dc.contributor.author | Turner, NC | |
dc.contributor.author | Finn, RS | |
dc.contributor.author | Martin, M | |
dc.contributor.author | Im, S-A | |
dc.contributor.author | DeMichele, A | |
dc.contributor.author | Ettl, J | |
dc.contributor.author | Diéras, V | |
dc.contributor.author | Moulder, S | |
dc.contributor.author | Lipatov, O | |
dc.contributor.author | Colleoni, M | |
dc.contributor.author | Cristofanilli, M | |
dc.contributor.author | Lu, DR | |
dc.contributor.author | Mori, A | |
dc.contributor.author | Giorgetti, C | |
dc.contributor.author | Iyer, S | |
dc.contributor.author | Bartlett, CH | |
dc.contributor.author | Gelmon, KA | |
dc.date.accessioned | 2018-07-05T13:23:28Z | |
dc.date.issued | 2018-03-01 | |
dc.identifier.citation | Annals of oncology : official journal of the European Society for Medical Oncology, 2018, 29 (3), pp. 669 - 680 | |
dc.identifier.issn | 0923-7534 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/2002 | |
dc.identifier.eissn | 1569-8041 | |
dc.identifier.doi | 10.1093/annonc/mdx797 | |
dc.description.abstract | BACKGROUND: This report assesses the efficacy and safety of palbociclib plus endocrine therapy (ET) in women with hormone receptor-positive, human epidermal growth factor receptor 2-negative advanced breast cancer (ABC) with or without visceral metastases. PATIENTS AND METHODS: Pre- and postmenopausal women with disease progression following prior ET (PALOMA-3; N = 521) and postmenopausal women untreated for ABC (PALOMA-2; N = 666) were randomized 2 : 1 to ET (fulvestrant or letrozole, respectively) plus palbociclib or placebo. Progression-free survival (PFS), safety, and patient-reported quality of life (QoL) were evaluated by prior treatment and visceral involvement. RESULTS: Visceral metastases incidence was higher in patients with prior resistance to ET (58.3%, PALOMA-3) than in patients naive to ET in the ABC setting (48.6%, PALOMA-2). In patients with prior resistance to ET and visceral metastases, median PFS (mPFS) was 9.2 months with palbociclib plus fulvestrant versus 3.4 months with placebo plus fulvestrant [hazard ratio (HR), 0.47; 95% confidence interval (CI), 0.35-0.61], and objective response rate (ORR) was 28.0% versus 6.7%, respectively. In patients with nonvisceral metastases, mPFS was 16.6 versus 7.3 months, HR 0.53; 95% CI 0.36-0.77. In patients with visceral disease and naive to ET in the advanced disease setting, mPFS was 19.3 months with palbociclib plus letrozole versus 12.9 months with placebo plus letrozole (HR 0.63; 95% CI 0.47-0.85); ORR was 55.1% versus 40.0%; in patients with nonvisceral disease, mPFS was not reached with palbociclib plus letrozole versus 16.8 months with placebo plus letrozole (HR 0.50; 95% CI 0.36-0.70). In patients with prior resistance to ET with visceral metastases, palbociclib plus fulvestrant significantly delayed deterioration of QoL versus placebo plus fulvestrant, whereas patient-reported QoL was maintained with palbociclib plus letrozole in patients naive to endocrine-based therapy for ABC. CONCLUSIONS: Palbociclib plus ET prolonged mPFS in patients with visceral metastases, increased ORRs, and in patients previously treated for ABC, delayed QoL deterioration, presenting a standard treatment option among patients with visceral metastases amenable to endocrine-based therapy. CLINICAL TRIAL REGISTRATION: NCT01942135, NCT01740427. | |
dc.format | Print | |
dc.format.extent | 669 - 680 | |
dc.language | eng | |
dc.language.iso | eng | |
dc.publisher | OXFORD UNIV PRESS | |
dc.rights.uri | https://creativecommons.org/licenses/by/4.0 | |
dc.subject | Viscera | |
dc.subject | Humans | |
dc.subject | Breast Neoplasms | |
dc.subject | Neoplasm Metastasis | |
dc.subject | Piperazines | |
dc.subject | Pyridines | |
dc.subject | Antineoplastic Agents, Hormonal | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Quality of Life | |
dc.subject | Adult | |
dc.subject | Aged | |
dc.subject | Aged, 80 and over | |
dc.subject | Middle Aged | |
dc.subject | Female | |
dc.subject | Fulvestrant | |
dc.subject | Letrozole | |
dc.subject | Progression-Free Survival | |
dc.title | Clinical considerations of the role of palbociclib in the management of advanced breast cancer patients with and without visceral metastases. | |
dc.type | Journal Article | |
dcterms.dateAccepted | 2018-02-14 | |
rioxxterms.versionofrecord | 10.1093/annonc/mdx797 | |
rioxxterms.licenseref.uri | https://creativecommons.org/licenses/by-nc/4.0 | |
rioxxterms.licenseref.startdate | 2018-03 | |
rioxxterms.type | Journal Article/Review | |
dc.relation.isPartOf | Annals of oncology : official journal of the European Society for Medical Oncology | |
pubs.issue | 3 | |
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 | 29 | |
pubs.embargo.terms | Not known | |
icr.researchteam | Molecular Oncology | |
dc.contributor.icrauthor | Turner, Nicholas | |