Serveur d'exploration sur les relations entre la France et l'Australie

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Palbociclib in Hormone-Receptor-Positive Advanced Breast Cancer.

Identifieur interne : 002860 ( PubMed/Checkpoint ); précédent : 002859; suivant : 002861

Palbociclib 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 Cristofanilli

Source :

RBID : pubmed:26030518

Descripteurs français

English descriptors

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:


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pubmed:26030518

Le document en format XML

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<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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<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>
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<Year>2015</Year>
<Month>07</Month>
<Day>16</Day>
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<Year>2015</Year>
<Month>07</Month>
<Day>23</Day>
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<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>
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<LastName>Turner</LastName>
<ForeName>Nicholas C</ForeName>
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<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>
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<Year>2015</Year>
<Month>06</Month>
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