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Título: | 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 |
Autor: | Salvador-Bofill, Javier CSIC ORCID; Moreno Antón, Fernando; Rodríguez Sánchez, C. A.; Galve Calvo, Elena; Hernando Melia, Cristina; Ciruelos, Eva María; Vidal, Maria; Jiménez-Rodriguez, Begoña; Cruz Merino, L. de la; Martínez Jañez, Noelia; Villanueva Vazquez, Rafael; Toro Salas, Rubén de; Antón Torres, Antonio; Álvarez López, Isabel Manuela; Gavila Gregori, Joaquín; Quiroga García, Vanesa; Vicente Rubio, Elena; Haba, J. De La; González, Santiago; Díaz Fernández, Nieves; Barnadas Molins, Agusti; Cantos Sánchez de Ibargüen, Blanca; Delgado-Mingorance Juan Ignacio; Bellet Ezquerra, M.; Casa, Sonia de; Gimeno, Asunción; Martín, Miguel CSIC | Palabras clave: | Ribociclib Advanced breast cancer CDK4/6 inhibitor Postmenopausal Premenopausal |
Fecha de publicación: | dic-2022 | Editor: | Elsevier | Citación: | The Breast 66: 77-84 (2022) | Resumen: | [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). [Trial registration] ClinicalTrials.gov NCT02941926. |
Versión del editor: | https://doi.org/10.1016/j.breast.2022.09.006 | URI: | http://hdl.handle.net/10261/307091 | DOI: | 10.1016/j.breast.2022.09.006 | ISSN: | 0960-9776 |
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CompLEEment-1-trial.pdf | 641,34 kB | Adobe PDF | Visualizar/Abrir |
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