dc.creator | Albanell, J. | es |
dc.creator | Martínez, M. T. | es |
dc.creator | Ramos, M. | es |
dc.creator | O´Connor, M. | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Santaballa, A. | es |
dc.creator | Rojo, F. | es |
dc.date.accessioned | 2022-09-21T10:59:34Z | |
dc.date.available | 2022-09-21T10:59:34Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Albanell, J., Martínez, M.T., Ramos, M., O´Connor, M., De la Cruz Merino, L., Santaballa, A. y Rojo, F. (2022). Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2–advanced breast cancer: GEICAM/2014–12 (FLIPPER). European Journal of Cancer, 161, 26-37. | |
dc.identifier.issn | 0959-8049 | es |
dc.identifier.issn | 1879-0852 | es |
dc.identifier.uri | https://hdl.handle.net/11441/137260 | |
dc.description.abstract | Background
The potential benefit of adding palbociclib to fulvestrant as first-line treatment in hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative endocrine-sensitive advanced breast cancer (ABC) patients remains uncharacterized.
Patients and methods
In this randomized (1:1), double-blind, phase II study, postmenopausal women with HR-positive, HER2-negative ABC with de novo metastatic disease or those who relapsed after >12 months of adjuvant endocrine therapy received palbociclib/fulvestrant or placebo/fulvestrant. Stratification was based on recurrent versus de novo metastatic disease and visceral involvement. The primary objective was one-year progression-free survival (PFS-1y) rate. The sample size was 190 patients. The two-sided alpha of 0.2, 80% of power to detect a difference between the arms, assuming PFS rates of 0.695 and 0.545 for palbociclib/fulvestrant and placebo/fulvestrant, respectively.
Results
In total, 189 patients were randomized to palbociclib/fulvestrant ([n = 94] or placebo/fulvestrant [n = 95]). 45.5% and 60.3% of patients had de novo metastatic disease and visceral involvement, respectively. PFS-1y rates were 83.5% and 71.9% in the palbociclib/fulvestrant and placebo/fulvestrant arms, (HR 0.55, 80% CI 0.36–0.83, P = 0.064). The median PFS were 31.8 and 22.0 months for the palbociclib/fulvestrant and placebo/fulvestrant arms (aHR 0.48, 80% CI 0.37–0.64, P = 0.001).
The most frequent grade 3–4 adverse events were neutropenia (68.1% vs. 0%), leucopenia (26.6% vs. 0%), anemia (3.2% vs. 0%), and lymphopenia (14.9% vs. 2.1%) for the palbociclib/fulvestrant and placebo/fulvestrant, respectively. The most frequent non-hematologic grade 3–4 adverse event was fatigue (4.3% vs. 0%).
Conclusions
Palbociclib/fulvestrant demonstrated better PFS-1y rates and median PFS than placebo/fulvestrant in HR-positive/HER2-negative endocrine-sensitive ABC patients. | es |
dc.format | application/pdf | es |
dc.format.extent | 12 p. | es |
dc.language.iso | eng | es |
dc.publisher | ELSEVIER SCI LTD | es |
dc.relation.ispartof | European Journal of Cancer, 161, 26-37. | |
dc.rights | Attribution-NonCommercial-NoDerivatives 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by-nc-nd/4.0/ | * |
dc.subject | Breast cancer | es |
dc.subject | Metastatic | es |
dc.subject | First-line | es |
dc.subject | Endocrine-sensitive | es |
dc.subject | Fulvestrant | es |
dc.subject | Palbociclib | es |
dc.subject | CDK 4/6 | es |
dc.title | Randomized phase II study of fulvestrant plus palbociclib or placebo in endocrine-sensitive, hormone receptor-positive/HER2–advanced breast cancer: GEICAM/2014–12 (FLIPPER) | es |
dc.type | info:eu-repo/semantics/article | es |
dcterms.identifier | https://ror.org/03yxnpp24 | |
dc.type.version | info:eu-repo/semantics/publishedVersion | es |
dc.rights.accessRights | info:eu-repo/semantics/openAccess | es |
dc.contributor.affiliation | Universidad de Sevilla. Departamento de Medicina | es |
dc.relation.publisherversion | https://www.sciencedirect.com/science/article/pii/S0959804921012211?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.ejca.2021.11.010 | es |
dc.journaltitle | European Journal of Cancer | es |
dc.publication.volumen | 161 | es |
dc.publication.initialPage | 26 | es |
dc.publication.endPage | 37 | es |