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><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><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><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></titleStmt><publicationStmt><idno type="wicri:source">PubMed</idno><date when="2014">2014</date><idno type="RBID">pubmed:24742739</idno><idno type="pmid">24742739</idno><idno type="doi">10.1016/S1470-2045(14)70138-X</idno><idno type="wicri:Area/PubMed/Corpus">003810</idno><idno type="wicri:explorRef" wicri:stream="PubMed" wicri:step="Corpus" wicri:corpus="PubMed">003810</idno></publicationStmt><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><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><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></analytic><series><title level="j">The Lancet. Oncology</title><idno type="eISSN">1474-5488</idno><imprint><date when="2014" type="published">2014</date></imprint></series></biblStruct></sourceDesc></fileDesc><profileDesc><textClass><keywords scheme="KwdEn" xml:lang="en"><term>Adult</term><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></keywords><keywords scheme="MESH" type="chemical" qualifier="administration & dosage" xml:lang="en"><term>Antibodies, Monoclonal, Humanized</term></keywords><keywords scheme="MESH" type="chemical" qualifier="analogs & derivatives" xml:lang="en"><term>Sirolimus</term></keywords><keywords scheme="MESH" qualifier="drug effects" xml:lang="en"><term>Drug Resistance, Neoplasm</term></keywords><keywords scheme="MESH" qualifier="drug therapy" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="genetics" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="mortality" xml:lang="en"><term>Breast Neoplasms</term></keywords><keywords scheme="MESH" qualifier="therapeutic use" xml:lang="en"><term>Antineoplastic Combined Chemotherapy Protocols</term><term>Sirolimus</term></keywords><keywords scheme="MESH" xml:lang="en"><term>Adult</term><term>Aged</term><term>Aged, 80 and over</term><term>Disease-Free Survival</term><term>Double-Blind Method</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>Trastuzumab</term><term>Treatment Outcome</term></keywords></textClass></profileDesc></teiHeader><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><AffiliationInfo><Affiliation>NHO Osaka National Hospital, Chuou-ku, Osaka, Japan.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Wilks</LastName><ForeName>Sharon</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Cancer Care Centers of South Texas, San Antonio, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Arena</LastName><ForeName>Francis</ForeName><Initials>F</Initials><AffiliationInfo><Affiliation>NYU Langone Arena Oncology, Lake Success, NY, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Isaacs</LastName><ForeName>Claudine</ForeName><Initials>C</Initials><AffiliationInfo><Affiliation>Lombardi Comprehensive Cancer Center, Georgetown University, Washington, DC, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Yap</LastName><ForeName>Yoon-Sim</ForeName><Initials>YS</Initials><AffiliationInfo><Affiliation>National Cancer Centre Singapore, Singapore.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Papai</LastName><ForeName>Zsuzsanna</ForeName><Initials>Z</Initials><AffiliationInfo><Affiliation>Oncology Department, Military Hospital, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lang</LastName><ForeName>Istvan</ForeName><Initials>I</Initials><AffiliationInfo><Affiliation>Orszagos Onkologiai Intezet, Budapest, Hungary.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Armstrong</LastName><ForeName>Anne</ForeName><Initials>A</Initials><AffiliationInfo><Affiliation>Christie Hospital NHS Foundation Trust, Manchester, UK.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Lerzo</LastName><ForeName>Guillermo</ForeName><Initials>G</Initials><AffiliationInfo><Affiliation>Sanatorio de la Providencia, Buenos Aires, Argentina.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>White</LastName><ForeName>Michelle</ForeName><Initials>M</Initials><AffiliationInfo><Affiliation>Monash Medical Center, Moorabbin Hospital, Bentleigh East, VIC, Australia; Cabrini Brighton Hospital, Brighton, VIC, Australia.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Shen</LastName><ForeName>Kunwei</ForeName><Initials>K</Initials><AffiliationInfo><Affiliation>Comprehensive Breast Health Center, RuiJin Hospital, School of Medicine, Shanghai JiaoTong University, Shanghai, China.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Litton</LastName><ForeName>Jennifer</ForeName><Initials>J</Initials><AffiliationInfo><Affiliation>University of Texas MD Anderson Cancer Center, Houston, TX, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Chen</LastName><ForeName>David</ForeName><Initials>D</Initials><AffiliationInfo><Affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Zhang</LastName><ForeName>Yufen</ForeName><Initials>Y</Initials><AffiliationInfo><Affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Ali</LastName><ForeName>Shyanne</ForeName><Initials>S</Initials><AffiliationInfo><Affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Taran</LastName><ForeName>Tetiana</ForeName><Initials>T</Initials><AffiliationInfo><Affiliation>Oncology Global Development, Novartis Pharmaceuticals Corporation, East Hanover, NJ, USA.</Affiliation></AffiliationInfo></Author><Author ValidYN="Y"><LastName>Gianni</LastName><ForeName>Luca</ForeName><Initials>L</Initials><AffiliationInfo><Affiliation>Ospedale San Raffaele Scientific Institute, Milan, Italy. Electronic address: gianni.luca@hsr.it.</Affiliation></AffiliationInfo></Author></AuthorList><Language>eng</Language><DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName><AccessionNumberList><AccessionNumber>NCT01007942</AccessionNumber></AccessionNumberList></DataBank></DataBankList><GrantList CompleteYN="Y"><Grant><GrantID>P30 CA016672</GrantID><Acronym>CA</Acronym><Agency>NCI NIH HHS</Agency><Country>United States</Country></Grant></GrantList><PublicationTypeList><PublicationType UI="D017428">Clinical Trial, Phase III</PublicationType><PublicationType UI="D016428">Journal Article</PublicationType><PublicationType UI="D016448">Multicenter Study</PublicationType><PublicationType UI="D016449">Randomized Controlled Trial</PublicationType></PublicationTypeList><ArticleDate DateType="Electronic"><Year>2014</Year><Month>04</Month><Day>14</Day></ArticleDate></Article><MedlineJournalInfo><Country>England</Country><MedlineTA>Lancet Oncol</MedlineTA><NlmUniqueID>100957246</NlmUniqueID><ISSNLinking>1470-2045</ISSNLinking></MedlineJournalInfo><ChemicalList><Chemical><RegistryNumber>0</RegistryNumber><NameOfSubstance UI="D061067">Antibodies, Monoclonal, Humanized</NameOfSubstance></Chemical><Chemical><RegistryNumber>9HW64Q8G6G</RegistryNumber><NameOfSubstance UI="D000068338">Everolimus</NameOfSubstance></Chemical><Chemical><RegistryNumber>P188ANX8CK</RegistryNumber><NameOfSubstance UI="D000068878">Trastuzumab</NameOfSubstance></Chemical><Chemical><RegistryNumber>W36ZG6FT64</RegistryNumber><NameOfSubstance UI="D020123">Sirolimus</NameOfSubstance></Chemical></ChemicalList><CitationSubset>IM</CitationSubset><CommentsCorrectionsList><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Oncol. 2014 Jul;15(8):e304-5</RefSource><PMID Version="1">24988930</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Oncol. 2014 May;15(6):541-2</RefSource><PMID Version="1">24807856</PMID></CommentsCorrections><CommentsCorrections RefType="CommentIn"><RefSource>Lancet Oncol. 2014 Jul;15(8):e304</RefSource><PMID Version="1">24988929</PMID></CommentsCorrections></CommentsCorrectionsList><MeshHeadingList><MeshHeading><DescriptorName UI="D000328" MajorTopicYN="N">Adult</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000368" MajorTopicYN="N">Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D000369" MajorTopicYN="N">Aged, 80 and over</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D061067" MajorTopicYN="N">Antibodies, Monoclonal, Humanized</DescriptorName><QualifierName UI="Q000008" MajorTopicYN="N">administration & dosage</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000971" MajorTopicYN="N">Antineoplastic Combined Chemotherapy Protocols</DescriptorName><QualifierName UI="Q000627" MajorTopicYN="Y">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D001943" MajorTopicYN="N">Breast Neoplasms</DescriptorName><QualifierName UI="Q000188" MajorTopicYN="Y">drug therapy</QualifierName><QualifierName UI="Q000235" MajorTopicYN="N">genetics</QualifierName><QualifierName UI="Q000401" MajorTopicYN="N">mortality</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D018572" MajorTopicYN="N">Disease-Free Survival</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D004311" MajorTopicYN="N">Double-Blind Method</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D019008" MajorTopicYN="N">Drug Resistance, Neoplasm</DescriptorName><QualifierName UI="Q000187" MajorTopicYN="Y">drug effects</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068338" MajorTopicYN="N">Everolimus</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D005260" MajorTopicYN="N">Female</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D018734" MajorTopicYN="N">Genes, erbB-2</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D006801" MajorTopicYN="N">Humans</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D053208" MajorTopicYN="N">Kaplan-Meier Estimate</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D008875" MajorTopicYN="N">Middle Aged</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016016" MajorTopicYN="N">Proportional Hazards Models</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D020123" MajorTopicYN="N">Sirolimus</DescriptorName><QualifierName UI="Q000031" MajorTopicYN="Y">analogs & derivatives</QualifierName><QualifierName UI="Q000627" MajorTopicYN="N">therapeutic use</QualifierName></MeshHeading><MeshHeading><DescriptorName UI="D000068878" MajorTopicYN="N">Trastuzumab</DescriptorName></MeshHeading><MeshHeading><DescriptorName UI="D016896" MajorTopicYN="N">Treatment Outcome</DescriptorName></MeshHeading></MeshHeadingList></MedlineCitation><PubmedData><History><PubMedPubDate PubStatus="entrez"><Year>2014</Year><Month>4</Month><Day>19</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="pubmed"><Year>2014</Year><Month>4</Month><Day>20</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate><PubMedPubDate PubStatus="medline"><Year>2014</Year><Month>6</Month><Day>24</Day><Hour>6</Hour><Minute>0</Minute></PubMedPubDate></History><PublicationStatus>ppublish</PublicationStatus><ArticleIdList><ArticleId IdType="pubmed">24742739</ArticleId><ArticleId IdType="pii">S1470-2045(14)70138-X</ArticleId><ArticleId IdType="doi">10.1016/S1470-2045(14)70138-X</ArticleId></ArticleIdList></PubmedData></pubmed></record>Pour manipuler ce document sous Unix (Dilib)
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