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dc.contributor.authorTurner, NC
dc.contributor.authorSlamon, DJ
dc.contributor.authorRo, J
dc.contributor.authorBondarenko, I
dc.contributor.authorIm, S-A
dc.contributor.authorMasuda, N
dc.contributor.authorColleoni, M
dc.contributor.authorDeMichele, A
dc.contributor.authorLoi, S
dc.contributor.authorVerma, S
dc.contributor.authorIwata, H
dc.contributor.authorHarbeck, N
dc.contributor.authorLoibl, S
dc.contributor.authorAndré, F
dc.contributor.authorPuyana Theall, K
dc.contributor.authorHuang, X
dc.contributor.authorGiorgetti, C
dc.contributor.authorHuang Bartlett, C
dc.contributor.authorCristofanilli, M
dc.date.accessioned2018-11-06T11:46:41Z
dc.date.issued2018-11
dc.identifier.citationThe New England journal of medicine, 2018, 379 (20), pp. 1926 - 1936
dc.identifier.issn0028-4793
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2912
dc.identifier.eissn1533-4406
dc.identifier.doi10.1056/nejmoa1810527
dc.description.abstractBackground The cyclin-dependent kinase 4 and 6 (CDK4/6) inhibitor palbociclib, in combination with fulvestrant therapy, prolongs progression-free survival among patients with hormone-receptor-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced breast cancer. We report the results of a prespecified analysis of overall survival.Methods We randomly assigned patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had progression or relapse during previous endocrine therapy to receive palbociclib plus fulvestrant or placebo plus fulvestrant. We analyzed overall survival; the effect of palbociclib according to the prespecified stratification factors of presence or absence of sensitivity to endocrine therapy, presence or absence of visceral metastatic disease, and menopausal status; the efficacy of subsequent therapies after disease progression; and safety.Results Among 521 patients who underwent randomization, the median overall survival was 34.9 months (95% confidence interval [CI], 28.8 to 40.0) in the palbociclib-fulvestrant group and 28.0 months (95% CI, 23.6 to 34.6) in the placebo-fulvestrant group (hazard ratio for death, 0.81; 95% CI, 0.64 to 1.03; P=0.09; absolute difference, 6.9 months). CDK4/6 inhibitor treatment after the completion of the trial regimen occurred in 16% of the patients in the placebo-fulvestrant group. Among 410 patients with sensitivity to previous endocrine therapy, the median overall survival was 39.7 months (95% CI, 34.8 to 45.7) in the palbociclib-fulvestrant group and 29.7 months (95% CI, 23.8 to 37.9) in the placebo-fulvestrant group (hazard ratio, 0.72; 95% CI, 0.55 to 0.94; absolute difference, 10.0 months). The median duration of subsequent therapy was similar in the two groups, and the median time to the receipt of chemotherapy was 17.6 months in the palbociclib-fulvestrant group, as compared with 8.8 months in the placebo-fulvestrant group (hazard ratio, 0.58; 95% CI, 0.47 to 0.73; P<0.001). No new safety signals were observed with 44.8 months of follow-up.Conclusions Among patients with hormone-receptor-positive, HER2-negative advanced breast cancer who had sensitivity to previous endocrine therapy, treatment with palbociclib-fulvestrant resulted in longer overall survival than treatment with placebo-fulvestrant. The differences in overall survival in the entire trial group were not significant. (Funded by Pfizer; PALOMA-3 ClinicalTrials.gov number, NCT01942135 .).
dc.formatPrint-Electronic
dc.format.extent1926 - 1936
dc.languageeng
dc.language.isoeng
dc.rights.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
dc.subjectHumans
dc.subjectBreast Neoplasms
dc.subjectPiperazines
dc.subjectPyridines
dc.subjectEstradiol
dc.subjectReceptors, Steroid
dc.subjectAntineoplastic Combined Chemotherapy Protocols
dc.subjectProtein Kinase Inhibitors
dc.subjectSurvival Analysis
dc.subjectDouble-Blind Method
dc.subjectAged
dc.subjectMiddle Aged
dc.subjectFemale
dc.subjectErbB Receptors
dc.subjectFulvestrant
dc.titleOverall Survival with Palbociclib and Fulvestrant in Advanced Breast Cancer.
dc.typeJournal Article
dcterms.dateAccepted2018-10-20
rioxxterms.versionofrecord10.1056/nejmoa1810527
rioxxterms.licenseref.urihttps://www.rioxx.net/licenses/under-embargo-all-rights-reserved
rioxxterms.licenseref.startdate2018-11
rioxxterms.typeJournal Article/Review
dc.relation.isPartOfThe New England journal of medicine
pubs.issue20
pubs.notesNot known
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.organisational-group/ICR
pubs.organisational-group/ICR/Primary Group
pubs.organisational-group/ICR/Primary Group/ICR Divisions
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research
pubs.organisational-group/ICR/Primary Group/ICR Divisions/Breast Cancer Research/Molecular Oncology
pubs.publication-statusPublished
pubs.volume379
pubs.embargo.termsNot known
icr.researchteamMolecular Oncologyen_US
dc.contributor.icrauthorTurner, Nicholasen


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