dc.contributor.author | Martín, M | |
dc.contributor.author | Zielinski, C | |
dc.contributor.author | Ruiz-Borrego, M | |
dc.contributor.author | Carrasco, E | |
dc.contributor.author | Ciruelos, EM | |
dc.contributor.author | Muñoz, M | |
dc.contributor.author | Bermejo, B | |
dc.contributor.author | Margelí, M | |
dc.contributor.author | Csöszi, T | |
dc.contributor.author | Antón, A | |
dc.contributor.author | Turner, N | |
dc.contributor.author | Casas, MI | |
dc.contributor.author | Morales, S | |
dc.contributor.author | Alba, E | |
dc.contributor.author | Calvo, L | |
dc.contributor.author | de la Haba-Rodríguez, J | |
dc.contributor.author | Ramos, M | |
dc.contributor.author | Murillo, L | |
dc.contributor.author | Santaballa, A | |
dc.contributor.author | Alonso-Romero, JL | |
dc.contributor.author | Sánchez-Rovira, P | |
dc.contributor.author | Corsaro, M | |
dc.contributor.author | Huang, X | |
dc.contributor.author | Thallinger, C | |
dc.contributor.author | Kahan, Z | |
dc.contributor.author | Gil-Gil, M | |
dc.coverage.spatial | England | |
dc.date.accessioned | 2022-09-05T11:10:18Z | |
dc.date.available | 2022-09-05T11:10:18Z | |
dc.date.issued | 2022-06-01 | |
dc.identifier | S0959-8049(22)00146-0 | |
dc.identifier.citation | European Journal of Cancer, 2022, 168 pp. 12 - 24 | en_US |
dc.identifier.issn | 0959-8049 | |
dc.identifier.uri | https://repository.icr.ac.uk/handle/internal/5405 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.eissn | 1879-0852 | |
dc.identifier.doi | 10.1016/j.ejca.2022.03.006 | |
dc.description.abstract | BACKGROUND: An earlier analysis of the PEARL phase III study showed that palbociclib plus endocrine therapy (ET) does not improve progression-free survival (PFS) over capecitabine in aromatase inhibitor-resistant, hormone receptor-positive/human epidermal growth factor receptor 2-negative metastatic breast cancer (MBC) patients. Here, we report the final overall survival (OS) analysis. METHODS: Postmenopausal patients (N = 601) were randomized 1:1 to capecitabine or palbociclib plus ET (exemestane, Cohort 1; fulvestrant, Cohort 2). OS was analysed in Cohort 2, the wild-type ESR1 population and the overall population. Additionally, we analysed subsequent systemic therapies and explored PFS2 (time from randomization to the end of the first subsequent therapy/death). RESULTS: OS was 31.1 months for palbociclib plus fulvestrant and 32.8 months for capecitabine (adjusted hazard ratio [aHR] 1.10, 95% confidence interval [CI] 0.81-1.50, P = 0.550). In the wild-type ESR1 population, OS was 37.2 months for palbociclib plus ET and 34.8 months for capecitabine (aHR 1.06, 95% CI 0.81-1.37, P = 0.683). In OS analyses, no subgroup showed superiority for palbociclib plus ET over capecitabine. OS in the overall population was 32.6 months for palbociclib plus ET and 30.9 months for capecitabine (P = 0.995). Subsequent systemic therapy was given to 79.8% and 82.9% of patients with palbociclib plus ET and capecitabine, respectively. Median PFS2 was similar between study arms (Cohort 2, P = 0.941; wild-type ESR1 population, P = 0.827). No new safety findings were observed. CONCLUSIONS: Palbociclib plus ET did not show a statistically superior OS compared to capecitabine in MBC patients progressing on aromatase inhibitors. TRIAL REGISTRATION: NCT02028507 (ClinTrials.gov), 2013-003170-27 (EudraCT). | |
dc.format | Print-Electronic | |
dc.format.extent | 12 - 24 | |
dc.language | eng | |
dc.language.iso | eng | en_US |
dc.publisher | ELSEVIER SCI LTD | en_US |
dc.relation.ispartof | European Journal of Cancer | |
dc.rights.uri | https://creativecommons.org/licenses/by-nc-nd/4.0/ | en_US |
dc.subject | CDK4/6 inhibitor | |
dc.subject | Capecitabine | |
dc.subject | Endocrine therapy | |
dc.subject | HER2–negative | |
dc.subject | Hormone receptor-positive metastatic breast cancer | |
dc.subject | Overall survival | |
dc.subject | Palbociclib | |
dc.subject | Antineoplastic Combined Chemotherapy Protocols | |
dc.subject | Aromatase Inhibitors | |
dc.subject | Breast Neoplasms | |
dc.subject | Capecitabine | |
dc.subject | Female | |
dc.subject | Fulvestrant | |
dc.subject | Humans | |
dc.subject | Piperazines | |
dc.subject | Postmenopause | |
dc.subject | Pyridines | |
dc.subject | Receptor, ErbB-2 | |
dc.subject | Receptors, Estrogen | |
dc.title | Overall survival with palbociclib plus endocrine therapy versus capecitabine in postmenopausal patients with hormone receptor-positive, HER2-negative metastatic breast cancer in the PEARL study. | en_US |
dc.type | Journal Article | |
dcterms.dateAccepted | 2022-03-07 | |
dc.date.updated | 2022-09-05T10:45:34Z | |
rioxxterms.version | VoR | en_US |
rioxxterms.versionofrecord | 10.1016/j.ejca.2022.03.006 | en_US |
rioxxterms.licenseref.startdate | 2022-06-01 | |
rioxxterms.type | Journal Article/Review | en_US |
pubs.author-url | https://www.ncbi.nlm.nih.gov/pubmed/35429901 | |
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.publisher-url | http://dx.doi.org/10.1016/j.ejca.2022.03.006 | |
pubs.volume | 168 | |
icr.researchteam | Molecular Oncology | en_US |
dc.contributor.icrauthor | Turner, Nicholas | |
icr.provenance | Deposited by Mr Arek Surman on 2022-09-05. Deposit type is initial. No. of files: 1. Files: 1-s2.0-S0959804922001460-main.pdf | |