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2022-09-28

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cc by (c) Salvador Bofill, Javier et al., 2022
Si us plau utilitzeu sempre aquest identificador per citar o enllaçar aquest document: https://hdl.handle.net/2445/190742

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

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https://doi.org/10.1016/j.breast.2022.09.006

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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

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Breast cancer

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Articles publicats en revistes (Institut d'lnvestigació Biomèdica de Bellvitge (IDIBELL))

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SALVADOR BOFILL, Javier, MORENO ANTON, Fernando, RODRÍGUEZ SÁNCHEZ, César a., GALVE CALVO, Elena, HERNANDO MELIA, Cristina, CIRUELOS, Eva, VIDAL LOSADA, Maria jesús, JIMÉNEZ RODRIGUEZ, Begoña, DE LA CRUZ MERINO, Luis, MARTÍNEZ JAÑEZ, Noelia, VILLANUEVA VÁZQUEZ, Rafael, DE TORO SALAS, Ruben, ANTON TORRES, Antonio, ALVAREZ LOPEZ, Isabel manuela, GAVILA GREGORI, Joaquin, QUIROGA GARCIA, Vanesa, VICENTE RUBIO, Elena, DE LA HABA RODRIGUEZ, Juan, GONZALEZ SANTIAGO, Santiago, DIAZ FERNANDEZ, Nieves, BARNADAS MOLINS, Agusti, CANTOS SANCHEZ DE IBARGÜEN, Blanca, DELGADO MINGORANCE, Juan ignacio, BELLET EZQUERRA, Meritxell, DE CASA, Sonia, GIMENO, Asuncion, MARTIN, Miguel. 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. _The Breast_. 2022. Vol. 66, núm. 77-84. [consulta: 6 de febrer de 2026]. ISSN: 1532-3080. [Disponible a: https://hdl.handle.net/2445/190742]

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