Safety and efficacy of ribociclib plus letrozole in patients with HR+, HER2- advanced breast cancer

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 re...

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Detalles Bibliográficos
Autores: Salvador Bofill, Javier|||0000-0002-8817-5299, Moreno Anton, Fernando, Rodríguez Sánchez, César A.|||0000-0003-3484-4829, Galve Calvo, Elena|||0000-0003-4204-5736, Hernando Melia, Cristina, Ciruelos, Eva|||0000-0002-2796-1042, Vidal Losada, Maria|||0000-0003-1992-5727, Jiménez-Rodriguez, Begoña, de La Cruz-Merino, Luis|||0000-0002-5333-0535, Martínez Jañez, Noelia, Villanueva Vazquez, Rafael, de Toro Salas, Ruben, Antón Torres, Antonio|||0000-0002-1925-4102, Alvarez Lopez, Isabel Manuela, Gavila Gregori, Joaquin, Quiroga García, Vanesa, Vicente Rubio, Elena, de la Haba Rodríguez, Juan Rafael|||0000-0001-5111-1702, Gonzalez-Santiago, Santiago, Diaz Fernandez, Nieves, Barnadas i Molins, Agustí|||0000-0002-0429-1349, Cantos Sanchez de Ibargüen, Blanca, Delgado Mingorance, Juan Ignacio, Bellet Ezquerra, Meritxell|||0000-0001-8859-8307, de Casa, Sonia, Gimeno, Asuncion, Martin, Miguel
Tipo de recurso: artículo
Fecha de publicación:2022
País:España
Institución:Universitat Autònoma de Barcelona
Repositorio:Dipòsit Digital de Documents de la UAB
Idioma:inglés
OAI Identifier:oai:ddd.uab.cat:281802
Acceso en línea:https://ddd.uab.cat/record/281802
https://dx.doi.org/urn:doi:10.1016/j.breast.2022.09.006
Access Level:acceso abierto
Palabra clave:Advanced breast cancer
CDK4/6 inhibitor
Postmenopausal
Premenopausal
Ribociclib
Descripción
Sumario: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.

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