Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.
Identifieur interne : 002860 ( PubMed/Checkpoint ); précédent : 002859; suivant : 002861Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.
Auteurs : Nicholas C. Turner [Australie] ; Jungsil Ro ; Fabrice André ; Sherene Loi ; Sunil Verma ; Hiroji Iwata ; Nadia Harbeck ; Sibylle Loibl ; Cynthia Huang Bartlett ; Ke Zhang ; Carla Giorgetti ; Sophia Randolph ; Maria Koehler ; Massimo CristofanilliSource :
- The New England journal of medicine [ 1533-4406 ] ; 2015.
Descripteurs français
- KwdFr :
- Adulte, Adulte d'âge moyen, Femelle, Humains, Inhibiteurs de protéines kinases (effets indésirables), Inhibiteurs de protéines kinases (usage thérapeutique), Kinase-4 cycline-dépendante (antagonistes et inhibiteurs), Kinase-6 cycline-dépendante (antagonistes et inhibiteurs), Marqueurs biologiques (analyse), Méthode en double aveugle, Oestradiol (analogues et dérivés), Oestradiol (effets indésirables), Oestradiol (usage thérapeutique), Pipérazines (effets indésirables), Pipérazines (usage thérapeutique), Protocoles de polychimiothérapie antinéoplasique (effets indésirables), Protocoles de polychimiothérapie antinéoplasique (usage thérapeutique), Pyridines (effets indésirables), Pyridines (usage thérapeutique), Récepteur ErbB-2 (analyse), Récepteurs des oestrogènes (analyse), Récepteurs à la progestérone (analyse), Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute, Tumeurs du sein (traitement médicamenteux).
- MESH :
- analogues et dérivés : Oestradiol.
- analyse : Marqueurs biologiques, Récepteur ErbB-2, Récepteurs des oestrogènes, Récepteurs à la progestérone.
- antagonistes et inhibiteurs : Kinase-4 cycline-dépendante, Kinase-6 cycline-dépendante.
- effets indésirables : Inhibiteurs de protéines kinases, Oestradiol, Pipérazines, Protocoles de polychimiothérapie antinéoplasique, Pyridines.
- traitement médicamenteux : Tumeurs du sein.
- usage thérapeutique : Inhibiteurs de protéines kinases, Oestradiol, Pipérazines, Protocoles de polychimiothérapie antinéoplasique, Pyridines.
- Adulte, Adulte d'âge moyen, Femelle, Humains, Méthode en double aveugle, Sujet âgé, Sujet âgé de 80 ans ou plus, Survie sans rechute.
English descriptors
- KwdEn :
- Adult, Aged, Aged, 80 and over, Antineoplastic Combined Chemotherapy Protocols (adverse effects), Antineoplastic Combined Chemotherapy Protocols (therapeutic use), Biomarkers (analysis), Breast Neoplasms (drug therapy), Cyclin-Dependent Kinase 4 (antagonists & inhibitors), Cyclin-Dependent Kinase 6 (antagonists & inhibitors), Disease-Free Survival, Double-Blind Method, Estradiol (adverse effects), Estradiol (analogs & derivatives), Estradiol (therapeutic use), Female, Humans, Middle Aged, Piperazines (adverse effects), Piperazines (therapeutic use), Protein Kinase Inhibitors (adverse effects), Protein Kinase Inhibitors (therapeutic use), Pyridines (adverse effects), Pyridines (therapeutic use), Receptor, ErbB-2 (analysis), Receptors, Estrogen (analysis), Receptors, Progesterone (analysis).
- MESH :
- chemical , adverse effects : Estradiol, Piperazines, Protein Kinase Inhibitors, Pyridines.
- chemical , analogs & derivatives : Estradiol.
- chemical , analysis : Biomarkers, Receptor, ErbB-2, Receptors, Estrogen, Receptors, Progesterone.
- adverse effects : Antineoplastic Combined Chemotherapy Protocols.
- chemical , antagonists & inhibitors : Cyclin-Dependent Kinase 4, Cyclin-Dependent Kinase 6.
- drug therapy : Breast Neoplasms.
- therapeutic use : Antineoplastic Combined Chemotherapy Protocols, Estradiol, Piperazines, Protein Kinase Inhibitors, Pyridines.
- Adult, Aged, Aged, 80 and over, Disease-Free Survival, Double-Blind Method, Female, Humans, Middle Aged.
Abstract
Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which promote progression from the G1 phase to the S phase of the cell cycle. We assessed the efficacy of palbociclib (an inhibitor of CDK4 and CDK6) and fulvestrant in advanced breast cancer.
DOI: 10.1056/NEJMoa1505270
PubMed: 26030518
Affiliations:
Links toward previous steps (curation, corpus...)
Links to Exploration step
pubmed:26030518Le document en format XML
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<affiliation wicri:level="4"><nlm:affiliation>From Royal Marsden Hospital, London (N.C.T.); National Cancer Center, Goyang-si, South Korea (J.R.); Institut Gustave Roussy, Villejuif, France (F.A.); Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia (S. Loi); Sunnybrook Odette Cancer Centre, Toronto (S.V.); Aichi Cancer Center Hospital, Nagoya, Japan (H.I.); Brustzentrum der Universität München, Munich (N.H.), and German Breast Group Forschungs, Neu-Isenburg (S. Loibl) - both in Germany; Pfizer, New York (C.H.B., M.K.), La Jolla, CA (K.Z., S.R.), and Milan (C.G.); and Thomas Jefferson University, Philadelphia (M.C.).</nlm:affiliation>
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<term>Antineoplastic Combined Chemotherapy Protocols (therapeutic use)</term>
<term>Biomarkers (analysis)</term>
<term>Breast Neoplasms (drug therapy)</term>
<term>Cyclin-Dependent Kinase 4 (antagonists & inhibitors)</term>
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<term>Humains</term>
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<term>Inhibiteurs de protéines kinases (usage thérapeutique)</term>
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<term>Sujet âgé de 80 ans ou plus</term>
<term>Survie sans rechute</term>
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<term>Receptors, Estrogen</term>
<term>Receptors, Progesterone</term>
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<term>Piperazines</term>
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<term>Pyridines</term>
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<term>Pipérazines</term>
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<term>Aged, 80 and over</term>
<term>Disease-Free Survival</term>
<term>Double-Blind Method</term>
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<term>Humans</term>
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<front><div type="abstract" xml:lang="en">Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which promote progression from the G1 phase to the S phase of the cell cycle. We assessed the efficacy of palbociclib (an inhibitor of CDK4 and CDK6) and fulvestrant in advanced breast cancer.</div>
</front>
</TEI>
<pubmed><MedlineCitation Status="MEDLINE" Owner="NLM"><PMID Version="1">26030518</PMID>
<DateCreated><Year>2015</Year>
<Month>07</Month>
<Day>16</Day>
</DateCreated>
<DateCompleted><Year>2015</Year>
<Month>07</Month>
<Day>23</Day>
</DateCompleted>
<DateRevised><Year>2016</Year>
<Month>02</Month>
<Day>02</Day>
</DateRevised>
<Article PubModel="Print-Electronic"><Journal><ISSN IssnType="Electronic">1533-4406</ISSN>
<JournalIssue CitedMedium="Internet"><Volume>373</Volume>
<Issue>3</Issue>
<PubDate><Year>2015</Year>
<Month>Jul</Month>
<Day>16</Day>
</PubDate>
</JournalIssue>
<Title>The New England journal of medicine</Title>
<ISOAbbreviation>N. Engl. J. Med.</ISOAbbreviation>
</Journal>
<ArticleTitle>Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.</ArticleTitle>
<Pagination><MedlinePgn>209-19</MedlinePgn>
</Pagination>
<ELocationID EIdType="doi" ValidYN="Y">10.1056/NEJMoa1505270</ELocationID>
<Abstract><AbstractText Label="BACKGROUND" NlmCategory="BACKGROUND">Growth of hormone-receptor-positive breast cancer is dependent on cyclin-dependent kinases 4 and 6 (CDK4 and CDK6), which promote progression from the G1 phase to the S phase of the cell cycle. We assessed the efficacy of palbociclib (an inhibitor of CDK4 and CDK6) and fulvestrant in advanced breast cancer.</AbstractText>
<AbstractText Label="METHODS" NlmCategory="METHODS">This phase 3 study involved 521 patients with advanced hormone-receptor-positive, human epidermal growth factor receptor 2-negative breast cancer that had relapsed or progressed during prior endocrine therapy. We randomly assigned patients in a 2:1 ratio to receive palbociclib and fulvestrant or placebo and fulvestrant. Premenopausal or perimenopausal women also received goserelin. The primary end point was investigator-assessed progression-free survival. Secondary end points included overall survival, objective response, rate of clinical benefit, patient-reported outcomes, and safety. A preplanned interim analysis was performed by an independent data and safety monitoring committee after 195 events of disease progression or death had occurred.</AbstractText>
<AbstractText Label="RESULTS" NlmCategory="RESULTS">The median progression-free survival was 9.2 months (95% confidence interval [CI], 7.5 to not estimable) with palbociclib-fulvestrant and 3.8 months (95% CI, 3.5 to 5.5) with placebo-fulvestrant (hazard ratio for disease progression or death, 0.42; 95% CI, 0.32 to 0.56; P<0.001). The most common grade 3 or 4 adverse events in the palbociclib-fulvestrant group were neutropenia (62.0%, vs. 0.6% in the placebo-fulvestrant group), leukopenia (25.2% vs. 0.6%), anemia (2.6% vs. 1.7%), thrombocytopenia (2.3% vs. 0%), and fatigue (2.0% vs. 1.2%). Febrile neutropenia was reported in 0.6% of palbociclib-treated patients and 0.6% of placebo-treated patients. The rate of discontinuation due to adverse events was 2.6% with palbociclib and 1.7% with placebo.</AbstractText>
<AbstractText Label="CONCLUSIONS" NlmCategory="CONCLUSIONS">Among patients with hormone-receptor-positive metastatic breast cancer who had progression of disease during prior endocrine therapy, palbociclib combined with fulvestrant resulted in longer progression-free survival than fulvestrant alone. (Funded by Pfizer; PALOMA3 ClinicalTrials.gov number, NCT01942135.).</AbstractText>
</Abstract>
<AuthorList CompleteYN="Y"><Author ValidYN="Y"><LastName>Turner</LastName>
<ForeName>Nicholas C</ForeName>
<Initials>NC</Initials>
<AffiliationInfo><Affiliation>From Royal Marsden Hospital, London (N.C.T.); National Cancer Center, Goyang-si, South Korea (J.R.); Institut Gustave Roussy, Villejuif, France (F.A.); Peter MacCallum Cancer Centre, University of Melbourne, Melbourne, VIC, Australia (S. Loi); Sunnybrook Odette Cancer Centre, Toronto (S.V.); Aichi Cancer Center Hospital, Nagoya, Japan (H.I.); Brustzentrum der Universität München, Munich (N.H.), and German Breast Group Forschungs, Neu-Isenburg (S. Loibl) - both in Germany; Pfizer, New York (C.H.B., M.K.), La Jolla, CA (K.Z., S.R.), and Milan (C.G.); and Thomas Jefferson University, Philadelphia (M.C.).</Affiliation>
</AffiliationInfo>
</Author>
<Author ValidYN="Y"><LastName>Ro</LastName>
<ForeName>Jungsil</ForeName>
<Initials>J</Initials>
</Author>
<Author ValidYN="Y"><LastName>André</LastName>
<ForeName>Fabrice</ForeName>
<Initials>F</Initials>
</Author>
<Author ValidYN="Y"><LastName>Loi</LastName>
<ForeName>Sherene</ForeName>
<Initials>S</Initials>
</Author>
<Author ValidYN="Y"><LastName>Verma</LastName>
<ForeName>Sunil</ForeName>
<Initials>S</Initials>
</Author>
<Author ValidYN="Y"><LastName>Iwata</LastName>
<ForeName>Hiroji</ForeName>
<Initials>H</Initials>
</Author>
<Author ValidYN="Y"><LastName>Harbeck</LastName>
<ForeName>Nadia</ForeName>
<Initials>N</Initials>
</Author>
<Author ValidYN="Y"><LastName>Loibl</LastName>
<ForeName>Sibylle</ForeName>
<Initials>S</Initials>
</Author>
<Author ValidYN="Y"><LastName>Huang Bartlett</LastName>
<ForeName>Cynthia</ForeName>
<Initials>C</Initials>
</Author>
<Author ValidYN="Y"><LastName>Zhang</LastName>
<ForeName>Ke</ForeName>
<Initials>K</Initials>
</Author>
<Author ValidYN="Y"><LastName>Giorgetti</LastName>
<ForeName>Carla</ForeName>
<Initials>C</Initials>
</Author>
<Author ValidYN="Y"><LastName>Randolph</LastName>
<ForeName>Sophia</ForeName>
<Initials>S</Initials>
</Author>
<Author ValidYN="Y"><LastName>Koehler</LastName>
<ForeName>Maria</ForeName>
<Initials>M</Initials>
</Author>
<Author ValidYN="Y"><LastName>Cristofanilli</LastName>
<ForeName>Massimo</ForeName>
<Initials>M</Initials>
</Author>
<Author ValidYN="Y"><CollectiveName>PALOMA3 Study Group</CollectiveName>
</Author>
</AuthorList>
<Language>eng</Language>
<DataBankList CompleteYN="Y"><DataBank><DataBankName>ClinicalTrials.gov</DataBankName>
<AccessionNumberList><AccessionNumber>NCT01942135</AccessionNumber>
</AccessionNumberList>
</DataBank>
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