dc.contributor.author | Cristofanilli, M | |
dc.contributor.author | DeMichele, A | |
dc.contributor.author | Giorgetti, C | |
dc.contributor.author | Turner, NC | |
dc.contributor.author | Slamon, DJ | |
dc.contributor.author | Im, S-A | |
dc.contributor.author | Masuda, N | |
dc.contributor.author | Verma, S | |
dc.contributor.author | Loi, S | |
dc.contributor.author | Colleoni, M | |
dc.contributor.author | Theall, KP | |
dc.contributor.author | Huang, X | |
dc.contributor.author | Liu, Y | |
dc.contributor.author | Bartlett, CH | |
dc.date.accessioned | 2018-11-14T11:05:35Z | |
dc.date.issued | 2018-11-01 | |
dc.identifier.citation | European journal of cancer (Oxford, England : 1990), 2018, 104 pp. 21 - 31 | |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2933 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2018.08.011 | |
dc.description.abstract | BACKGROUND: 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). | |
dc.format | Print-Electronic | |
dc.format.extent | 21 - 31 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | ELSEVIER SCI LTD | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Humans | |
dc.subject | Carcinoma | |
dc.subject | Breast Neoplasms | |
dc.subject | Neoplasms, Hormone-Dependent | |
dc.subject | Piperazines | |
dc.subject | Pyridines | |
dc.subject | Progesterone | |
dc.subject | Receptor, erbB-2 | |
dc.subject | Neoplasm Proteins | |
dc.subject | Receptors, Estrogen | |
dc.subject | Receptors, Progesterone | |
dc.subject | Antineoplastic Agents, Hormonal | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Estrogens | |
dc.subject | Disease-Free Survival | |
dc.subject | Proportional Hazards Models | |
dc.subject | Follow-Up Studies | |
dc.subject | Double-Blind Method | |
dc.subject | Drug Resistance, Neoplasm | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Kaplan-Meier Estimate | |
dc.subject | Fulvestrant | |
dc.subject | Progression-Free Survival | |
dc.title | Predictors 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. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-08-16 | |
rioxxterms.versionofrecord | 10.1016/j.ejca.2018.08.011 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by/4.0 | |
rioxxterms.licenseref.startdate | 2018-11 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | European journal of cancer (Oxford, England : 1990) | |
pubs.notes | Not 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-status | Published | |
pubs.volume | 104 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Molecular Oncology | |
dc.contributor.icrauthor | Turner, Nicholas | |