%0 Journal Article
%A Salvador Bofill, Javier
%A Moreno Anton, Fernando
%A Rodriguez Sanchez, Cesar Augusto
%A Galve Calvo, Elena
%A Hernando Melia, Cristina
%A Ciruelos Gil, Eva Maria
%A Vidal, Maria
%A Jiménez-Rodriguez, Begoña
%A De la Cruz Merino, Luis
%A Martínez Jañez, Noelia
%A Villanueva Vazquez, Rafael
%A de Toro Salas, Ruben
%A Anton Torres, Antonio
%A Alvarez Lopez, Isabel Manuela
%A Gavila Gregori, Joaquin
%A Quiroga Garcia, Vanesa
%A Vicente Rubio, Elena
%A De la Haba-Rodriguez, Juan
%A Gonzalez-Santiago, Santiago
%A Diaz Fernandez, Nieves
%A Barnadas Molins, Agusti
%A Cantos Sanchez de Ibargüen, Blanca
%A Delgado Mingorance, Juan Ignacio
%A Bellet Ezquerra, Meritxell
%A de Casa, Sonia
%A Gimeno, Asuncion
%A Martin, Miguel
%T 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.
%D 2022
%U http://hdl.handle.net/10668/22065
%X 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. 
%K Advanced breast cancer
%K CDK4/6 inhibitor
%K Postmenopausal
%K Premenopausal
%K Ribociclib
%K Área de Gestión Sanitaria de Jerez, Costa Noroeste y Sierra de Cádiz
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