dc.creator | Salvador Bofill, Francisco Javier | es |
dc.creator | Moreno Antón, Fernando | es |
dc.creator | Rodríguez Sánchez, César Augusto | es |
dc.creator | Galve Calvo, Elena | es |
dc.creator | Hernando Melia, Cristina | es |
dc.creator | Ciruelos Gil | es |
dc.creator | Cruz Merino, Luis de la | es |
dc.creator | Martín, Miguel | es |
dc.date.accessioned | 2024-03-06T16:35:52Z | |
dc.date.available | 2024-03-06T16:35:52Z | |
dc.date.issued | 2022 | |
dc.identifier.citation | Salvador Bofill, F.J., Moreno Antón, F., Rodríguez Sánchez, C.A., Galve Calvo, E., Hernando Melia, C., Ciruelos Gil, ,...,Martín, M. (2022). Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial. Breast, 66, 771-84. https://doi.org/10.1016/j.breast.2022.09.006. | |
dc.identifier.issn | 0960-9776 | es |
dc.identifier.issn | 1532-3080 | es |
dc.identifier.uri | https://hdl.handle.net/11441/155903 | |
dc.description.abstract | Background: Breast cancer is the most common malignancy and the second leading cause of cancer-related
mortality in Spanish women. Ribociclib in combination with endocrine therapy (ET) has shown superiority in
prolonging survival in patients with hormone receptor-positive (HR+), human epidermal growth factor receptor
2-negative (HER2− ) advanced breast cancer (ABC) vs. ET alone.
Methods: CompLEEment-1 is a single-arm, open-label phase 3b trial evaluating ribociclib plus letrozole in a broad
population of patients with HR+, HER2– ABC. The primary endpoints were safety and tolerability. Here we
report data for Spanish patients enrolled in CompLEEment-1.
Results: A total of 526 patients were evaluated (median follow-up: 26.97 months). Baseline characteristics
showed a diverse population with a median age of 54 years. At study entry, 56.5% of patients had visceral
metastases and 8.7% had received prior chemotherapy for advanced disease. Rates of all-grade and Grade ≥3
adverse events (AEs) were 99.0% and 76.2%, respectively; 21.3% of patients experienced a serious AE, and
15.8% of AEs led to treatment discontinuation. AEs of special interest of neutropenia, increased alanine
aminotransferase, increased aspartate aminotransferase and QTcF prolongation occurred in 77.8%, 14.8%,
11.4% and 4.0% of patients, respectively. Patients aged >70 years experienced increased rates of all-grade and
Grade ≥3 neutropenia and anemia. Efficacy results were consistent with the global study.
Conclusions: Results from Spanish patients enrolled in CompLEEment-1 are consistent with global data showing
efficacy and a manageable safety profile for ribociclib plus letrozole treatment in patients with HR+, HER2−
ABC, including populations of interest (NCT02941926). | es |
dc.format | application/pdf | es |
dc.format.extent | 8 p. | es |
dc.language.iso | eng | es |
dc.publisher | Elsevier | es |
dc.relation.ispartof | Breast, 66, 771-84. | |
dc.rights | Atribución 4.0 Internacional | * |
dc.rights.uri | http://creativecommons.org/licenses/by/4.0/ | * |
dc.subject | Advanced breast cancer | es |
dc.subject | Ribociclib | es |
dc.subject | CDK4/6 inhibitor | es |
dc.subject | Postmenopausal | es |
dc.subject | Premenopausal | es |
dc.title | Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2– advanced breast cancer: Results from the Spanish sub-population of the phase 3b CompLEEment-1 trial | es |
dc.type | info:eu-repo/semantics/article | es |
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/S0960977622001606?via%3Dihub | es |
dc.identifier.doi | 10.1016/j.breast.2022.09.006 | es |
dc.journaltitle | Breast | es |
dc.publication.volumen | 66 | es |
dc.publication.initialPage | 771 | es |
dc.publication.endPage | 84 | es |