RT Journal Article
T1 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.
A1 Salvador Bofill, Javier
A1 Moreno Anton, Fernando
A1 Rodriguez Sanchez, Cesar Augusto
A1 Galve Calvo, Elena
A1 Hernando Melia, Cristina
A1 Ciruelos Gil, Eva Maria
A1 Vidal, Maria
A1 Jiménez-Rodriguez, Begoña
A1 De la Cruz Merino, Luis
A1 Martínez Jañez, Noelia
A1 Villanueva Vazquez, Rafael
A1 de Toro Salas, Ruben
A1 Anton Torres, Antonio
A1 Alvarez Lopez, Isabel Manuela
A1 Gavila Gregori, Joaquin
A1 Quiroga Garcia, Vanesa
A1 Vicente Rubio, Elena
A1 De la Haba-Rodriguez, Juan
A1 Gonzalez-Santiago, Santiago
A1 Diaz Fernandez, Nieves
A1 Barnadas Molins, Agusti
A1 Cantos Sanchez de Ibargüen, Blanca
A1 Delgado Mingorance, Juan Ignacio
A1 Bellet Ezquerra, Meritxell
A1 de Casa, Sonia
A1 Gimeno, Asuncion
A1 Martin, Miguel
K1 Advanced breast cancer
K1 CDK4/6 inhibitor
K1 Postmenopausal
K1 Premenopausal
K1 Ribociclib
K1 Área de Gestión Sanitaria de Jerez, Costa Noroeste y Sierra de Cádiz
AB 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. 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. 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. 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. 
YR 2022
FD 2022-09-24
LK http://hdl.handle.net/10668/22065
UL http://hdl.handle.net/10668/22065
LA en
NO Salvador Bofill J, Moreno Anton F, Rodriguez Sanchez CA, Galve Calvo E, Hernando Melia C, Ciruelos Gil EM, et al. 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. 2022 Dec;66:77-84
DS RISalud
RD Apr 4, 2025