Show simple item record

dc.contributor.authorCristofanilli, Men_US
dc.contributor.authorDeMichele, Aen_US
dc.contributor.authorGiorgetti, Cen_US
dc.contributor.authorTurner, NCen_US
dc.contributor.authorSlamon, DJen_US
dc.contributor.authorIm, S-Aen_US
dc.contributor.authorMasuda, Nen_US
dc.contributor.authorVerma, Sen_US
dc.contributor.authorLoi, Sen_US
dc.contributor.authorColleoni, Men_US
dc.contributor.authorTheall, KPen_US
dc.contributor.authorHuang, Xen_US
dc.contributor.authorLiu, Yen_US
dc.contributor.authorBartlett, CHen_US
dc.coverage.spatialEnglanden_US
dc.date.accessioned2018-11-14T11:05:35Z
dc.date.issued2018-11en_US
dc.identifierhttps://www.ncbi.nlm.nih.gov/pubmed/30308388en_US
dc.identifierS0959-8049(18)31148-1en_US
dc.identifier.citationEur J Cancer, 2018, 104 pp. 21 - 31en_US
dc.identifier.urihttps://repository.icr.ac.uk/handle/internal/2933
dc.identifier.eissn1879-0852en_US
dc.identifier.doi10.1016/j.ejca.2018.08.011en_US
dc.description.abstractBACKGROUND: The addition of palbociclib to fulvestrant improved clinical outcomes over placebo-fulvestrant in endocrine-pretreated metastatic breast cancer (MBC) patients in PALOMA-3. Here, we examined factors predictive of long-term benefit. METHODS: Premenopausal-peri/postmenopausal patients with endocrine-resistant, hormone receptor-positive (HR+)/human epidermal growth factor receptor 2-negative MBC were randomised 2:1 to fulvestrant (500 mg) and either palbociclib (125 mg/d; 3/1 schedule; n = 347) or placebo (n = 174). Baseline characteristics, mutation status and HR expression levels were compared in patients with and without prolonged benefit (treatment duration ≥18 months). RESULTS: By August 2016, 100 patients (29%) on palbociclib-fulvestrant and 26 (15%) on placebo-fulvestrant demonstrated prolonged benefit, with long-term responders in both arms sharing common clinical characteristics. They usually had less disease burden at baseline versus those treated <18 months, such as having one disease site (40% vs 29% on palbociclib-fulvestrant and 69% vs 29% on placebo-fulvestrant), bone-only disease (32% vs 22% and 46% vs 17%) and were less heavily pretreated (69% vs 56% and 73% vs 60% had ≤2 prior therapies). Baseline tumour ESR1 and PIK3CA mutation rates were lower among long-term responders in both arms; median oestrogen receptor H-scores were similar, whereas progesterone receptor H-scores were higher among long-term responders. CONCLUSIONS: This exploratory analysis demonstrates that some patients with endocrine-resistant MBC derive significant and prolonged benefit when treated with palbociclib-fulvestrant, with fewer patients experiencing similar efficacy with placebo-fulvestrant. The current analysis did not identify specific molecular or clinical factors prognostic of long-term benefit with palbociclib-fulvestrant (ClinicalTrials.gov, NCT01942135).en_US
dc.format.extent21 - 31en_US
dc.languageengen_US
dc.language.isoengen_US
dc.rights.urihttp://creativecommons.org/licenses/by/4.0/en_US
dc.subjectAdvanced breast canceren_US
dc.subjectFulvestranten_US
dc.subjectHR+/HER2–en_US
dc.subjectLong-term responseen_US
dc.subjectPalbocicliben_US
dc.titlePredictors of prolonged benefit from palbociclib plus fulvestrant in women with endocrine-resistant hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer in PALOMA-3.en_US
dc.typeJournal Article
dcterms.dateAccepted2018-08-16en_US
rioxxterms.versionofrecord10.1016/j.ejca.2018.08.011en_US
rioxxterms.licenseref.startdate2018-11en_US
rioxxterms.typeJournal Article/Reviewen_US
dc.relation.isPartOfEur J Canceren_US
pubs.notesNot knownen_US
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-statusPublisheden_US
pubs.volume104en_US
pubs.embargo.termsNot knownen_US
icr.researchteamMolecular Oncologyen_US
dc.contributor.icrauthorTurner, Nicholasen_US


Files in this item

Thumbnail

This item appears in the following Collection(s)

Show simple item record

http://creativecommons.org/licenses/by/4.0/
Except where otherwise noted, this item's license is described as http://creativecommons.org/licenses/by/4.0/