unit U981, Université Paris Sud, Institut Gustave Roussy, Villejuif, France.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>O'Regan</LastName>
<ForeName>Ruth</ForeName>
<Initials>R</Initials>
<AffiliationInfo><Affiliation>Winship Cancer Institute of Emory University, Atlanta, GA, USA.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ozguroglu</LastName>
<ForeName>Mustafa</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Cerrahpasa Medical Faculty, Department of Medicine, Division of Medical Oncology, Istanbul University, Istanbul, Turkey.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Toi</LastName>
<ForeName>Masakazu</ForeName>
<Initials>M</Initials>
<AffiliationInfo><Affiliation>Kyoto University, Sakyo-ku, Kyoto, Japan.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Xu</LastName>
<ForeName>Binghe</ForeName>
<Initials>B</Initials>
<AffiliationInfo><Affiliation>Department of Medical Oncology, Cancer Hospital and Institute, Chinese Academy of Medical Sciences and Peking Union Medical College, Chaoyang District, Beijing, China.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Jerusalem</LastName>
<ForeName>Guy</ForeName>
<Initials>G</Initials>
<AffiliationInfo><Affiliation>Centre Hospitalier Universitaire du Sart-Tilman, Domaine Universitaire B35, Liège, Belgium.</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Masuda</LastName>
<ForeName>Norikazu</ForeName>
<Initials>N</Initials>
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<Initials>A</Initials>
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<Initials>J</Initials>
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<Initials>D</Initials>
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<Initials>Y</Initials>
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<Agency>NCI NIH HHS</Agency>
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<ISSNLinking>1470-2045</ISSNLinking>
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<MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName>
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<MeshHeading><DescriptorName UI="D018734" MajorTopicYN="N">Genes, erbB-2</DescriptorName>
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<MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName>
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<MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName>
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<MeshHeading><DescriptorName UI="D020123" MajorTopicYN="N">Sirolimus</DescriptorName>
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<QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName>
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</MeshHeading>
<MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName>
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